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Q&A: Get flu shot early this year? Same time as COVID vaccine?

Article Type
Changed
Thu, 08/26/2021 - 15:43

With first-time COVID-19 immunizations continuing and the plan to offer booster vaccines to most Americans starting next month, what are the considerations for getting COVID-19 and flu shots at the same time?

This news organization asked Andrew T. Pavia, MD, for his advice. He is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City, and a fellow of the Infectious Diseases Society of America.
 

Q: With COVID-19 cases surging, is it a good idea to get the flu shot early this season?

Dr. Pavia: I don’t think there is a rush to do it in August, but it is a good idea to get a flu shot this season. The consequences of getting the flu while COVID is circulating are serious.

Q: What are the implications?

There are some we know and some we don’t know. If you develop flu-like symptoms, you’re going to have to get tested. You’re going to have to stay home quite a bit longer if you get a definitive (positive COVID-19) test than you would simply with flu symptoms. Also, you’re probably going to miss work when your workplace is very stressed or your children are stressed by having COVID circulating in schools.

The part we know less about are the implications of getting the flu and COVID together. There is some reason to believe if you get them together, the illness will be more severe. We are seeing that with RSV (respiratory syncytial virus) and parainfluenza and COVID coinfections in children. They appear to be quite severe.

But for flu, we just don’t have the data yet. That’s because there really was no cocirculation of COVID and influenza with the exception of parts of China for a brief part of February and March.
 

Q: Will the planned administration of booster COVID-19 shots this fall affect the number of people who get the flu vaccine or how it’s distributed?

It creates a lot of logistical challenges, particularly for hospitals and other places that need to vaccinate a large number of their employees for flu and that will need to give COVID boosters at about the same time period. It also creates logistical challenges for doctors’ offices.

But we don’t know of any reason why you can’t give the two shots together.
 

Q: Is it possible flu season will be more severe because we isolated and wore masks, etc., last winter? Any science behind that?

The more you study flu, the less you can predict, and I’ve been studying flu for a long time. There are reasons that might suggest a severe flu season – there has been limited immunity, and some people are not wearing masks effectively and they are gathering again. Those are things we believe protected us from influenza last season.

But we have not seen flu emerge yet. Normally we look to Australia, New Zealand, and South Africa during their winter – which is our summer – to get some idea of what is over the horizon for the Northern Hemisphere. Flu activity in Australia has been very modest this year.

That might mean flu may not show up for a while, but I would be loathe to make a prediction.
 

 

 

Q: What are the chances we’ll see a flu outbreak like we’re seeing with RSV, which is normally a winter illness?

The fact that we had a summer RSV surge just gives you an idea of how the normal epidemiology of viral infections has been disrupted. It means anything could happen with influenza. It could show up late summer or fall or wait until next spring.

We really don’t understand how those interactions work. When a new flu strain emerges, it often ignores the traditional behavior and shows up in the spring or fall. It happened in the 2009 pandemic, it happened in 1918.

The one thing I would safely predict about the next flu wave is that it will surprise us.
 

Q: Are you hopeful that combination vaccines in development from a number of companies, such as Moderna, Novavax, and Vivaldi, will be effective?

It is beginning to look like COVID will be with us for the foreseeable future – maybe as a seasonal virus or maybe as an ongoing pandemic. We are going to need to protect (ourselves) simultaneously against the flu and COVID. A single shot is a great way to do that – nobody wants two needles; nobody wants two trips to get vaccinated.

An effective combination vaccine would be a really great tool.

We have to wait to see what the science shows us, because they are quite different viruses. We won’t know if a combination vaccine works well and has acceptable side effects until we do those studies.
 

Q. Do you know at this point whether the side effects from two vaccines would be additive? Is there any way to predict that?

There is no way to predict. There are so many things that go into whether someone has side effects that we don’t understand. With fairly reactogenic vaccines like the mRNA vaccines, lots of people have no side effects whatsoever and others are really uncomfortable for 24 hours.

Flu is generally a better tolerated vaccine. There are still people who get muscle aches and very sore arms. I don’t think we can predict if getting two will be additive or just the same as getting one vaccine.
 

Q: Other than convenience and the benefit for people who are needle-phobic, are there any other advantages of combining them into one shot?

The logistics alone are enough to justify having one effective product if we can make one. It should reduce the overall cost of administration and reduce time off from work.

The combination vaccines given by pediatricians have been very successful. They reduce the number of needles for kids and make it much easier for parents and the pediatricians administering them. The same principle should apply to adults, who sometimes are less brave about needles than kids are.

Historically, combined vaccines in general have worked as well as vaccines given alone, but there have been exceptions. We just have to see what the products look like.
 

Q: For now, the flu vaccine and COVID-19 vaccine are single products. If you get them separately, is it better to put some time between the two?

We don’t know. There are studies that probably won’t be out in time to decide in September. They are looking at whether you get an equivalent immune response if you give them together or apart.

For now, I would say the advantage of getting them together is if you do get side effects, you’ll only get them once – one day to suffer through them. Also, it’s one trip to the doctor.

The potential advantage of separating them is that is how we developed and tested the vaccines. If you do react to them, side effects could be milder, but it will be on two separate days.

I would recommend doing whatever works so that you get both vaccines in a timely manner.

I’m going to get my flu shot as soon as it’s available. If I’m due for a COVID booster at that time, I would probably do them together.
 

Q: Do you foresee a point in the future when the predominant strain of SARS-CoV-2 will be one of the components of a flu vaccine, like we did in the past with H1N1, etc?

It really remains to be seen, but it is very conceivable it could happen. The same companies that developed COVID-19 vaccines are working on flu vaccines.

Q: Any other advice for people concerned about getting immunized against both COVID-19 and influenza in the coming months?

There is no side effect of the vaccine that begins to approach the risk you face from either disease. It’s really one of the best things you can do to protect yourself is to get vaccinated.

In the case of flu, the vaccine is only modestly effective, but it still saves tens of thousands of lives each year. The SARS-CoV-2 vaccine is a much better vaccine and a deadlier disease.

Dr. Pavia consulted for GlaxoSmithKline on influenza testing.

A version of this article first appeared on Medscape.com.

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With first-time COVID-19 immunizations continuing and the plan to offer booster vaccines to most Americans starting next month, what are the considerations for getting COVID-19 and flu shots at the same time?

This news organization asked Andrew T. Pavia, MD, for his advice. He is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City, and a fellow of the Infectious Diseases Society of America.
 

Q: With COVID-19 cases surging, is it a good idea to get the flu shot early this season?

Dr. Pavia: I don’t think there is a rush to do it in August, but it is a good idea to get a flu shot this season. The consequences of getting the flu while COVID is circulating are serious.

Q: What are the implications?

There are some we know and some we don’t know. If you develop flu-like symptoms, you’re going to have to get tested. You’re going to have to stay home quite a bit longer if you get a definitive (positive COVID-19) test than you would simply with flu symptoms. Also, you’re probably going to miss work when your workplace is very stressed or your children are stressed by having COVID circulating in schools.

The part we know less about are the implications of getting the flu and COVID together. There is some reason to believe if you get them together, the illness will be more severe. We are seeing that with RSV (respiratory syncytial virus) and parainfluenza and COVID coinfections in children. They appear to be quite severe.

But for flu, we just don’t have the data yet. That’s because there really was no cocirculation of COVID and influenza with the exception of parts of China for a brief part of February and March.
 

Q: Will the planned administration of booster COVID-19 shots this fall affect the number of people who get the flu vaccine or how it’s distributed?

It creates a lot of logistical challenges, particularly for hospitals and other places that need to vaccinate a large number of their employees for flu and that will need to give COVID boosters at about the same time period. It also creates logistical challenges for doctors’ offices.

But we don’t know of any reason why you can’t give the two shots together.
 

Q: Is it possible flu season will be more severe because we isolated and wore masks, etc., last winter? Any science behind that?

The more you study flu, the less you can predict, and I’ve been studying flu for a long time. There are reasons that might suggest a severe flu season – there has been limited immunity, and some people are not wearing masks effectively and they are gathering again. Those are things we believe protected us from influenza last season.

But we have not seen flu emerge yet. Normally we look to Australia, New Zealand, and South Africa during their winter – which is our summer – to get some idea of what is over the horizon for the Northern Hemisphere. Flu activity in Australia has been very modest this year.

That might mean flu may not show up for a while, but I would be loathe to make a prediction.
 

 

 

Q: What are the chances we’ll see a flu outbreak like we’re seeing with RSV, which is normally a winter illness?

The fact that we had a summer RSV surge just gives you an idea of how the normal epidemiology of viral infections has been disrupted. It means anything could happen with influenza. It could show up late summer or fall or wait until next spring.

We really don’t understand how those interactions work. When a new flu strain emerges, it often ignores the traditional behavior and shows up in the spring or fall. It happened in the 2009 pandemic, it happened in 1918.

The one thing I would safely predict about the next flu wave is that it will surprise us.
 

Q: Are you hopeful that combination vaccines in development from a number of companies, such as Moderna, Novavax, and Vivaldi, will be effective?

It is beginning to look like COVID will be with us for the foreseeable future – maybe as a seasonal virus or maybe as an ongoing pandemic. We are going to need to protect (ourselves) simultaneously against the flu and COVID. A single shot is a great way to do that – nobody wants two needles; nobody wants two trips to get vaccinated.

An effective combination vaccine would be a really great tool.

We have to wait to see what the science shows us, because they are quite different viruses. We won’t know if a combination vaccine works well and has acceptable side effects until we do those studies.
 

Q. Do you know at this point whether the side effects from two vaccines would be additive? Is there any way to predict that?

There is no way to predict. There are so many things that go into whether someone has side effects that we don’t understand. With fairly reactogenic vaccines like the mRNA vaccines, lots of people have no side effects whatsoever and others are really uncomfortable for 24 hours.

Flu is generally a better tolerated vaccine. There are still people who get muscle aches and very sore arms. I don’t think we can predict if getting two will be additive or just the same as getting one vaccine.
 

Q: Other than convenience and the benefit for people who are needle-phobic, are there any other advantages of combining them into one shot?

The logistics alone are enough to justify having one effective product if we can make one. It should reduce the overall cost of administration and reduce time off from work.

The combination vaccines given by pediatricians have been very successful. They reduce the number of needles for kids and make it much easier for parents and the pediatricians administering them. The same principle should apply to adults, who sometimes are less brave about needles than kids are.

Historically, combined vaccines in general have worked as well as vaccines given alone, but there have been exceptions. We just have to see what the products look like.
 

Q: For now, the flu vaccine and COVID-19 vaccine are single products. If you get them separately, is it better to put some time between the two?

We don’t know. There are studies that probably won’t be out in time to decide in September. They are looking at whether you get an equivalent immune response if you give them together or apart.

For now, I would say the advantage of getting them together is if you do get side effects, you’ll only get them once – one day to suffer through them. Also, it’s one trip to the doctor.

The potential advantage of separating them is that is how we developed and tested the vaccines. If you do react to them, side effects could be milder, but it will be on two separate days.

I would recommend doing whatever works so that you get both vaccines in a timely manner.

I’m going to get my flu shot as soon as it’s available. If I’m due for a COVID booster at that time, I would probably do them together.
 

Q: Do you foresee a point in the future when the predominant strain of SARS-CoV-2 will be one of the components of a flu vaccine, like we did in the past with H1N1, etc?

It really remains to be seen, but it is very conceivable it could happen. The same companies that developed COVID-19 vaccines are working on flu vaccines.

Q: Any other advice for people concerned about getting immunized against both COVID-19 and influenza in the coming months?

There is no side effect of the vaccine that begins to approach the risk you face from either disease. It’s really one of the best things you can do to protect yourself is to get vaccinated.

In the case of flu, the vaccine is only modestly effective, but it still saves tens of thousands of lives each year. The SARS-CoV-2 vaccine is a much better vaccine and a deadlier disease.

Dr. Pavia consulted for GlaxoSmithKline on influenza testing.

A version of this article first appeared on Medscape.com.

With first-time COVID-19 immunizations continuing and the plan to offer booster vaccines to most Americans starting next month, what are the considerations for getting COVID-19 and flu shots at the same time?

This news organization asked Andrew T. Pavia, MD, for his advice. He is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City, and a fellow of the Infectious Diseases Society of America.
 

Q: With COVID-19 cases surging, is it a good idea to get the flu shot early this season?

Dr. Pavia: I don’t think there is a rush to do it in August, but it is a good idea to get a flu shot this season. The consequences of getting the flu while COVID is circulating are serious.

Q: What are the implications?

There are some we know and some we don’t know. If you develop flu-like symptoms, you’re going to have to get tested. You’re going to have to stay home quite a bit longer if you get a definitive (positive COVID-19) test than you would simply with flu symptoms. Also, you’re probably going to miss work when your workplace is very stressed or your children are stressed by having COVID circulating in schools.

The part we know less about are the implications of getting the flu and COVID together. There is some reason to believe if you get them together, the illness will be more severe. We are seeing that with RSV (respiratory syncytial virus) and parainfluenza and COVID coinfections in children. They appear to be quite severe.

But for flu, we just don’t have the data yet. That’s because there really was no cocirculation of COVID and influenza with the exception of parts of China for a brief part of February and March.
 

Q: Will the planned administration of booster COVID-19 shots this fall affect the number of people who get the flu vaccine or how it’s distributed?

It creates a lot of logistical challenges, particularly for hospitals and other places that need to vaccinate a large number of their employees for flu and that will need to give COVID boosters at about the same time period. It also creates logistical challenges for doctors’ offices.

But we don’t know of any reason why you can’t give the two shots together.
 

Q: Is it possible flu season will be more severe because we isolated and wore masks, etc., last winter? Any science behind that?

The more you study flu, the less you can predict, and I’ve been studying flu for a long time. There are reasons that might suggest a severe flu season – there has been limited immunity, and some people are not wearing masks effectively and they are gathering again. Those are things we believe protected us from influenza last season.

But we have not seen flu emerge yet. Normally we look to Australia, New Zealand, and South Africa during their winter – which is our summer – to get some idea of what is over the horizon for the Northern Hemisphere. Flu activity in Australia has been very modest this year.

That might mean flu may not show up for a while, but I would be loathe to make a prediction.
 

 

 

Q: What are the chances we’ll see a flu outbreak like we’re seeing with RSV, which is normally a winter illness?

The fact that we had a summer RSV surge just gives you an idea of how the normal epidemiology of viral infections has been disrupted. It means anything could happen with influenza. It could show up late summer or fall or wait until next spring.

We really don’t understand how those interactions work. When a new flu strain emerges, it often ignores the traditional behavior and shows up in the spring or fall. It happened in the 2009 pandemic, it happened in 1918.

The one thing I would safely predict about the next flu wave is that it will surprise us.
 

Q: Are you hopeful that combination vaccines in development from a number of companies, such as Moderna, Novavax, and Vivaldi, will be effective?

It is beginning to look like COVID will be with us for the foreseeable future – maybe as a seasonal virus or maybe as an ongoing pandemic. We are going to need to protect (ourselves) simultaneously against the flu and COVID. A single shot is a great way to do that – nobody wants two needles; nobody wants two trips to get vaccinated.

An effective combination vaccine would be a really great tool.

We have to wait to see what the science shows us, because they are quite different viruses. We won’t know if a combination vaccine works well and has acceptable side effects until we do those studies.
 

Q. Do you know at this point whether the side effects from two vaccines would be additive? Is there any way to predict that?

There is no way to predict. There are so many things that go into whether someone has side effects that we don’t understand. With fairly reactogenic vaccines like the mRNA vaccines, lots of people have no side effects whatsoever and others are really uncomfortable for 24 hours.

Flu is generally a better tolerated vaccine. There are still people who get muscle aches and very sore arms. I don’t think we can predict if getting two will be additive or just the same as getting one vaccine.
 

Q: Other than convenience and the benefit for people who are needle-phobic, are there any other advantages of combining them into one shot?

The logistics alone are enough to justify having one effective product if we can make one. It should reduce the overall cost of administration and reduce time off from work.

The combination vaccines given by pediatricians have been very successful. They reduce the number of needles for kids and make it much easier for parents and the pediatricians administering them. The same principle should apply to adults, who sometimes are less brave about needles than kids are.

Historically, combined vaccines in general have worked as well as vaccines given alone, but there have been exceptions. We just have to see what the products look like.
 

Q: For now, the flu vaccine and COVID-19 vaccine are single products. If you get them separately, is it better to put some time between the two?

We don’t know. There are studies that probably won’t be out in time to decide in September. They are looking at whether you get an equivalent immune response if you give them together or apart.

For now, I would say the advantage of getting them together is if you do get side effects, you’ll only get them once – one day to suffer through them. Also, it’s one trip to the doctor.

The potential advantage of separating them is that is how we developed and tested the vaccines. If you do react to them, side effects could be milder, but it will be on two separate days.

I would recommend doing whatever works so that you get both vaccines in a timely manner.

I’m going to get my flu shot as soon as it’s available. If I’m due for a COVID booster at that time, I would probably do them together.
 

Q: Do you foresee a point in the future when the predominant strain of SARS-CoV-2 will be one of the components of a flu vaccine, like we did in the past with H1N1, etc?

It really remains to be seen, but it is very conceivable it could happen. The same companies that developed COVID-19 vaccines are working on flu vaccines.

Q: Any other advice for people concerned about getting immunized against both COVID-19 and influenza in the coming months?

There is no side effect of the vaccine that begins to approach the risk you face from either disease. It’s really one of the best things you can do to protect yourself is to get vaccinated.

In the case of flu, the vaccine is only modestly effective, but it still saves tens of thousands of lives each year. The SARS-CoV-2 vaccine is a much better vaccine and a deadlier disease.

Dr. Pavia consulted for GlaxoSmithKline on influenza testing.

A version of this article first appeared on Medscape.com.

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COVID-19 mitigation measures led to shifts in typical annual respiratory virus patterns

Article Type
Changed
Thu, 08/26/2021 - 15:43

Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.

Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.

“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.

The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.

Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.

“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.

The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.

Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.

The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.

A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”

Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.

“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”

Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.

RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.

The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.

The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.

Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.

Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.

Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.

“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”

Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.

The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.

The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”

Dr. Brewer, of UCLA, agreed.

All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”

The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.

Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.

Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.

Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.

The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.

Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.

“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.

The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.

Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.

“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.

The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.

Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.

The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.

A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”

Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.

“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”

Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.

RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.

The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.

The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.

Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.

Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.

Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.

“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”

Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.

The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.

The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”

Dr. Brewer, of UCLA, agreed.

All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”

The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.

Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.

Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.

Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.

The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.

Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.

“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.

The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.

Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.

“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.

The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.

Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.

The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.

A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”

Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.

“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”

Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.

RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.

The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.

The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.

Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.

Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.

Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.

“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”

Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.

The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.

The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”

Dr. Brewer, of UCLA, agreed.

All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”

The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.

Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.

Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.

Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.

The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Giving flu and COVID-19 shots at same time appears safe, effective: Study

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Changed
Thu, 08/26/2021 - 15:45

 

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

 

 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

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Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

 

 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

 

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

 

 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

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NIAID advances universal flu vaccine candidate into phase 1 trial

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Mon, 06/14/2021 - 11:38

 

Last month, U.S. government researchers began a test of an experimental influenza vaccine that they hope will provide long-lasting immunity against multiple strains of the virus. Their project adds to the many approaches that have been tried in the decades-long quest for a universal flu shot.

For the first time, the National Institute of Allergy and Infectious Diseases (NIAID) is testing an investigational flu vaccine, known as FluMos-v1, on people. Researchers in recent years have targeted the stalk or stem of an influenza surface protein called hemagglutinin (HA) in trying to develop better flu vaccines. NIAID said FluMos-v1 is designed to spark production of antibodies against the HA protein from different virus strains, which could make it superior to vaccines now available, NIAID said.

“It could be longer lasting than the traditional flu vaccine and give us what we call super seasonal protection that might go beyond just one flu season to next year’s or the year after, or offer additional protection in a pandemic setting,” Alicia T. Widge, MD, of NIAID’s Vaccine Research Center, who is the principal investigator of the trial, said in an interview.

The phase 1 study (NCT04896086) aims to enroll 35 participants, 15 of whom will receive a single intramuscular injection of a comparator treatment, Flucelvax, which has already been approved by the U.S. Food and Drug Administration. The FluMos-v1 group will start with five participants who will receive one 20-μg dose. If no safety problems emerge at that dosage, another 15 volunteers will receive one 60-μg dose of the investigational vaccine.

The incorporation of a comparator group in the phase 1 study may help investigators get an early idea of how well FluMos-v1 compares to a marketed product, Dr. Widge said. The test will be carried out through the National Institutes of Health Clinical Center.
 

‘Renaissance’ of flu-vaccine research?

Currently, flu vaccines are reformulated each year in an attempt to match the dominant strain for the upcoming season, an effort that often falls notably short. The estimated vaccine effectiveness rate in the United States has ranged from a low of 19% to a high of 60% in recent years, according to the Centers for Disease Control and Prevention.

Scientists have been working for decades on a universal flu vaccine that would offer better results but haven’t yet identified the right strategy to outwit mutations in the virus. Recent setbacks include BiondVax Pharmaceuticals’ October 2020 announcement of a failed phase 3 trial of its experimental M-001 universal flu vaccine candidate.

But advances in understanding the immune system may set the stage for a “renaissance” in efforts to develop a universal flu vaccine, Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview.

The COVID-19 pandemic has spurred greater interest in the need to develop a universal flu vaccine, he said. Dr. Osterholm said he is “more optimistic now than ever” about the chances for developing vaccines that can fend off multiple strains over longer periods, although the goal of a shot that can ward off influenza in all cases may remain elusive.

“How good can we make them? Will they ever be really universal? Will they have long periods of protection? I don’t think any of us know that yet,” Dr. Osterholm said. “But this is not the influenza vaccine world of 5 or 7 years ago.”

The mRNA technology used to develop the world’s first approved COVID-19 vaccines, for example, may be applied against influenza, Dr. Osterholm said.

In January 2021, Moderna announced plans to test three development candidates for a seasonal influenza vaccine and aims to start a phase 1 study this year. In an April interview on CNBC’s Squawk Box program, Moderna’s chief executive, Stephané Bancel, spoke about the company’s plans to eventually create a combination vaccine for SARS-Cov-2 and flu viruses.

SARS-CoV-2 “is not going away.” Like flu, this virus will persist and change forms, Ms. Bancel said. Creating a flu shot that outperforms the existing ones would boost confidence in influenza vaccines, which many people now skip, Ms. Bancel said. People might someday be able to get a combination of this more effective flu shot with a COVID-19 vaccine booster in their local pharmacies.

“You can take one dose and then have a nice winter,” Ms. Bancel said of Moderna’s goal for a combination vaccine.

A version of this article first appeared on Medscape.com.

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Last month, U.S. government researchers began a test of an experimental influenza vaccine that they hope will provide long-lasting immunity against multiple strains of the virus. Their project adds to the many approaches that have been tried in the decades-long quest for a universal flu shot.

For the first time, the National Institute of Allergy and Infectious Diseases (NIAID) is testing an investigational flu vaccine, known as FluMos-v1, on people. Researchers in recent years have targeted the stalk or stem of an influenza surface protein called hemagglutinin (HA) in trying to develop better flu vaccines. NIAID said FluMos-v1 is designed to spark production of antibodies against the HA protein from different virus strains, which could make it superior to vaccines now available, NIAID said.

“It could be longer lasting than the traditional flu vaccine and give us what we call super seasonal protection that might go beyond just one flu season to next year’s or the year after, or offer additional protection in a pandemic setting,” Alicia T. Widge, MD, of NIAID’s Vaccine Research Center, who is the principal investigator of the trial, said in an interview.

The phase 1 study (NCT04896086) aims to enroll 35 participants, 15 of whom will receive a single intramuscular injection of a comparator treatment, Flucelvax, which has already been approved by the U.S. Food and Drug Administration. The FluMos-v1 group will start with five participants who will receive one 20-μg dose. If no safety problems emerge at that dosage, another 15 volunteers will receive one 60-μg dose of the investigational vaccine.

The incorporation of a comparator group in the phase 1 study may help investigators get an early idea of how well FluMos-v1 compares to a marketed product, Dr. Widge said. The test will be carried out through the National Institutes of Health Clinical Center.
 

‘Renaissance’ of flu-vaccine research?

Currently, flu vaccines are reformulated each year in an attempt to match the dominant strain for the upcoming season, an effort that often falls notably short. The estimated vaccine effectiveness rate in the United States has ranged from a low of 19% to a high of 60% in recent years, according to the Centers for Disease Control and Prevention.

Scientists have been working for decades on a universal flu vaccine that would offer better results but haven’t yet identified the right strategy to outwit mutations in the virus. Recent setbacks include BiondVax Pharmaceuticals’ October 2020 announcement of a failed phase 3 trial of its experimental M-001 universal flu vaccine candidate.

But advances in understanding the immune system may set the stage for a “renaissance” in efforts to develop a universal flu vaccine, Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview.

The COVID-19 pandemic has spurred greater interest in the need to develop a universal flu vaccine, he said. Dr. Osterholm said he is “more optimistic now than ever” about the chances for developing vaccines that can fend off multiple strains over longer periods, although the goal of a shot that can ward off influenza in all cases may remain elusive.

“How good can we make them? Will they ever be really universal? Will they have long periods of protection? I don’t think any of us know that yet,” Dr. Osterholm said. “But this is not the influenza vaccine world of 5 or 7 years ago.”

The mRNA technology used to develop the world’s first approved COVID-19 vaccines, for example, may be applied against influenza, Dr. Osterholm said.

In January 2021, Moderna announced plans to test three development candidates for a seasonal influenza vaccine and aims to start a phase 1 study this year. In an April interview on CNBC’s Squawk Box program, Moderna’s chief executive, Stephané Bancel, spoke about the company’s plans to eventually create a combination vaccine for SARS-Cov-2 and flu viruses.

SARS-CoV-2 “is not going away.” Like flu, this virus will persist and change forms, Ms. Bancel said. Creating a flu shot that outperforms the existing ones would boost confidence in influenza vaccines, which many people now skip, Ms. Bancel said. People might someday be able to get a combination of this more effective flu shot with a COVID-19 vaccine booster in their local pharmacies.

“You can take one dose and then have a nice winter,” Ms. Bancel said of Moderna’s goal for a combination vaccine.

A version of this article first appeared on Medscape.com.

 

Last month, U.S. government researchers began a test of an experimental influenza vaccine that they hope will provide long-lasting immunity against multiple strains of the virus. Their project adds to the many approaches that have been tried in the decades-long quest for a universal flu shot.

For the first time, the National Institute of Allergy and Infectious Diseases (NIAID) is testing an investigational flu vaccine, known as FluMos-v1, on people. Researchers in recent years have targeted the stalk or stem of an influenza surface protein called hemagglutinin (HA) in trying to develop better flu vaccines. NIAID said FluMos-v1 is designed to spark production of antibodies against the HA protein from different virus strains, which could make it superior to vaccines now available, NIAID said.

“It could be longer lasting than the traditional flu vaccine and give us what we call super seasonal protection that might go beyond just one flu season to next year’s or the year after, or offer additional protection in a pandemic setting,” Alicia T. Widge, MD, of NIAID’s Vaccine Research Center, who is the principal investigator of the trial, said in an interview.

The phase 1 study (NCT04896086) aims to enroll 35 participants, 15 of whom will receive a single intramuscular injection of a comparator treatment, Flucelvax, which has already been approved by the U.S. Food and Drug Administration. The FluMos-v1 group will start with five participants who will receive one 20-μg dose. If no safety problems emerge at that dosage, another 15 volunteers will receive one 60-μg dose of the investigational vaccine.

The incorporation of a comparator group in the phase 1 study may help investigators get an early idea of how well FluMos-v1 compares to a marketed product, Dr. Widge said. The test will be carried out through the National Institutes of Health Clinical Center.
 

‘Renaissance’ of flu-vaccine research?

Currently, flu vaccines are reformulated each year in an attempt to match the dominant strain for the upcoming season, an effort that often falls notably short. The estimated vaccine effectiveness rate in the United States has ranged from a low of 19% to a high of 60% in recent years, according to the Centers for Disease Control and Prevention.

Scientists have been working for decades on a universal flu vaccine that would offer better results but haven’t yet identified the right strategy to outwit mutations in the virus. Recent setbacks include BiondVax Pharmaceuticals’ October 2020 announcement of a failed phase 3 trial of its experimental M-001 universal flu vaccine candidate.

But advances in understanding the immune system may set the stage for a “renaissance” in efforts to develop a universal flu vaccine, Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview.

The COVID-19 pandemic has spurred greater interest in the need to develop a universal flu vaccine, he said. Dr. Osterholm said he is “more optimistic now than ever” about the chances for developing vaccines that can fend off multiple strains over longer periods, although the goal of a shot that can ward off influenza in all cases may remain elusive.

“How good can we make them? Will they ever be really universal? Will they have long periods of protection? I don’t think any of us know that yet,” Dr. Osterholm said. “But this is not the influenza vaccine world of 5 or 7 years ago.”

The mRNA technology used to develop the world’s first approved COVID-19 vaccines, for example, may be applied against influenza, Dr. Osterholm said.

In January 2021, Moderna announced plans to test three development candidates for a seasonal influenza vaccine and aims to start a phase 1 study this year. In an April interview on CNBC’s Squawk Box program, Moderna’s chief executive, Stephané Bancel, spoke about the company’s plans to eventually create a combination vaccine for SARS-Cov-2 and flu viruses.

SARS-CoV-2 “is not going away.” Like flu, this virus will persist and change forms, Ms. Bancel said. Creating a flu shot that outperforms the existing ones would boost confidence in influenza vaccines, which many people now skip, Ms. Bancel said. People might someday be able to get a combination of this more effective flu shot with a COVID-19 vaccine booster in their local pharmacies.

“You can take one dose and then have a nice winter,” Ms. Bancel said of Moderna’s goal for a combination vaccine.

A version of this article first appeared on Medscape.com.

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Influenza-related maternal morbidity has more than doubled over 15 years

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Mon, 02/22/2021 - 15:19

 

Despite slightly decreasing numbers of pregnant women hospitalized with influenza, the rate of morbidity among those who do have influenza has substantially increased from 2000 to 2015, likely due in part to an increase in comorbidities.

Maternal patients who have influenza while hospitalized for delivery are twice as likely to develop severe maternal morbidity than are those without influenza, according to findings from a new study presented at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Pregnant women were also at substantially greater risk of sepsis or shock, needing mechanical ventilation, and acute respiratory distress syndrome. In fact, rates of overall severe maternal morbidity and of influenza-related complications have increased in maternal patients with influenza by more than 200% from 2000 to 2015.

“It was striking to see how the rate of delivery hospitalizations complicated by influenza has remained relatively stable with a small decline, but the rates of severe maternal morbidity were increasing and so markedly among those with influenza,” Timothy Wen, MD, MPH, a maternal-fetal medicine clinical fellow at the University of California, San Francisco, said in an interview. “The findings suggest that influenza may either be a contributor to rising rates of severe maternal morbidity or synergistically amplifying existing comorbidities to worsen outcomes,” he said during his presentation.

The increased risk of influenza complications in pregnant women became particularly apparent during the 2009-2010 H1N1 influenza pandemic. “Physiologic and immunologic changes predispose pregnant patients to higher risk for complications such as pneumonia, intensive care unit admission, and inpatient mortality,” Dr. Wen told attendees. But data have been scarce since H1N1.

The researchers conducted a cross-sectional analysis of delivery hospitalizations from 2000 to 2015 using the Nationwide Inpatient Sample, which includes about 20% of all U.S. inpatient hospitalizations from all payers. They looked at all maternal patients aged 15-54 who had a diagnosis of influenza. In looking at potential associations between influenza and morbidity, they adjusted their calculations for maternal age, payer status, median income, and race/ethnicity as well as the hospital factors of location, teaching status, and region. They also adjusted for a dozen clinical factors.

Of 62.7 million hospitalizations, 0.67% involved severe maternal mortality, including the following influenza complications:

  • 0.02% with shock/sepsis.
  • 0.01% needing mechanical ventilation.
  • 0.04% with acute respiratory distress syndrome.

The 182,228 patients with influenza represented a rate of 29 cases per 10,000 deliveries, and 2.09% of them involved severe maternal morbidity, compared to severe maternal morbidity in just 0.66% of deliveries without influenza.

When looking specifically at rates of shock/sepsis, mechanical ventilation, and acute respiratory distress syndrome, the data revealed similar trends, with substantially higher proportions of patients with influenza experiencing these complications compared to maternal patients without influenza. For example, 0.3% of patients with influenza developed shock/sepsis whereas only 0.04% of patients without influenza did. Acute respiratory distress syndrome was similarly more common in patients with flu (0.45% vs. 0.04%), as was the need for mechanical ventilation (0.09% vs. 0.01%).

During the 15-year study period, the rate of maternal hospitalizations with influenza infections declined about 1.5%, from 30 to 24 per 10,000 deliveries. But trends with severe maternal morbidity in patients with influenza went in the other direction, increasing more than 200% over 15 years, from 100 to 342 cases of severe maternal morbidity per 10,000 patients with influenza. An increase also occurred in patients without influenza, but it was more modest, a nearly 50% increase, from 53 to 79 cases per 10,000 hospitalizations.

From year to year, severe maternal morbidity increased 5.3% annually among hospitalizations with influenza – more than twice the rate of a 2.4% annual increase among hospitalizations without influenza.

The researchers found that influenza is linked to twice the risk of severe maternal morbidity (adjusted risk ratio [aRR] = 2.08, P < .01). There were similarly higher risks with influenza of sepsis/shock (aRR = 3.23), mechanical ventilation (aRR = 6.04), and acute respiratory distress syndrome (aRR = 5.76; all P < .01).

Among the possible reasons for the increase in influenza morbidity – despite a decrease in influenza infections in this population – is the increase in the medical complexity of the patient population, Dr. Wen said.

“Patients who are getting pregnant today likely have more comorbid conditions (chronic hypertension, obesity, pregestational diabetes mellitus, etc.) than they did decades prior,” Dr. Wen said. “Clinically, it means that we have a baseline patient population at a higher risk of susceptibility for influenza and its complications.”

Maternal influenza immunization rates have meanwhile stagnated, Dr. Wen added. Influenza “is something that we know is preventable, or at least mitigated, by a vaccine,” he said. “Our results serve as a reminder for clinicians to continue counseling on the importance of influenza vaccination among pregnant patients, and even in those who are planning to become pregnant.”

He said these findings suggest the need for a low threshold for treating pregnant patients who have influenza symptoms with over-the-counter therapies or closely monitoring them.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa, found the increase in morbidity in those with flu particularly unexpected and concerning.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa
Dr. Adetola Louis-Jacques


“What surprised me was the big difference in how severe maternal morbidity rates increased over time in the influenza group compared to the group without influenza,” Dr. Louis-Jacques, who moderated the session, said in an interview. She agreed with Dr. Wen that the findings underscore the benefits of immunization.

“The study means we should reinforce to mothers how important the vaccine is. It’s critical,” Dr. Louis-Jacques said. “We should encourage mothers to get it and focus on educating women, trying to understand and allay [any concerns about the vaccine] and reinforce the importance of flu vaccination to decrease the likelihood of these mothers getting pretty sick during pregnancy.”

Dr. Wen and Dr. Louis-Jacques had no disclosures.

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Despite slightly decreasing numbers of pregnant women hospitalized with influenza, the rate of morbidity among those who do have influenza has substantially increased from 2000 to 2015, likely due in part to an increase in comorbidities.

Maternal patients who have influenza while hospitalized for delivery are twice as likely to develop severe maternal morbidity than are those without influenza, according to findings from a new study presented at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Pregnant women were also at substantially greater risk of sepsis or shock, needing mechanical ventilation, and acute respiratory distress syndrome. In fact, rates of overall severe maternal morbidity and of influenza-related complications have increased in maternal patients with influenza by more than 200% from 2000 to 2015.

“It was striking to see how the rate of delivery hospitalizations complicated by influenza has remained relatively stable with a small decline, but the rates of severe maternal morbidity were increasing and so markedly among those with influenza,” Timothy Wen, MD, MPH, a maternal-fetal medicine clinical fellow at the University of California, San Francisco, said in an interview. “The findings suggest that influenza may either be a contributor to rising rates of severe maternal morbidity or synergistically amplifying existing comorbidities to worsen outcomes,” he said during his presentation.

The increased risk of influenza complications in pregnant women became particularly apparent during the 2009-2010 H1N1 influenza pandemic. “Physiologic and immunologic changes predispose pregnant patients to higher risk for complications such as pneumonia, intensive care unit admission, and inpatient mortality,” Dr. Wen told attendees. But data have been scarce since H1N1.

The researchers conducted a cross-sectional analysis of delivery hospitalizations from 2000 to 2015 using the Nationwide Inpatient Sample, which includes about 20% of all U.S. inpatient hospitalizations from all payers. They looked at all maternal patients aged 15-54 who had a diagnosis of influenza. In looking at potential associations between influenza and morbidity, they adjusted their calculations for maternal age, payer status, median income, and race/ethnicity as well as the hospital factors of location, teaching status, and region. They also adjusted for a dozen clinical factors.

Of 62.7 million hospitalizations, 0.67% involved severe maternal mortality, including the following influenza complications:

  • 0.02% with shock/sepsis.
  • 0.01% needing mechanical ventilation.
  • 0.04% with acute respiratory distress syndrome.

The 182,228 patients with influenza represented a rate of 29 cases per 10,000 deliveries, and 2.09% of them involved severe maternal morbidity, compared to severe maternal morbidity in just 0.66% of deliveries without influenza.

When looking specifically at rates of shock/sepsis, mechanical ventilation, and acute respiratory distress syndrome, the data revealed similar trends, with substantially higher proportions of patients with influenza experiencing these complications compared to maternal patients without influenza. For example, 0.3% of patients with influenza developed shock/sepsis whereas only 0.04% of patients without influenza did. Acute respiratory distress syndrome was similarly more common in patients with flu (0.45% vs. 0.04%), as was the need for mechanical ventilation (0.09% vs. 0.01%).

During the 15-year study period, the rate of maternal hospitalizations with influenza infections declined about 1.5%, from 30 to 24 per 10,000 deliveries. But trends with severe maternal morbidity in patients with influenza went in the other direction, increasing more than 200% over 15 years, from 100 to 342 cases of severe maternal morbidity per 10,000 patients with influenza. An increase also occurred in patients without influenza, but it was more modest, a nearly 50% increase, from 53 to 79 cases per 10,000 hospitalizations.

From year to year, severe maternal morbidity increased 5.3% annually among hospitalizations with influenza – more than twice the rate of a 2.4% annual increase among hospitalizations without influenza.

The researchers found that influenza is linked to twice the risk of severe maternal morbidity (adjusted risk ratio [aRR] = 2.08, P < .01). There were similarly higher risks with influenza of sepsis/shock (aRR = 3.23), mechanical ventilation (aRR = 6.04), and acute respiratory distress syndrome (aRR = 5.76; all P < .01).

Among the possible reasons for the increase in influenza morbidity – despite a decrease in influenza infections in this population – is the increase in the medical complexity of the patient population, Dr. Wen said.

“Patients who are getting pregnant today likely have more comorbid conditions (chronic hypertension, obesity, pregestational diabetes mellitus, etc.) than they did decades prior,” Dr. Wen said. “Clinically, it means that we have a baseline patient population at a higher risk of susceptibility for influenza and its complications.”

Maternal influenza immunization rates have meanwhile stagnated, Dr. Wen added. Influenza “is something that we know is preventable, or at least mitigated, by a vaccine,” he said. “Our results serve as a reminder for clinicians to continue counseling on the importance of influenza vaccination among pregnant patients, and even in those who are planning to become pregnant.”

He said these findings suggest the need for a low threshold for treating pregnant patients who have influenza symptoms with over-the-counter therapies or closely monitoring them.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa, found the increase in morbidity in those with flu particularly unexpected and concerning.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa
Dr. Adetola Louis-Jacques


“What surprised me was the big difference in how severe maternal morbidity rates increased over time in the influenza group compared to the group without influenza,” Dr. Louis-Jacques, who moderated the session, said in an interview. She agreed with Dr. Wen that the findings underscore the benefits of immunization.

“The study means we should reinforce to mothers how important the vaccine is. It’s critical,” Dr. Louis-Jacques said. “We should encourage mothers to get it and focus on educating women, trying to understand and allay [any concerns about the vaccine] and reinforce the importance of flu vaccination to decrease the likelihood of these mothers getting pretty sick during pregnancy.”

Dr. Wen and Dr. Louis-Jacques had no disclosures.

 

Despite slightly decreasing numbers of pregnant women hospitalized with influenza, the rate of morbidity among those who do have influenza has substantially increased from 2000 to 2015, likely due in part to an increase in comorbidities.

Maternal patients who have influenza while hospitalized for delivery are twice as likely to develop severe maternal morbidity than are those without influenza, according to findings from a new study presented at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Pregnant women were also at substantially greater risk of sepsis or shock, needing mechanical ventilation, and acute respiratory distress syndrome. In fact, rates of overall severe maternal morbidity and of influenza-related complications have increased in maternal patients with influenza by more than 200% from 2000 to 2015.

“It was striking to see how the rate of delivery hospitalizations complicated by influenza has remained relatively stable with a small decline, but the rates of severe maternal morbidity were increasing and so markedly among those with influenza,” Timothy Wen, MD, MPH, a maternal-fetal medicine clinical fellow at the University of California, San Francisco, said in an interview. “The findings suggest that influenza may either be a contributor to rising rates of severe maternal morbidity or synergistically amplifying existing comorbidities to worsen outcomes,” he said during his presentation.

The increased risk of influenza complications in pregnant women became particularly apparent during the 2009-2010 H1N1 influenza pandemic. “Physiologic and immunologic changes predispose pregnant patients to higher risk for complications such as pneumonia, intensive care unit admission, and inpatient mortality,” Dr. Wen told attendees. But data have been scarce since H1N1.

The researchers conducted a cross-sectional analysis of delivery hospitalizations from 2000 to 2015 using the Nationwide Inpatient Sample, which includes about 20% of all U.S. inpatient hospitalizations from all payers. They looked at all maternal patients aged 15-54 who had a diagnosis of influenza. In looking at potential associations between influenza and morbidity, they adjusted their calculations for maternal age, payer status, median income, and race/ethnicity as well as the hospital factors of location, teaching status, and region. They also adjusted for a dozen clinical factors.

Of 62.7 million hospitalizations, 0.67% involved severe maternal mortality, including the following influenza complications:

  • 0.02% with shock/sepsis.
  • 0.01% needing mechanical ventilation.
  • 0.04% with acute respiratory distress syndrome.

The 182,228 patients with influenza represented a rate of 29 cases per 10,000 deliveries, and 2.09% of them involved severe maternal morbidity, compared to severe maternal morbidity in just 0.66% of deliveries without influenza.

When looking specifically at rates of shock/sepsis, mechanical ventilation, and acute respiratory distress syndrome, the data revealed similar trends, with substantially higher proportions of patients with influenza experiencing these complications compared to maternal patients without influenza. For example, 0.3% of patients with influenza developed shock/sepsis whereas only 0.04% of patients without influenza did. Acute respiratory distress syndrome was similarly more common in patients with flu (0.45% vs. 0.04%), as was the need for mechanical ventilation (0.09% vs. 0.01%).

During the 15-year study period, the rate of maternal hospitalizations with influenza infections declined about 1.5%, from 30 to 24 per 10,000 deliveries. But trends with severe maternal morbidity in patients with influenza went in the other direction, increasing more than 200% over 15 years, from 100 to 342 cases of severe maternal morbidity per 10,000 patients with influenza. An increase also occurred in patients without influenza, but it was more modest, a nearly 50% increase, from 53 to 79 cases per 10,000 hospitalizations.

From year to year, severe maternal morbidity increased 5.3% annually among hospitalizations with influenza – more than twice the rate of a 2.4% annual increase among hospitalizations without influenza.

The researchers found that influenza is linked to twice the risk of severe maternal morbidity (adjusted risk ratio [aRR] = 2.08, P < .01). There were similarly higher risks with influenza of sepsis/shock (aRR = 3.23), mechanical ventilation (aRR = 6.04), and acute respiratory distress syndrome (aRR = 5.76; all P < .01).

Among the possible reasons for the increase in influenza morbidity – despite a decrease in influenza infections in this population – is the increase in the medical complexity of the patient population, Dr. Wen said.

“Patients who are getting pregnant today likely have more comorbid conditions (chronic hypertension, obesity, pregestational diabetes mellitus, etc.) than they did decades prior,” Dr. Wen said. “Clinically, it means that we have a baseline patient population at a higher risk of susceptibility for influenza and its complications.”

Maternal influenza immunization rates have meanwhile stagnated, Dr. Wen added. Influenza “is something that we know is preventable, or at least mitigated, by a vaccine,” he said. “Our results serve as a reminder for clinicians to continue counseling on the importance of influenza vaccination among pregnant patients, and even in those who are planning to become pregnant.”

He said these findings suggest the need for a low threshold for treating pregnant patients who have influenza symptoms with over-the-counter therapies or closely monitoring them.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa, found the increase in morbidity in those with flu particularly unexpected and concerning.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa
Dr. Adetola Louis-Jacques


“What surprised me was the big difference in how severe maternal morbidity rates increased over time in the influenza group compared to the group without influenza,” Dr. Louis-Jacques, who moderated the session, said in an interview. She agreed with Dr. Wen that the findings underscore the benefits of immunization.

“The study means we should reinforce to mothers how important the vaccine is. It’s critical,” Dr. Louis-Jacques said. “We should encourage mothers to get it and focus on educating women, trying to understand and allay [any concerns about the vaccine] and reinforce the importance of flu vaccination to decrease the likelihood of these mothers getting pretty sick during pregnancy.”

Dr. Wen and Dr. Louis-Jacques had no disclosures.

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CLL, MBL had lower response rates to flu vaccination, compared with healthy adults

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Fri, 12/16/2022 - 11:31

 

Immunogenicity of the high-dose influenza vaccine (HD IIV3) in patients with chronic lymphocytic leukemia (CLL) and monoclonal B-cell lymphocytosis (MBL, the precursor state to CLL) was found lower than reported in healthy adults according to a report in Vaccine.

In addition, immunogenicity to influenza B was found to be greater in those patients with MBL, compared with those with CLL.

“Acute and chronic leukemia patients hospitalized with influenza infection document a case fatality rate of 25%-37%,” according to Jennifer A. Whitaker, MD, of the Mayo Clinic, Rochester, Minn., and colleagues in pointing out the importance of their study.

The prospective pilot study assessed the humoral immune responses of patients to the 2013-2014 and 2014-2015 HD IIV3 (Fluzone High-Dose; Sanofi Pasteur), which was administered as part of routine clinical care in 30 patients (17 with previously untreated CLL and 13 with MBL). The median patient age was 69.5 years.

The primary outcomes were seroconversion and seroprotection, as measured by hemagglutination inhibition assay (HAI).
 

Lower response rate

At day 28 post vaccination, the seroprotection rates for the overall cohort were 19/30 (63.3%) for A/H1N1, 21/23 (91.3%) for A/H3N2, and 13/30 (43.3%) for influenza B. Patients with MBL achieved significantly higher day 28 HAI geometric mean titers (GMT), compared with CLL patients (54.1 vs. 12.1]; P = .01), In addition, MBL patients achieved higher day 28 seroprotection rates against the influenza B vaccine strain virus than did those with CLL (76.9% vs. 17.6%; P = .002). Seroconversion rates for the overall cohort were 3/30 (10%) for A/H1N1; 5/23 (21.7%) for A/H3N2; and 3/30 (10%) for influenza B. No individual with CLL demonstrated seroconversion for influenza B, according to the researchers.

“Our studies reinforce rigorous adherence to vaccination strategies in patients with hematologic malignancy, including those with CLL, given the increased risk of serious complications among those experiencing influenza infection,” the authors stated.

“Even suboptimal responses to influenza vaccination can provide partial protection, reduce hospitalization rates, and/or prevent serious disease complications. Given the recent major issue with novel and aggressive viruses such COVID-19, we absolutely must continue with larger prospective studies to confirm these findings and evaluate vaccine effectiveness in preventing influenza or other novel viruses in these populations,” the researchers concluded.

This study was funded by the National Institutes of Health. Dr. Whitaker reported having no disclosures. Several of the coauthors reported financial relationships with a variety of pharmaceutical and biotechnology companies.

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Immunogenicity of the high-dose influenza vaccine (HD IIV3) in patients with chronic lymphocytic leukemia (CLL) and monoclonal B-cell lymphocytosis (MBL, the precursor state to CLL) was found lower than reported in healthy adults according to a report in Vaccine.

In addition, immunogenicity to influenza B was found to be greater in those patients with MBL, compared with those with CLL.

“Acute and chronic leukemia patients hospitalized with influenza infection document a case fatality rate of 25%-37%,” according to Jennifer A. Whitaker, MD, of the Mayo Clinic, Rochester, Minn., and colleagues in pointing out the importance of their study.

The prospective pilot study assessed the humoral immune responses of patients to the 2013-2014 and 2014-2015 HD IIV3 (Fluzone High-Dose; Sanofi Pasteur), which was administered as part of routine clinical care in 30 patients (17 with previously untreated CLL and 13 with MBL). The median patient age was 69.5 years.

The primary outcomes were seroconversion and seroprotection, as measured by hemagglutination inhibition assay (HAI).
 

Lower response rate

At day 28 post vaccination, the seroprotection rates for the overall cohort were 19/30 (63.3%) for A/H1N1, 21/23 (91.3%) for A/H3N2, and 13/30 (43.3%) for influenza B. Patients with MBL achieved significantly higher day 28 HAI geometric mean titers (GMT), compared with CLL patients (54.1 vs. 12.1]; P = .01), In addition, MBL patients achieved higher day 28 seroprotection rates against the influenza B vaccine strain virus than did those with CLL (76.9% vs. 17.6%; P = .002). Seroconversion rates for the overall cohort were 3/30 (10%) for A/H1N1; 5/23 (21.7%) for A/H3N2; and 3/30 (10%) for influenza B. No individual with CLL demonstrated seroconversion for influenza B, according to the researchers.

“Our studies reinforce rigorous adherence to vaccination strategies in patients with hematologic malignancy, including those with CLL, given the increased risk of serious complications among those experiencing influenza infection,” the authors stated.

“Even suboptimal responses to influenza vaccination can provide partial protection, reduce hospitalization rates, and/or prevent serious disease complications. Given the recent major issue with novel and aggressive viruses such COVID-19, we absolutely must continue with larger prospective studies to confirm these findings and evaluate vaccine effectiveness in preventing influenza or other novel viruses in these populations,” the researchers concluded.

This study was funded by the National Institutes of Health. Dr. Whitaker reported having no disclosures. Several of the coauthors reported financial relationships with a variety of pharmaceutical and biotechnology companies.

 

Immunogenicity of the high-dose influenza vaccine (HD IIV3) in patients with chronic lymphocytic leukemia (CLL) and monoclonal B-cell lymphocytosis (MBL, the precursor state to CLL) was found lower than reported in healthy adults according to a report in Vaccine.

In addition, immunogenicity to influenza B was found to be greater in those patients with MBL, compared with those with CLL.

“Acute and chronic leukemia patients hospitalized with influenza infection document a case fatality rate of 25%-37%,” according to Jennifer A. Whitaker, MD, of the Mayo Clinic, Rochester, Minn., and colleagues in pointing out the importance of their study.

The prospective pilot study assessed the humoral immune responses of patients to the 2013-2014 and 2014-2015 HD IIV3 (Fluzone High-Dose; Sanofi Pasteur), which was administered as part of routine clinical care in 30 patients (17 with previously untreated CLL and 13 with MBL). The median patient age was 69.5 years.

The primary outcomes were seroconversion and seroprotection, as measured by hemagglutination inhibition assay (HAI).
 

Lower response rate

At day 28 post vaccination, the seroprotection rates for the overall cohort were 19/30 (63.3%) for A/H1N1, 21/23 (91.3%) for A/H3N2, and 13/30 (43.3%) for influenza B. Patients with MBL achieved significantly higher day 28 HAI geometric mean titers (GMT), compared with CLL patients (54.1 vs. 12.1]; P = .01), In addition, MBL patients achieved higher day 28 seroprotection rates against the influenza B vaccine strain virus than did those with CLL (76.9% vs. 17.6%; P = .002). Seroconversion rates for the overall cohort were 3/30 (10%) for A/H1N1; 5/23 (21.7%) for A/H3N2; and 3/30 (10%) for influenza B. No individual with CLL demonstrated seroconversion for influenza B, according to the researchers.

“Our studies reinforce rigorous adherence to vaccination strategies in patients with hematologic malignancy, including those with CLL, given the increased risk of serious complications among those experiencing influenza infection,” the authors stated.

“Even suboptimal responses to influenza vaccination can provide partial protection, reduce hospitalization rates, and/or prevent serious disease complications. Given the recent major issue with novel and aggressive viruses such COVID-19, we absolutely must continue with larger prospective studies to confirm these findings and evaluate vaccine effectiveness in preventing influenza or other novel viruses in these populations,” the researchers concluded.

This study was funded by the National Institutes of Health. Dr. Whitaker reported having no disclosures. Several of the coauthors reported financial relationships with a variety of pharmaceutical and biotechnology companies.

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COVID protections suppressed flu season in U.S.

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Thu, 08/26/2021 - 15:52

Last fall, health experts said it was possible the United States could experience an easy 2020-21 flu season because health measures to fight COVID-19 would also thwart the spread of influenza.

It looks like that happened – and then some. Numbers are strikingly low for cases of the flu and other common respiratory and gastrointestinal viruses, health experts told the Washington Post.

“It’s crazy,” Lynnette Brammer, MPH, who leads the domestic influenza surveillance team at the Centers for Disease Control and Prevention, told the Washington Post. “This is my 30th flu season. I never would have expected to see flu activity this low.”

Influenza A, influenza B, parainfluenza, norovirus, respiratory syncytial virus, human metapneumovirus, and the bacteria that cause whooping cough and pneumonia are circulating at near-record-low levels.

As an example, the Washington Post said in the third week of December 2019, the CDC’s network of clinical labs reported 16.2% of almost 30,000 samples tested positive for influenza A. During the same period in 2020, only 0.3% tested positive.

But there’s a possible downside to this suppression of viruses, because flu and other viruses may rebound once the coronavirus is brought under control.

“The best analogy is to a forest fire,” Bryan Grenfell, PhD, an epidemiologist and population biologist at Princeton (N.J.) University, told the Washington Post. “For the fire to spread, it needs to have unburned wood. For epidemics to spread, they require people who haven’t previously been infected. So if people don’t get infected this year by these viruses, they likely will at some point later on.”

American health experts like Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, said last fall that they noticed Australia and other nations in the southern hemisphere had easy flu seasons, apparently because of COVID protection measures. The flu season there runs March through August.

COVID-19 now has a very low presence in Australia, but in recent months the flu has been making a comeback. Flu cases among children aged 5 and younger rose sixfold by December, when such cases are usually at their lowest, the Washington Post said.

“That’s an important cautionary tale for us,” said Kevin Messacar, MD, an infectious disease doctor at Children’s Hospital Colorado, Aurora. “Just because we get through the winter and don’t see much RSV or influenza doesn’t mean we’ll be out of the woods.”

A version of this article first appeared on WebMD.com.

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Last fall, health experts said it was possible the United States could experience an easy 2020-21 flu season because health measures to fight COVID-19 would also thwart the spread of influenza.

It looks like that happened – and then some. Numbers are strikingly low for cases of the flu and other common respiratory and gastrointestinal viruses, health experts told the Washington Post.

“It’s crazy,” Lynnette Brammer, MPH, who leads the domestic influenza surveillance team at the Centers for Disease Control and Prevention, told the Washington Post. “This is my 30th flu season. I never would have expected to see flu activity this low.”

Influenza A, influenza B, parainfluenza, norovirus, respiratory syncytial virus, human metapneumovirus, and the bacteria that cause whooping cough and pneumonia are circulating at near-record-low levels.

As an example, the Washington Post said in the third week of December 2019, the CDC’s network of clinical labs reported 16.2% of almost 30,000 samples tested positive for influenza A. During the same period in 2020, only 0.3% tested positive.

But there’s a possible downside to this suppression of viruses, because flu and other viruses may rebound once the coronavirus is brought under control.

“The best analogy is to a forest fire,” Bryan Grenfell, PhD, an epidemiologist and population biologist at Princeton (N.J.) University, told the Washington Post. “For the fire to spread, it needs to have unburned wood. For epidemics to spread, they require people who haven’t previously been infected. So if people don’t get infected this year by these viruses, they likely will at some point later on.”

American health experts like Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, said last fall that they noticed Australia and other nations in the southern hemisphere had easy flu seasons, apparently because of COVID protection measures. The flu season there runs March through August.

COVID-19 now has a very low presence in Australia, but in recent months the flu has been making a comeback. Flu cases among children aged 5 and younger rose sixfold by December, when such cases are usually at their lowest, the Washington Post said.

“That’s an important cautionary tale for us,” said Kevin Messacar, MD, an infectious disease doctor at Children’s Hospital Colorado, Aurora. “Just because we get through the winter and don’t see much RSV or influenza doesn’t mean we’ll be out of the woods.”

A version of this article first appeared on WebMD.com.

Last fall, health experts said it was possible the United States could experience an easy 2020-21 flu season because health measures to fight COVID-19 would also thwart the spread of influenza.

It looks like that happened – and then some. Numbers are strikingly low for cases of the flu and other common respiratory and gastrointestinal viruses, health experts told the Washington Post.

“It’s crazy,” Lynnette Brammer, MPH, who leads the domestic influenza surveillance team at the Centers for Disease Control and Prevention, told the Washington Post. “This is my 30th flu season. I never would have expected to see flu activity this low.”

Influenza A, influenza B, parainfluenza, norovirus, respiratory syncytial virus, human metapneumovirus, and the bacteria that cause whooping cough and pneumonia are circulating at near-record-low levels.

As an example, the Washington Post said in the third week of December 2019, the CDC’s network of clinical labs reported 16.2% of almost 30,000 samples tested positive for influenza A. During the same period in 2020, only 0.3% tested positive.

But there’s a possible downside to this suppression of viruses, because flu and other viruses may rebound once the coronavirus is brought under control.

“The best analogy is to a forest fire,” Bryan Grenfell, PhD, an epidemiologist and population biologist at Princeton (N.J.) University, told the Washington Post. “For the fire to spread, it needs to have unburned wood. For epidemics to spread, they require people who haven’t previously been infected. So if people don’t get infected this year by these viruses, they likely will at some point later on.”

American health experts like Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, said last fall that they noticed Australia and other nations in the southern hemisphere had easy flu seasons, apparently because of COVID protection measures. The flu season there runs March through August.

COVID-19 now has a very low presence in Australia, but in recent months the flu has been making a comeback. Flu cases among children aged 5 and younger rose sixfold by December, when such cases are usually at their lowest, the Washington Post said.

“That’s an important cautionary tale for us,” said Kevin Messacar, MD, an infectious disease doctor at Children’s Hospital Colorado, Aurora. “Just because we get through the winter and don’t see much RSV or influenza doesn’t mean we’ll be out of the woods.”

A version of this article first appeared on WebMD.com.

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FDA expands Xofluza indication to include postexposure flu prophylaxis

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Wed, 12/02/2020 - 09:31

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrheabronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrheabronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrheabronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

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Few women hospitalized for influenza have been vaccinated

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Wed, 10/28/2020 - 09:16

Fewer than one-third of women hospitalized with influenza receive the recommended flu vaccine, according to a study using data over nine flu seasons.

Researchers analyzed data from 9,652 women ages 15-44 who were hospitalized with laboratory-confirmed influenza from October through April during the 2010-2019 influenza seasons. Data were pulled from the U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET).

Of those women, 2,697 (28%) were pregnant. Median age was 28 and median gestational age was 32 weeks. Those studied included 36% who were non-Hispanic White; 29% non-Hispanic Black; and 20% Hispanic women.

Some 89% of the women, pregnant and nonpregnant, received antivirals while in the hospital but only 31% reported they had received the flu vaccine in the current season, despite guideline recommendations citing clear evidence that vaccination is safe for mother and baby.

Rachel Holstein, MPH, an epidemiology and information science fellow at the Centers for Disease Control and Prevention, who presented her team’s work as part of IDWeek 2020, explained that the mother’s vaccination can help protect the baby from flu infection for several months after birth, before the baby can be vaccinated.

She noted that pregnant women are at high risk for influenza-associated hospitalization.

“Changes in the immune system, heart, and lungs during pregnancy make pregnant women, and women up to 2 weeks post partum, more prone to severe illness from flu, including illness resulting in hospitalization,” she said in an interview

“Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to one-half,” she said. “A 2018 study showed that getting a flu shot reduced a pregnant woman’s risk of being hospitalized with flu by an average of 40%.»

FluSurv-NET data show hospitalizations were more common in the third trimester of pregnancy compared with the first and second, Holstein said. The most common underlying conditions among these women were asthma (23%) and obesity (10%), and 12% were current tobacco smokers. Overall, 5% of pregnant women with flu required ICU admission, 2% needed mechanical ventilation, and 6% developed pneumonia.
 

Vaccine uptake lowest in first two trimesters

Holstein said vaccine coverage was lowest among women in their first or second trimesters for all 9 seasons, and overall vaccination coverage increased significantly over time.

Uptake also differed by age. The data showed coverage was lower among women aged 15-34 years, compared with women 35 years and older (34% vs. 50%).

“It was as low as 15% among pregnant women aged 15-34 years in the 2011-12 season,” she added.

Jeanne Sheffield, MD, director of the division of maternal-fetal medicine at Johns Hopkins Medicine, Baltimore, said in an interview the low uptake of vaccine shown in this study is both familiar and frustrating.

She said education from health care providers has improved, but women are nonetheless frequently fearful. She pointed out the widespread phenomenon of vaccine hesitancy in the general population.

Coverage was 45.3% among adults in the 2018-2019 flu season, 8.2 percentage points higher than coverage during the 2017-18 season (37.1%) according to CDC estimates.

Added to that, she said, is further hesitancy when women believe vaccination could harm the unborn baby, despite “very good data that flu vaccine is safe in pregnancy, acceptable in pregnancy in all trimesters, and is optimal standard of care.”

Holstein added, “We know from past research that a range of factors – including negative attitudes and beliefs about vaccines, less knowledge about and access to vaccines, and a lack of trust in healthcare providers and vaccines – can contribute to lower vaccination rates.”

Healthcare providers play a key role in increasing flu vaccinations among pregnant women, she said.

“A provider recommendation, combined with an offer to administer a flu vaccine at the time of visit, remains one of the best ways to accomplish this,” Holstein said.

Holstein and Sheffield have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Fewer than one-third of women hospitalized with influenza receive the recommended flu vaccine, according to a study using data over nine flu seasons.

Researchers analyzed data from 9,652 women ages 15-44 who were hospitalized with laboratory-confirmed influenza from October through April during the 2010-2019 influenza seasons. Data were pulled from the U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET).

Of those women, 2,697 (28%) were pregnant. Median age was 28 and median gestational age was 32 weeks. Those studied included 36% who were non-Hispanic White; 29% non-Hispanic Black; and 20% Hispanic women.

Some 89% of the women, pregnant and nonpregnant, received antivirals while in the hospital but only 31% reported they had received the flu vaccine in the current season, despite guideline recommendations citing clear evidence that vaccination is safe for mother and baby.

Rachel Holstein, MPH, an epidemiology and information science fellow at the Centers for Disease Control and Prevention, who presented her team’s work as part of IDWeek 2020, explained that the mother’s vaccination can help protect the baby from flu infection for several months after birth, before the baby can be vaccinated.

She noted that pregnant women are at high risk for influenza-associated hospitalization.

“Changes in the immune system, heart, and lungs during pregnancy make pregnant women, and women up to 2 weeks post partum, more prone to severe illness from flu, including illness resulting in hospitalization,” she said in an interview

“Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to one-half,” she said. “A 2018 study showed that getting a flu shot reduced a pregnant woman’s risk of being hospitalized with flu by an average of 40%.»

FluSurv-NET data show hospitalizations were more common in the third trimester of pregnancy compared with the first and second, Holstein said. The most common underlying conditions among these women were asthma (23%) and obesity (10%), and 12% were current tobacco smokers. Overall, 5% of pregnant women with flu required ICU admission, 2% needed mechanical ventilation, and 6% developed pneumonia.
 

Vaccine uptake lowest in first two trimesters

Holstein said vaccine coverage was lowest among women in their first or second trimesters for all 9 seasons, and overall vaccination coverage increased significantly over time.

Uptake also differed by age. The data showed coverage was lower among women aged 15-34 years, compared with women 35 years and older (34% vs. 50%).

“It was as low as 15% among pregnant women aged 15-34 years in the 2011-12 season,” she added.

Jeanne Sheffield, MD, director of the division of maternal-fetal medicine at Johns Hopkins Medicine, Baltimore, said in an interview the low uptake of vaccine shown in this study is both familiar and frustrating.

She said education from health care providers has improved, but women are nonetheless frequently fearful. She pointed out the widespread phenomenon of vaccine hesitancy in the general population.

Coverage was 45.3% among adults in the 2018-2019 flu season, 8.2 percentage points higher than coverage during the 2017-18 season (37.1%) according to CDC estimates.

Added to that, she said, is further hesitancy when women believe vaccination could harm the unborn baby, despite “very good data that flu vaccine is safe in pregnancy, acceptable in pregnancy in all trimesters, and is optimal standard of care.”

Holstein added, “We know from past research that a range of factors – including negative attitudes and beliefs about vaccines, less knowledge about and access to vaccines, and a lack of trust in healthcare providers and vaccines – can contribute to lower vaccination rates.”

Healthcare providers play a key role in increasing flu vaccinations among pregnant women, she said.

“A provider recommendation, combined with an offer to administer a flu vaccine at the time of visit, remains one of the best ways to accomplish this,” Holstein said.

Holstein and Sheffield have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Fewer than one-third of women hospitalized with influenza receive the recommended flu vaccine, according to a study using data over nine flu seasons.

Researchers analyzed data from 9,652 women ages 15-44 who were hospitalized with laboratory-confirmed influenza from October through April during the 2010-2019 influenza seasons. Data were pulled from the U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET).

Of those women, 2,697 (28%) were pregnant. Median age was 28 and median gestational age was 32 weeks. Those studied included 36% who were non-Hispanic White; 29% non-Hispanic Black; and 20% Hispanic women.

Some 89% of the women, pregnant and nonpregnant, received antivirals while in the hospital but only 31% reported they had received the flu vaccine in the current season, despite guideline recommendations citing clear evidence that vaccination is safe for mother and baby.

Rachel Holstein, MPH, an epidemiology and information science fellow at the Centers for Disease Control and Prevention, who presented her team’s work as part of IDWeek 2020, explained that the mother’s vaccination can help protect the baby from flu infection for several months after birth, before the baby can be vaccinated.

She noted that pregnant women are at high risk for influenza-associated hospitalization.

“Changes in the immune system, heart, and lungs during pregnancy make pregnant women, and women up to 2 weeks post partum, more prone to severe illness from flu, including illness resulting in hospitalization,” she said in an interview

“Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to one-half,” she said. “A 2018 study showed that getting a flu shot reduced a pregnant woman’s risk of being hospitalized with flu by an average of 40%.»

FluSurv-NET data show hospitalizations were more common in the third trimester of pregnancy compared with the first and second, Holstein said. The most common underlying conditions among these women were asthma (23%) and obesity (10%), and 12% were current tobacco smokers. Overall, 5% of pregnant women with flu required ICU admission, 2% needed mechanical ventilation, and 6% developed pneumonia.
 

Vaccine uptake lowest in first two trimesters

Holstein said vaccine coverage was lowest among women in their first or second trimesters for all 9 seasons, and overall vaccination coverage increased significantly over time.

Uptake also differed by age. The data showed coverage was lower among women aged 15-34 years, compared with women 35 years and older (34% vs. 50%).

“It was as low as 15% among pregnant women aged 15-34 years in the 2011-12 season,” she added.

Jeanne Sheffield, MD, director of the division of maternal-fetal medicine at Johns Hopkins Medicine, Baltimore, said in an interview the low uptake of vaccine shown in this study is both familiar and frustrating.

She said education from health care providers has improved, but women are nonetheless frequently fearful. She pointed out the widespread phenomenon of vaccine hesitancy in the general population.

Coverage was 45.3% among adults in the 2018-2019 flu season, 8.2 percentage points higher than coverage during the 2017-18 season (37.1%) according to CDC estimates.

Added to that, she said, is further hesitancy when women believe vaccination could harm the unborn baby, despite “very good data that flu vaccine is safe in pregnancy, acceptable in pregnancy in all trimesters, and is optimal standard of care.”

Holstein added, “We know from past research that a range of factors – including negative attitudes and beliefs about vaccines, less knowledge about and access to vaccines, and a lack of trust in healthcare providers and vaccines – can contribute to lower vaccination rates.”

Healthcare providers play a key role in increasing flu vaccinations among pregnant women, she said.

“A provider recommendation, combined with an offer to administer a flu vaccine at the time of visit, remains one of the best ways to accomplish this,” Holstein said.

Holstein and Sheffield have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Flu vaccine significantly cuts pediatric hospitalizations

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Wed, 10/14/2020 - 11:55

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

young boy being vaccinated
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“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

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Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

young boy being vaccinated
Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

young boy being vaccinated
Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

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