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ACIP approves new influenza vaccine recommendations
FROM AN ACIP MEETING
by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) after a lengthy debate over specifics regarding recommendations for pregnant women.
The proposed recommendation that sparked the debate would change the wording of the previous recommendation for pregnant women to receive a seasonal inactivated vaccine (IIV) to “any licensed, recommended, and age-appropriate, trivalent or quadrivalent IIV or RIV [recombinant influenza vaccine] may be used.”
“I think there’s a subtle, but important difference here between making what would appear to be an affirmative statement that RIV is safe in pregnant women, versus just staying silent on it, and saying ‘we’re not saying you shouldn’t use it, but we don’t have enough data to affirmatively say it is safe,’ ” said Cindy Pellegrini, senior vice president of Public Policy and Government Affairs at the March of Dimes Foundation.
In response, members of the committee pointed out that the responsibility of determining safety lies with the Food and Drug Administration, which has already licensed the Flublok trivalent vaccine with expectations that the quadrivalent vaccine soon will follow.
While Lisa Grohskopf, MD, MPH, medical officer of the influenza division of the CDC, did acknowledge that there were more data on the safety of inactivated influenza vaccines, she asserted to the committee that “the general overall safety profile of Flublok in comparison to inactivated vaccines is reassuring.”
“For example, one concern that arises is reactogenicity and inflammation. [In terms of] overall reactogenicity in the studies where Flublok and inactivated vaccines have been compared, rates of the adverse and systemic reactions were similar,” Dr. Grohskopf said.
A motion was made to change the wording of the recommendation; however, the motion was not passed, and the eventual vote on the approval was conducted.
The ACIP also voted unanimously to change the safe age limit noted in influenza guidelines for use of Afluria (IIV3) from 9 years and older to 5 years and older. A footnote saying that the ACIP recommends Afluria for children 9 years and older will be removed.
This change, which mirrors the licensing Afluria has with the FDA, was based on research conducted by Seqirus that showed fever levels were the same for Afluria trivalent and quadrivalent vaccines in children 5 to 9 years old, both of which were less than historical vaccine rates.
The approved recommendations will be sent to the director of the CDC and the U.S. Department of Health and Human Services. Once reviewed and approved, the final recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report. The committee members had no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
FROM AN ACIP MEETING
by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) after a lengthy debate over specifics regarding recommendations for pregnant women.
The proposed recommendation that sparked the debate would change the wording of the previous recommendation for pregnant women to receive a seasonal inactivated vaccine (IIV) to “any licensed, recommended, and age-appropriate, trivalent or quadrivalent IIV or RIV [recombinant influenza vaccine] may be used.”
“I think there’s a subtle, but important difference here between making what would appear to be an affirmative statement that RIV is safe in pregnant women, versus just staying silent on it, and saying ‘we’re not saying you shouldn’t use it, but we don’t have enough data to affirmatively say it is safe,’ ” said Cindy Pellegrini, senior vice president of Public Policy and Government Affairs at the March of Dimes Foundation.
In response, members of the committee pointed out that the responsibility of determining safety lies with the Food and Drug Administration, which has already licensed the Flublok trivalent vaccine with expectations that the quadrivalent vaccine soon will follow.
While Lisa Grohskopf, MD, MPH, medical officer of the influenza division of the CDC, did acknowledge that there were more data on the safety of inactivated influenza vaccines, she asserted to the committee that “the general overall safety profile of Flublok in comparison to inactivated vaccines is reassuring.”
“For example, one concern that arises is reactogenicity and inflammation. [In terms of] overall reactogenicity in the studies where Flublok and inactivated vaccines have been compared, rates of the adverse and systemic reactions were similar,” Dr. Grohskopf said.
A motion was made to change the wording of the recommendation; however, the motion was not passed, and the eventual vote on the approval was conducted.
The ACIP also voted unanimously to change the safe age limit noted in influenza guidelines for use of Afluria (IIV3) from 9 years and older to 5 years and older. A footnote saying that the ACIP recommends Afluria for children 9 years and older will be removed.
This change, which mirrors the licensing Afluria has with the FDA, was based on research conducted by Seqirus that showed fever levels were the same for Afluria trivalent and quadrivalent vaccines in children 5 to 9 years old, both of which were less than historical vaccine rates.
The approved recommendations will be sent to the director of the CDC and the U.S. Department of Health and Human Services. Once reviewed and approved, the final recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report. The committee members had no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
FROM AN ACIP MEETING
by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) after a lengthy debate over specifics regarding recommendations for pregnant women.
The proposed recommendation that sparked the debate would change the wording of the previous recommendation for pregnant women to receive a seasonal inactivated vaccine (IIV) to “any licensed, recommended, and age-appropriate, trivalent or quadrivalent IIV or RIV [recombinant influenza vaccine] may be used.”
“I think there’s a subtle, but important difference here between making what would appear to be an affirmative statement that RIV is safe in pregnant women, versus just staying silent on it, and saying ‘we’re not saying you shouldn’t use it, but we don’t have enough data to affirmatively say it is safe,’ ” said Cindy Pellegrini, senior vice president of Public Policy and Government Affairs at the March of Dimes Foundation.
In response, members of the committee pointed out that the responsibility of determining safety lies with the Food and Drug Administration, which has already licensed the Flublok trivalent vaccine with expectations that the quadrivalent vaccine soon will follow.
While Lisa Grohskopf, MD, MPH, medical officer of the influenza division of the CDC, did acknowledge that there were more data on the safety of inactivated influenza vaccines, she asserted to the committee that “the general overall safety profile of Flublok in comparison to inactivated vaccines is reassuring.”
“For example, one concern that arises is reactogenicity and inflammation. [In terms of] overall reactogenicity in the studies where Flublok and inactivated vaccines have been compared, rates of the adverse and systemic reactions were similar,” Dr. Grohskopf said.
A motion was made to change the wording of the recommendation; however, the motion was not passed, and the eventual vote on the approval was conducted.
The ACIP also voted unanimously to change the safe age limit noted in influenza guidelines for use of Afluria (IIV3) from 9 years and older to 5 years and older. A footnote saying that the ACIP recommends Afluria for children 9 years and older will be removed.
This change, which mirrors the licensing Afluria has with the FDA, was based on research conducted by Seqirus that showed fever levels were the same for Afluria trivalent and quadrivalent vaccines in children 5 to 9 years old, both of which were less than historical vaccine rates.
The approved recommendations will be sent to the director of the CDC and the U.S. Department of Health and Human Services. Once reviewed and approved, the final recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report. The committee members had no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
ACIP approves new hepatitis A vaccine draft recommendations
, including a focus on catch-up vaccines for adolescents and those over age 40 years.
While hepatitis A cases have dropped significantly since the vaccine’s debut – with the number of reported cases in 2015 dropping to 1,390, compared with 9,606 in 1971 – previous recommendations regarding catch-up vaccinations suggested patients should consider treatment, as opposed to catch-up vaccination.
Adult catch-up vaccines now are recommended to be considered in areas with increasing disease risks, an addition that was not part of the current recommendations but has been changed because of evidence that patients over 40 years old are more vulnerable to the virus and more likely to be hospitalized if infected, said Noele Nelson, MD, PhD, of the Division of Viral Hepatitis at the CDC.
“Increasing proportions of adults in the United States are susceptible to hepatitis A ... due to reduced exposure to virus early in life and significant serum prevalence in older adults greater and equal to 40 years,” said Dr. Nelson. “In addition, there is low two-dose vaccination coverage among adults, including high risk adults, and morbidity and mortality increases with age.”
Recommendations for pregnant women also have been updated with a more definitive message. Previous recommendations advised pregnant women to weigh the options of acquiring hepatitis A against possible adverse effects of the vaccine. But, new evidence was presented at the meeting: in a study of 139 pregnant women vaccinated between 1996 and 2015 who experienced adverse effects, only seven of the effects were considered serious, and no maternal or infant deaths were apparent. In light of this, the ACIP approved the recommendation change to advise all pregnant women to be vaccinated, if they have not already been so before pregnancy.
Updates also included recommendations for patients with chronic liver disease, who are considered to be members of a high-risk population. Newly approved recommendations include a section on epidemiology, which states that, while those with chronic liver disease are not at increased risk for hepatitis A virus infection unless they experience fecal-oral exposure to the virus, those with acute hepatitis A may be more at risk to develop more severe liver disease. Recommendations for those with chronic liver disease also include a statement advising patients to seek immunoglobulin, as well as a hepatitis A, vaccination as soon as possible after exposure.
The ACIP also approved a change in recommendations to advise all residents and caretakers of those living in a group home, specifically those caring for developmentally disabled patients, to be vaccinated because of the historically high endemic nature of such institutions.
Committee members hope these new recommendations will help the United States reach its goal of a national hepatitis A case ratio of 0.3/100,000 people and a hepatitis A vaccination rate of 85%.
If these recommendations are approved by the director of the CDC and the U.S. Health Department, as they usually are, they will be published in the CDC’s Weekly Morbidity and Mortality Report.
Members of the committee reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
, including a focus on catch-up vaccines for adolescents and those over age 40 years.
While hepatitis A cases have dropped significantly since the vaccine’s debut – with the number of reported cases in 2015 dropping to 1,390, compared with 9,606 in 1971 – previous recommendations regarding catch-up vaccinations suggested patients should consider treatment, as opposed to catch-up vaccination.
Adult catch-up vaccines now are recommended to be considered in areas with increasing disease risks, an addition that was not part of the current recommendations but has been changed because of evidence that patients over 40 years old are more vulnerable to the virus and more likely to be hospitalized if infected, said Noele Nelson, MD, PhD, of the Division of Viral Hepatitis at the CDC.
“Increasing proportions of adults in the United States are susceptible to hepatitis A ... due to reduced exposure to virus early in life and significant serum prevalence in older adults greater and equal to 40 years,” said Dr. Nelson. “In addition, there is low two-dose vaccination coverage among adults, including high risk adults, and morbidity and mortality increases with age.”
Recommendations for pregnant women also have been updated with a more definitive message. Previous recommendations advised pregnant women to weigh the options of acquiring hepatitis A against possible adverse effects of the vaccine. But, new evidence was presented at the meeting: in a study of 139 pregnant women vaccinated between 1996 and 2015 who experienced adverse effects, only seven of the effects were considered serious, and no maternal or infant deaths were apparent. In light of this, the ACIP approved the recommendation change to advise all pregnant women to be vaccinated, if they have not already been so before pregnancy.
Updates also included recommendations for patients with chronic liver disease, who are considered to be members of a high-risk population. Newly approved recommendations include a section on epidemiology, which states that, while those with chronic liver disease are not at increased risk for hepatitis A virus infection unless they experience fecal-oral exposure to the virus, those with acute hepatitis A may be more at risk to develop more severe liver disease. Recommendations for those with chronic liver disease also include a statement advising patients to seek immunoglobulin, as well as a hepatitis A, vaccination as soon as possible after exposure.
The ACIP also approved a change in recommendations to advise all residents and caretakers of those living in a group home, specifically those caring for developmentally disabled patients, to be vaccinated because of the historically high endemic nature of such institutions.
Committee members hope these new recommendations will help the United States reach its goal of a national hepatitis A case ratio of 0.3/100,000 people and a hepatitis A vaccination rate of 85%.
If these recommendations are approved by the director of the CDC and the U.S. Health Department, as they usually are, they will be published in the CDC’s Weekly Morbidity and Mortality Report.
Members of the committee reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
, including a focus on catch-up vaccines for adolescents and those over age 40 years.
While hepatitis A cases have dropped significantly since the vaccine’s debut – with the number of reported cases in 2015 dropping to 1,390, compared with 9,606 in 1971 – previous recommendations regarding catch-up vaccinations suggested patients should consider treatment, as opposed to catch-up vaccination.
Adult catch-up vaccines now are recommended to be considered in areas with increasing disease risks, an addition that was not part of the current recommendations but has been changed because of evidence that patients over 40 years old are more vulnerable to the virus and more likely to be hospitalized if infected, said Noele Nelson, MD, PhD, of the Division of Viral Hepatitis at the CDC.
“Increasing proportions of adults in the United States are susceptible to hepatitis A ... due to reduced exposure to virus early in life and significant serum prevalence in older adults greater and equal to 40 years,” said Dr. Nelson. “In addition, there is low two-dose vaccination coverage among adults, including high risk adults, and morbidity and mortality increases with age.”
Recommendations for pregnant women also have been updated with a more definitive message. Previous recommendations advised pregnant women to weigh the options of acquiring hepatitis A against possible adverse effects of the vaccine. But, new evidence was presented at the meeting: in a study of 139 pregnant women vaccinated between 1996 and 2015 who experienced adverse effects, only seven of the effects were considered serious, and no maternal or infant deaths were apparent. In light of this, the ACIP approved the recommendation change to advise all pregnant women to be vaccinated, if they have not already been so before pregnancy.
Updates also included recommendations for patients with chronic liver disease, who are considered to be members of a high-risk population. Newly approved recommendations include a section on epidemiology, which states that, while those with chronic liver disease are not at increased risk for hepatitis A virus infection unless they experience fecal-oral exposure to the virus, those with acute hepatitis A may be more at risk to develop more severe liver disease. Recommendations for those with chronic liver disease also include a statement advising patients to seek immunoglobulin, as well as a hepatitis A, vaccination as soon as possible after exposure.
The ACIP also approved a change in recommendations to advise all residents and caretakers of those living in a group home, specifically those caring for developmentally disabled patients, to be vaccinated because of the historically high endemic nature of such institutions.
Committee members hope these new recommendations will help the United States reach its goal of a national hepatitis A case ratio of 0.3/100,000 people and a hepatitis A vaccination rate of 85%.
If these recommendations are approved by the director of the CDC and the U.S. Health Department, as they usually are, they will be published in the CDC’s Weekly Morbidity and Mortality Report.
Members of the committee reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
FROM ACIP MEETING