Immunocompromised Adults Advised to Receive PCV13 Vaccine

ATLANTA – The 13-valent pneumococcal conjugate vaccine should be given to all immunocompromised adults aged 19 years and older, according to new recommendations from the Centers for Disease Control and Prevention.

In a unanimous vote at its June meeting, the CDC’s Advisory Committee on Immunization Practices said that the 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13]) is recommended for the same adults who are currently advised to receive two doses of the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax]), including those with immunocompromising conditions. Patients who are immunocompromised include individuals with HIV infection, hematologic cancer, solid cancer, organ transplant, chronic renal failure/nephrotic syndrome, and diseases requiring treatment with immunosuppressive drugs, as well as patients with functional or anatomic asplenia, cerebrospinal fluid leaks, and cochlear implants.

The new recommendation calls for the use of PCV13 in addition to PPSV23.

According to Dr. Sandra A. Fryhofer, the liaison to the Advisory Committee on Immunization Practices (ACIP) from the American College of Physicians, "We’re very excited that there’s finally some guidance for internists about what to do with immunocompromised patients. Of course, we don’t have all the data yet. ... But this is the best we could do for now. On the surface it’s a very complicated recommendation schedule, but I think as we get more experience with it, maybe it will get easier in the implementation," she said in an interview.

Immunocompromised individuals are at significantly elevated risk for invasive pneumococcal disease (IPD). According to one study, that risk is 173-fold higher among HIV-infected individuals and 186 times higher in those with hematologic cancer compared with age-matched controls (J. Infect. Dis. 2005;192:377-86).

A cost-effectiveness analysis presented at the meeting found that use of PCV13 was cost saving for all the immunocompromised groups together, and for dialysis patients specifically. For HIV-infected patients, the cost per quality-adjusted life year gained was $3,206, well within the bounds of what is considered cost effective, according to the CDC’s Dr. Charles Stoecker.

However, Dr. Fryhofer, of Emory University in Atlanta, noted that the relative costs of PCV13 and PPSV23 – $124.37 versus $55.02 per dose in 2009 – are also likely to factor into the decision about a broader recommendation for PCV13. "This vaccine is more than twice the price of the vaccine we’ve been using. Cost effectiveness is important, and we have to think about stewardship in our resources. But certainly, pneumococcal disease is a leading killer."

The decision for the use of PCV13 in immunocompromised people was made despite the fact that the only study on vaccine efficacy in such individuals investigated the previous 7-valent formulation of the vaccine (PCV7), and was conducted in HIV-infected adults in Malawi (N. Engl. J. Med. 2010;362:812-22). "The only data we have are quite limited and not always applicable to the population we’re looking at, but we believe the data are sufficient to determine that the vaccine may be beneficial in these populations and will not cause harm," ACIP pneumococcal working group chair Dr. Nancy M. Bennett said in an interview. No further vaccine efficacy data are anticipated for the immunocompromised groups, she noted.

The vote for use of PCV13 in immunocompromised adults was taken in two parts, one for those aged 19 and older who have never received a pneumococcal vaccine, and the other for those who already received one or more doses of PPSV23. The former group should receive a single dose of PCV13, followed by a dose of PPSV23 at least 8 weeks later. After that, the current recommendations remain unchanged: a second dose of PPSV23 5 years later, and another one at age 65 or later.

For immunocompromised adults aged 19 and older who have already received one or more doses of PPSV23, the recommendation is to give PCV13 1 year or longer after the most recent PPSV23 dose. A second dose of PPSV23 is recommended 1 or more years after the first PCV13 dose and 5 or more years after the first PPSV23 dose.

Prevnar 13 is licensed for the prevention of IPD in children aged 6 weeks through 5 years, and for the prevention of both IPD and pneumococcal pneumonia in adults aged 50 years and older. The adult licensure, announced by the Food and Drug Administration on Dec. 30, 2011, was based on data showing noninferior immunogenicity compared with PPSV23.

Wider Use Under Consideration

At its February 2012 meeting, the ACIP decided to defer a vote on recommending PCV13 for all adults aged 50 years and older until additional data become available. That vote could come as early as February 2013, but it is more likely to be made at the June 2013 ACIP meeting, said Dr. Bennett, professor of medicine and community and preventive medicine at the University of Rochester (N.Y.).

Specifically, the committee is awaiting two pieces of data before deciding whether to recommend the routine use of PCV13 in adults aged 50 years and older. One is the indirect impact on adults – the so-called herd effect – of the now-routine use of PCV13 in children. Data collected thus far suggest that there has already been a decline in IPD cases since PCV13 was introduced in 2010, specifically due to the PCV13 strains 19A and 7F, the CDC’s Dr. Matthew Moore said.

The committee is also waiting for PCV13 vaccine efficacy data from a large trial in the Netherlands titled CAPITA (Community Acquired Pneumonia Immunization Trial in Adults), which aims to establish the efficacy of PCV13 in the prevention of a first episode of vaccine-serotype specific pneumococcal CAP in 85,000 community-dwelling adults aged 65 years and older (Neth. J. Med. 2008;66:378-83).

"We are interested in whether or not this vaccine should be used in the general population over the age of 50," said Dr. Bennett. "Pneumococcal pneumonia is really the holy grail. That is what we would like to be preventing since it’s much more pervasive than invasive pneumococcal disease. But unfortunately, most studies look at [IPD] as the outcome rather than pneumonia. So [the CAPITA study] is very very important, because if we can show that the vaccine prevents pneumonia in adults – something that’s been very difficult to show with any of the pneumococcal vaccines – then we would really have good evidence upon which to base the recommendation."

All of the sources for this story reported that they had no conflicts of interest.

ATLANTA – The 13-valent pneumococcal conjugate vaccine should be given to all immunocompromised adults aged 19 years and older, according to new recommendations from the Centers for Disease Control and Prevention.

In a unanimous vote at its June meeting, the CDC’s Advisory Committee on Immunization Practices said that the 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13]) is recommended for the same adults who are currently advised to receive two doses of the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax]), including those with immunocompromising conditions. Patients who are immunocompromised include individuals with HIV infection, hematologic cancer, solid cancer, organ transplant, chronic renal failure/nephrotic syndrome, and diseases requiring treatment with immunosuppressive drugs, as well as patients with functional or anatomic asplenia, cerebrospinal fluid leaks, and cochlear implants.

The new recommendation calls for the use of PCV13 in addition to PPSV23.

According to Dr. Sandra A. Fryhofer, the liaison to the Advisory Committee on Immunization Practices (ACIP) from the American College of Physicians, "We’re very excited that there’s finally some guidance for internists about what to do with immunocompromised patients. Of course, we don’t have all the data yet. ... But this is the best we could do for now. On the surface it’s a very complicated recommendation schedule, but I think as we get more experience with it, maybe it will get easier in the implementation," she said in an interview.

Immunocompromised individuals are at significantly elevated risk for invasive pneumococcal disease (IPD). According to one study, that risk is 173-fold higher among HIV-infected individuals and 186 times higher in those with hematologic cancer compared with age-matched controls (J. Infect. Dis. 2005;192:377-86).

A cost-effectiveness analysis presented at the meeting found that use of PCV13 was cost saving for all the immunocompromised groups together, and for dialysis patients specifically. For HIV-infected patients, the cost per quality-adjusted life year gained was $3,206, well within the bounds of what is considered cost effective, according to the CDC’s Dr. Charles Stoecker.

However, Dr. Fryhofer, of Emory University in Atlanta, noted that the relative costs of PCV13 and PPSV23 – $124.37 versus $55.02 per dose in 2009 – are also likely to factor into the decision about a broader recommendation for PCV13. "This vaccine is more than twice the price of the vaccine we’ve been using. Cost effectiveness is important, and we have to think about stewardship in our resources. But certainly, pneumococcal disease is a leading killer."

The decision for the use of PCV13 in immunocompromised people was made despite the fact that the only study on vaccine efficacy in such individuals investigated the previous 7-valent formulation of the vaccine (PCV7), and was conducted in HIV-infected adults in Malawi (N. Engl. J. Med. 2010;362:812-22). "The only data we have are quite limited and not always applicable to the population we’re looking at, but we believe the data are sufficient to determine that the vaccine may be beneficial in these populations and will not cause harm," ACIP pneumococcal working group chair Dr. Nancy M. Bennett said in an interview. No further vaccine efficacy data are anticipated for the immunocompromised groups, she noted.

The vote for use of PCV13 in immunocompromised adults was taken in two parts, one for those aged 19 and older who have never received a pneumococcal vaccine, and the other for those who already received one or more doses of PPSV23. The former group should receive a single dose of PCV13, followed by a dose of PPSV23 at least 8 weeks later. After that, the current recommendations remain unchanged: a second dose of PPSV23 5 years later, and another one at age 65 or later.

For immunocompromised adults aged 19 and older who have already received one or more doses of PPSV23, the recommendation is to give PCV13 1 year or longer after the most recent PPSV23 dose. A second dose of PPSV23 is recommended 1 or more years after the first PCV13 dose and 5 or more years after the first PPSV23 dose.

Prevnar 13 is licensed for the prevention of IPD in children aged 6 weeks through 5 years, and for the prevention of both IPD and pneumococcal pneumonia in adults aged 50 years and older. The adult licensure, announced by the Food and Drug Administration on Dec. 30, 2011, was based on data showing noninferior immunogenicity compared with PPSV23.

Wider Use Under Consideration

At its February 2012 meeting, the ACIP decided to defer a vote on recommending PCV13 for all adults aged 50 years and older until additional data become available. That vote could come as early as February 2013, but it is more likely to be made at the June 2013 ACIP meeting, said Dr. Bennett, professor of medicine and community and preventive medicine at the University of Rochester (N.Y.).

Specifically, the committee is awaiting two pieces of data before deciding whether to recommend the routine use of PCV13 in adults aged 50 years and older. One is the indirect impact on adults – the so-called herd effect – of the now-routine use of PCV13 in children. Data collected thus far suggest that there has already been a decline in IPD cases since PCV13 was introduced in 2010, specifically due to the PCV13 strains 19A and 7F, the CDC’s Dr. Matthew Moore said.

The committee is also waiting for PCV13 vaccine efficacy data from a large trial in the Netherlands titled CAPITA (Community Acquired Pneumonia Immunization Trial in Adults), which aims to establish the efficacy of PCV13 in the prevention of a first episode of vaccine-serotype specific pneumococcal CAP in 85,000 community-dwelling adults aged 65 years and older (Neth. J. Med. 2008;66:378-83).

"We are interested in whether or not this vaccine should be used in the general population over the age of 50," said Dr. Bennett. "Pneumococcal pneumonia is really the holy grail. That is what we would like to be preventing since it’s much more pervasive than invasive pneumococcal disease. But unfortunately, most studies look at [IPD] as the outcome rather than pneumonia. So [the CAPITA study] is very very important, because if we can show that the vaccine prevents pneumonia in adults – something that’s been very difficult to show with any of the pneumococcal vaccines – then we would really have good evidence upon which to base the recommendation."

All of the sources for this story reported that they had no conflicts of interest.

ATLANTA – The 13-valent pneumococcal conjugate vaccine should be given to all immunocompromised adults aged 19 years and older, according to new recommendations from the Centers for Disease Control and Prevention.

In a unanimous vote at its June meeting, the CDC’s Advisory Committee on Immunization Practices said that the 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13]) is recommended for the same adults who are currently advised to receive two doses of the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax]), including those with immunocompromising conditions. Patients who are immunocompromised include individuals with HIV infection, hematologic cancer, solid cancer, organ transplant, chronic renal failure/nephrotic syndrome, and diseases requiring treatment with immunosuppressive drugs, as well as patients with functional or anatomic asplenia, cerebrospinal fluid leaks, and cochlear implants.

The new recommendation calls for the use of PCV13 in addition to PPSV23.

According to Dr. Sandra A. Fryhofer, the liaison to the Advisory Committee on Immunization Practices (ACIP) from the American College of Physicians, "We’re very excited that there’s finally some guidance for internists about what to do with immunocompromised patients. Of course, we don’t have all the data yet. ... But this is the best we could do for now. On the surface it’s a very complicated recommendation schedule, but I think as we get more experience with it, maybe it will get easier in the implementation," she said in an interview.

Immunocompromised individuals are at significantly elevated risk for invasive pneumococcal disease (IPD). According to one study, that risk is 173-fold higher among HIV-infected individuals and 186 times higher in those with hematologic cancer compared with age-matched controls (J. Infect. Dis. 2005;192:377-86).

A cost-effectiveness analysis presented at the meeting found that use of PCV13 was cost saving for all the immunocompromised groups together, and for dialysis patients specifically. For HIV-infected patients, the cost per quality-adjusted life year gained was $3,206, well within the bounds of what is considered cost effective, according to the CDC’s Dr. Charles Stoecker.

However, Dr. Fryhofer, of Emory University in Atlanta, noted that the relative costs of PCV13 and PPSV23 – $124.37 versus $55.02 per dose in 2009 – are also likely to factor into the decision about a broader recommendation for PCV13. "This vaccine is more than twice the price of the vaccine we’ve been using. Cost effectiveness is important, and we have to think about stewardship in our resources. But certainly, pneumococcal disease is a leading killer."

The decision for the use of PCV13 in immunocompromised people was made despite the fact that the only study on vaccine efficacy in such individuals investigated the previous 7-valent formulation of the vaccine (PCV7), and was conducted in HIV-infected adults in Malawi (N. Engl. J. Med. 2010;362:812-22). "The only data we have are quite limited and not always applicable to the population we’re looking at, but we believe the data are sufficient to determine that the vaccine may be beneficial in these populations and will not cause harm," ACIP pneumococcal working group chair Dr. Nancy M. Bennett said in an interview. No further vaccine efficacy data are anticipated for the immunocompromised groups, she noted.

The vote for use of PCV13 in immunocompromised adults was taken in two parts, one for those aged 19 and older who have never received a pneumococcal vaccine, and the other for those who already received one or more doses of PPSV23. The former group should receive a single dose of PCV13, followed by a dose of PPSV23 at least 8 weeks later. After that, the current recommendations remain unchanged: a second dose of PPSV23 5 years later, and another one at age 65 or later.

For immunocompromised adults aged 19 and older who have already received one or more doses of PPSV23, the recommendation is to give PCV13 1 year or longer after the most recent PPSV23 dose. A second dose of PPSV23 is recommended 1 or more years after the first PCV13 dose and 5 or more years after the first PPSV23 dose.

Prevnar 13 is licensed for the prevention of IPD in children aged 6 weeks through 5 years, and for the prevention of both IPD and pneumococcal pneumonia in adults aged 50 years and older. The adult licensure, announced by the Food and Drug Administration on Dec. 30, 2011, was based on data showing noninferior immunogenicity compared with PPSV23.

Wider Use Under Consideration

At its February 2012 meeting, the ACIP decided to defer a vote on recommending PCV13 for all adults aged 50 years and older until additional data become available. That vote could come as early as February 2013, but it is more likely to be made at the June 2013 ACIP meeting, said Dr. Bennett, professor of medicine and community and preventive medicine at the University of Rochester (N.Y.).

Specifically, the committee is awaiting two pieces of data before deciding whether to recommend the routine use of PCV13 in adults aged 50 years and older. One is the indirect impact on adults – the so-called herd effect – of the now-routine use of PCV13 in children. Data collected thus far suggest that there has already been a decline in IPD cases since PCV13 was introduced in 2010, specifically due to the PCV13 strains 19A and 7F, the CDC’s Dr. Matthew Moore said.

The committee is also waiting for PCV13 vaccine efficacy data from a large trial in the Netherlands titled CAPITA (Community Acquired Pneumonia Immunization Trial in Adults), which aims to establish the efficacy of PCV13 in the prevention of a first episode of vaccine-serotype specific pneumococcal CAP in 85,000 community-dwelling adults aged 65 years and older (Neth. J. Med. 2008;66:378-83).

"We are interested in whether or not this vaccine should be used in the general population over the age of 50," said Dr. Bennett. "Pneumococcal pneumonia is really the holy grail. That is what we would like to be preventing since it’s much more pervasive than invasive pneumococcal disease. But unfortunately, most studies look at [IPD] as the outcome rather than pneumonia. So [the CAPITA study] is very very important, because if we can show that the vaccine prevents pneumonia in adults – something that’s been very difficult to show with any of the pneumococcal vaccines – then we would really have good evidence upon which to base the recommendation."

All of the sources for this story reported that they had no conflicts of interest.