CDC ACIP 3090-12

ATLANTA – Despite federal efforts to make adult immunization a higher priority, recent increases in use have been modest at best, according to Dr. Walter W. Williams an epidemiologist with the Centers for Disease Control and Prevention.

In a comparison of 2009 and 2010 data from the NHIS (National Health Interview Survey), an annual in-home survey that includes 7,624 noninstitutionalized adults aged 19-64 years, Dr. Williams found that the use of tetanus-diphtheria-acellular pertussis (Tdap) vaccination, for example, increased by almost 2%, rising to 8%. Herpes zoster vaccination rates among those aged 60 years and older increased by 4%, rising to 14%. And human papillomavirus (HPV) vaccination rates among women aged 19-26 years increased by nearly 4%, rising to 21%.

Racial disparities were seen for nearly all immunization rates, with non-Hispanic whites generally having higher rates than did black, Hispanic, or Asian adults. Pneumococcal vaccine coverage among adults aged 65 years and older was 64% for whites, compared with 46% for blacks and 39% for Hispanics/Latinos. Receipt of zoster vaccine among those at least aged 60 years was 17% for whites, compared with 5% for blacks and 4% for Hispanics/Latinos.

"These data highlight the problems that we have with our adult program or lack thereof," said Kristen R. Ehresmann, R.N., the director of the infectious disease epidemiology, prevention and control division of the Minnesota Department of Health, St. Paul.

Sara Rosenbaum, an attorney and a member of the CDC’s Advisory Committee on Immunization Practices, concurred. "I think these data are testament to the fact that we don’t really have an adult immunization program," she said, noting the lack of funding.

Ms. Rosenbaum, who teaches at George Washington University in Washington, also noted that "the zoster numbers tell us that there’s something terribly wrong right now with the way Medicare immunization coverage works for zoster," referring to the current system whereby Medicare covers Zostavax under Part D (prescription drug coverage), which physicians can’t bill directly.

But Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases countered that although the Medicare issue has been a "headache," the primary concern about Zostavax has been a supply problem, which is now resolved. Moreover, the vaccine is recommended for adults beginning at age 60, and most who are aged 60-65 are insured privately. "We actually have an opportunity now that the supply is good for every stakeholder to try to take advantage of a good vaccine for a very common bad disease, at least in the population that couldn’t access it because of supply, and now they can," she said.

Sandra A. Fryhofer, the ACIP liaison from the American College of Physicians (ACP), said that she found these latest data "very sobering. ... The excitement that we in this room share for adult vaccination has to go outside this room and out to our physicians and other providers."

Part of the problem for physicians in the trenches may be the failure of their reminder systems, said ACIP member Dr. Jonathan Temte, a family physician. "When I see children in my practice, it’s largely a well-care [visit] and vaccines are a big part [of those]. When I see my typical older adult for well care, I’m seeing six or seven or eight comorbid conditions at the same time. ... For adult immunizations, having reminder systems that are flawlessly built into your [electronic medical record] systems are so very important."

However, "most of us ... unfortunately have even learned how to ignore the warnings that pop up on our EMR screens because of all the chaos. We need to do a better job with those reminder systems," said Dr. Temte, professor of family medicine at the University of Wisconsin, Madison.

Signs that adult vaccination is moving up on the priority list include the fact it has gained increasing amounts of airtime at the thrice-yearly meetings held by ACIP. Back in the 1990s, the agendas for those meetings may have included one or two adult-focused topics amidst a much longer list of pediatric vaccine issues.

Today, some ACIP agendas are almost entirely geared toward adults. At the recent June meeting, topics included the use of the 13-valent conjugate pneumococcal vaccine for immunocompromised adults, hepatitis B vaccine for health care personnel in whom protection is uncertain, and postexposure prophylaxis with anthrax vaccine, as well as an entire session specifically focused on the woefully low rates of vaccine coverage for prevention of noninfluenza conditions among adults.

Dr. Carolyn B. Bridges, associate director for Adult Immunizations at the CDC’s Immunization Services Division, reported on the first-ever National Adult Immunization Summit, held May 15-17 in Atlanta. Sponsored by the American Medical Association, the National Vaccine Program Office, and the CDC, the meeting was patterned after the National Influenza Vaccine Summit (www.preventinfluenza.org).

Key action items were identified by five working groups that were formed to address patient, provider, and decision-maker education; access and collaboration; and quality/performance measures. In addition, an Interagency Adult Immunization Task Force was initiated within the U.S. Department of Health and Human Services.

Among the needs identified were improved documentation/communication via immunization information systems and EMRs; decreased policy and legal barriers for vaccine providers; increased education and incentivization of providers, such as via performance or quality measures; and decreased complexity of the adult vaccination schedule. Over the next several weeks, the AMA, the CDC, and the NVPO will develop an initial list of key action items and will prepare proceedings of the summit for submission to a peer-reviewed journal. Another Adult Immunization Summit is anticipated for 2013, Dr. Bridges said.

In the meantime, here’s a helpful resource list developed from the summit.

None of the sources in this story reported having conflicts of interest.

ATLANTA – Despite federal efforts to make adult immunization a higher priority, recent increases in use have been modest at best, according to Dr. Walter W. Williams an epidemiologist with the Centers for Disease Control and Prevention.

In a comparison of 2009 and 2010 data from the NHIS (National Health Interview Survey), an annual in-home survey that includes 7,624 noninstitutionalized adults aged 19-64 years, Dr. Williams found that the use of tetanus-diphtheria-acellular pertussis (Tdap) vaccination, for example, increased by almost 2%, rising to 8%. Herpes zoster vaccination rates among those aged 60 years and older increased by 4%, rising to 14%. And human papillomavirus (HPV) vaccination rates among women aged 19-26 years increased by nearly 4%, rising to 21%.

Racial disparities were seen for nearly all immunization rates, with non-Hispanic whites generally having higher rates than did black, Hispanic, or Asian adults. Pneumococcal vaccine coverage among adults aged 65 years and older was 64% for whites, compared with 46% for blacks and 39% for Hispanics/Latinos. Receipt of zoster vaccine among those at least aged 60 years was 17% for whites, compared with 5% for blacks and 4% for Hispanics/Latinos.

"These data highlight the problems that we have with our adult program or lack thereof," said Kristen R. Ehresmann, R.N., the director of the infectious disease epidemiology, prevention and control division of the Minnesota Department of Health, St. Paul.

Sara Rosenbaum, an attorney and a member of the CDC’s Advisory Committee on Immunization Practices, concurred. "I think these data are testament to the fact that we don’t really have an adult immunization program," she said, noting the lack of funding.

Ms. Rosenbaum, who teaches at George Washington University in Washington, also noted that "the zoster numbers tell us that there’s something terribly wrong right now with the way Medicare immunization coverage works for zoster," referring to the current system whereby Medicare covers Zostavax under Part D (prescription drug coverage), which physicians can’t bill directly.

But Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases countered that although the Medicare issue has been a "headache," the primary concern about Zostavax has been a supply problem, which is now resolved. Moreover, the vaccine is recommended for adults beginning at age 60, and most who are aged 60-65 are insured privately. "We actually have an opportunity now that the supply is good for every stakeholder to try to take advantage of a good vaccine for a very common bad disease, at least in the population that couldn’t access it because of supply, and now they can," she said.

Sandra A. Fryhofer, the ACIP liaison from the American College of Physicians (ACP), said that she found these latest data "very sobering. ... The excitement that we in this room share for adult vaccination has to go outside this room and out to our physicians and other providers."

Part of the problem for physicians in the trenches may be the failure of their reminder systems, said ACIP member Dr. Jonathan Temte, a family physician. "When I see children in my practice, it’s largely a well-care [visit] and vaccines are a big part [of those]. When I see my typical older adult for well care, I’m seeing six or seven or eight comorbid conditions at the same time. ... For adult immunizations, having reminder systems that are flawlessly built into your [electronic medical record] systems are so very important."

However, "most of us ... unfortunately have even learned how to ignore the warnings that pop up on our EMR screens because of all the chaos. We need to do a better job with those reminder systems," said Dr. Temte, professor of family medicine at the University of Wisconsin, Madison.

Signs that adult vaccination is moving up on the priority list include the fact it has gained increasing amounts of airtime at the thrice-yearly meetings held by ACIP. Back in the 1990s, the agendas for those meetings may have included one or two adult-focused topics amidst a much longer list of pediatric vaccine issues.

Today, some ACIP agendas are almost entirely geared toward adults. At the recent June meeting, topics included the use of the 13-valent conjugate pneumococcal vaccine for immunocompromised adults, hepatitis B vaccine for health care personnel in whom protection is uncertain, and postexposure prophylaxis with anthrax vaccine, as well as an entire session specifically focused on the woefully low rates of vaccine coverage for prevention of noninfluenza conditions among adults.

Dr. Carolyn B. Bridges, associate director for Adult Immunizations at the CDC’s Immunization Services Division, reported on the first-ever National Adult Immunization Summit, held May 15-17 in Atlanta. Sponsored by the American Medical Association, the National Vaccine Program Office, and the CDC, the meeting was patterned after the National Influenza Vaccine Summit (www.preventinfluenza.org).

Key action items were identified by five working groups that were formed to address patient, provider, and decision-maker education; access and collaboration; and quality/performance measures. In addition, an Interagency Adult Immunization Task Force was initiated within the U.S. Department of Health and Human Services.

Among the needs identified were improved documentation/communication via immunization information systems and EMRs; decreased policy and legal barriers for vaccine providers; increased education and incentivization of providers, such as via performance or quality measures; and decreased complexity of the adult vaccination schedule. Over the next several weeks, the AMA, the CDC, and the NVPO will develop an initial list of key action items and will prepare proceedings of the summit for submission to a peer-reviewed journal. Another Adult Immunization Summit is anticipated for 2013, Dr. Bridges said.

In the meantime, here’s a helpful resource list developed from the summit.

None of the sources in this story reported having conflicts of interest.

ATLANTA – Despite federal efforts to make adult immunization a higher priority, recent increases in use have been modest at best, according to Dr. Walter W. Williams an epidemiologist with the Centers for Disease Control and Prevention.

In a comparison of 2009 and 2010 data from the NHIS (National Health Interview Survey), an annual in-home survey that includes 7,624 noninstitutionalized adults aged 19-64 years, Dr. Williams found that the use of tetanus-diphtheria-acellular pertussis (Tdap) vaccination, for example, increased by almost 2%, rising to 8%. Herpes zoster vaccination rates among those aged 60 years and older increased by 4%, rising to 14%. And human papillomavirus (HPV) vaccination rates among women aged 19-26 years increased by nearly 4%, rising to 21%.

Racial disparities were seen for nearly all immunization rates, with non-Hispanic whites generally having higher rates than did black, Hispanic, or Asian adults. Pneumococcal vaccine coverage among adults aged 65 years and older was 64% for whites, compared with 46% for blacks and 39% for Hispanics/Latinos. Receipt of zoster vaccine among those at least aged 60 years was 17% for whites, compared with 5% for blacks and 4% for Hispanics/Latinos.

"These data highlight the problems that we have with our adult program or lack thereof," said Kristen R. Ehresmann, R.N., the director of the infectious disease epidemiology, prevention and control division of the Minnesota Department of Health, St. Paul.

Sara Rosenbaum, an attorney and a member of the CDC’s Advisory Committee on Immunization Practices, concurred. "I think these data are testament to the fact that we don’t really have an adult immunization program," she said, noting the lack of funding.

Ms. Rosenbaum, who teaches at George Washington University in Washington, also noted that "the zoster numbers tell us that there’s something terribly wrong right now with the way Medicare immunization coverage works for zoster," referring to the current system whereby Medicare covers Zostavax under Part D (prescription drug coverage), which physicians can’t bill directly.

But Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases countered that although the Medicare issue has been a "headache," the primary concern about Zostavax has been a supply problem, which is now resolved. Moreover, the vaccine is recommended for adults beginning at age 60, and most who are aged 60-65 are insured privately. "We actually have an opportunity now that the supply is good for every stakeholder to try to take advantage of a good vaccine for a very common bad disease, at least in the population that couldn’t access it because of supply, and now they can," she said.

Sandra A. Fryhofer, the ACIP liaison from the American College of Physicians (ACP), said that she found these latest data "very sobering. ... The excitement that we in this room share for adult vaccination has to go outside this room and out to our physicians and other providers."

Part of the problem for physicians in the trenches may be the failure of their reminder systems, said ACIP member Dr. Jonathan Temte, a family physician. "When I see children in my practice, it’s largely a well-care [visit] and vaccines are a big part [of those]. When I see my typical older adult for well care, I’m seeing six or seven or eight comorbid conditions at the same time. ... For adult immunizations, having reminder systems that are flawlessly built into your [electronic medical record] systems are so very important."

However, "most of us ... unfortunately have even learned how to ignore the warnings that pop up on our EMR screens because of all the chaos. We need to do a better job with those reminder systems," said Dr. Temte, professor of family medicine at the University of Wisconsin, Madison.

Signs that adult vaccination is moving up on the priority list include the fact it has gained increasing amounts of airtime at the thrice-yearly meetings held by ACIP. Back in the 1990s, the agendas for those meetings may have included one or two adult-focused topics amidst a much longer list of pediatric vaccine issues.

Today, some ACIP agendas are almost entirely geared toward adults. At the recent June meeting, topics included the use of the 13-valent conjugate pneumococcal vaccine for immunocompromised adults, hepatitis B vaccine for health care personnel in whom protection is uncertain, and postexposure prophylaxis with anthrax vaccine, as well as an entire session specifically focused on the woefully low rates of vaccine coverage for prevention of noninfluenza conditions among adults.

Dr. Carolyn B. Bridges, associate director for Adult Immunizations at the CDC’s Immunization Services Division, reported on the first-ever National Adult Immunization Summit, held May 15-17 in Atlanta. Sponsored by the American Medical Association, the National Vaccine Program Office, and the CDC, the meeting was patterned after the National Influenza Vaccine Summit (www.preventinfluenza.org).

Key action items were identified by five working groups that were formed to address patient, provider, and decision-maker education; access and collaboration; and quality/performance measures. In addition, an Interagency Adult Immunization Task Force was initiated within the U.S. Department of Health and Human Services.

Among the needs identified were improved documentation/communication via immunization information systems and EMRs; decreased policy and legal barriers for vaccine providers; increased education and incentivization of providers, such as via performance or quality measures; and decreased complexity of the adult vaccination schedule. Over the next several weeks, the AMA, the CDC, and the NVPO will develop an initial list of key action items and will prepare proceedings of the summit for submission to a peer-reviewed journal. Another Adult Immunization Summit is anticipated for 2013, Dr. Bridges said.

In the meantime, here’s a helpful resource list developed from the summit.

None of the sources in this story reported having 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.

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 2012-2013 influenza vaccination statement from the Centers for Disease Control and Prevention’s vaccine advisory panel is expected to contain a new algorithm for children aged 6 months through 8 years to determine whether they need one or two doses.

The CDC’s Advisory Committee on Immunization Practices voted to approve the same algorithm approved by the American Academy of Pediatrics’ Committee on Infectious Disease earlier this year:

© Yarinca/istockphoto.com

• First, has the child ever received influenza vaccine?

• If yes, did the child receive two or more total doses of seasonal vaccine since July 2010?

• If yes, give one dose. If not, or if the information isn’t known, give two doses.

• If the child has never received influenza vaccine or the information isn’t known, give two doses.

The algorithm was necessary because children younger than 9 years of age need two doses of seasonal vaccine in order to establish immune system priming, and two out of the three influenza strains included in the 2012-2013 influenza vaccine – A/Victoria/361/2011 (H3N2) and B/Wisconsin/1/2010 – are different from those of the 2011-2012 vaccine. The one that remains the same is the 2009 pandemic strain A/California/7/2009, which was available in 2009 as a monovalent vaccine and then was included in the seasonal 2010-2011 and 2011-2012 flu vaccines, said Dr. Lisa Grohskopf of the CDC’s Influenza Division.

The algorithm was designed to be simple, the AAP’s liaison Dr. Michael T. Brady said in an interview. "Thirty-five percent or so of children receive vaccines outside of their medical home. That creates a problem with access to the information. Also, many pediatricians will set up vaccine clinics designed to move children through quickly. ... You’d like to make it so that any child who needs two gets two [doses of the flu vaccine]."

But, he said, if the information is available, then the option is still there to use it. "The option is, do you want to put the onus on the pediatrician to try to track everything down, or do you want to try to make it more fail-safe so that it’s easier? What this does in general is make it simple. But if you want to get the information and avoid an extra dose, that’s fine," said Dr. Brady, professor and chair of pediatrics at the Ohio State University and Nationwide Children’s Hospital, both in Columbus.

Once adopted by the CDC and published in the CDC’s Morbidity and Mortality Report, the influenza vaccine statement will also contain information about the strains selected for 2012-2013, a reiteration of the universal recommendation for flu vaccine for all individuals aged 6 months and older, and an acknowledgement of the recently-approved quadrivalent live attenuated vaccine, which is expected to be available for the 2013-2014.

The statement also will include an update of an investigation into an increased risk for febrile seizures associated with receipt of the trivalent inactivated influenza vaccine (TIV) in conjunction with the 13-valent pneumococcal conjugate vaccine. The elevated risk was seen for seizures following TIV in children aged 6-23 months in surveillance data for 2011-2012 among children aged 6-23 months, but not in those aged 24-59 months.

At the meeting, the committee also voted use of the vaccine via the new algorithm into the federal Vaccines for Children Program.

As a CDC employee, Dr. Grohskopf has no disclosures. Dr. Brady stated that he has no relevant financial disclosures.

ATLANTA – The 2012-2013 influenza vaccination statement from the Centers for Disease Control and Prevention’s vaccine advisory panel is expected to contain a new algorithm for children aged 6 months through 8 years to determine whether they need one or two doses.

The CDC’s Advisory Committee on Immunization Practices voted to approve the same algorithm approved by the American Academy of Pediatrics’ Committee on Infectious Disease earlier this year:

© Yarinca/istockphoto.com

• First, has the child ever received influenza vaccine?

• If yes, did the child receive two or more total doses of seasonal vaccine since July 2010?

• If yes, give one dose. If not, or if the information isn’t known, give two doses.

• If the child has never received influenza vaccine or the information isn’t known, give two doses.

The algorithm was necessary because children younger than 9 years of age need two doses of seasonal vaccine in order to establish immune system priming, and two out of the three influenza strains included in the 2012-2013 influenza vaccine – A/Victoria/361/2011 (H3N2) and B/Wisconsin/1/2010 – are different from those of the 2011-2012 vaccine. The one that remains the same is the 2009 pandemic strain A/California/7/2009, which was available in 2009 as a monovalent vaccine and then was included in the seasonal 2010-2011 and 2011-2012 flu vaccines, said Dr. Lisa Grohskopf of the CDC’s Influenza Division.

The algorithm was designed to be simple, the AAP’s liaison Dr. Michael T. Brady said in an interview. "Thirty-five percent or so of children receive vaccines outside of their medical home. That creates a problem with access to the information. Also, many pediatricians will set up vaccine clinics designed to move children through quickly. ... You’d like to make it so that any child who needs two gets two [doses of the flu vaccine]."

But, he said, if the information is available, then the option is still there to use it. "The option is, do you want to put the onus on the pediatrician to try to track everything down, or do you want to try to make it more fail-safe so that it’s easier? What this does in general is make it simple. But if you want to get the information and avoid an extra dose, that’s fine," said Dr. Brady, professor and chair of pediatrics at the Ohio State University and Nationwide Children’s Hospital, both in Columbus.

Once adopted by the CDC and published in the CDC’s Morbidity and Mortality Report, the influenza vaccine statement will also contain information about the strains selected for 2012-2013, a reiteration of the universal recommendation for flu vaccine for all individuals aged 6 months and older, and an acknowledgement of the recently-approved quadrivalent live attenuated vaccine, which is expected to be available for the 2013-2014.

The statement also will include an update of an investigation into an increased risk for febrile seizures associated with receipt of the trivalent inactivated influenza vaccine (TIV) in conjunction with the 13-valent pneumococcal conjugate vaccine. The elevated risk was seen for seizures following TIV in children aged 6-23 months in surveillance data for 2011-2012 among children aged 6-23 months, but not in those aged 24-59 months.

At the meeting, the committee also voted use of the vaccine via the new algorithm into the federal Vaccines for Children Program.

As a CDC employee, Dr. Grohskopf has no disclosures. Dr. Brady stated that he has no relevant financial disclosures.

ATLANTA – The 2012-2013 influenza vaccination statement from the Centers for Disease Control and Prevention’s vaccine advisory panel is expected to contain a new algorithm for children aged 6 months through 8 years to determine whether they need one or two doses.

The CDC’s Advisory Committee on Immunization Practices voted to approve the same algorithm approved by the American Academy of Pediatrics’ Committee on Infectious Disease earlier this year:

© Yarinca/istockphoto.com

• First, has the child ever received influenza vaccine?

• If yes, did the child receive two or more total doses of seasonal vaccine since July 2010?

• If yes, give one dose. If not, or if the information isn’t known, give two doses.

• If the child has never received influenza vaccine or the information isn’t known, give two doses.

The algorithm was necessary because children younger than 9 years of age need two doses of seasonal vaccine in order to establish immune system priming, and two out of the three influenza strains included in the 2012-2013 influenza vaccine – A/Victoria/361/2011 (H3N2) and B/Wisconsin/1/2010 – are different from those of the 2011-2012 vaccine. The one that remains the same is the 2009 pandemic strain A/California/7/2009, which was available in 2009 as a monovalent vaccine and then was included in the seasonal 2010-2011 and 2011-2012 flu vaccines, said Dr. Lisa Grohskopf of the CDC’s Influenza Division.

The algorithm was designed to be simple, the AAP’s liaison Dr. Michael T. Brady said in an interview. "Thirty-five percent or so of children receive vaccines outside of their medical home. That creates a problem with access to the information. Also, many pediatricians will set up vaccine clinics designed to move children through quickly. ... You’d like to make it so that any child who needs two gets two [doses of the flu vaccine]."

But, he said, if the information is available, then the option is still there to use it. "The option is, do you want to put the onus on the pediatrician to try to track everything down, or do you want to try to make it more fail-safe so that it’s easier? What this does in general is make it simple. But if you want to get the information and avoid an extra dose, that’s fine," said Dr. Brady, professor and chair of pediatrics at the Ohio State University and Nationwide Children’s Hospital, both in Columbus.

Once adopted by the CDC and published in the CDC’s Morbidity and Mortality Report, the influenza vaccine statement will also contain information about the strains selected for 2012-2013, a reiteration of the universal recommendation for flu vaccine for all individuals aged 6 months and older, and an acknowledgement of the recently-approved quadrivalent live attenuated vaccine, which is expected to be available for the 2013-2014.

The statement also will include an update of an investigation into an increased risk for febrile seizures associated with receipt of the trivalent inactivated influenza vaccine (TIV) in conjunction with the 13-valent pneumococcal conjugate vaccine. The elevated risk was seen for seizures following TIV in children aged 6-23 months in surveillance data for 2011-2012 among children aged 6-23 months, but not in those aged 24-59 months.

At the meeting, the committee also voted use of the vaccine via the new algorithm into the federal Vaccines for Children Program.

As a CDC employee, Dr. Grohskopf has no disclosures. Dr. Brady stated that he has no relevant financial disclosures.