ACIP Expands Recommendation on PCV13 to Include Certain High-risk Kids, Teens

Additions to VFC Program Among Other Committee Actions

February 26, 2013 05:05 pm Matt Brown

The CDC's Advisory Committee on Immunization Practices (ACIP) voted to expand the age recommendation for administration of the 13-valent pneumococcal conjugate vaccine (PCV13) to certain individuals during its Feb. 20-21 meeting(www.cdc.gov) in Atlanta. Committee members also discussed and voted on a number of other vaccine-related issues of interest to family physicians.

According to Jamie Loehr, M.D., of Ithaca, N.Y., the AAFP's liaison to the ACIP, the committee voted unanimously to provisionally recommend that PCV13, which is marketed by Pfizer Inc. as Prevnar 13, routinely be given to immunocompromised, PCV13-naive children and adolescents ages 6 to18 years.

"The definition of immunocompromised that the committee used refers to (the fact that there is) a markedly increased rate of invasive pneumococcal disease in high-risk individuals with asplenia, cochlear implants, cerebrospinal fluid leaks, HIV and other immunocompromising conditions," Loehr said. Most family medicine practices won't see this scenario, he acknowledged, but FPs should be prepared for the eventuality. "In short, this is a very small group of very high-risk patients."

Loehr also noted that the recommendation will not be relevant in 15 years, specifically because physicians have been giving PCV13 vaccinations for the past three years.

story highlights

  • The CDC's Advisory Committee on Immunization Practices (ACIP) voted to recommend administration of the 13-valent pneumococcal conjugate vaccine (PCV13) to certain asplenic and/or immunocompromised, PCV13-naive children and teens ages 6 to18 years. This vaccine recommendation also was added to the CDC's Vaccines for Children (VFC) program.
  • The Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid vaccine (HibMenCY) was added to the VFC program for use as a Hib vaccine in certain infants at risk for meningitis.
  • The ACIP unanimously approved four new influenza vaccine types for use in the 2013-14 flu season: the quadrivalent live virus, quadrivalent inactivated, cell culture inactivated and recombinant flu vaccines.

"Basically, people are going to 'age out' of this because they will have gotten this shot as infants and then will not require a booster," he told AAFP News Now. "So (the PCV13 recommendation) is more of a catch-up over the next several years."

In a subsequent vote, committee members approved adding PCV13 for the same patient population to the CDC's Vaccines for Children (VFC) program.

Other Vaccine Changes, Approvals

Loehr said the committee discussed the Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid (HibMenCY) vaccine at length, eventually voting unanimously to include HibMenCY in the VFC program, but only for children at high risk for meningitis.

"The concern was that if VFC approved it, then HibMenCY would start being recommended for Hib protection, and that wasn't the goal when committee members voted on it four months ago," Loehr explained. "They felt that it was not a good recommendation to be using this vaccine for routine use.

"However, it is a valid Hib vaccine, so it is approved to be used with the understanding that it should also be used within the context of the meningitis recommendations."

The ACIP also unanimously approved four new influenza vaccine formulations for use in the 2013-14 flu season: the quadrivalent live virus, quadrivalent inactivated, cell culture inactivated and recombinant flu vaccines.

In addition, the committee reiterated its recommendation that everyone older than age 6 months should receive a flu vaccine each season, Loehr said.

General Immunization Recommendations

The ACIP made several other general provisional recommendations, the first dealing with timing and spacing of vaccinations.

"There is a 'grace period,' or four-day window, before the minimum date at which a vaccine will be considered acceptable," Loehr said. "For example, if the minimum age for hepatitis A is 12 months and the vaccine is given two days before the child's first birthday, that vaccine is considered valid.

"However, the live vaccine rule -- live vaccines must be given 28 days apart -- trumps the grace period rule. So, if a second live vaccine, such as varicella, is given 26 days after the first live vaccine, such as measles, mumps and rubella, the varicella immunization is not considered valid."

According to Loehr, the ACIP also concluded that although one additional febrile seizure can be expected among every 2,200 children who receive the inactivated influenza vaccine at the same time as the PCV13 vaccine, the benefit of simultaneous administration of the two vaccines outweighs the increased risk of febrile seizures.

In addition, ACIP members identified an exception to the usual rule that two inactivated vaccines can be given at the same time.

"Specifically, the simultaneous administration of PCV13 and (Sanofi Pasteur's HibMenCY vaccine) Menactra in patients with asplenia leads to a suboptimal response for some pneumococcal serotypes," Loehr said. "So, the recommendation is to give PCV13 first and then Menactra one month later."

ACIP recommendations are considered provisional until they have been approved by the CDC director and HHS and published in Morbidity and Mortality Weekly Report. Only after those steps have occurred would the recommendation be formally reviewed by the AAFP Commission on Health of the Public and Science's Subcommittee on Clinical Preventive Services for possible adoption.

Tdap, Future Meeting Topics

ACIP members received an update regarding immunization safety monitoring of the tetanus, diphtheria and acellular pertussis (Tdap) immunization program for pregnant women included in the 2012-13 schedules, said Loehr. Under the new guidelines, providers of prenatal care should administer a Tdap dose during each pregnancy irrespective of immunization history. If not administered during pregnancy, Tdap should be given immediately postpartum.

"The pertussis working group reported on the ongoing plans on immunization safety monitoring for Tdap administered to pregnant women," Loehr said. "They've talked about how they're going to (monitor) it, and, so far, no unusual pattern of maternal, fetal or infant outcomes has appeared. They also reported that studies are, hopefully, going to be completed in 2015 with more data, so they are paying attention to the concerns."

With regard to future ACIP discussions, Loehr said that although data suggest Tdap efficacy decreases with time, there's very clear evidence that indicates that Tdap revaccination, either at five or 10 years, provides robust protection with a similar safety profile.

"So the question that will probably come up in June is: 'What will the ACIP recommendation be for revaccination with Tdap?'" he said.


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