(Editor's Note: This story was modified after publication to clarify that the committee voted to adopt a Category B serogroup B meningococcal vaccine recommendation.)
During its June 24-25 meeting,(www.cdc.gov) the CDC's Advisory Committee on Immunization Practices (ACIP) voted to issue a Category B(www.cdc.gov) recommendation for the use of two serogroup B meningococcal (MenB) vaccines in patients ages 16-23 for short-term protection against the disease, with a preference for administration between ages 16 and 18.
Previously, the ACIP had recommended the two MenB vaccines -- Pfizer's Trumenba, which is given as a three-dose series, and Novartis' Bexsero, which is given as a two-dose series -- only for people ages 10 and older who are at increased risk for serogroup B meningococcal disease. High-risk groups include those with persistent complement component deficiencies, anatomic or functional asplenia, microbiologists working with serogroup B meningitis, and populations at risk because of outbreaks.
The FDA-approved indication for MenB vaccine is limited to those ages 10-25, but the ACIP saw no theoretical difference in calling for its use in older individuals and so broadened the recommendation.
AAFP liaison to the ACIP Jamie Loehr, M.D., of Ithaca, N.Y., told AAFP News that at this meeting, the group decided to expand the recommendation beyond just those at high risk to individuals ages 16-23 via a B recommendation because the committee concluded that "this is a very deadly disease that's devastating for families, and if we didn't have a B recommendation (and, consequently, mandatory insurance coverage), there would be inequity as to who could afford it." On the other hand, Loehr added, the vaccine wasn't sufficiently cost-effective to warrant an A recommendation.
- During its June 24-25 meeting, the CDC's Advisory Committee on Immunization Practices (ACIP) adopted a Category B recommendation for use of the two serogroup B meningococcal vaccines in patients ages 16-23 for short-term protection against the disease.
- For children ages 6 months to 9 years, the ACIP recommended that if a child has previously received two or more total doses of trivalent or quadrivalent influenza vaccine, the child only needs one dose in the 2015-2016 season.
- The ACIP voted to recommend that for patients 65 and older, the interval between administration of 13-valent pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine be one year regardless of which vaccine was given first.
Among concerns expressed during the ACIP meeting about the MenB vaccine recommendation were those involving side effects from the vaccines, said Loehr. In two related studies, anaphylaxis was seen in some vaccine recipients, with one case per 11,000 in one study and one case per 59,000 in another.
Family physician and ACIP voting member Douglas Campos-Outcalt, M.D., M.P.A., of Phoenix, told AAFP News that another concern linked to the B recommendation was paying for universal vaccination of those ages 16-23, which he estimated would cost roughly $2 billion to $4 billion, while the number of infections and deaths prevented would be very few. The entire CDC budget is $6 billion to $7 billion, he pointed out.
"I do not want to downplay the significance of a death from meningitis -- each death takes a human toll -- I just want to put this debate on meningococcus B into perspective," Campos-Outcalt said.
Loehr said that 14 public comments were introduced during the MenB discussion -- the most he had ever seen at an ACIP meeting. Commenters included a parent of a child who had died of the disease, who sought to ensure that the child was not viewed simply as a statistic. The National Meningitis Association also sent a petition with more than 1,200 signatures requesting a broad-based recommendation.
Deborah Wexler, M.D., from the Immunization Action Coalition, requested the ACIP recommendation be clear and simple and also that the costs to families dealing with the disease and those associated with managing outbreaks at colleges be considered.
Influenza Vaccination and Miscarriage
The ACIP's Influenza Work Group presented a study at the meeting that showed an increased risk for staphylococcal bacteremia spontaneous abortion (SAB) among women in their first trimester of pregnancy who had received the annual influenza vaccine in the previous 28 days.
The case-control study covered the 2010-2011 and 2011-2012 influenza seasons and included 485 patients in each arm. The research showed an adjusted odds ratio of 2.0 (1.1-3.6) for receipt of the trivalent inactivated influenza vaccine in the 28 days before SAB compared to an unvaccinated window.
FP Jonathan Temte
Recognized for ACIP work
Anne Schuchat, M.D., assistant surgeon general and director of the CDC's National Center for Immunization and Respiratory Diseases, offered outgoing CDC Advisory Committee on Immunization Practices (ACIP) Chair and family physician Jonathan Temte, M.D., Ph.D., of Madison, Wis., a heartfelt thank you for his long service to the ACIP during the group's June 24-25 meeting.
Schuchat pointed out that Temte had attended 36 straight ACIP meetings, first as the AAFP's liaison to the group, then as an ACIP voting member and, finally, as its chair.
Current AAFP liaison to the ACIP Jamie Loehr, M.D., of Ithaca, N.Y., echoed these sentiments when he told AAFP News that during his tenure, Temte has offered invaluable service to both the AAFP and the ACIP.
"He brought great analysis and evidence-based thinking to the panel," Loehr said.
However, Loehr noted, this study contradicts several other studies on the topic, including two recently published meta-analyses that contained much larger numbers of participants that he examined after the meeting.
"When I look at those meta-analyses, which included several studies and very large numbers (one with more than 60,000 for SAB), I am more comfortable with the safety of influenza vaccines for pregnant women," Loehr said. "But this is an area where I think we still need ongoing surveillance."
According to information from the Influenza Work Group that was presented during the meeting, good evidence indicates that immunization with high-dose versus standard-dose influenza vaccine is associated with a decreased rate of laboratory-confirmed influenza, but no good evidence shows that rates of severe influenza complications such as pneumonia, hospitalization and death drop as a result.
"Thus, (committee members) did not feel a preferential recommendation was warranted at this time," Loehr said.
One observational study(www.thelancet.com) published in March in The Lancet Infectious Diseases was not included in time for this GRADE (grading for recommendations, assessment, development and evaluations) analysis but could be in the future, Loehr said. It showed high-dose influenza vaccine was 22 percent more effective in patients 65 and older than standard-dose vaccine in preventing probable influenza (i.e., nonlaboratory-confirmed) and influenza hospital admissions.
For children ages 6 months to 9 years, the ACIP recommended that if a child has previously received two or more total doses of trivalent or quadrivalent influenza vaccine, the child only needs one dose in the 2015-2016 season. In all other instances (including unknown vaccination status), the child should receive two doses for the 2015-2016 season.
Pneumococcal Vaccine Interval
The ACIP also voted to recommend that for patients 65 and older, the interval between administration of 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar) and pneumococcal polysaccharide vaccine (PPSV23; Pneumovax) be one year regardless of which vaccine was given first.
Previously, the interval protocol was to administer the second dose at one year or more if PPSV23 was given first but only six months later if PCV13 was given initially. This led to confusion.
"There wasn't data to show that the six to 12 months was necessary, and (the CDC) was getting so many questions about why is it six months one way but one year if given in reverse, the ACIP decided to make things uniform," Loehr said.
He added that the immunity data for administering the vaccines one year apart are favorable, and this timing already is covered under Medicare's policy.
October ACIP Meeting
According to Loehr, one hot topic at the Oct. 29-30 ACIP meeting might stem from questions the CDC has fielded about administering the nine-valent HPV vaccine (HPV9; Gardasil 9) after a full series of the quadrivalent vaccine (HPV4; Gardasil) has been given.
He said the ACIP could potentially release guidance on transitioning from HPV4 to HPV9, but at present, the group is not recommending a series of HPV9 if a patient has already received a full series of HPV4.
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