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Highlights from June Meeting of Advisory Committee on Immunization Practices

June 30, 2016 1 comment

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Three times a year a specialized group of medical and public health experts meet to review scientific data related to vaccine safety and effectiveness. This group, known as the Advisory Committee on Immunization Practices (ACIP), has an enormous responsibility.  They establish, update and continually evaluate all the vaccine recommendations that are made in the United States for infants, adolescents and adults. Health insurance coverage of vaccines is based on these recommendations and the ACIP guidelines are considered the gold standard among healthcare providers.

Last week, in their second meeting of 2016, the ACIP discussed cholera, meningococcal, hepatitis, influenza, RSV and HPV vaccines, as well as the safety of maternal Tdap immunization and the laboratory containment of Poliovirus Type 2.  

Below you will find a recap of the highlights of the June 2016 ACIP meeting to help keep you informed of the latest ACIP recommendations and considerations. 

Influenza Vaccine

The most significant and somewhat surprising decision that occurred during last week’s ACIP meeting was that the Committee voted in favor of an interim recommendation that live attenuated influenza vaccine (LAIV), also known as the nasal spray flu vaccine, should not be used during the 2016-2017 flu season. 

The vote followed an extensive review of data investigating the effectiveness of the nasal spray flu vaccine over the past three flu seasons.  The data showed vaccine effectiveness for nasal spray vaccine among children 2 through 17 years during 2015-2016 was only 3% effective (with a 95% Confidence Interval of -49-37%). In comparison, flu shots had a vaccine effectiveness estimate of 63% against any flu virus among children 2 through 17 years (with a 95% Confidence Interval of 52-72%). This estimate clearly indicates that while no protective benefit could be measured from the nasal spray vaccine in this past season, flu shots provided measurable protection in comparison.

The disappointing vaccine effectiveness data for the nasal spray vaccine during the 2015-2016 season follows two previous seasons (2013-2014 and 2014-2015) that also showed poor and/or lower than expected vaccine effectiveness for LAIV.  (More information about past LAIV VE data is available here.)

child_h1n1_flu_shotWhile it’s disheartening to see data suggesting that the nasal spray flu vaccine did not work as well as expected, the data did suggest that flu shots did perform well and offered substantial protection against influenza this past season. Some patients prefer the nasal spray flu vaccine due to an aversion to needles and may be disappointed in this vote. However, the action taken by the ACIP  emphasizes the important role they fill in continually measuring and evaluating vaccine effectiveness.  Only after a thorough review of the latest scientific data and discussion among the Committee do they decide to alter vaccine recommendations to ensure that they are in the best interest of the public’s health.

ACIP continues to recommend annual flu vaccination, with either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV) for everyone 6 months and older and the CDC expects that there should be no shortage of injectable vaccines.  However, it should be noted that with the ACIP vote the nasal spray flu vaccine should not be used during the 2016-2017 season and therefore should not be offered by providers or clinics and will not be covered under the Vaccines For Children (VFC) program.

Cholera Vaccine

A vote was taken to recommend the vaccine for people traveling to high risk areas. 

For more information about cholera visit the CDC travel page here and for up-to-date travel alerts that address various destinations and diseases, we recommend visiting Passport Health’s travel alerts here.

Meningococcal Vaccine

The first part of the discussion of meningococcal vaccines was a consideration of the data on the serogroup B vaccine Trumenba.  This particular vaccine is currently administered on a three dose schedule, however Pfizer’s Dr. Laura York indicated during her presentation that the FDA has approved both a 2 and 3 dose schedule based on the data showing both schedules to be considered safe and effective.  While immunity data suggests that the 3 dose schedule may confer slightly greater immunity over longer periods of time, the 2 dose schedule would be considered optimal in the case of an outbreak or when it is important to confer rapid immunity.   The committee will be reviewing more data on the duration of immunity and the safety of a 2 dose versus 3 dose schedule at the October meeting, before a formal recommendation is made for persons at increased risk, for use during outbreaks or for all healthy adolescents. Read more…

New ACIP Recommendations for Meningococcal, Influenza and HPV Vaccines

March 10, 2015 3 comments
Photo Credit: James Gathany, Centers for Disease Control and Prevention

Photo Credit: James Gathany, Centers for Disease Control and Prevention

written by: Amy Pisani, MS, Executive Director, Every Child By Two

The Advisory Committee on Immunization Practices (ACIP) conducted an abbreviated meeting on February 26, 2015 due to the threat of a winter storm in the Atlanta, Georgia region.  The ACIP, which consists of 15 voting members who have expertise in vaccinology, immunology, healthcare and public health, makes recommendations to the Centers for Disease Control and Prevention (CDC) regarding vaccinations approved for use by the Food and Drug Administration (FDA).  The recommendations pertain to the timing and intervals of vaccines which are included on the childhood, adolescent and adult immunization schedules.   At this February meeting, the ACIP conducted three important votes which altered or created new recommendations for meningococcal vaccine, influenza vaccine and HPV vaccine.  

Meningococcal Serogroup B Vaccine

Two new vaccines to protect against meningococcal serogroup B, which has been spreading through college campuses in recent years, were recently approved by the FDA. The Trumenba vaccine is developed by Pfizer Pharmaceuticals and requires three doses and the Bexsero vaccine has been developed by Novartis Vaccines and Diagnostics requiring two doses.  The ACIP has previously recommended one dose of MCV4 vaccine at ages 11-12, and a booster at age 16 to protects against the A, C, W and Y strains of meningococcal bacteria   Nearly 80% of teens between the ages of 13 and 17 have received at least one dose of the MCV4 vaccine, which is fairly remarkable considering the fact that it is recommended, but not mandated for use within states nationwide.  However, because of the complicated nature of the virus, the new meningococcal serogroup B vaccine would require a separate series of shots, in addition to those recommended for MCV4 vaccine.

The serogroup B strain of meningococcal is considered the most common cause of meningococcal disease  among adolescents here in the U.S. with a fatality rate of 12 percent in 11-19 year olds and 17 percent in 20 year olds over the last 14 years.  While the number of meningococcal cases have declined since 1996, many advocates believe that the aggressive nature of this disease, which often kills or maims it’s victims within hours, necessitates a broad recommendation for the vaccine.  However, the ACIP discussion at the February meeting was limited to recommendations for those at high risk for serogroup B infection, with a follow up vote anticipated at the upcoming June meeting where the Committee will review data and make a determination on whether to recommend the vaccine for a broader population. Authors note-  added June 2015: At the June ACIP meeting the following recommendation was made “A serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age.”

Several advocates traveled to the meeting to provide their testimonials.  These included parents of those lost to the disease as well as survivors who have suffered amputations and serious life-long health consequences of this invasive disease.  Dr. Mary Ferris, who helped lead efforts to contain the 2014 meningococcal outbreak at University of California’s Santa Barbara campus, provided compelling testimony regarding the impact of the outbreak on the university.  Ferris noted that four cases, one of which led to the amputation of a student, spread panic throughout the campus and the local community.  Students were banned from volunteering at the on-campus daycare and attempts were made by the local community to close the campus entirely.   Dr. Ferris urged the Committee to consider the broadest recommendation Read more…