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CDC publishes ACIP 2015-2016 influenza vaccine guidelines
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The CDC’s Advisory Committee on Immunization Practices published updated influenza vaccination recommendations for the 2015-2016 influenza season in a recent MMWR.
According to the report, the formula composition for 2015-2016 trivalent vaccine includes hemagglutinin (HA) derived from an A/California/7/2009 (H1N1)-like virus, an A/Switzerland/9715293/2013 (H3N2)-like virus, and a B/Phuket/3073/2013-like (Yamagata lineage) virus. These vaccines will be included in quadrivalent influenza vaccines, along with a B/Brisbane/60/2008-like (Victoria lineage) virus.
Population recommendations
During a Feb. 26 meeting, the ACIP unanimously voted in favor of annual influenza vaccinations in all people aged 6 months and older without contraindications. The report recommends children aged 6 months to 8 years receive the first dose as soon as possible and the second dose at least 4 weeks later.
However, with respect to the consistent A(H1N1) virus circulation since 2009 and the introduction of an A/California/7/2009(H1N1)-like virus in 2010, separate vaccinations with the virus are no longer recommended in children aged 6 to 8 years. The ACIP recommends that children who received two or more doses of trivalent or quadrivalent vaccine in seasons prior to July 2015 only need a single dose.
In older populations at least 65 years of age, previous findings showed that antibody levels induced by vaccine declined 6 months after vaccination. However, the committee wrote that delaying vaccination could result in missed opportunities.
“Vaccination programs should balance maximizing the likelihood of persistence of vaccine-induced protection through the season with avoiding missed opportunities to vaccinate or vaccinating after influenza virus circulation begins,” they wrote.
Vaccination with history of egg allergy
Recent data demonstrated that influenza vaccines did not trigger allergic reactions in patients with a history of egg allergy, and inactivated influenza vaccines (IIVs) with as much as 0.7 g/0.5 mL were tolerated, the researchers wrote. However, limited data are available on the use of live attenuated influenza vaccine (LAIV) in patients with egg allergy histories.
Researchers estimated a 1.3% incidence rate of systemic allergic reaction including anaphylaxis in children administered LAIV. Therefore, IIV or RIV3 vaccines are recommended in these populations. Physicians familiar with manifestations of egg allergy should administer IIV vaccines and observe patients for 30 minutes or longer. Any severe allergic reaction should be considered a contraindication to future vaccinations, according to the report.
LAIV vs. IIV
In light of conflicting and limited data indicating that LAIV is more efficacious than IIV, the committee retracted the suggestion of administering LAIV over IIV in patients aged 2 to 49 years. Other recommendations in the report state LAIV should not be administered to patients less than 2 years or greater than 49 years of age, pregnant women, immunocompromised patients, children with contraindications detailed in the package insert, patients with an egg allergy, children with asthma aged 2 to 4 years, and patients who consumed influenza antiviral medications within 48 hours of administration.
Product approvals
The report also listed new and updated vaccine products recently approved by the FDA, which included:
the administration of Afluria (bioCSL) using the Stratis needle-free jet injector (PharmaJet.), a reusable spring-powered device, in patients aged 18 to 64 years;
the expanded use of Flublok (RIV3, Protein Sciences) in patients aged 50 years and older (previously approved in patients aged 18 to 49 years); and
the modified formulation of Fluzone Intradermal Quadrivalent (Sanofi Pasteur) in patients aged 18 to 64 years.
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Sandra Adamson Fryhofer
Delivery of this year’s flu vaccine has begun (I received my first partial shipment on Aug. 19). This season’s flu vaccine formula has had a makeover that one hopes will translate into a good match for flu virus strains circulating during the 2015-2016 flu season.
Who needs vaccination is easy. The ACIP recommends yearly flu vaccination for everyone aged 6 months and older. The question is which vaccine to give (and receive). ACIP does not express a preference for use of any particular product over another.
The upcoming season’s vaccine choices have been expanded in age range, degree of coverage and innovation. For patients with needle phobia, the totally needle-free jet injector PhamaJet has been FDA approved to deliver the flu vaccine Afluria (bioCSL) to adults aged 18 to 64 years The skinny needle intradermal flu vaccination has gone totally quadrivalent, thus offering expanded protection to those aged 18 to 64 years. The totally egg-free Flublok (RIV3, Protein Sciences) no longer has an upper age limit and is now a choice for adults aged 18 years and older.
ACIP’s flu vaccination policy update note has been published in MMWR and includes a handy dandy “cheat sheet,” a table listing this season’s “players and stats,” including trade name, manufacturers, presentation, mercury content , ovalbumin (egg protein) content, age indications, latex warnings, and with route of administration.
ACIP still says the intranasal flu vaccine should only be given to the healthy (nonpregnant) patients aged 2 to 49 years. LAIV should also not be given to caregivers of severely immunosuppressed individuals requiring a protective environment. Recipients of LAIV should avoid contact with severely immunosuppressed individuals for at least 1 week due to theoretical concerns of inadvertent flu virus transmission.
Egg allergy is no longer an absolute contraindication to flu vaccination. Flu vaccination recommendations for egg-allergic individuals have been tweaked. Those of all ages with mild — hives only — egg allergy may receive the flu shot (IIV). For adults aged 18 years and older with egg allergy of any severity, the totally egg free RIV3 is also an option. Egg-allergic patients should not receive LAIV due to paucity of study data in this population. The 30-minute observation period after vaccination is reiterated for egg-allergic individuals.
This year’s ACIP flu policy note also acknowledges the expanded knowledge base for those with more severe egg allergy (angioedema, respiratory distress, lightheadedness, recurrent emesis), including those who have required epinephrine in the past. Egg-allergic adults may receive RIV3 if available. If not, IIV may be given by “a physician with experience in the recognition and management of severe allergic conditions.”
Organized medicine (American College of Physicians and AMA) have tightened policy on nonmedical exemptions to immunizations. It will be interesting to see if these policy changes influence flu vaccination coverage rates in the upcoming season. Although flu vaccination is not 100% effective, it is still our best bet for keeping us healthy, well, and protected from flu.
Let the race (to universal flu vaccination coverage) begin. Ready, set, vaccinate!
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