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FDA advisory committee recommends keeping strains similar in next year’s flu vaccine
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The FDA’s Vaccines and Related Biological Products Advisory Committee has recommended keeping the same three influenza strains in the 2011-2012 influenza vaccine that are in the current season’s vaccine.
Nancy Cox, PhD, director of the CDC’s Influenza Division, noted that the three strains, A/California/7/2009 (H1N1)-like virus, A/Perth/16/2009 (H3N2)-like virus, and the B/Brisbane/60/2008-like virus, continue to circulate throughout the world.
In the United States and Canada, the H3N2 influenza virus appears to be the dominant strain this year. Cox noted increases in B strains, including the B/Yamagata/16/88 lineage. The dominance of this strain prompted a discussion among the committee about the importance of a possible quadrivalent influenza vaccine or a potential monovalent vaccine that would be designed to target certain B strains moving forward.
Several vaccine manufacturers in attendance of the meeting noted that quadrivalent vaccines are a possibility, but likely not until 2013. Panel members and representatives from several pharmaceutical companies noted the difficulties involved in narrowing the list of strains to be used so as to produce vaccines in a timely matter.
Febrile seizure risk
The committee also heard data regarding febrile seizures and influenza vaccine. David Martin, MD, MPH, who is the pharmacovigilance branch chief in FDA's Center for Biologics Evaluation and Research, described a slightly elevated risk of seizures in children aged 12 through 23 months who also received the new pneumococcal conjugate vaccine (PCV13) in the Vaccine Safety Datalink (VSD). The same risk was not noted in children ages 6 to 23 months and those older than 23 months.
The VSD analysis involving influenza vaccine and pneumococcal conjugate vaccine was preceded by a signal for seizures after influenza vaccine in VSD, and by a data mining signal for influenza vaccine and febrile seizure disproportionality in the Vaccine Adverse Event Reporting System (VAERS).
Federal health officials beefed up surveillance efforts for seizures in young children after reports in the Southern Hemisphere suggested higher-than-expected rates of seizures after immunization with an influenza vaccine manufactured by CSL.
Martin said FDA and CDC officials are continuing to monitor the reports and will conduct additional analyses to address concomitant vaccination. — by Colleen Zacharyczuk
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