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FDA panel recommends strains for 2012-2013 flu vaccine
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The FDA’s Vaccines and Related Biological Products Advisory Committee recommended the strains to be included in the influenza virus vaccine for the 2012-2013 season.
Using data from a number of influenza surveillance sources, the Vaccines and Related Biological Products Advisory Committee voted to retain the influenza A/California/7/2009-like virus that was included in this year’s vaccine. For the influenza A (H3N2) component, the committee chose to replace the current influenza A/Perth/2009 strain with the influenza A/Victoria/361/2011 (H3N2)-like virus.
For influenza B, the committee voted to replace influenza B/Brisbane/60/2008-like virus with the influenza B/Wisconsin/1/2010-like virus.
Lisa Grohskopf, MD, MPH, of the Epidemiology and Prevention Branch in the Influenza Division of the CDC, reported on surveillance data from the US 2011-2012 influenza, which indicated that influenza A predominated in 94% of isolates in the more than 78,000 isolates tested. Influenza B accounted for 6% of influenza cases.
Grohskopf said the current influenza season represents the “latest start in 29 consecutive seasons” of influenza.
Nancy J. Cox, PhD, of the WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza at the CDC, said global surveillance of influenza has indicated similar trends as the United States regarding the slow start to the season. As a result, panel members said, this year’s selection had less data for selection analysis than in past years.
Disclosure: The researchers report no relevant financial disclosures.
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Every year, late in February, the Vaccine and Related Biologic Products Advisory Committee (VRBPAC) of the FDA meets to discuss the strains to be included in the next year’s influenza vaccine. The decision made on that day is driven by a wealth of influenza surveillance data generated by WHO collaborating centers for surveillance, epidemiology and control of influenza.
In the United States, Nancy J. Cox, PhD, director of the Influenza Division, National Center for Immunization and Respiratory Diseases of the CDC, summarizes the data on the worldwide circulation of influenza virus by type and subtype. In addition, summary data are presented on the antigenic characterization of the viruses and molecular epidemiology on the hemagglutinin (HA) and neuraminidase (NA) genes on countless isolates that were acquired through the collaborating laboratories of WHO and the National Respiratory and Enteric Virus Surveillance System of the CDC. This type of information is critical in making the best vaccine strain selection for the subsequent year.
The 2011-12 influenza season has been unusual because of its late start and low-level influenza activity compared with the 2010-11 influenza season. The late start and low-level activity translates to fewer available isolates, in particular, for influenza B viruses because to date they have been a minor component of the overall influenza viruses circulating in the US. An additional difficulty in the selection of the influenza B vaccine strain is that two influenza B lineages are co-circulating, but only one of the influenza B lineages is currently included in the trivalent vaccine formulation.
Hopefully, in the near future, a quadrivalent influenza vaccine containing influenza viruses representing influenza A (H3N2), influenza A (H1N1) and the two B lineages will circumvent the current difficulty in the influenza B virus vaccine strain selection.
This year, VRBPAC voted to keep the current influenza A (H1N1)pdm09 virus and make changes to the influenza A (H3N2) and influenza B vaccine components. The virus vaccine strains selected for the 2012-13 influenza season are influenza A/California/7/2009 (H1N1)-like virus, influenza A/Victoria/361/2011 (H3N2)-like virus and influenza B/Wisconsin/1/2010-like virus of the B/Yamagata lineage. Each year after the selection of the vaccine strains, vaccine manufacturers and the FDA have a herculean task to ensure adequate vaccine supplies are available by late summer to begin the universal influenza immunization campaign of all individuals aged 6 months and older in the US. We are indebted to the outstanding worldwide infrastructure that is in place for influenza surveillance and the high quality scientific data that is generated every year so that the best possible decision is made in selecting the virus formulation for the next year influenza vaccine.
Pedro A. Piedra, MD
Departments of Pediatrics and Molecular Virology and Microbiology
Baylor College of Medicine
Houston
Disclosure: Dr. Piedra is a member of VRBPAC. However, his comments do not represent the view of the FDA.
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