FDA includes Fujian strain in next year's flu vaccine

Mar 19, 2004 (CIDRAP News) – The Food and Drug Administration (FDA) has completed its recommendations for next season's influenza vaccine, calling for inclusion of the A Fujian viral strain that caused most flu cases in the United States this winter.

The FDA's Vaccines and Related Biological Products Advisory Committee recommended that the vaccine contain the same strains as recommended by the World Health Organization (WHO). These are A/New Caledonia/20/99(HIN1), A/Fujian/411/2002(H3N2), and B/Shanghai/361/2002.

In a meeting Feb 18 and 19, the committee recommended the two A strains and provisionally recommended the B strain. The panel finalized its decision on the B strain in a teleconference Mar 17, according to FDA spokeswoman Lenore Gelb.

The FDA recommends the composition of the next season's flu vaccine early in the year because it takes several months for manufacturers to produce the vaccine on a large scale. In selecting the vaccine components, the agency considers the epidemiology of new flu virus strains, responses to current vaccines, and the availability of new candidate strains for manufacturing.

More than 80% of influenza virus isolates that were antigenically characterized by the Centers for Disease Control and Prevention (CDC) this flu season were the A Fujian strain, according to CDC reports. Because it emerged too late for manufacture, the Fujian strain was not included in this year's vaccine.

See also:

Summary report on February meeting of FDA's Vaccines and Related Biologics Advisory Committee
http://www.fda.gov/ohrms/dockets/ac/04/minutes/4020m1_quick%20summary.pdf

WHO influenza vaccine recommendations for 2004-05
http://www.who.int/influenza/vaccines/vaccinerecommendations1/en/index11.html

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