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September 2005 The FDA recently approved a new influenza vaccine for adults (Fluarix, GlaxoSmithKline). The vaccine is approved to immunize adults against influenza A and B both contained in the vaccine. The approval of Fluarix breaks new ground, according to an FDA release, because it is the first vaccine approved using the agency’s accelerated approval process. GSK demonstrated that after vaccination with Fluarix, adults made protective antibodies in the blood that the FDA felt are likely to be protective against influenza. “Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market,” said FDA commissioner Lester Crawford. In related news, the FDA inspected the Chiron Corp. plant in the U.K. to see if it can supply vaccine for this season. Last year, there was a shortage in influenza vaccine because of manufacturing issues at the plant. The FDA said that Chiron has taken steps to address the issues at its Liverpool facility; however, more work is needed. The amount of vaccine that Chiron will be able to supply the U.S. market has not yet been determined, the FDA said. On the avian influenza vaccine front, preliminary study data about the H5N1 vaccine showed the vaccine was effective. The date came from the first cohort of 117 people (out of 450 people to be studied) observed for safety before testing the vaccine in the remaining cohorts. Researchers will likely complete the clinical trial and final analysis by October, according to John J. Treanor, MD, making it possible that the United States could have a viable candidate to fight the top suspect for an influenza pandemic by the end of the year. Treanor is professor of medicine in the infectious disease division of the University of Rochester School of Medicine and Dentistry in New York. This ongoing vaccine research, funded by the NIH, is not the sole pandemic vaccine activity. Chiron Corp. also has a candidate vaccine against both the H5N1 and H9N2 strains in clinical trials. To date, avian influenza has been associated with 112 confirmed cases and 57 deaths. Birds carrying the flu strain have been found outside of Asia. |
