Regulatory News, In Brief

GSK's unadjuvanted H1N1 vaccine approved: FDA approved GlaxoSmithKline's unadjuvanted H1N1 vaccine Nov. 10 for use in adults. Like the other H1N1 vaccines, which do not include adjuvants, it was approved as a strain change supplement to the firm's seasonal flu vaccine, FluLaval. The U.S. government has placed an order for 7.6 million doses. GSK expects to begin shipping the vaccine in December, with the full order filled by the end of the year. Until now, GSK has been the only one of the five seasonal flu vaccine manufactures without an FDA-approved H1N1 vaccine. Much of the firm's effort has been focused on its adjuvanted product, which is approved elsewhere in the world, but not in the U.S. The firm declined to comment on plans to submit the adjuvanted product to FDA, but did say it has not yet been asked by the U.S. government to fill a bulk adjuvant order. Testifying at the Senate HELP Committee Nov. 10, American Enterprise Institute fellow and former FDAer Scott Gottlieb asserted that the decision to forgo use of adjuvants limited the ability of the U.S. government to stretch an already limited stock of H1N1 vaccine raw material, and said FDA should consider creating a guidance on the development and use of the additives. The agency avoided the risk of releasing an adjuvanted swine flu vaccine, but it did recently approve the first vaccine with a novel adjuvant for the U.S. market - finally clearing GSK's HPV vaccine Cervarix in October (1"The Pink Sheet," Oct. 19, 2009). The international markets offer more advanced views on adjuvants, and GSK has orders for 440 million doses of its adjuvanted H1N1 vaccine Pandemrix (2"The Pink Sheet," Nov. 2, 2009, p. 18). Clinical trials on both adjuvanted and unadjuvanted vaccine are ongoing in North America, Europe and Japan