Companies Update Pandemic (H1N1) Flu Vaccine Projects

GlaxoSmithKline (London), Novartis (Basel, Switzerland), sanofi aventis (Paris), and Baxter International (Deerfield, IL) recently provided updates as to the development, manufacture, or shipment of pandemic (H1N1) vaccines. 

GSK announced that the first supplies of its pandemic (H1N1) adjuvanted vaccine will be shipped to governments during the week of Oct. 5, 2009. Shipments of the vaccine will be further delivered in the fourth quarter of 2009 and the first half of 2010. The vaccine deliveries are contingent on a number of factors, including government import/export regulations, regulatory approvals, approvals for outsourced packaging and filling, and testing required by reference laboratories. 

GSK confirmed on Aug. 4, 2009, that it had contracts in place to supply 291 million doses of the vaccine and had a variety of agreements in place with the US government to supply pandemic products worth $250 million, according to a company press release. Since that date, 22 government orders have been made to supply a further 149 million doses of the vaccine, bringing the total number of doses ordered for GSK’s pandemic vaccines to 440 million. The company says that discussions continue with governments for further supplies.

In other news, the European Commission approved Novartis’s Focetria and GSK’s Pandemrix as vaccines for the influenza pandemic (H1N1) 2009. Effective Oct. 1, 2009, the vaccines are authorized for use in all member states of the European Union and the EEA (Iceland, Liechtenstein and Norway). The approval follows a positive opinion recommending approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) on Sept. 24, 2009.

EMEA also recommended to the EC that an additional vaccine against influenza A (H1N1), Celvapan, a cell-culture based and nonadjuvanted vaccine, from Baxter (Deerfield, IL) be granted marketing authorization.

Sanofi Pasteur, the vaccines arm of sanofi aventis, provided an update on the clinical testing for its US licensed influenza A (H1N1) 2009 monovalent vaccine in adults 18–64 years of age and over the age of 65 years. Sanofi Pasteur began clinical trials on the vaccine in August 2009 to test its immunogenicity and safety. Final data from these trials, following a second dose of the vaccine, will provide additional information to guide recommendations on optimal dose, number of doses, and schedule. The company said that data from the studies indicated that one dose of the vaccine produces a robust immune response. The vaccine was licensed by the US Food and Drug Administration on Sept. 15 as a monovalent strain change to Sanofi Pasteur’s licensed seasonal influenza vaccine.