Pandemic flu vaccine projects continue to make progress

Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Pharmaceutical Technology Europe

GlaxoSmithKline (GSK), Novartis, sanofi aventis and Baxter International have provided updates regarding the development, manufacture and shipment of pandemic (H1NI) vaccines.

GlaxoSmithKline (GSK), Novartis, sanofi aventis and Baxter International have provided updates regarding the development, manufacture and shipment of pandemic (H1NI) vaccines.

GSK announced that the first supplies of its H1N1 adjuvanted vaccine will be shipped to governments this week. Shipments of the vaccine will be further delivered in the Q4 of 2009 and the first half of 2010, although the 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 4 August 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 agreed 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 EC has approved Novartis’s Focetria and GSK’s Pandemrix as vaccines for the influenza pandemic 2009 in all member states of the EU 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 EMEA on 24 September 2009.

The EMEA has also recommended to the European Commission that an additional vaccine against influenza a (H1NI), Celvapan, a cell-culture based and nonadjuvanted vaccine, from Baxter be granted marketing authorization.

Sanofi Pasteur, the vaccines arm of sanofi Aventis, provided an update on the clinical testing for its US licensed influenza 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 FDA on 15 September as a monovalent strain change to Sanofi Pastuer’s licensed seasonal influenza vaccine.