A reference strain of the H1N1 swine flu virus was received by several vaccine manufacturers in May and since then companies have raced through the development, trials and manufacture to ensure a product is ready for winter.
This process is now nearing the end, with the US Food and Drug Administration (FDA) expecting to distribute the vaccines nationally when initial lots become available in the next four weeks.
Margaret Hamburg, Commissioner at the FDA, described the approvals as “good news for our nation's response to the 2009 H1N1 influenza virus”. A press statement from the agency added that the products are manufactured using the same processes and the companies have a long record of producing safe seasonal influenza vaccines.
Global preparation
Given the scale of the vaccination effort underway in the US approval is a boost for the companies involved. Sanofi is the only company so far to respond to the development, describing it as a “key milestone” in the immunisation process.
In addition Sanofi is pushing forward with clinical development of its H1N1 vaccine manufactured in France and is in close consultation with European authorities. However, according to Reuters Sanofi’s vaccine is not one of the three treatments that are initially being assessed in Europe.
The article reports that the European Medicines Agency (EMEA) will consider vaccines from GlaxoSmithKline, Novartis and Baxter on the week commencing September 21, with licensing expected to occur early in October.
This puts the EMEA behind the FDA and Chinese State Food and Drug Administration (SFDA), which have both approved H1N1 vaccines over the past two weeks.