H1N1 vaccines approved by FDA, to be available by mid-October

Today, FDA licensed four vaccines against H1N1 influenza (swine flu). Distribution of the initial doses is likely to begin within the next four weeks, according to HHS secretary Kathleen Sebelius. Here is coverage of today's announcement from the Associated Press and Wall Street Journal.

The vaccines approved today include MedImmune's nasal spray vaccine and injectable vaccines from SanofiPasteur, Novartis, and CSL Limited. Each of these manufacturers produces seasonal flu vaccines in the United States, as does GSK, whose H1N1 vaccine was not included in today's announcement. None of the vaccines contain adjuvants, a recent focus of concern among vaccine safety critics, and thimerosal-free vaccine will be available for those preferring it.

With respect to supply, CIDRAP News reports:

"The Department of Health and Human Services (HHS) has ordered about 195 million doses of H1N1 vaccine. According to a recent federal report, Novartis is expected to contribute 45.7% of that, Sanofi 26.4%, CSL 18.7%, MedImmune 5.8%, and GSK 3.4%."

Today's news is not at all surprising, especially following the favorable clinical trial results announced last week by NIH and published on the website of the New England Journal of Medicine. (Particularly encouraging were findings that only one dose of the vaccine was needed to produce immunity. This means that vaccine supply should be much larger and mass vaccination relatively less challenging than if two doses were required, as had been the expectation until last week's results.)

Over the past few days, the CDC H1N1 vaccination website has added increased information on vaccine safety, focusing particularly on concerns related to thimerosal and Guillain-Barre syndrome.

It bears repeating that the H1N1 vaccination program in the United States will be completely voluntary. (Vaccination will be required, however, for uniformed personnel in the U.S. military, according to this Department of Defense statement.)