Final FDA Approval for H1N1 Vaccine Is Granted

Yesterday, the Food and Drug Administration (FDA) gave final approval to four vaccines developed to fight the H1N1 influenza virus. The four drugmakers granted approval are CSL Ltd, MedImmune LLC, Novartis Vaccines and Diagnostics Ltd, and Sanofi Pasteur Inc. It is expected that the vaccines will be available for shipment within one month.

According to the FDA press release: “Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.” Clinical studies have shown that the vaccine is well tolerated, with only occasional side effects.

The vaccine will come in both an injectable dose and a nasal spray. There are also two formulas, one with and one without thimerasol, a mercury-containing preservative. The FDA did warn that “people with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.”

As with any other drug or vaccine, the FDA will monitor adverse events.