H1N1 Vaccine Approved
The FDA has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next 4 weeks.
All four firms manufacturing the H1N1 vaccines--CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc., used the same processes.
"The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," said Jesse Goodman, MD, FDA acting chief scientist.
The vaccines induce a robust immune response in most healthy adults 8 to 10 days after a single dose. As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.
In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.
Vaccines against three seasonal virus strains are already available, but do not protect against the 2009 H1N1 virus.