FDA has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines are made by CSL, MedImmune, Novartis Vaccines and Diagnostics, and Sanofi Pasteur. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.
“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” says FDA commissioner, Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”
All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines. “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,” says Jesse Goodman, M.D., FDA acting chief scientist.
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, FDA explains. Ongoing clinical studies will provide additional information about the optimal dose in children. FDA will accordingly update dosing recommendations. Sanofi Pasteur is reportedly the only provider of the vaccine for populations as young as six months.
The agency says that it is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse-event monitoring, information sharing, and analysis during and after the 2009 H1N1 vaccination program.