September 15, 2009
2009 H1N1 (swine) influenza virus vaccines approvedThe FDA announced that it has approved four vaccines against the 2009 H1N1 (swine) influenza virus. The vaccines are made by CSL Limited, MedImmune, Novartis, and sanofi pasteur. These approvals are based on preliminary data from adults participating in multiple clinical studies which showed the 2009 H1N1 vaccines to induce a robust immune response in most healthy adults 8–10 days after a single dose, as occurs with the seasonal influenza vaccine. Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.
The vaccines are expected to become available nationally within the next four weeks.
For more information visit www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm.