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| |  FDA Approves Four Vaccines for the 2009 Influenza A(H1N1) Virus ROCKVILLE, Md -- September 15, 2009 -- The US Food and Drug Administration (FDA) has approved 4 vaccines against the 2009 influenza A(H1N1) virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next 4 weeks. “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, Rockville, Maryland. Based on preliminary data from adults participating in ongoing, multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults 8 to 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. 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. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated. 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. For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and fever in children aged 2 to 6 years. As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organisations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. SOURCE: US Food and Drug Administration
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