The U.S. Food and Drug Administration announced that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the first lots become available, which are anticipated inside the following month.
"This vaccine will help protect people from major illness and death from influenza. 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,” " declared Jesse Goodman, M.D, FDA acting chief scientist.
Clinical studies under way will supply extra information about the best dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are anticipated in the 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.
Potential complications of the H1N1 vaccines are anticipated to be like those of seasonal influenza vaccines. For the injected vaccine, the most typical side effect is tenderness at the injection site. Other complications may include mild fever, body aches, and fatigue for one or two days after the inoculation. For the nasal spray vaccine, the most typical complications include runny nose or nasal congestion for every age, sore throats in adults, and - in kids two to six years of age - fever.
As with any medical product, surprising or rare significant inauspicious events may happen. Vaccines against 3 seasonal virus strains are available and may be used but they don't defend against the 2009 H1N1 virus.
