The U.S. Food and Drug Administration (FDA) approved yet another seasonal flu vaccine on Friday, November 27, 2009. Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved for people ages 18 years and older to prevent the seasonal flu (influenza virus subtypes A and B). It is not effective against the H1N1 Swine flu.
“The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.
The common side effects for this vaccine are similar to those for other flu vaccines: pain, swelling and redness at the injection site, headache, muscle aches and malaise (feeling bad). People with severe or life-threatening allergies to chicken eggs should not have the vaccine.
Because this vaccine was approved via the FDA’s accelerated approval process, Novartis is required to conduct further studies to confirm that the vaccine is effective in preventing the seasonal flu.
The information in this article is from an FDA press release.
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