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FDA Approves 4 Swine Flu Vaccines
Date:9/15/2009

inical studies of the H1N1 vaccine are continuing to determine the optimal dose in children, with the results expected shortly, the FDA said.

The four vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, and have a proven safety record producing seasonal influenza vaccines, according to the FDA.

The preliminary trials of the vaccine has shown it to be well-tolerated, with side effects typical of seasonal flu vaccines. Those side effects include soreness at the injection site, as well as possible 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 -- in children 2 to 6 years old -- fever, the FDA said.

The FDA stressed that the H1N1 vaccine won't protect against regular seasonal flu. That's why people are urged to get their seasonal flu shots now, even though the H1N1 virus accounts for about 98 percent of the flu circulating right now in the United States.

"We think the novel strain of H1N1 is going to be widely circulating, but as the season progresses we may see other seasonal flu viruses emerge and start to spread. So it makes sense that people get their seasonal flu shot, because we could very well see those strains of influenza circulate widely as our season progresses," said Tom Skinner, a spokesman for the U.S. Centers for Disease Control and Prevention.

On Monday, several news studies suggested that people infected with swine flu seem to be contagious longer than patients with ordinary seasonal flu.

But it's not clear what impact the findings will have on health-care experts' recommendations to combat the H1N1 swine flu, since the virus continues to produce relatively mild infections in most people and reco
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