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FDA APPROVES

H1N1 VACCINES

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....The Food and Drug Administration approved the pandemic H1N1 influenza vaccine from four different manufacturers, clearing the way for the vaccine to be administered as soon as enough of it is available. The approval was announced to Congress by Health and Human Services Secretary Kathleen Sebelius.

The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

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 -- in children 2 to 6 years old -- fever.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.

Officials from the National Institute of Allergy and Infectious Diseases announced Friday that the vaccine was safe and produced adequate immunity with only one dose. Researchers had feared that two doses would be required, limiting the amount of vaccine available and complicating the logistics for delivering it.

The United States has ordered enough vaccine for 195 million doses, meaning that "We will have enough vaccine available for everyone," Sebelius said. About 45 million doses are expected to be available by the middle of October, and officials are targeting those in the highest-risk groups -- primarily pregnant women and healthcare workers. Many people fear the vaccine because of its supposed "experimental" nature and perceived safety issues, but government scientists note that it is virtually identical to the seasonal flu vaccine, which has been given safely to hundreds of millions of people.

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