FDA Commissioner Addresses Nation's Health Care Professionals on H1N1 Vaccine Safety

FDA Commissioner Margaret A. Hamburg today sent a letter to America’s health care professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on safety monitoring of the 2009 H1N1 vaccines.

“In November, I wrote to thank you for your efforts during the 2009 H1N1 influenza outbreak and to provide information about the development and FDA approval of the H1N1 vaccines,” Hamburg wrote. “I mentioned our continuing robust efforts to monitor the safety of these vaccines and now would like to reassure you that, to date, the safety assessment is very encouraging.

“As a key part of our missions, the FDA, the Centers for Disease Control and Prevention, other agencies across the Department of Health and Human Services, and other parts of the federal government, including the Department of Defense and the Department of Veterans Affairs, have enhanced and expanded our vaccine safety monitoring systems to detect and quickly investigate any unexpected, rare, or serious adverse events. These additional systems enhance our ability to determine whether any adverse events can be attributed to H1N1 influenza vaccines. A detailed description of vaccine safety efforts is available online at www.flu.gov.

“According to the January 8, 2010 update of FDA and CDC vaccine safety monitoring activities, as of December 30, 2009 the total number of doses of H1N1 vaccines distributed was 99.3 million and the vast majority (94%) of adverse events reported to VAERS were classified as "non-serious" (e.g., soreness at the vaccine injection site). Weekly updates on FDA and CDC vaccine safety monitoring activities are available through the VAERS web site http://vaers.hhs.gov/resources/h1n1update#top.”

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