Safety monitoring to detect and quickly investigate any unexpected, rare or serious adverse events with the H1N1 vaccine has earned a “very encouraging” assessment from Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, M.D.

The FDA, the Centers for Disease Control and Prevention (CDC), and 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 their vaccine safety monitoring systems and provided a detailed description of vaccine safety efforts, which can be found online at www.flu.gov.

The monitoring efforts involve two different surveillance systems, the Vaccine Adverse Event Reporting System (VAERS) and the CDC’s Vaccine Safety Datalink (VSD). The FDA and CDC are assessing the H1N1 vaccine safety data on a continuing basis and have published a detailed report  on the safety profile of the 11.3 million doses of live, attenuated monovalent vaccine (LAMV) for intranasal administration and 34.9 million doses of monovalent, inactivated, split-virus or subunit vaccines for injection (MIV) that were distributed.

As of November 24, 2009, the FDA and CDC evaluated 3,783 reports of adverse events reported to VAERS and found no increase in any of the pre-selected adverse events under surveillance, such as Guillain-Barre syndrome.

Monitoring of activities as of December 30, 2009, during which a total number of vaccines distributed was 99.3 million, the vast majority (94 percent) of adverse events reported to VAERS were classified as “non-serious” with symptoms such as soreness at the vaccine injection site.

“To date, our experience with the H1N1 influenza vaccination program has met high safety expectations, based on the track record of the licensed seasonal vaccines, including live attenuated and inactivated vaccines. We are also collaborating with other agencies around the world to share our vaccine safety information and experiences. Should any safety concerns arise, we will evaluate them thoroughly and bring them to the public’s attention quickly,” Dr. Hamburg said in her update.

While H1N1 influenza disease transmission appears to be waning, Dr. Hamburg says that there is a significant possibility that the disease will return. Twelve states – California, Georgia, Hawaii, Indiana, Maine, Nevada, New Hampshire, New Jersey, New Mexico, New York, Tennessee, and Virginia – continue to report regional influenza activity. As a result, everyone, especially those in high-risk groups, are encouraged to get the H1N1 vaccine as soon as it becomes available to them in their communities.

“While antiviral resistance remains at low levels, future potential development of resistance is still a concern, so immunization is the best protection,” Dr. Hamburg urged. 



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