January 19, 2010
FDA update on H1N1 vaccine safety monitoringThe Commissioner of Food and Drugs has issued a letter to update healthcare professionals on the FDA/CDC experience with the H1N1 vaccination program and to provide some detail on the current vaccine safety monitoring program. The FDA and CDC are assessing H1N1 vaccine safety on a continuing basis and have published a detailed report describing the safety profile of H1N1 vaccines in the United States (www.cdc.gov/mmwr/preview/mmwrhtml/mm58e1204a1.htm). No substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported. No increase in any of the pre-selected adverse events under surveillance (eg, Guillain-Barré syndrome) has been seen in Vaccine Safety Datalink (VSD) data.
While H1N1 influenza disease transmission appears to be waning, there is a significant possibility it 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. The FDA is recommending that people in high-risk groups be vaccinated as soon as the H1N1 vaccine is available in their communities, and that people who are not in high-risk groups be vaccinated when it becomes available to them.
The complete Commissioners Letter to Healthcare Professionals can be found at: www.fda.gov/NewsEvents/PublicHealthFocus/ucm197733.htm.