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| |  FDA Update on H1N1 Vaccine Safety ROCKVILLE, Md -- January 15, 2010 -- The US Food and Drug Administration (FDA) today sent out an update to healthcare professionals on the safety of the influenza A(H1N1) vaccine. Margaret A. Hamburg, MD, US Food and Drug Administration (FDA), Rockville, Maryland, wrote: The FDA, the Centers for Disease Control and Prevention (CDC), 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 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 the influenza H1N1 vaccines. At the heart of our monitoring efforts are 2 surveillance systems used to help identify safety issues: the Vaccine Adverse Event Reporting System (VAERS) and the CDC’s Vaccine Safety Datalink (VSD). The FDA and the 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. The report analyses the safety data after 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) were distributed. As noted in the report, FDA and CDC evaluated 3,783 reports of adverse events submitted to VAERS through November 24, 2009. The analysis of VSD data was based on 438,376 people vaccinated with H1N1 vaccines (323,345 MIV and 115,031 LAMV) in managed-care organisations in the VSD as of November 24. 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, such as Guillain-Barré syndrome, has been seen in VSD data. 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 The National Vaccine Advisory Committee (NVAC) created the H1N1 Vaccine Safety Risk Assessment Working Group to review 2009 H1N1 vaccine safety data. This working group of outside experts conducts regular, rapid reviews of available data from the federal safety monitoring systems and presents them to NVAC and federal leadership for appropriate policy action and follow-up available here: http://www.hhs.gov/nvpo/nvac/index.html 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. While H1N1 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. SOURCE: US Food and Drug Administration
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