Independent experts to study safety data on H1N1 vaccine

By Rob Stein
Washington Post Staff Writer
Monday, November 2, 2009

An independent panel of experts will meet Monday to review the safety of the swine flu vaccine as part of the government's efforts to monitor the unprecedented immunization campaign.

The National Vaccine Advisory Committee's H1N1 Vaccine Safety Working Group will review the results of data being collected by the government to detect any problems with the vaccine as soon as possible.

According to a summary of data the panel will review, about 10,352 people have received the injected vaccine and 501 have gotten the FluMist nasal spray in 13 studies funded by the Health and Human Services Department's Biomedical Advanced Research and Development Authority.

Of those who received the injections, 6,098 got standard vaccine while 4,254 received shots containing a substance known as an "adjuvant," which is designed to boost the effectiveness but is not being used widely. That included 5,776 adults and 4,576 children.

The subjects received two doses 21 or 28 days apart and were to be followed for six months if they did not receive an adjuvant and for a year if they did.

"After preliminary review of available safety data, the rate and nature of local and systemic reactions following each dose appear to be acceptable and similar to other influenza vaccines," according to the summary.

"To date, no serious adverse events have suggested any safety signals with H1N1 vaccines. There have been no serious adverse events in the opinion of the investigator definitely related to the vaccine," the summary states.

The summary notes, however, that "the limited size of the database is not sufficient to exclude rare adverse events" and "the safety data available for review is limited because studies are still ongoing."

A second summary of data collected through Oct. 20 by the National Institutes of Health from its own studies involving 3,630 children, pregnant women and non-pregnant adults similarly found that there "have been 'adverse events,' but none that have been attributed directly to the vaccine."

"The most common issue is pain and some swelling at the injection site for a day or two. We see this with any injectable vaccine to one degree or another," it states.

Although the vaccine was produced in record time, federal health officials have issued repeated assurances that there is no reason to doubt the vaccine's safety because it was produced by the same companies that have been making the seasonal vaccine for years using the same process and the same facilities.

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