Independent experts to study safety data on H1N1 vaccine

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 rate 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."

WASHINGTON - Independent health advisers will begin monitoring the safety of the H1N1 flu vaccine today, an extra step that the government promised in this year's unprecedented program to watch for possible side effects.
Dr. Marie McCormick of the Harvard School of Public Health is chairwoman of the special working group whose task is to raise a red flag if members feel federal health officials miss anything.
"Given the rapidity with which this particular vaccine was rolled out, there seems to be an extra-special obligation to make sure things remain as uncomplicated as they have in the past," McCormick said.
McCormick's group will begin its work today by reviewing data from early studies of the vaccine in more than 10,000 people, some conducted by the government and others by manufacturers.