Independent experts to review H1N1 vaccine safety

An independent panel of experts will meet on Monday to review the safety of the swine flu vaccine, as part of government efforts to monitor an unprecedented vaccination campaign.

The National Vaccine Advisory Committee's H1N1 vaccine safety panel will review the results of data collected by the government, to spot any problems with the vaccine as early as possible.

According to a summary of the data, the panel will review about 10,352 people who received the vaccine by injection and 501 who got the FluMist nasal spray, in 13 studies funded by the Department of Health and Human Services.

Of those who had the injection, 6,098 got the basic vaccine and 4,254 a vaccine containing an adjuvant, a substance that boosts its effect but isn't widely used in the US. They included 5,776 adults and 4,576 children. They received two doses 21 or 28 days apart and were to be followed for six months, or for a year if they got the adjuvant.

"After an initial review of the data, the rate and nature of reactions after each dose appear acceptable and similar to other flu vaccines," the summary says. "To date, no serious adverse events have been suggested and nothing has suggested a problem with the safety of the H1N1 vaccines. However, the limited size of the database is not enough to rule out rare events, and safety data so far are limited because the studies are still ongoing."

A second summary of data collected up to 20 October by the National Institutes of Health, from its own studies of 3,630 children and pregnant and non-pregnant women, found some adverse events, but none directly linked to the vaccine. "The most common issue is pain and some swelling at the injection site for a day or two. We see that with any injected vaccine to some degree."

Although the vaccine was produced in record time, federal health officials have repeatedly said there is no reason to doubt its safety, because it was made by the same companies that have made the seasonal vaccine for years, using the same process and the same methods.