This Article is From Nov 03, 2009

Swine flu vaccine for pregnant women

Swine flu vaccine for pregnant women
New York: One dose of swine flu vaccine protects pregnant women against the flu, but children under 10 still need two doses, U.S. officials said Monday, announcing further results of clinical trials of the vaccine.

They also announced the formation of a panel of experts from outside the government to watch for any rare or unexpected side effects as millions of Americans get vaccinated.

As of Monday, 30 million doses of vaccine were available; that is in line with what federal officials predicted two weeks ago, although in late summer they predicted 40 million and in midsummer one federal official optimistically predicted 120 million by this time.

The vaccine was rushed out to the public before all clinical trials could be finished because the virus had a second wave starting in late August. But the trial results, though limited, could further reassure the many pregnant women who have already been vaccinated or who have been nervous about getting the shots.

The 50 healthy pregnant women in the trial did not experience any unusual rates of side effects and one 15-microgram dose gave a protective level of antibodies, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, which is overseeing the trials.

Children from 6 months to 9 years old should still get two doses, about a month apart, Fauci said. But the first dose usually provides partial protection, meaning a child might still catch the flu but would be more likely to have a mild case.

The World Health Organization last week recommended one dose of vaccine for all children, but the United States is ignoring that advice. WHO's primary goal is to make sure that the world's vaccine supplies stretch as far as possible among the world's children. It endorses vaccine-stretching adjuvants and favors one dose per child so more children can get one.

U.S. health officials, by contrast, are trying to make sure that American children are fully protected first. They have also decided not to use adjuvants, even though they think they are safe, because anti-vaccine lobbyists have campaigned against them, calling them dangerous, and officials feared that some Americans would be scared away from being vaccinated.

Fourteen countries are now using swine flu vaccines and all appear to be safe, said Marie-Paule Kieny, director of vaccine research for WHO. Most European countries and Canada use vaccines with adjuvants, which are usually mixtures of water and oil that, for unknown reasons, increase the immune response and make smaller doses of vaccine work better.

WHO's expert panel also concluded that live nasal-spray vaccines are safe for pregnant women, while federal health officials have taken a more conservative position, suggesting that pregnant women stick to the shots, which contain a killed virus.

A new advisory group that will monitor the national vaccination drive for any unexpected side effects met Monday for the first time, said Dr. Bruce Gellin, director of the National Vaccine Program Office. "They are becoming familiar with the data streams that are available," and getting briefings about the clinical trials, Gellin said.

There has long been a database on which doctors are encouraged to report any bad reactions to vaccine among their patients, but there will also be reports from health insurers, local health departments, school districts and the like, as well as news reports.

Eventually, Gellin said, the panel will meet every two weeks and report monthly, but members can meet by teleconference on short notice if necessary.
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