Nearly 5 Million Doses of Nasal Swine Flu Vaccine Recalled

ByABC News
December 23, 2009, 4:23 PM

Dec. 24 -- WEDNESDAY, Dec. 23 (HealthDay News) -- Nearly 5 million doses of a nasal spray version of swine flu vaccine have been recalled because the vaccine loses some potency over time, but not enough to diminish its protective effect, U.S. health officials announced Tuesday.

The recall involves more than 4.6 million doses of vaccine produced by drug maker MedImmune. Most of the doses have already been used, according to the U.S. Food and Drug Administration, which added that the vaccine was strong enough when it was distributed in October and November.

Pat El-Hinnawy, an FDA spokeswoman, said the action was a "voluntary, non-safety related recall. There are no safety concerns about the vaccine. The decrease in potency is not likely to be clinically significant. Individuals who received doses from the recalled lots do not need to be revaccinated."

The recall is the second swine flu vaccine recall this month prompted by a decline in potency. Manufacturer Sanofi Pasteur recalled nearly 800,000 children's doses of injectable H1N1 swine flu vaccine because tests showed they had lost some protective effect, but not enough to require revaccination.

On Tuesday, a top U.S. health official reported that the number of cases of H1N1 swine flu infection continues to decrease and the vaccine supply is now plentiful, but too few Americans are getting inoculated.

"The H1N1 vaccine supply is getting better and better," Dr. Anne Schuchat, director of the U.S. Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases, said during an afternoon press conference.

While cases of swine flu infection continue to diminish around the country, the H1N1 virus is still the dominant flu strain, Schuchat said. "Disease is at a better state around the country, less virus is circulating," she said. "But still everything we are seeing in terms of the flu strains is the H1N1 virus. So it's not gone at all."

There's no way to predict whether there will be a resurgence of swine flu, which peaked nationwide in early November with 48 states reporting widespread activity.