By Tom Randall --Editors: Donna Alvarado, Angela Zimm
(Bloomberg) -- AstraZeneca Plc's MedImmune unit announced a recall of 4.7 million doses of its nasal spray version of the swine flu vaccine because tests showed a decline in potency, U.S. regulators said.
There are no questions about the safety of the doses, and people who have already been inoculated don't need to get vaccinated again, said Norman Baylor, director of vaccines research and review for the U.S. Food and Drug Administration. About 3,000 of the doses remain in warehouses, and AstraZeneca will contact clinics that may still have unused vials, he said.
The recall follows a similar move on Dec. 15 by Sanofi- Aventis SA, which recalled 800,000 doses of swine flu vaccine. After vaccines are shipped from the manufacturers, companies keep samples from each lot and continue to test them for potency declines, Baylor said. Both swine flu vaccine recalls were voluntary after potency dropped below pre-specified thresholds.
"There are no safety concerns with these lots," Baylor said in a conference call with reporters today. "We do see a decline in potency every now and then."
Tor Constantino, a spokesman for London-based AstraZeneca, didn't immediately return an e-mail seeking comment.
Press release site: http://www.businessweek.com/news/2009-12-23/astrazeneca-recalls-4-7-million-swine-flu-spray-doses-update1-.html
Alameda received weak swine flu vaccineThursday, December 24, 2009
(12-24) 12:50 PST SAN FRANCISCO -- Millions more doses of swine flu vaccine were recalled this week after routine tests found they weren't strong enough to meet minimum public health standards for protection against the virus.
About 4.7 million doses of the weak vaccine were sent nationwide in October and November, and the vast majority already have been given to people. California public health officials said Thursday they weren't sure how many doses the state received.
At least one Bay Area county - Alameda - received some of the doses. San Francisco officials said they don't believe any of the recalled vaccine was given out during this week's vaccination clinic, where about 16,000 doses were given.
The vaccine was strong enough when it was distributed but had weakened over time and fallen below minimum potency levels by this month, according to the manufacturer, MedImmune.
There is no safety risk with the weakened vaccine, and public health officials said there's no need for people who received the recalled doses to get revaccinated.
"The vaccine is perfectly safe, and in fact, even though the basis of the recall was some slight fall-off in the potency of the vaccine, the vaccine is still effective," Dr. Mark Horton, director of the California Department of Public Health, said in a media briefing Thursday.
This is the second recall of swine flu vaccine since it was first distributed in October. Last week, about 800,000 doses were recalled after they were found to have lost potency.
Horton said the state now has received more than 12 million doses of vaccine - enough that public health officials are encouraging anyone who wants the vaccine to get it. Until very recently, only people at high risk of getting the disease or becoming seriously ill from it were allowed to get the vaccine in most parts of the country.
On Thursday State public health officials also discussed a new report that said swine flu in pregnant women can be severe and even fatal if women don't get quick treatment with antiviral drugs.
Dr. Janice Louie, head of influenza and respiratory diseases for the state Public Health Department, urged pregnant women to see their doctors immediately if they have any flu-like symptoms and encouraged doctors to treat suspected swine flu cases with antivirals as soon as possible, even if a preliminary flu test is negative.