The flu vaccine shortages and delays of recent years might finally be over, federal health officials say but they're keeping their fingers crossed.
A string of problems, from 2004's sudden loss of half the U.S. vaccine supply because of contamination at a plant in England to last year's distribution delays because of slow growth of vaccine virus, has reinforced health officials' reluctance to make predictions.
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But vaccine manufacturers say they have begun to ship vaccine and expect to be able to produce up to a record 132 million doses for this flu season. The supply includes:
- 50 million doses from Sanofi Pasteur.
- 40 million from Novartis.
- 30 million to 35 million from GlaxoSmithKline.
- 7 million from MedImmune (maker of FluMist nasal spray).
But the total number could change.
A fifth company, CLS Bio-therapies, based in Australia, could enter the field if the Food and Drug Administration approves its application, and MedImmune, maker of FluMist, may lower its estimate. Shipment of FluMist was delayed because of manufacturing problems at the company's plant in England. It got FDA clearance on Sept. 7, but is still awaiting word on its request to label the vaccine for use in toddlers. Current labeling is for healthy people ages 5-49, but an FDA panel recommended it for children as young as 2.
"We had previously stated we were going to make about 7 million doses," says MedImmune spokeswoman Karen Lancaster, but "we may adjust that downward, because that was based on being able to go out in early September."
The Centers for Disease Control and Prevention recommends annual flu vaccine for about 215 million people who are either at high risk for serious flu complications, such as the elderly, ill and very young or those who are caretakers or family members of those at high risk.
"It's safe to say all our recommended groups fall below the goals we have for them," says CDC flu expert Jeanne Santoli. For instance, the 65-and-older group falls below the target of 90% immunized, she says. About 65%-69% of people in that age group get flu shots.
One strategy to improve coverage and reduce the toll of flu, which kills an estimated 36,000 people a year, is to encourage people to think of flu vaccine beyond Thanksgiving.
Flu season runs from October to May, but doctors usually try to vaccinate patients before the end of November. Now the CDC advises doctors to offer vaccine well into the winter months, because flu usually peaks in February or later.
To emphasize the point, the CDC is planning its National Influenza Vaccination week for the week after Thanksgiving. The CDC's goal is to "remind everyone how serious influenza is, how important it is to be vaccinated, and that providers need to continue immunizing people," she says. "We've got a tool to protect people, and this year we have a more-than-sufficient amount of it."