FDA approves new flu-shot supplier as vaccine season approaches
Wednesday, August 31st 2005, 10:56 am
By: News On 6
WASHINGTON (AP) _ The government approved a new flu shot Wednesday, clearing a third U.S. supplier even as doctors await word of just how much vaccine will be available this year.
The Food and Drug Administration approved Fluarix to immunize adults 18 and older. The shots are made in Germany by a subsidiary of GlaxoSmithKline. The company didn't immediately say how many shots it could supply this flu season, but earlier had estimated that it could provide 10 million doses.
The government hasn't yet predicted just how much flu vaccine the nation will have this fall, after last year's surprise shortage when British regulators shut down a U.S. supplier, Chiron Corp., because of the discovery of contaminated vaccine.
Sanofi-Pasteur remains the nation's leading flu shot provider, with an estimated 50 million to 60 million doses planned for this fall.
Some 3 million doses of a nasal-spray vaccine that's for use only by healthy people, MedImmune Inc.'s FluMist, also are anticipated.
Glaxo has long supplied flu vaccine for other countries, but Wednesday's FDA clearance licenses the company for sale here for the first time. The FDA granted that license under a special fast-track approval system that will require Glaxo to do follow up studies verifying that the level of protective antibodies its brand of shots produced in recipients does translate into true flu protection.
``Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health,'' said Health and Human Services Secretary Mike Leavitt.
Also Wednesday, Chiron announced that it had passed one step _ an inspection of its factory in Britain _ toward again winning FDA approval to sell flu shots here, but it still has more work to do with no guarantee of clearance before flu vaccination begins in October.
Because of the uncertainty about supplies, federal health officials already are planning to urge the elderly and others most at risk from the flu to be the first vaccinated. High-risk people include those 65 or older, nursing home residents, anyone with a chronic condition such as heart or lung disease, babies and toddlers ages 6-23 months, pregnant women and health providers who care for high-risk patients.
If there's plenty of vaccine, the Centers for Disease Control and Prevention will tell healthier people to roll up their sleeves, too.