FDA Clears Chiron Plant for Flu Vaccine
The supply outlook for flu vaccine this year improved Wednesday as two manufacturers cleared crucial regulatory hurdles.
Chiron Corp.'s troubled factory in England passed a key Food and Drug Administration inspection, putting the company on track to return to the U.S. market.
British pharmaceutical giant GlaxoSmithKline, meanwhile, received FDA approval to sell its flu shots in the U.S. for the first time.
Taken together, the developments eased worries about a severe vaccine shortage. Nonetheless, experts cautioned that supplies could be tight if the flu season hits hard.
“We’re cautiously optimistic,” said Curtis Allen, spokesman for the national Centers for Disease Control and Prevention.
Last fall, Chiron scrapped 52 million doses of its vaccine -- half the anticipated U.S. supply -- after bacterial contamination was found at the Emeryville, Calif.-based company’s plant. The loss caused public health authorities to ration shots.
Chiron implemented a massive overhaul of its factory so it could resume vaccine production for the 2005 season. After a nine-day review in July, FDA inspectors concluded the company’s improvements were “generally acceptable,” Chiron said.
Although some regulatory obstacles remain, the company said it hoped to ship 18 million to 26 million doses to the U.S. this year.
Chiron’s vaccine still needs supplementary FDA approvals related to a change in the manufacturing process and must pass safety and potency tests before shots can be sold. In addition, British regulators might inspect the factory before the company ships vaccine, Chiron said.
Jennifer Chao, an analyst with Deutsche Bank Securities, said in a note to investors that approval was expected and predicted that Chiron would ship 22 million doses. But she said Chiron’s future in the marketplace would be hurt by its own missteps and the entry of GlaxoSmithKline, a formidable competitor.
With approval of its vaccine Wednesday, Glaxo became the third potential supplier of shots to the U.S. The company said it expected to provide 8 million doses. Another European drug maker, Sanofi-Pasteur, said it expected to ship 60 million shots.
Annual demand for flu shots depends on the timing and severity of the flu. Gregory Poland, head of the Mayo Clinic’s vaccine research group, said it was not clear how the coming season would shape up.
One bad sign is that Australia, where it is now winter, is having a difficult flu season, Poland said. Conditions in the southern hemisphere often hint at the severity of the flu in the U.S. and countries north of the equator.
However, another indicator of a bad season -- outbreaks on cruise ships packed with vacationers from around the globe -- has not materialized. So signals are mixed, Poland said.
During last year’s mild flu season, the U.S. used 57 million of the 61 million doses available.