West Coast Editor
With Chiron Corp.'s once-famously troubled overseas plant cleared to make flu vaccine this year, and with an offer on the table from Novartis AG to buy the company for $4.5 billion, the U.S. Centers for Disease Control and Prevention said Chiron and other manufacturers could come up with 97 million doses for the this year's season.
They could - but they might not.
Even as vaccine makers other than Chiron revved their engines, the CDC pointedly made note of "uncertainties" about the supply, and proposed that patient groups such as the very young, old, or pregnant, be given priority over others until Oct. 24.
"The exact number of available doses and timing of vaccine distribution for the 2005-06 season remain unknown," the CDC said.
In a press release, Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said it was "pleased" by Emeryville, Calif.-based Chiron's efforts, but "additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season." The agency "will evaluate the implementation and effectiveness of their corrective actions going forward," he said.
Lenore Gelb, spokeswoman for the FDA, told BioWorld Today she could not comment beyond the agency's formal statements on the flu-vaccine subject.
Chiron last year failed to provide the U.S. with 46 million to 48 million Fluvirin shots last year after regulators shut down the Liverpool, UK, manufacturing plant because of sterility issues. Since then, British authorities and the FDA have given their blessings to the plant - the FDA called conditions at Liverpool "generally acceptable" - though Chiron said it will only make 18 million to 26 million doses this year.
The company also said in July that it would not provide Begrivac flu vaccine to the German and UK markets because of bacterial contamination. Still, Novartis' buyout offer of $40 per share is a 10 percent premium to the company's closing stock price last Wednesday of $36.44. (See BioWorld Today, July 21, 2005 and Sept. 2, 2005.)
Among the firms stepping up to the influenza plate for the coming season is London-based GlaxoSmithKline plc, whose Fluarix won FDA clearance last week. GSK plans to crank out as many as 8 million doses. MedImmune Inc., of Gaithersburg, Md., has not disclosed how many doses of FluMist nasal vaccine it will provide. But the biggest contributor will be Paris-based Sanofi-Aventis Group, which aims to produce 60 million doses.
Even ID Biomedical Corp., of Vancouver, British Columbia, could get into the act if its Fluviral product - under review by the by FDA - wins accelerated approval soon.
MedImmune noted that FluMist, which the CDC said can be given to any non-pregnant, healthy person age 5 to 49, is not subject to the tiered recommendations for priority use of the trivalent inactivated influenza vaccine.
Last week was a busy one for MedImmune, which entered a licensing deal with GSK for anti-staphylococcal monoclonal antibodies and, separately, said it would take over all U.S. sales of the monoclonal antibody Synagis (palivizumab) for respiratory syncytial virus from co-promoter Abbott Laboratories, of Abbott Park, Ill., after June 2006. (See BioWorld Today, Aug. 30, 2005, and Sept. 1, 2005.)
Specifically, the groups that the CDC proposes should get the vaccine (until Oct. 24) are people 65 or over, children between 6 months and 23 months of age, pregnant women, health care workers, and people who has a chronic illness or live with or care for children under 6 months of age.
Assuming supplies are adequate, the CDC recommends flu vaccine be made available to all adults after Oct. 24.
A lurking threat is the avian flu, of which more than 100 cases have been reported in Asia. There was news on that front recently, too, with Novavax Inc. posting good results with its vaccine against the H9N2 avian flu strain, produced with the company's Virus-Like Particle technology, effectively protected animals when challenged with live virus. (See BioWorld Today, Aug. 26, 2005.)