Sanofi Says Swine-Flu Vaccine Produces 'Robust' Response
DOW JONES NEWSWIRES
The vaccines unit of French pharmaceutical company Sanofi-Aventis SA (SNY)
unit said the company's U.S.-licensed swine-flu vaccine produced a "robust"
immune response on adult test subjects, even those aged over 65.
Sanofi Pasteur said a single 15-microgram dose provided antibody response
three weeks after vaccination that is considered "protective."
The data, from a study of 849 adults, confirm preliminary data from another
study by the National Institutes of Health, Sanofi Pasteur said. The company
began U.S. clinical trials in early August, including adults 18 to 64, adults 65
and older, and children 6 months to 9 years old.
The ultimate findings will be used to determine the recommended dosages and
schedule for the vaccine, which was licensed by the U.S. Food and Drug
Administration on Sept. 15.
Although Sanofi-Aventis delivered its first shipment of swine-flu vaccine to
the U.S. government Tuesday, ahead of schedule, the company cautioned then that
the shots may not become immediately available for administration because they
will have to work their way through government distribution channels.
Last week, the director of the U.S. Centers for Disease Control and Prevention
said the first doses of an H1N1 vaccine should become available by about Oct. 6.
Sanofi has contracted with the U.S. government to supply a total of 75.3
million doses of its H1N1 vaccine, manufactured at a plant in Swiftwater, Pa.
Other manufacturers also have supply contracts with the U.S., including
GlaxoSmithKline PLC (GSK) and AstraZeneca PLC (AZN).
AstraZeneca's MedImmune unit began moving its H1N1 vaccine from its
distribution center to U.S. regional distribution centers a week ago. Novartis
AG (NVS) began shipping its H1N1 vaccine for distribution in the U.S. on Sunday.
Drug distributor McKesson Corp. (MCK) is handling the distribution of the
vaccines under a contract with the U.S. government.
The swine flu, or H1N1 influenza virus, began spreading rapidly earlier this
year, and as of last week there had been more than 300,000 laboratory-confirmed
cases and 3,917 deaths in 191 countries and territories, according to the World
Health Organization. WHO has declared it a pandemic, and vaccine makers and
health officials have been working quickly to make vaccines against the virus
available to as many people as possible.
In recent trading, Sanofi's American depositary shares were down 65 cents, or
1.8%, to $36.30 as part of a broad market decline. The shares are up 7.5% over
the past year.
-By Mike Barris, Dow Jones Newswires; 212-416-2330; mike.barris@dowjones.com
(END) Dow Jones Newswires
10-01-091258ET
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