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Sanofi Pasteur starts testing swine flu vaccine
Published in Saudi Press Agency on 07 - 08 - 2009


French drugmaker Sanofi Pasteur began human
trials of its swine flu vaccine this week in about 2,000
people in the United States, the company said Friday _
becoming the third company conducting clinical trials on
swine flu vaccines, according to AP.
Sanofi Pasteur's trials began Thursday, testing both the
vaccine's safety and how many doses would be needed to
protect people from swine flu, the company said in a
statement. Most experts think two doses will be necessary.
The World Health Organization's vaccine chief Marie-Paule
Kieny said Thursday that drugmakers were «on track,» and
that the first batches of swine flu, or H1N1, vaccine
should be delivered in September.
Sanofi Pasteur, which makes about 40 percent of the
world's flu vaccine, has applied to the U.S. Food and Drug
Administration for fast-track licensing for the vaccine.
Kieny said safety was not compromised in granting quick
licenses before full safety tests are finished _ a practice
European and U.S. drug regulators also use for seasonal flu
vaccines. Clinical tests on new vaccines can take up to a
year or more.
The European Medicines Agency said approving a swine flu
vaccine for EU countries could take five days.
The WHO said Northern Hemisphere countries, as well as
Southern Hemisphere doctors and nurses, should get a
vaccine first because swine flu is expected to surge in the
north when the regular flu season begins later this year.
Sanofi Pasteur has contracts with several governments,
including France and the U.S., to provide swine flu vaccine
and other products in bulk.
Meanwhile, Swiss pharmaceutical Novartis AG said this week
it started testing its swine flu vaccine in about 6,000
people in Britain, Germany and the U.S.
Last month, Australian company CSL also began testing its
vaccine in Australia.
The vaccines being tested by Novartis and Sanofi Pasteur
contain adjuvants _ ingredients intended to boost the
body's immune response. Adjuvants, which also stretch a
vaccine's active ingredient further to make more doses, are
used in European flu vaccines but not in the U.S. The WHO
has recommended they be used in swine flu vaccines to
increase the global supply.
Health officials have said there is little or no
information on how vaccines containing adjuvants affect
pregnant women and children _ two groups thought to be
particularly vulnerable to swine flu.


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