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China to approve single-dose swine flu vaccines
Published in Saudi Press Agency on 02 - 09 - 2009

China is close to approving homegrown swine flu vaccines that manufacturers said that they can protect people with a single dose, an encouraging development for health
officials racing to prepare for an expected spike in cases
this winter, according to AP.
Experts said China's versions could boost global efforts
to fight the virus if claims they work with just one dose
are proven.
Many health authorities have assumed two doses would be
needed to offer complete protection against the new H1N1
virus, so a single-dose vaccine means producers could
distribute supplies to more people more quickly.
The World Health Organization said it was encouraged after
reviewing details of trials of one of the two Chinese
vaccines. However, experts said more test results were
needed from other vaccine makers around the world to
determine if one dose would be potent enough.
«Everybody is desperately hoping that one will do because
then that's much easier to administer,» said Jodie
McVernon, a vaccine expert at the University of Melbourne
who is involved in Australian trials of swine flu vaccines
for young children. She said she had not seen the Chinese
trial results.
China's State Food and Drug Administration said at least
two vaccines are near approval after completing clinical
trials last month and passing reviews by panels of about 40
experts this week. Another four vaccines are being
reviewed, according to the agency.
The vaccine makers, Sinovac Biotech Ltd. and Hualan
Biological Engineering Inc., said the clinical trials show
they are effective in single doses when used on people aged
3 to 60 years.
International health experts say swine flu has not been as
severe as initially feared. At least 2,185 people have
died, but most other cases are mild and require no
treatment. Worries remain that a rash of new infections
could overwhelm hospitals and health authorities,
particularly in poorer countries.
In about two weeks, the U.S. expects to announce initial
trial results from its vaccine, which is the same type as
China's Sinovac version, said Dr. Anthony Fauci of the
National Institutes of Health, who is overseeing American
swine-flu vaccine tests.
«From what I've seen and heard of the data, it looks
encouraging,» Fauci said of Sinovac's clinical trials.
«This is very good news. Let's hope the material that
we're using has similar results.»
WHO said information provided by Sinovac shows that in
trials, the vaccines were tested in three formulations of
15 microgram doses, and all gave antibody responses that
satisfied regulatory criteria.
«We have no reason to doubt what Sinovac is reporting,»
said Melinda Henry, a WHO spokeswoman in Geneva.
«Certainly if one dose proves sufficient to produce the
desired immune response, this would be very encouraging in
terms of augmenting the global supply of vaccine in the
near future.»
China aims to have enough swine flu vaccines for 5 percent
of its population by the end of the year, Health Minister
Chen Zhu said at a recent flu symposium in Beijing.


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