First Vaccine for Foiling Swine Flu to Be Tested

[Cees Binkhorst]

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Dus Tamiflu niet meer nodig?

Groet / Cees

http://www.bloomberg.com/apps/news?pid=20601202&sid=axGUR71t446g#
By Simeon Bennett

July 21 (Bloomberg) -- The first human trials of a swine- flu vaccine are
set to begin in Australia as deaths and infections from the H1N1 virus
mount worldwide, intensifying demand for a protective shot.

CSL Ltd., the only flu-vaccine maker in the Southern Hemisphere, plans to
start the research tomorrow in Adelaide by injecting a group of healthy
volunteers with its experimental vaccine, the company said last week.
Melbourne-based CSL plans to test the shot in 240 people, ages 18 to 64,
during the next seven weeks in preparation for filling orders from
Australia, the U.S. and Singapore.

The World Health Organization and CSL’s larger rivals, including
Sanofi-Aventis SA, will be watching the test to determine how much antigen
-- the key substance in vaccines --is needed to prevent people from
getting infected. The results will help makers decide how many shots can
be produced and how many people vaccinated.

“The world will be watching to see the immunogenicity results of this
first clinical trial,” Marie-Paule Kieny, director of the Geneva-based
WHO’s initiative for vaccine research, said by e-mail. “It is likely to be
indicative of how the other vaccine candidates will perform.”

Swine flu, known as A(H1N1), has sickened so many people worldwide that
the WHO has said it isn’t essential to test every suspected case and has
recommended reporting hospitalizations. How much vaccine can be produced,
how fast, and how effective it will prove to be are still unknown as the
pandemic virus spreads.

Hundreds of Deaths

A total of 94,512 laboratory-confirmed cases of swine flu, resulting in
429 deaths, had been counted as of July 6, according to figures released
by the WHO before it stopped issuing tables showing cases in all countries
with the virus.

Health-care workers are the “main priority group” to get the shot when it
becomes available, the WHO said on July 13. Individual countries should
decide on priority when inoculating other groups such as children and the
elderly, the United Nations agency said.

CSL shares closed little changed at A$30.01 today. The stock has fallen 11
percent in 2009, after dropping 7.3 percent last year.

There isn’t any commercial advantage to being the first maker to start
human trials, as most manufacturers already have orders to supply vaccines
to governments, said David Low, a health-care analyst at Deutsche Bank AG
in Sydney.

“Being first is probably more of a PR coup,” Low said in a telephone
interview on July 16.

Sales Projection

CSL may record sales of A$300 million ($244 million) this year for its
swine-flu vaccine, said Alexander Smith, a health- care analyst at
JPMorgan Chase & Co. in Sydney.

“That sounds reasonable,” said Rachel David, a CSL spokeswoman.

Two shots of vaccine will probably be needed to protect people against the
pandemic virus, said Michael Osterholm, director of the Center for
Infectious Disease Research and Policy, at the University of Minnesota in
Minneapolis.

CSL has a contract to supply 21 million doses to Australia’s government,
David said. It also has an order from the U.S. for $180 million of
antigen, enough for 20 million to 40 million doses, depending on the
results of trials, she said. The company has an order from Singapore,
David said, declining to give details.

Sanofi, Novartis

Novartis AG expects to start trials of its shot this month, Eric Althoff,
a spokesman for the Basel, Switzerland-based drugmaker, said in a July 14
e-mail, without giving a date. Sanofi plans to start tests of its shot in
August, Albert Garcia, a spokesman for the Paris-based company’s vaccines
unit, said in a phone interview on July 16.

David Outhwaite, a spokesman for GlaxoSmithKline Plc, declined to answer
questions about the London-based drugmaker’s plans to test its shot.

Baxter International Inc., based in Deerfield, Illinois, will produce a
vaccine by early August, after which the company will perform clinical
testing, said Chris Bona, a company spokesman.

The U.S. Centers for Disease Control and Prevention, based in Atlanta, has
said it expects a vaccine ready for widespread distribution in October.

Sinovac Biotech Ltd., a Beijing-based flu-vaccine maker, expects to
complete production of the first batch of its shot by the end of this
month and start trials after that, Helen Yang, a company spokeswoman, said
in an e-mail.

CSL will give each volunteer two shots, three weeks apart, to determine
how many doses are needed to get the right immune response, David said.
CSL is also testing the CSL425 vaccine, known as Panvax (H1N1
A/California) in Australia, in two dose sizes to see which is more
effective, she said.

The company is conducting the trials through CMAX, the clinical research
unit of IDT Australia Ltd.

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