By Simeon Bennett
July 22 (Bloomberg) -- Nurse Luiza Duszynski flicks her syringe, squeezes a few drops of clear liquid from the needle and pushes it into Tara Seaton’s arm. With that, she became one of the world’s first recipients of a vaccine for swine flu.
Seaton is among the 240 healthy adult volunteers in Australia who CSL Ltd. began injecting today with its experimental vaccine against H1N1, the new virus strain that sparked the first influenza pandemic in 41 years.
“It was fine, I didn’t even feel it,” Seaton, a 28-year- old post-office assistant, said from the Royal Adelaide Hospital, where she received the shot.
CSL is testing the vaccine over the next seven weeks as it prepares to fill orders from Australia, the U.S. and Singapore. The World Health Organization and Melbourne-based CSL’s larger rivals such as Sanofi-Aventis SA will be watching the test to help determine whether one or two shots are needed to protect people and how many doses can be produced.
“The fundamental data that we and others around the world are interested in are the immune response to the first and second dose,” Andrew Cuthbertson, CSL’s chief scientific officer, told reporters in Adelaide. The test results will also show the effects of different doses, he said.
Volunteers are required to keep a diary for six months and record any signs and symptoms, including nausea, increased temperature and swelling around the injection area, Seaton said.
Swine flu has killed more than 700 people globally and sickened so many the WHO has stopped issuing a daily tally.
Other Makers
Novartis AG expects to start trials of its shot this month, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today, 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.
“It is reasonable to say that, if all goes well, we will start delivering the vaccine by November or December,” Garcia said late yesterday. “This is the most reasonable time frame.”
David Outhwaite, a spokesman for GlaxoSmithKline Plc, declined to answer questions about the London-based drugmaker’s plans to test its shot. Deerfield, Illinois-based Baxter International Inc. will produce a vaccine by early August, after which it will perform clinical tests, spokesman Chris Bona said.
CDC Forecast
The Atlanta-based U.S. Centers for Disease Control and Prevention has said it expects a vaccine ready for widespread distribution in October.
Vaxine Pty, a South Australian biotechnology company, said it started tests on 300 volunteers in Adelaide on July 22 using a vaccine that’s boosted with a novel sugar-based compound. The company, based in Adelaide’s Flinders Medical Centre, has no orders yet for its experimental shot, Research Director Nikolai Petrovsky said in a telephone interview today.
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.
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
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 the Australian government and an order from the U.S. for $180 million of antigen, enough for 20 million to 40 million doses, David said. The company also has an order from Singapore, she said, declining to give details.
The company is producing the CSL425 vaccine at capacity with the current customer base, David said.
The vaccine maker will give volunteers aged 18 to 64 years two shots, three weeks apart, to determine how many doses are needed to get the right level of protection, David said.
CSL is also testing the pandemic vaccine, known as Panvax (H1N1 A/California) in Australia, in a regular and double dose to see which is more effective, she said.
Volunteer Seaton said she had no fears about the injection and any possible side effects. The A$400 she received for participating in the trial was a bonus.
“I thought, worst-case scenario, if everyone gets swine flu then I’ll be vaccinated against it,” she said.
To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net
Last Updated: July 22, 2009 06:38 EDT
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