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Swiss, Chinese unveil one-shot swine flu vaccines

US cool on one-shot swine flu vaccine
The United States will continue to work toward a two-shot vaccine against swine flu, a top health official said Thursday after Chinese and Swiss pharmaceutical companies said they have developed single-dose A(H1N1) vaccines. "We look forward to seeing the data from China and elsewhere about vaccine efficacy," Dr Thomas Frieden, head of the Centers for Disease Control and Prevention (CDC) told a news conference. "But fundamentally we have to look at the US vaccine and how that vaccine does in the trials that are under way," Frieden said. The World Health Organization (WHO) said Thursday that China would likely be the first country to vaccinate its huge population against swine flu after Beijing announced it has approved a single-dose vaccine, produced by Chinese company Sinovac. Earlier Thursday, Swiss pharmaceutical giant Novartis said trials on its swine flu vaccine indicated that a single dose could be enough to offer protection against the A(H1N1) virus. But Frieden pointed out that the Swiss were testing an adjuvanted vaccine -- one with material added to boost the immune response -- while the United States did not anticipate using such methods. "We don't anticipate that we will be using adjuvanted vaccine in most of the scenarios that we anticipate now, although that could change," Frieden said. "And we expect that the likelihood of needing two doses with a vaccine that is not adjuvanted is higher than with adjuvanted vaccine," he added. The United States has "never had adjuvanted flu vaccine, but we are not totally ruling it out because some adjuvanted materials were purchased and we are conducting clinical trials with them this year," Joe Quimby, senior press officer at the CDC, told AFP. Even if a one-dose vaccine were developed in the United States, young children, who are one of the groups that swine flu has hit the hardest, would probably be given a two-dose vaccine against A(H1N1) influenza. "For seasonal flu with children under the age of nine, we commonly use two different vaccine doses. So it's very likely that at least for children, two doses are going to be required" for swine flu, said Frieden. The CDC has recommended that five target groups totalling around 160 million people should be first in line for swine flu shots when they become available in October. Between 45 and 52 million doses of the vaccine are expected to be available in the United States by mid-October, officials have said. The priority groups for vaccination are pregnant women, people in contact with children under six months of age, healthcare workers and emergency medical personnel, children and young people between the ages of six months and 24 years of age, and non-elderly adults with underlying medical conditions. Swine flu has claimed at least 2,185 lives around the world since the WHO first reported a widespread outbreak of the viral illness in Mexico in April.
by Staff Writers
Basel, Switzerland (AFP) Sept 3, 2009
Swiss pharmaceutical giant Novartis said Thursday it had tested a new swine flu vaccine that may work after one dose while health chiefs hailed another one-dose drug developed in China.

Novartis said it was ready to produce one million doses of the vaccine before the end of the year in a bid to blunt the spread of swine flu which has already claimed at least 2,185 lives.

The drug giant said it was in talks to supply 35 countries with the new vaccine and had signed deals worth 979 millions dollars (685.4 million euros) to supply the US government.

China earlier Thursday granted approval to its first homegrown vaccine, which producer Sinovac says is effective after only one dose.

"The Sinovac (A)H1N1 vaccine is officially approved," said the head of the State Food and Drug Administration's drug registration department, Zhang Wei. Nine other Chinese companies were developing swine flu vaccines, he said.

The World Health Organisation paised China's research and said it could become the first country to protect its population against vthe pandemic.

Until now experts had maintained that two doses of vaccine would be necessary to protect against the A(H1N1) infection, straining limited vaccine supplies.

But clinical trials of the Novartis drug and of the Chinese vaccine showed that single doses could work, easing fears raised by the World Health Organisation (WHO) of a dangerous shortage of flu vaccine in the coming months.

"The pilot trial results are encouraging," said Andrin Oswald, chief executive of Novartis Vaccines and Diagnostics, referring to a trial of the vaccine conducted by Leicester University in Britain on 100 healthy volunteers aged 18 to 50.

While "two doses seem to provide better protection, one dose ... may be sufficient to protect adults against swine flu," he said.

More than two dozen pharmaceutical companies around the world are racing to test, produce and ship vaccines before the global swine flu pandemic enters an expected second wave later this year.

Last month WHO chief Margaret Chan said that vaccine supplies would be "extremely limited" in coming months, but one-dose drugs would help alleviate that concern.

"Initial information is encouraging and indicates that where supplies are limited because of restricted production, one-dose per person vaccines will provide population protection against swine flu," said Andrew Weiss, pharamaceutical company analyst at Vontobel Bank here.

Approval of the Sinovac vaccine came just days after China's health ministry warned of a potential mass outbreak as hundreds of millions of students went back to school this week with the winter flu season looming.

The ministry said China had confirmed 3,981 cases of swine flu as of Wednesday, but no deaths.

But following the vaccine tests, the WHO said China was could become the first country to vaccinate its people.

"The Chinese were very rapid on this, and we can congratulate them for having shared their trial results with us," said Marie-Paule Kieny, who heads the UN health agency's vaccine research.

It is now "likely that China would be the first country to vaccinate its population" against the flu.

The agency says 2,185 people have died worldwide after contracting swine flu which has now been detected in nearly every country in the world.

An Albanian heart patient suffering from swine flu died in an Athens hospital on Thursday and Norway registered its first death from the disease.

Meanwhile the US Centers for Disease Control and Prevention said it would announce details on Thursday on how it will deal with the spread of the virus as the flu season approaches.

Most Americans are confident their government can prevent a nationwide epidemic, according to a new poll conducted by CNN/Opinion Research Corporation.

earlier related report
China approves one-dose homegrown swine flu vaccine
China on Thursday granted approval to its first home-grown swine flu vaccine, which producer Sinovac says is effective after only one dose, as the country braces for a feared winter outbreak.

The decision could boost the global fight against A(H1N1) influenza, as most experts had assumed that two doses of vaccine per person would be needed to provide adequate protection.

"The Sinovac (A)H1N1 vaccine is officially approved," the head of the State Food and Drug Administration's drug registration department, Zhang Wei, told reporters.

"The completion of trials for Beijing Sinovac's vaccine has shown this vaccine to be very safe," the regulatory agency said in a written statement announcing the decision.

Hans Troedsson, the outgoing WHO representative in China, told AFP ahead of the decision that a one-dose vaccine would be "very important as it means we can vaccinate twice as many."

Zhang said the SFDA was looking at applications from nine other Chinese companies which are developing vaccines against the A(H1N1) virus, with decisions expected by mid-September.

The approval of the Sinovac vaccine came just days after China's health ministry warned of the growing risk of a mass outbreak as hundreds of millions of students went back to school this week with the winter flu season looming.

"With fall and winter approaching, the risk of a large-scale outbreak is increasing... and the possibility of the first death is gradually rising," the ministry said Monday.

The ministry said China had confirmed 3,981 cases of swine flu as of Wednesday, but no deaths had been reported.

The World Health Organization (WHO) says at least 2,185 people have died worldwide after contracting swine flu, now the most prevalent strain of influenza. It has been detected in nearly every country in the world.

The UN health body has warned of a possible A(H1N1) vaccine shortage as winter -- and the regular flu season -- approaches in the northern hemisphere.

"We know that supplies will be extremely limited for some months to come," WHO chief Margaret Chan said last month.

Countries in the northern hemisphere have so far ordered more than one billion doses of swine flu vaccine, according to the WHO.

More than two dozen pharmaceutical companies around the world are racing to test, produce and ship vaccines before the global pandemic enters an expected second wave.

Five of those firms are expected to account for more than 80 percent of production: Sanofi-Pasteur in France, AstraZeneca and GlaxoSmithKline (GSK) in Britain, Baxter in the United States, and the Swiss group Novartis.

But Sinovac announced after clinical trials in mid-August that its one-dose formula had proven effective -- a major advantage as the vaccine would be easier to administer and available to more people.

"We have not found any negative side-effects -- it is safe and reliable," Sinovac president Yin Weidong told AFP in a recent interview at the company's Beijing headquarters.

Swiss pharmaceutical giant Novartis said Thursday that its clinical trial of its vaccine had shown "encouraging" results and suggested that one dose could suffice.

Andrin Oswald, chief executive of Novartis Vaccines and Diagnostics, added that while "two doses seem to provide better protection," one dose of Novartis's Celtura vaccine "may be sufficient to protect adults."

The Chinese government plans to vaccinate 65 million people, or five percent of the total population of 1.3 billion, before year's end.

Britain and France received their first batches of swine flu vaccine in late August. The United States and Australia expect to launch vaccination programmes in October.

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