BEIJING – 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.
In Geneva, the World Health Organisation (WHO) hailed the announcement of the vaccine's official approval and congratulated Sinovac for its "rapid" work.
"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.
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 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 proved to be 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.