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Third Swine Flu Vaccine Nears EU Approval

by VR Sreeraman on  October 3, 2009 at 5:09 PM Drug News   - G J E 4
European regulators, fighting the threat of a second wave of deadly swine flu, on Friday paved the way for a third pandemic vaccine to be approved for use across the European Union.
 Third Swine Flu Vaccine Nears EU Approval
Third Swine Flu Vaccine Nears EU Approval
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The London-based European Medicines Agency (EMEA) recommended that the European Commission give the green light for the Celvapan vaccine, produced by US drugs firm Baxter, to be used across the EU's 27 member nations.

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"The EMEA has recommended to the European Commission that an additional vaccine against influenza A(H1N1), Celvapan from Baxter, be granted a marketing authorisation," it said in a statement.

"Adoption of an authorisation decision by the European Commission is expected shortly."

European authorities have already fast-tracked approval of two other vaccines, Pandemrix from British firm GlaxoSmithKline and Focetria from Swiss peer Novartis, amid mounting fears about the new winter influenza season.

Adding to the sense of urgency, Britain reported yet another jump in swine flu infections on Thursday.

The European Commission had approved Pandemrix and Focetria on Tuesday following their recent recommendation by the EMEA.

In Britain, the worst hit European nation from swine flu, vaccinations are expected to begin later this month.

Governments in the northern hemisphere have ordered swine flu vaccines ahead of the winter season as they brace for a second wave of the virus, which spread across the world after emerging in Mexico and the United States in April.

The number of new swine flu cases in Britain jumped last week, health officials had revealed on Thursday.

About 14,000 people contracted the A(H1N1) virus in England last week, up from 9,000 the week before, while cases in Scotland almost doubled to 13,800, according to the Health Protection Agency.

"It's steadily mounting," Britain's Chief Medical Officer Liam Donaldson had said on Thursday.

"We're not seeing the sort of explosive increase, doubling week on week that we've seen in some previous pandemics, but it is the start of the second peak, we are pretty confident of that," he told the BBC.

The figures are nowhere near the peak of more than 100,000 new cases in a week in July. But Donaldson said: "There is still time for that to happen."

"The good news about the vaccine is that we got the green light, the approval of the vaccine in Europe and we expect to be able to begin to administer it in the second half of October," he told Sky News.

The number of deaths of people with swine flu stands at 85 in Britain, with 72 in England, 10 in Scotland, two in Northern Ireland and one in Wales.

The Republic of Ireland reported Thursday two more deaths, bringing the total number of swine flu-linked fatalities there to four.

GSK announced Wednesday that it would next week begin shipping its Pandemrix vaccine across Europe.

Last week, the World Health Organization (WHO) said pharmaceutical firms can produce only three billion doses of swine flu vaccines a year, covering less than half of the global population.

However, tests on vaccines show that just one jab would offer sufficient protection against the A(H1N1) virus and that the vaccine is as safe as seasonal flu vaccines, the UN agency added.

At least 3,917 people have died from the A(H1N1) virus since it was uncovered in April, according to the WHO. There have been 2,948 fatalities in the Americas region.

Source: AFP
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