First H1N1 vaccines recommended

European healthcare regulators recommended two swine flu vaccines for approval today, clearing the way for mass vaccination programmes to start within weeks.

The European Medicines Agency (EMEA) expert committee on new drugs gave the go-ahead for the first H1N1 swine flu vaccines from GlaxoSmithKline and Novartis, called Pandemrix and Focetria.

The shots will now go for final approval from European Commission, a process that should take between 10 and 20 days under an accelerated regulation system for pandemic vaccines.

A third vaccine from Baxter, which had also been submitted under the fast-track "mock-up" procedure, did not get a green light, but the agency said it was still reviewing this and other applications.

"We are working with the company (Baxter) to get all of the information that we need so that a recommendation can be made shortly," said a spokeswoman.

Manufacturers and governments have been scrambling for vaccines to target the new H1N1 flu strain, which was declared a pandemic in June.

The World Health Organisation (WHO) said on Thursday that drugmakers will only be able to produce enough H1N1 vaccine each year for half the planet -- around 3 billion doses per year -- meaning governments will have to decide who should get the limited supplies.

The WHO added that a single dose should be enough to give immunity to healthy adults and older children from the virus commonly known as swine flu.

TWO DOSES...FOR NOW

The EMEA, however, said it was currently recommending two doses be given, at an interval of three weeks, although it acknowledged preliminary data suggested one dose might suffice and this recommendation could be updated as new data comes in.

The London-based watchdog said it was confident the new vaccines were safe, despite being rushed through the approval process, adding manufacturers would have to carry out safety studies in 9,000 subjects for each vaccine after launch.

"Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine should not substantially affect the safety or level of protection offered," the agency said in a statement.

Both the Glaxo and Novartis shots contain adjuvants -- substances that enhance the immune response so that less active ingredient, or antigen, can be used in each dose.

Glaxo said its vaccine contained just 3.75 micrograms of antigen while the Novartis product contains 7.5 micrograms. That compares with 15 micrograms needed in non-adjuvanted vaccines.

Most rich nations have contracts with drugmakers to obtain enough vaccine to cover their populations and governments have already been building up stockpiles ahead of the shots winning regulatory approval.

But poorer countries lack the financial resources to compete for an early share of limited supplies.

Earlier this month, America's Food and Drug Administration (FDA) approved H1N1 flu vaccines from four drugmakers -- Sanofi-Aventis, CSL, AstraZeneca's Medimmune unit and Novartis.

The WHO says it will begin an initial distribution of around 300 million doses of H1N1 vaccine donated by rich nations to more than 90 developing countries from November.