2 VACCINES APPROVED BY EMEA FOR H1N1

LONDON (Reuters) Sep 25 - European healthcare regulators recommended two H1N1 flu vaccines for approval on Friday, clearing the way for mass vaccination programs to start imminently.

The European Medicines Agency (EMEA) said its 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 now only need final approval from the European Commission, a move EMEA chief executive Thomas Lonngren said he expected to happen "very rapidly... hopefully next week" as part of 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 watchdog said it was still reviewing this and other applications.

A spokeswoman for Baxter said it expected to receive a positive opinion "within days".

The World Health Organization (WHO) has said that a single dose should be enough to give immunity to healthy adults and older children. 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 to enhance the immune response. 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.

Earlier this month, America's Food and Drug Administration (FDA) approved H1N1 flu vaccines from four drug makers -- 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.