3rd UPDATE: Glaxo, Novartis Swine Flu Vaccines Recommended

The European Medicines Agency Friday recommended approval of swine flu vaccines from Novartis AG (NOVN.VX) and GlaxoSmithKline PLC (GSK.LN), following a swift review by its experts to ensure the vaccines are available to European citizens by the autumn.

The European Medicines Agency, or EMEA, said it recommended the European Commission grant marketing authorization to Novartis's Focetria and GlaxoSmithKline's Pandemrix, which were developed in record time once the World Health Organization identified the virus strain and provided it to companies working on vaccines.

Clinical trials are ongoing, but the EMEA said it was able to approve the vaccines thanks to data from trials of earlier pandemic flu shots. Decades of experience fighting flu show the efficacy and safety of vaccines aren't affected when they are tweaked to provide protection against different strains, the agency said.

Other drug makers, including AstraZeneca PLC (AZN.LN), Baxter International Inc. (BAX) and Sanofi-Aventis S.A. (SAN.FR), also have swine flu vaccines and the EMEA said other applications for marketing approval are being reviewed.

At 1245 GMT, shares in GlaxoSmithKline were up 12.5 pence or 1.3% at 1,221.5 pence, while Novartis shares were down 15 cents or 0.3% at CHF50.

A GlaxoSmithKline spokeswoman said the company expects a decision on approval from the European Commission within 10 to 12 working days, far faster than the 65 or so days normally taken.

The Brentford, England-based company has so far received orders for about 291 million doses of vaccine, the spokeswoman said.

Novartis said in a statement is has already started deliveries of Focetria to governments across Europe. A spokesman said the company is in talks with more than 35 governments about providing the vaccine.

The Swiss drug maker added it plans deliveries of swine flu vaccine to the U.S. by early October, following approval there Sept. 15.

The swine flu outbreak began in Mexico in April and was declared a pandemic by the World Health Organization, or WHO, in June. Thursday, WHO said it estimated global vaccine production capacity stands at 3 billion doses, not enough to vaccinate the world's 6.8 billion people.

Still, it praised regulatory authorities' and vaccine manufacturers' "extraordinary efforts" to expedite the availability of vaccines.

Australia, the U.S., China and Hungary are among other countries that have approved swine flu vaccines for use.

Company Web site: www.emea.europa.eu

-By Jason Douglas, Dow Jones Newswires; 44-20-7842-9272; [e-mail]

(Julia Mengewein in Zurich contributed to this article.)