Washington Editor

WASHINGTON - The FDA Tuesday licensed four vaccines against the 2009 H1N1 swine-origin influenza A virus, despite the fact that clinical trials are still ongoing of the products.

Health and Human Services Secretary Kathleen Sebelius first revealed the FDA's decision Tuesday afternoon during a House Energy and Commerce Committee hearing, which the FDA later confirmed in a statement.

The four vaccines approved are made by Melbourne, Australia-based CSL Ltd.; Basel, Switzerland-based Novartis AG; Paris-based Sanofi-Aventis Group and Gaithersburg, Md.-based MedImmune Inc., which makes a nasal spray vaccine.

However, London-based GlaxoSmithKline plc's H1N1 vaccine candidate was not included in Tuesday's licensing actions. GSK spokesman Jeff Mclaughlin said his company was continuing to work with the FDA on its strain change biologics licensing application supplement.

The strain change supplement is the process the FDA currently uses each year when approving seasonal flu vaccines and was what was used to approve the four H1N1 vaccines.

The FDA's decision to license the four companies' vaccines before the clinical trials have been completed was unanimously recommended in July by the FDA's Vaccines and Related Biological Products Advisory Committee. (See BioWorld Today, July 24, 2009.)

Jesse Goodman, the FDA's acting chief scientist, insisted that the approved H1N1 vaccines have been undergoing the same "rigorous" FDA manufacturing oversight, product quality testing and lot-release procedures that apply to seasonal influenza vaccines.

The agency noted that the companies approved to market the H1N1 flu vaccines "have a long record of producing safe seasonal influenza vaccines."

Early study results reported last week from multiple trials showed that only one shot rather than two of the H1N1 flu vaccine was sufficient to induce a robust immune response in most healthy adults and did so within eight to 10 days, much quicker than the 21 days expected. (See BioWorld Today, Sept. 14, 2009.)

McLaughlin said GSK's clinical trial results, released Monday, showed a similar outcome.

Results from ongoing clinical studies in children and pregnant women will provide additional information about the optimal dose for protection in those populations, regulators said.

The monovalent H1N1 vaccines approved by the FDA, however, vary in the age groups for use.

MedImmune's intranasal H1N1 vaccine is approved for active immunization of people ages 2 to 49 years, while Sanofi's vaccine is approved for as young as 6 months with no upper age cutoff.

Novartis' vaccine is approved for people as young as 4 years, while CSL's is approved for those 18 years or older.

The FDA said the H1N1 flu vaccines so far in clinical trials have been well tolerated, with adverse effects similar to those of seasonal flu vaccines.

The most common adverse effect for the injected vaccines was soreness at the injection site, with other adverse effects including mild fever, body aches and fatigue for a few days after the inoculation.

For MedImmune's nasal spray vaccine, the most common adverse effects included runny nose or nasal congestion for all ages, sore throats in adults, and fever in children ages 2 to 6 years.

The FDA noted that the 2009 H1N1 vaccines are being produced in formulations with and without thimerosal, a mercury-containing preservative, which also is included in some seasonal flu vaccines.

Regulators cautioned that people with severe or life-threatening allergies to chicken eggs or to any other substance in the vaccine should not be exposed to the H1N1 flu vaccine.

The FDA said it was working closely with government agencies and nongovernment groups to enhance adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program.

During Tuesday's House hearing, Sebelius noted that the H1N1 vaccines were being made available to states at no cost and would be distributed starting in a few weeks to 90,000 sites across the U.S.

States have the responsibility to distribute the vaccines to their residents, she added.

Sebelius said it was unlikely that other newer technology-produced vaccines, such as cell-based vaccines or protein-based vaccines developed through genetically engineering of tobacco plants, would be available during the 2009-10 H1N1 flu season.

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