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UPDATE 1-EU agency begins review of H1N1 flu vaccine data
July 24, 2009 / 12:01 PM / 8 years ago

UPDATE 1-EU agency begins review of H1N1 flu vaccine data

LONDON, July 24 (Reuters) - Europe’s drug watchdog has begun reviewing data on pandemic flu vaccines with the goal of getting medicines to protect against the H1N1 virus approved before flu season starts in the Northern Hemisphere, likely in September.

The European Medicines Agency said on Friday it would speed the review of data -- which began in July -- as vaccine manufacturers make them available.

“Given the public health threat posed by the current pandemic, the Agency’s goal is to ensure data submitted to support marketing authorisations for vaccines are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September,” it said in a statement.

“Additional clinical trials in adults and children are currently being initiated by the vaccine manufacturers and the results will be reviewed in the coming months as they become available.”

On Thursday the U.S. Food and Drug Administration said it would help companies design ways to quickly test experimental versions of the vaccine, which experts say is likely to be given to people alongside the seasonal flu vaccine.

H1N1 pandemic flu has spread to some 160 countries and killed about 800 people, and needs to be watched carefully in case it mutates and becomes more severe in winter, the World Health Organisation said on Friday.

The new virus, commonly known as swine flu, has been infecting people worldwide because no one has natural immunity to it. Like all influenza viruses, it may circulate more widely in colder weather and could also mutate in winter, he said.

The WHO so far has promises of 150 million doses from two manufacturers for developing countries and is negotiating with other producers for further doses which will be earmarked for the least developed countries, he said.

On Thursday five companies making H1N1 vaccine laid out their plans for testing various formulas for the U.S. market. AstraZeneca’s (AZN.L) MedImmune unit, Australia’s CSL Ltd (CSL.AX), GlaxoSmithKline Plc (GSK.L), Novartis AG NOVN.VX and Sanofi-Aventis SA (SASY.PA) all are making H1N1 vaccines. (Reporting by Michael Kahn. Additional reporting by Laura MacInnis and Jonathan Lynn in Geneva; Editing by David Cowell) ($1 = 0.7030 euro)

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