Glaxo's H1N1 vaccine approved

Posted November 11, 2009

— GlaxoSmithKline (NYSE: GSK) plans to begin deliveries of more than 7 million doses of a version of its H1N1 pandemic vaccine to the U.S. in December now that it has received approval from the U.S. Food and Drug Administration.

However, clinical testing continues for the adjuvanted, or boosted, version of the vaccine.

GSK said Tuesday that the FDA had approved its “supplemental biologics application,” clearing the way for production at its vaccine plant in Canada.

The U.S. government has already contracted with GSK for 7.6 million doses.

The unadjuvanted vaccine is for use in adults.

Testing of the adjuvanted – which is boosted by compounds designed to increase the response of the human immune system – is continuing in North America, Europe and Japan, GSK said.

Also on Tuesday, GSK said it had reached an agreement with the World Health Organization to donate 50 million doses of the adjuvanted vaccine to developing countries. Shipments should begin before the end of the month, GSK said.

“GSK is committed to supporting governments and health authorities around the world in their efforts to protect their populations against this pandemic. Our commitment recognizes the needs of developing countries, and this donation of 50 million doses will enable vaccination to begin soon in some of the world’s poorest countries.” said Andrew Witty, GlaxoSmithKline’s chief executive officer, in a statement.

WHO hailed the agreement.

"We welcome this very generous donation by GlaxoSmithKline, which will go to protect the health of the world's poorest people,” said WHO Director-General Margaret Chan. “This is a real gesture of global solidarity towards those who would not be otherwise able to have access to the vaccine.”

GSK maintains its U.S. headquarters in RTP and employs some 4,000 people in the area.


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  • wattsun Nov 12, 2009

    Why is WRAL ignoring Numerous stories like this regarding the H1N1 vaccine(killshot)?

    Teen Diagnosed With Guillain-Barre Syndrome After Swine Flu Shot.

    Jordan McFarland, 14, was hospitalized for five days after coming down with Guillain-Barre syndrome hours after receiving a vaccination for H1N1.

  • djcgriffin Nov 11, 2009

    wait??? What do they mean by "It's version."
    *pulls down sleeve and thinks twice about getting vaccine*

  • 007KnightRider Nov 11, 2009

    "supplemental biologics application". Why aren't all companies using the same method to develop the H1N1 vaccine? One company may add one product while the other doesn't, that's not right. No wonder some folks are dying or having complications after treatment.

  • BluHevn Nov 11, 2009

    I wonder how much profit they expect from this. I also wonder how many people a year die from the regular flu a year anyway. This H1N1 flu might just be all hype. People die from the flu anyway.

  • iron fist Nov 11, 2009

    time4real, what do you mean by "your own people"? GSK is based in the United Kingdom. Are you living in England?
    GSK US Pharma HQ is in RTP

  • Hatchcover Nov 11, 2009

    happymom - Good to see some intelligence posted.

  • lizard78 Nov 11, 2009

    GSK has employed folks in the RTP for several years.

  • Caveman93 Nov 11, 2009

    The "helping of the poor developing countries" should be translated: Population Control or Soft-Kill.

    +1! Yeah, how many preganant women have had miscarriages so far after getting this shot??? Crazy to take it!

  • happymom Nov 11, 2009

    BTW, H2O is an ingredient in fertilizer. Perhaps we should warn people against coming into contact with it too?

  • happymom Nov 11, 2009

    mtadish, just how do you propose to "boost everyone's immune system so they wouldn't get infected with this or the seasonal flu" without the vaccine.

    Your fertilizer claim has no merit. It's bunk, plain and simple.

    I suggest you put down the fluffy Suzanne-Sommers-like books and pick up a real infectious disease or immunology textbook. The immune system can not be "boosted" against flu without having the opportunity to develop antibodies against the specific strain of flu circulating in the population. THAT'S WHAT THE VACCINES DO.

    Unless people have an allergy to eggs or have had Guillain-Barré Syndrome as a result of a flu vaccine (the chances of this are rare by the way, something like 1 per million), you shouldn't get it. Outside that, flu vaccines are perfectly safe.

    And, no, I don't work for a Pharm company. I do, however, work in the field of infectious diseases, and I know bunk when I see it. Lately, I've seen a little too much.