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WHO: No licensed swine flu vaccine until end of year

Posted July 14, 2009

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— A fully licensed swine flu vaccine might not be available until the end of the year, a top official at the World Health Organization said Monday, in a report that could affect many countries' vaccination plans.

GlaxoSmithKline (NYSE: GSK), which operates its U.S. headquarters in Research Triangle Park, N.C., and Novartis (NYSE: NVS), which is building a vaccine production plant in Holly Springs, are under U.S. government contract to produce vaccines.

Meanwhile, on Monday, the U.S. government stepped up its efforts to acquire H1N1 vaccines.

Under new contracts, the Health and Human Services department awarded $71.4 million to GSK for its adjuvant, $346 million to Novartis for vaccine and another $344 million for its adjuvant, $61.4 million to Sanofi for vaccine and $61 million to MedImmune for nasal spray vaccine.

Several drugmakers are currently considering using adjuvants, ingredients used to stretch a vaccine's active ingredient, which could allow for many more vaccine doses. But little or no data exists on the safety of vaccines with adjuvants in populations including children and pregnant women. And in the U.S., there are no licensed flu vaccines that use adjuvants.

“We recognize that preparedness is shared responsibility between federal, tribal, state, local governments, private organizations and individuals,” said HHS Secretary Kathleen Sebelius in a statement. “We are doing our part to be as prepared as possible for the impact that this infectious disease could have on our country.

“Vaccines may serve an important role in that preparedness,” she added. “The action we are taking today will provide flexibility in a future immunization program, if a program is recommended.”

Countries could use emergency provisions to get the vaccines out quicker if they decide their populations need them, Marie-Paule Kieny, director of WHO's Initiative for Vaccine Research, said during a news conference.

The swine flu viruses currently being used to develop a vaccine aren't producing enough of the ingredient needed for the vaccine, and WHO has asked its laboratory network to produce a new set of viruses as soon as possible.

So far, the swine flu viruses being used are only producing about half as much "yield" to make vaccines as regular flu viruses.

Last week, WHO reported nearly 95,000 cases of swine flu worldwide including 429 deaths. Most people who get the virus only experience mild symptoms and don't need treatment to get better.

In a presentation to WHO's vaccines advisory group last week, Kieny said a lower-producing vaccine would significantly delay the timeline for vaccines. That could complicate many Western countries' plans to roll out vaccines in the fall.

British Health Minister Andy Burnham promised that vaccines would start arriving in the U.K. in August - and predicted the country could see up to 100,000 cases a day by the end of that month.

Before countries can start any mass swine flu vaccination campaigns, the vaccines need to be vetted by regulatory authorities for safety issues. That means testing the vaccines in a small number of humans first, which can take weeks or months.

"I think it will be a very significant challenge to have vaccines going into peoples' arms in any meaningful number by September," said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota. "At this point, it is still is an issue of when will it be available, who will get it, and what will be the dose?"

Kieny said many of those questions remain unanswered at the moment. But she said WHO's vaccine advisory group recommended that health care workers receive the first swine flu shots since they are on the front lines of the global outbreak.

On Monday, British health authorities said a family doctor died over the weekend after contracting swine flu.

WHO's vaccine experts recommend that countries decided that certain groups should get the vaccine first - like pregnant women, people with chronic respiratory problems or obesity, children, and possibly young to middle-aged adults, who have been disproportionately affected by the virus.

The decision to start vaccinating people against swine flu - which so far remains a mild virus in most people - will ultimately be a gamble, since there will be limited data on any vaccine. Until millions of people start receiving the shots, experts will not know about rare and potentially dangerous side effects.

The public health community may still be scarred by the U.S.' disastrous 1976 swine flu vaccination campaign, which was abruptly stopped after hundreds of people reported developing Guillain-Barre syndrome, a paralyzing disorder, after getting the flu vaccine.

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  • confederateyankee Jul 14, 2009

    27615 apparently doesn't know very much about the 1918 Pandemic that slaughtered more people than World War I.

    That swine flu--the closest known variant to this avian-swine variant we now face--came through in the spring and summer as a very mild case as well, before reemerging in the fall with a much more lethal punch.

  • scientistjo Jul 14, 2009

    You all will be pounding down the doors for vaccine if tens/hundreds of thousands start getting sick and dying. If they didn't make the vaccine, you'd say "where's the vaccine...why no vaccine?"

  • djbyrdnc Jul 14, 2009

    You know most doctors are not testing for this flu. So the
    numbers that are released by the state are not correct. How many people are getting sick at all of these summer camps? But when you go to the doctor they do not test and you spend $100.00
    and still go home rest, drink and eat chicken noodle soup. Your state government at work.

  • 27615 Jul 14, 2009

    Is this vaccine really needed? nope

  • Grandpeople Jul 14, 2009

    let's see how many people they put to work with the millions $. I bet none. The vaccines from GSK will be produced outside the us but they continue to lay off US workers. I would use the Novartis drug first if I knew I could get it - they are at least in NC and USA.

  • whatelseisnew Jul 14, 2009

    And yet if a company wants to bring a new medicine to market they have to jump through all kinds of hoops. Even after jumping through said hoops they face massive liability issues, particularly in this country with politicians that are bought and paid for by the lawyers.

    I for sure will not be taking this vaccine.

  • ncguy71 Jul 14, 2009

    "The decision to start vaccinating people against swine flu - which so far remains a mild virus in most people - will ultimately be a gamble, since there will be limited data on any vaccine.

    "Until millions of people start receiving the shots, experts will not know about rare and potentially dangerous side effects."

    Now - that really make me feel safe.

    No one will be sticking a needle in me or any of my family members even if there are mandatory vaccinations ordered.

    You have a right and an obligation to refuse this potential poison.

    This vaccine is being rushed to the market with no trials or testing.

    So - if something goes wrong - it will be - "oops my bad" from the government and too late to do anything about it.

  • time4real Jul 14, 2009

    well don't go to MX or eat pork before then!

  • DeathRow-IFeelYourPain-NOT Jul 14, 2009

    No vaccine until the end of the year. First of all, is a vaccine really needed since its been so mild? Second, if it mutates and becomes a "meaner" strain, will the vaccine they produce fight the new strain?