WASHINGTON, Feb. 21 (UPI) -- The European Medicines Agency Thursday recommended approval of the first vaccine designed to protect humans against H5N1, the virus that causes bird flu.
Prepandrix, made by GlaxoSmithKline Biologicals, is a pre-pandemic vaccine "intended to trigger an immune response against the H5N1 strain of the influenza virus before or during an officially declared influenza pandemic," the agency said in a statement.
The statement said the recommendation had been sent to the European Commission, which would decide whether to authorize its sale. The commission generally approves such recommendations within a month or two.
H5N1 is a virus that causes flu in birds and has killed millions of them around the globe. Currently, although humans can catch the disease from birds -- and most who do so die -- it is not transmissible between humans. Scientists fear that a mutated strain might become transmissible between humans and spark a new global influenza pandemic.
Although the new drug is designed to protect against existing strains, the agency said it was working on "the assumption that vaccination with Prepandrix will provide a clinically useful degree of cross-protection against the strain that causes the next pandemic."
"No one knows how effective (pre-pandemic vaccines) will be," Dr. Joan Pfinsgraff told United Press International.
Pfinsgraff is director of health intelligence for Annapolis, Md.-based iJET Intelligent Risk Systems, a business intelligence firm that studies pandemic preparedness.
"The idea is that even a poorly matched pre-pandemic vaccine will be of some benefit," she said, adding that most European nations had pandemic preparedness plans calling for such vaccines to be used on frontline health workers and other first responders, with the general population being vaccinated with a drug designed specifically against the strain causing the pandemic -- which could take four to six months to develop.
But she said Norway and Switzerland had plans calling for stockpiles large enough to vaccinate the whole population with pre-pandemic drugs.
In a statement, GSK said that a "number of national governments" have expressed interest in stockpiling the vaccine.
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Shaun Waterman, UPI Homeland and National Security Editor
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