The Free Press, Mankato, MN

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August 16, 2013

New 4-strain flu vaccine gets FDA approval

RALEIGH, N.C. — People for the first time will have the option of getting inoculated against the flu with a newly developed 4-strain vaccine rather than the 3-strain vaccine that’s been in use for decades.

The U.S. Food and Drug Administration approved a shot for four flu strains Thursday — after approving a similar vaccine in December — as preventives against the virus that kills thousands of Americans each year. Both vaccines were developed by pharmaceutical giant GlaxoSmithKline after public health officials repeatedly wrongly predicted which flu strains would be the most dominant. GSK plans to deliver about 10 million doses for the upcoming flu season, along with at least 12 million doses of the traditional flu vaccine made for three strains.

The two GSK vaccines — Flulaval Quadrivalent and Fluarix Quadrivalent — are approved for children as young as 3 years old.

“This is the first influenza season coming up where quadrivalent vaccine will be available,” said Leonard Friedland, GSK’s director for scientific affairs and public health. “We expect in the next few years the market will switch to quadrivalent formulations.”

GSK, which employs 4,600 people in the Triangle area of North Carolina, will be the dominant supplier of the new vaccine, at least in the first year. Two other makers of 4-strain flu vaccine will either produce a limited supply or a vaccine in inhaler form.

Friedland said the new vaccines will provide broader coverage against influenza viruses that health experts project to be the most prevalent, but will not provide total immunity against influenza. GSK’s new vaccines are made in Germany and in Canada.

“There will be broader protection,” Friedland said.

Each year the World Health Organization recommends to public health agencies which flu vaccine formulations to stockpile. The recommendation is based on the organization’s prediction of which flu strains will be active that year.

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