From Our 2009 Archives

Swine Flu Vaccines Get FDA Nod

First Swine Flu Vaccines to Arrive Within Weeks

By Daniel J. DeNoon
WebMD Health News

Reviewed By Louise Chang, MD

Sept. 15, 2009 -- The FDA has approved four swine flu vaccines, which will make up 96% of the 195 million doses the U.S. has purchased.

The Latest on
H1N1 Swine Flu

Vaccinations will start by mid-October. Some early lots of vaccine may arrive even earlier.

"This vaccine will help protect individuals from serious illness and death from influenza," FDA Commissioner Margaret A. Hamburg, MD, says in a news release.

The vaccines are made by CSL Ltd., Novartis Vaccines and Diagnostics Ltd., Sanofi Pasteur Inc., and MedImmune LLC. The MedImmune vaccine is the swine flu version of FluMist, which is a nasal spray. The other three vaccines are traditional flu shots.

FDA approval was expected, as the vaccines are made the same way as seasonal flu vaccines. The FDA has previously said it considers the swine flu vaccine merely a strain change from the seasonal flu vaccine, avoiding the lengthy approval process that new vaccines must go through.

GlaxoSmithKline has also been expected to provide some vaccine to the U.S. It's not yet clear why that vaccine was not included in today's announcement, but GlaxoSmithKline was scheduled to provide less than 4% of this year's U.S. swine flu vaccine supply.

Novartis is expected to supply nearly half of the U.S. supply, with Sanofi and CSL providing much of the rest. However, MedImmune has said that it has been able to make more vaccine than had been anticipated.

Who's First for Swine Flu Vaccine?

About half the U.S. population is among those recommended to receive the vaccine:

  • Everyone ages 6 months to 24 years
  • Pregnant women
  • Anyone who lives with or cares for infants under 6 months of age
  • Health care and emergency response personnel
  • People ages 25 to 64 who have health conditions that increase their risk of severe flu complications

Eventually there will be plenty of swine flu vaccine. But supplies will be limited in the first weeks, so some areas may give the first shots to a smaller group of people:

  • All kids ages 6 months to 4 years
  • Pregnant women
  • Anyone who lives with or cares for infants under 6 months of age
  • Health care workers and emergency workers with direct patient contact
  • Kids ages 5 through 18 with chronic medical conditions

And when vaccine demand is met at the local level, the vaccine will be offered to everyone who wants it, regardless of risk group.

The priority groups for swine flu vaccine differ from those for seasonal flu vaccine. Elderly people are at the most risk of seasonal flu, and they and their caretakers should get their seasonal flu shots right away.

But relatively few elderly people have come down with swine flu, so they are not in the priority groups for swine flu vaccine.

SOURCES: News release, FDA. CDC web site.

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