FDA Approves 4 Swine Flu Vaccines

Sept. 16 -- TUESDAY, Sept. 15 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday approved four H1N1 swine flu vaccines, with the first doses expected to be available within four weeks.

"Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus," FDA Commissioner Dr. Margaret A. Hamburg said in a news release. "This vaccine will help protect individuals from serious illness and death from influenza."

The federal government has ordered 195 million doses, but may order more doses if needed, Hamburg said. Typically, 100 million Americans get vaccinated for the regular seasonal flu each year.

An estimated 45 million doses of the vaccines are expected by mid-October. Children and young adults, who seem to be more susceptible to the H1N1 swine flu, as well as pregnant women, health-care workers and people with chronic health conditions such as asthma, diabetes and heart disease, are priority candidates for the vaccine.

Since it first emerged in Mexico and the United States last spring, the H1N1 swine flu has continued to produce relatively mild illness in most people -- much like the seasonal flu -- and recovery is fairly swift.

"The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," Dr. Jesse Goodman, the FDA's acting chief scientist, said in the news release.

Preliminary results from clinical trials have shown that just one dose of the H1N1 swine flu shots trigger the desired immune response in most healthy adults eight to 10 days after inoculation, the same as the seasonal influenza vaccine. Health officials had been concerned that two doses of H1N1 swine flu vaccine would be required, greatly diminishing available supplies.

Clinical studies of the H1N1 vaccine are continuing, to determine the optimal dose in children. Those results are expected shortly, the FDA said.