Cold, Flu, & Cough Health Center

Swine Flu Vaccine by October, Say Makers

Monitoring for Potential Changes in H1N1 Virus continued...

Five manufacturers are licensed to make influenza vaccines in the U.S. All five are ramping up efforts to produce and test H1N1 vaccine.

Companies change the virus strains that go into the regular flu vaccine for each flu season. Companies are typically not required to submit brand-new safety and effectiveness data for each new vaccine. FDA officials said they are allowing companies to test the separate H1N1 vaccine under the same rules.

But that could mean that the pandemic vaccine gains an FDA license and hits the market before full safety data is available, though officials stressed that the process is typical of new vaccine licenses for each new flu season.

"If an immunization program is recommended, we may not, depending on the situation, may not have all that information," said Jesse Goodman, MD, FDA's acting chief scientist.