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Swine Flu Vaccine by October, Say Makers

Manufacturers Tell FDA Panel That Vaccine Could Be Ready for 50 Million People by Mid-October
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Monitoring for Potential Changes in H1N1 Virus continued...

Children and adolescents appear more vulnerable to H1N1 infection than adults. Federal officials earlier this month suggested they will mount a large-scale vaccination campaign in U.S. schools provided that adequate vaccine supplies become available in the fall.

In mid-July, the National Biodefense Safety Board (NBSB) -- a board of advisors to the Health and Human Services Department -- recommended that swine flu vaccine should be fast-tracked. The NBSB recommended vaccinations should begin in mid-September -- soon after schools open.

The Advisory Committee on Immunizations Practices (ACIP) is set to meet next week to decide which groups should be first in line to receive vaccines. That list will likely include children, but could also include health care workers, pregnant women, and adults with chronic diseases.

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.

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