Swine Flu Vaccine (2)

Swine Flu Vaccine: When?

Swine Flu Vaccine Timeline: Key Decisions, Key Milestones

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Preparing the Country for the Swine Flu Vaccine

Beginning with the July 9 Flu Summit, federal health officials stepped up work with state and local officials to lay the groundwork for a massive immunization effort. HHS Secretary Kathleen Sebelius has pledged $7.5 billion in preparedness funds and $350 million in direct grants to states and territories.

August

Administer Vaccine Now or Later?

By mid- to late-August, seasonal flu vaccine -- the normal, three-in-one vaccine against seasonal flu -- will start arriving. The CDC will recommend people get their flu shots or flu sniffs earlier than usual this year, to make way for possible pandemic flu vaccination.

If there seems to be a huge increase in pandemic flu cases, officials will be tempted to trigger vaccine delivery before safety and efficacy studies are completed.

Would that be safe? The pandemic swine flu bug is a type A H1N1 virus. One of the seasonal flu bugs is a type A H1N1 flu bug. Seasonal vaccine doesn't protect against the new swine flu bug. But there's a long history of safety and efficacy for flu vaccines made of H1N1 antigens, notes flu expert John Treanor, MD, chief of infectious diseases at the University of Rochester, New York.

"You might be sitting at the end of August faced with the decision to do this," Treanor tells WebMD. "If we wait, we can't do vaccination until November. If the pandemic flu follows the seasonal-flu pattern with the bulk of activity in January through March, fine. But if we see this second wave coming in September, we might be faced with the decision to do vaccinations without clinical data."

An HHS advisory committee on July 17 strongly recommended that Sebelius give the green light to vaccine production by Aug. 15 -- before safety and dosing tests are finished. That would mean 60 to 80 million vaccine doses could be ready by Sept. 15.

How fast pandemic flu vaccine gets to people depends on the decision whether to give the vaccine in the traditional way or with something called an adjuvant.

A vaccine includes a piece of virus that evokes a flu-specific immune response. It's called a flu antigen. An adjuvant boosts immune responses to the vaccine and could make the antigen supply go four times as far, allowing the U.S. to share some of its vaccine with the rest of the world. Adjuvant may also elicit broader immune responses, which would be very important if the swine flu virus's genetic code "drifts" a bit before the next pandemic wave.

Vaccinating all Americans would be an effort of historic proportions.

"This would be the largest vaccine drop that has ever happened in the world," says Robin Robinson, PhD. Robinson is the director of the Biomedical Advanced Research and Development Authority (BARDA), the HHS authority that makes sure the nation has the biomedical supplies it needs for emergencies.

"The most we've ever done for seasonal flu vaccine is about 120 million doses in 75 days," he tells WebMD. "At this point, with an antigen-alone pandemic vaccine, we would see about 160 million doses in 30 days. If we go with adjuvant it could be over 300 million in 30 days -- and more coming back behind it."