Swine Flu Vaccine: When?
Swine Flu Vaccine Timeline: Key Decisions, Key Milestones
Administer Vaccine Now or Later? continued...
"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."
Making Sure the Vaccine Is Safe
The most important question about a pandemic flu vaccine is whether it will be safe. Unfortunately, like nearly everything about flu bugs, safety can't be guaranteed 100%.