U.S. health officials tried to play down worries today that the country might be unprepared for pandemic swine flu come this fall. Vaccine producers are having trouble producing large amounts of the vaccine, and some experts predict other countries where vaccine is being produced may hoard it. But in a teleconference today, flu specialist Anne Schuchat of the Centers for Disease Control and Prevention in Atlanta said she wasn't concerned.
Last week, the World Health organization reported that vaccine companies have obtained yields of the pandemic vaccine that are 50% to 75% lower than those for seasonal flu vaccine. They will try to improve on that with new vaccine strains, but even if they fail, U.S. pandemic planning has incorporated such setbacks, Schuchat told reporters. "For our planning assumptions, we're really on track and not concerned about meeting expectations," she said.
Today, an Associated Press story also suggested—as others have before it—that vaccine contracts might prove worthless if the countries where the vaccine is produced put their own population first and stop the product from being exported. (Most of the vaccine under contract by the United States is produced in Europe.) But Schuchat said that "the concerns that have been raised in the media have not been part of the dialogue" with manufacturers. "We haven't gotten information that makes us question the supply that we've been promised."
Plans are now taking shape for an elaborate testing program of the new H1N1 vaccines in the United States, funded in part by the National Institutes of Health and carried out at the Vaccine and Treatment Evaluation Units, a network of clinical centers around the country. "Manufacturers and NIH have been working together to plan these studies," chief scientist Jesse Goodman of the Food and Drug Administration said at the briefing today. "We are going to integrate them into an entire program so that we can answer as many questions as we can." The plans will be discussed on 23 July at a meeting of FDA's Vaccines and Related Biological Products Advisory Committee; "we expect the initial trials to be starting very shortly," Goodman said.
The studies will also test vaccines with adjuvants. New, so-called oil-in-water adjuvants could make the vaccines more potent and might stretch the limited vaccine supply, but the compounds, already in use in Europe, have not received FDA approval. The U.S. could still use them, Schuchat said, presumably through a so-called emergency-use authorization instead of the normal licensure pathway. But it will do so only if the studies show the adjuvants to be "clearly beneficial and needed," Goodman said. Bruce Gellin, director of the National Vaccine Program Office, added that he has "high expectations" that the shots will work without adjuvants, as seasonal flu vaccines do.
Which groups should be targeted for the vaccine, and who should be first in line if the supply falls short, will be discussed on 29 July at a special meeting of the Advisory Committee for Immunization Practices in Atlanta.