Health Experts to F.D.A.: Make Your Vaccine Deliberations Public

A coalition of leading public health experts urged the Food and Drug Administration on Wednesday night to conduct full safety and efficacy reviews of potential coronavirus vaccines before making the products widely available to the public.

In a letter signed by nearly 400 experts in infectious diseases, vaccines and other medical specialties, the group called on Dr. Stephen Hahn, the F.D.A. commissioner, to be forthcoming about the agency’s deliberations over whether to approve any new vaccine, in order to gain the public’s trust.

“We must be able to explain to the public what we know and what we don’t know about these vaccines,” noted the letter, which was organized by the nonprofit Center for Science in the Public Interest. “For that to happen, we must be able to witness a transparent and rigorous F.D.A. approval process that is devoid of political considerations.”

More than 30 experimental coronavirus vaccines are in clinical trials, with several companies racing to have the first product in the United States ready by the end of the year. The federal government has promised more than $9 billion to companies for these efforts to date. But many people are highly skeptical of these new vaccines, and might refuse to get them.

“Collaborations between scientists, the pharmaceutical industry and the federal government may bring us to a remarkable and historic achievement,” the letter said. “But an effective vaccine will only be truly useful if a large proportion of the public is willing to take it.”

The signers included academic researchers and former government officials from around the country, including the former surgeon general Dr. Joycelyn Elders; the former F.D.A. chief Dr. Jane E. Henney; and Dr. Luciana Borio, the former director for medical and biodefense preparedness at the National Security Council.

In an effort to reassure the public, Dr. Hahn said recently that he would seek the advice of the F.D.A.’s Vaccines and Related Biological Products Advisory Committee, although he has not said when the group would meet or which vaccine candidates it would consider.

The F.D.A. declined to comment on the letter Wednesday evening.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s vaccine advisory panel, was also among the signers. In an interview, Dr. Offit called the agency’s emergency authorization for


Go to Source
Author: Sheila Kaplan
August 8, 2020