Vaccine for COVID-19 will need outside expert review, U.S. regulator says

FILE PHOTO: Stephen M. Hahn, commissioner of U.S. Food and Drugs Administration, speaks during a Senate Health, Education, Labor and Pensions Committee hearing on efforts to get back to work and school during the coronavirus disease (COVID-19) outbreak, in Washington, D.C., U.S. June 30, 2020. Al Drago/Pool via REUTERS

(Reuters) - The United States will need to have independent experts review COVID-19 vaccine candidates before approval, the country’s top drug regulator said on Friday, offering reassurance that his agency would not cut corners in the race to roll out a vaccine.

U.S. Food and Drug Administration Commissioner Stephen Hahn said COVID-19 vaccine candidates will be reviewed according to established legal and regulatory standards for medical products, including by an outside advisory committee.

"Given the widespread potential use of a COVID-19 vaccine, transparent discussion at FDA's Vaccines and Related Biological Products Advisory Committee will be needed...", Hahn and colleagues wrote in the Journal of the American Medical Association. (

The U.S. government’s Operation Warp Speed aims to expedite development of a vaccine and therapies to treat the novel coronavirus, and the emphasis on speed has provoked public anxiety about the safety and effectiveness of these vaccines, Hahn and the other officials wrote.

“There is a line separating the government’s efforts to focus resources and funding to scale vaccine development from FDA’s review processes, which are rooted in federal statute and established FDA regulations,” they added.

Earlier this week, the country’s infectious diseases chief, Anthony Fauci, told Reuters political pressure will not determine when a coronavirus vaccine is approved. At about the same time, U.S. President Donald Trump said it was possible for the country to have a coronavirus vaccine before the Nov. 3 election.

More than 159,000 people have died in the United States from COVID-19 and more than 4.89 million cases have been reported in the country and its territories, according to Reuters tallies.

Reporting by Vishwadha Chander and Manojna Maddipatla in Bengaluru; editing by Peter Henderson and Sriraj Kalluvila