Democrats Ask FDA to Shed More Light on Vaccine Review Process

Three high-ranking House Democrats have asked FDA Commissioner Stephen Hahn for more details of the agency’s review process for COVID-19 vaccines.

In advance of a July 2 briefing on FDA policies for COVID-19 vaccine development, trials, review and deployment, Reps. Carolyn Maloney (D-N.Y.), chairwoman of the Committee on Oversight and Reform, James Clyburn (D-S.C.), chairman of the Select Subcommittee on the Coronavirus Crisis, and Raja Krishnamoorthi (D-Ill.), chairman of the Subcommittee on Economic and Consumer Policy, asked for detailed information in a letter.

For example, they asked him to elaborate on the FDA’s decision-making process for vaccines applying for Emergency Use Authorization (EUA) or other pathways. They also called for more transparency for the information the agency will require from vaccine makers, and when and how the information will be made public.

 “The public has questions about whether corners are being cut. The title of the administration’s vaccine plan, ‘Operation Warp Speed,’ did not help ease those concerns,” the lawmakers wrote. “We should start addressing questions now. If we wait until a vaccine candidate is in hand before announcing the rules by which it will be judged, people will not have faith in the process.”

The three lawmakers also asked Hahn to require all vaccine candidates to demonstrate their safety and effectiveness through full stage 3 clinical trials with a minimum of 30,000 volunteers. That approximate number of participants has been recommended previously by National Institutes of Health (NIH) Director Francis Collins, they noted.

The lawmakers also offered suggestions for improving public confidence in the FDA’s decisions about coronavirus vaccine candidates.

“When you are presented with a promising vaccine candidate, you will face tremendous pressure to deploy it. The rules must be laid out now, so that if you have to say ‘no’ to deploying a vaccine, the public will understand why,” the lawmakers said. “And if you say ‘yes,’ the public will trust that decision.”

For example, they requested that Hahn make vaccine safety and effectiveness data available to independent scientists, including members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), who they believe can increase the public’s faith in the agency’s process.

“Transparency in review is going to be critical,” the lawmakers wrote. “If you commit to involving [the advisory committee] in the decision-making process for every vaccine candidate, it will significantly increase public confidence in your future decisions.”

Read the full letter here: www.fdanews.com/06-23-20-CBMRKClyburntoHahnFDA.pdf. — James Miessler