Biologics

House Committee Wants Covid Vaccine Transparency

David McFarland

— 2 min read
Share

Democratic leaders of the House Committee on Oversight and Reform are calling on FDA commissioner Stephen Hahn to take steps now to ensure complete transparency in the development, review, and deployment of any Covid-19 vaccines. In a 6/18 letter, the committee leaders said the best way to bolster citizen trust that any decision is being made in the best interest of the public health is to “create transparency in how that decision will be made, how a vaccine arrives at that decision point, and how a vaccine will be deployed.”

The letter says the Trump administration’s Operation Warp Speed vaccine development program leads to questions about whether corners are being cut. “We should start addressing questions now,” it says. “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. We want the American people to be confident that FDA will not allow vaccine developers to cut corners, and that FDA will not approve coronavirus vaccines unless they are safe and effective.”

The Democrats say that one way for Hahn to promote consumer confidence in a vaccine is to declare that any candidate will have to prove itself to be safe and effective in a complete Phase 3 clinical trial of at least 30,000 volunteers.

The committee leaders ask for a staff briefing covering: 

  •          the decision-making process, the decision-makers and their roles, and the evaluation criteria that will be employed for vaccines applying for emergency use authorization or any other FDA approval pathway;
  •          the role of the Vaccine and Related Biological Products Advisory Committee (VRPBAC) in the design of clinical trials, the review of safety and efficacy data of vaccine candidates, requesting more information from vaccine candidate makers, authorizing a vaccine candidate for deployment, and planning deployment;
  •          the categories and format of information FDA will require vaccine manufacturers to submit for review and when and how that information will be made available to the VRBPAC and the public;
  •          the design of Phase 3 clinical trials, including whether the agency will commit to requiring a minimum number of subjects, such as 30,000;
  •          deployment decisions and post-deployment monitoring of vaccine outcomes; and
  •          the process for coordinating action among the relevant federal agencies with jurisdiction over vaccine development, review, approval, manufacture, and deployment.

 

Read more