Washington, D.C. -Oversight and Reform Committee Chairwoman Carolyn B. Maloney, Select Subcommittee on the Coronavirus Crisis Chairman James E. Clyburn, and Subcommittee on Economic and Consumer Policy Chairman Raja Krishnamoorthi sent a letter to the Food and Drug Administration (FDA) requesting a staff briefing on the agency’s policies and procedures that will guide decisions about the development, review, and deployment of any eventual coronavirus vaccines.
“Scientists are racing to create a coronavirus vaccine to protect us all. While they are engaged in their noble pursuit, we need to plan ahead," the Chairs wrote. “When a vaccine candidate is ready, it will be up to you, Dr. Hahn, to decide whether it is safe enough and effective enough to be given to the American people. We trust that you will make that decision in the best interest of the public health. And the best way to bolster that trust is to create transparency in how that decision will be made, how a vaccine arrives to that decision point, and how a vaccine will be deployed."
In the letter, the Chairs suggest simple steps FDA Commissioner Stephen Hahn could take to bolster the public’s confidence:
* Declare that any vaccine candidate will have to prove itself safe and effective in a complete Stage 3 clinical trial with at least 30,000 volunteers;
* Design clinical trials, including the demographics of the subjects, to ensure that FDA has the appropriate data to weigh the risks and benefits of an eventual vaccine candidate and how it might be deployed;
* Make data about the vaccines’ safety and effectiveness available to independent scientists, like the Vaccine and Related Biological Products Advisory Committee, and commit to seeking their input; and
* Coordinate among the public health agencies with a consortium like the Public Health Emergency Medical Countermeasure Enterprise, which would be built into the process from the beginning to ensure that all efforts are contributing to a successful vaccine program.
National Institutes of Health Director Francis Collins has already endorsed the 30,000-person floor, explaining that there is not “enough power in the analysis, to be able to document the vaccine works unless you get to roughly that number."
“Dr. Hahn, when you are presented with a promising vaccine candidate, you will face tremendous pressure to deploy it. For you, and for the confidence of the public, the rules must be laid out now, so that if you have to say no to deploying a vaccine, the public will understand why. And if you say yes, the public will trust that decision," added the Chairs.
