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Regulatory Focus™ > News Articles > 2020 > 6 > Lawmakers ask FDA to outline COVID-19 vaccine approval process

Lawmakers ask FDA to outline COVID-19 vaccine approval process

Posted 22 June 2020 | By Denise Fulton 

Lawmakers ask FDA to outline COVID-19 vaccine approval process

Credit: Peter Griffin CC0 Public Domain

Key Democratic members in the US House of Representatives have called on Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.
In a letter dated 18 June, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairman of the committee’s Subcommittee on Economic and Consumer Policy, along with Rep. James Clyburn (D-SC), chairman of the Select Subcommittee on the Coronavirus Crisis, offered suggestions as to how Hahn could improve public confidence in any COVID-19 vaccines his agency might authorize. They also invited the commissioner to brief their staff on the topic on 2 July.
Specifically, the lawmakers advocated for basing any approval on Phase 3 trials with at least 30,000 participants, a threshold the lawmakers expressed confidence in as it was proffered as of sufficient statistical power by Francis Collins, MD, director of the National Institutes of Health, in an interview with CNN. Further, vaccine approval trials should include a demographically varied population, the lawmakers wrote.
To improve transparency, the lawmakers also asked Hahn to commit to including the FDA Vaccine and Related Biological Products Advisory Committee in reviewing any potential vaccine candidates and the National Vaccine Advisory Committee (an agency of the Health and Human Services department) as a resource to help advise on “difficult and sensitive questions of how to prioritize limited quantities of an approved vaccine—who is first in line.”
The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), a federal agency tasked with coordinating federal countermeasures to chemical, biological, radiological and nuclear threats, as well as emerging infectious disease, should be called upon to facilitate interagency cooperation, the lawmakers wrote.
“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. 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,” the lawmakers wrote.

They gave Hahn until 24 June to confirm his appearance before committee staff.


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