Action Alert: Two Upcoming FDA Emergency Use Authorization Meetings

Questions regarding the upcoming C0VID vaccine, how it will be developed, rolled out, and if it will be mandated are at the forefront of our work here at TFVC. While details are emerging, we have a unique opportunity to make our voices heard.

Who is this committee?
The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. https://www.fda.gov/advisory-committees

What is this committee’s job?
This FDA Advisory Committee will meet in two open sessions to discuss Emergency Use Authorization (EUA) of both COVID-19 vaccine candidates. In this instance, an EUA would allow use of unapproved vaccines to prevent Covid-19. At this meeting, vaccine manufacturers will present the findings of their fast tracked trials in hopes that the committee will issue an EUA, allowing nationwide vaccine distribution.

What is an EUA:
Under an Emergency Use Authorization, the FDA permits the use of unapproved medical products during health emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.

The EUA process is different from the usual FDA approval or licensing process because the EUA permits authorization based on significantly less data than what is normally required for approval or licensure. This enables the FDA to authorize the emergency use of medical products that meet the criteria within weeks rather than months to years.

It should be noted that the FDA has never granted an EUA to a previously unapproved vaccine. Vaccines approved under an EUA will likely have questionable informed consent procedures and their manufacturers will have no liability for vaccine injuries.

What Can You Do?

Provide public comment and attend online! Details below:

December 10, 2020: Pfizer (for use in individuals 16 years and older)
Submit Public Comment:
https://www.regulations.gov/document?D=FDA-2020-N-1898-0036

Attend Online: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement

December 17, 2020: Moderna (for use in individuals 18 years and older)
Submit Public Comment:
https://www.regulations.gov/document?D=FDA-2020-N-2242-0001

Attend online: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement

Concerns to discuss in your public comment:
– How will manufacturers be held liable for their product?
– What is the plan for reporting vaccine reactions or injury?
– Who will compensate for damages?
– Will there be protections for those opting out?
– Will this vaccine be mandated for certain populations?
– What is the process for ensuring informed consent?

This is what they say:

“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

How are they going to ensure the public’s trust during the EUA process?

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