06/09/2021 / By News Editors
A group of 27 clinicians, researchers and advocates last week filed an urgent Citizen Petition with the U.S. Food and Drug Administration (FDA) urging the agency not to prematurely grant full approval to any COVID vaccine.
(Article by Megan Redshaw republished from ChildrensHealthDefense.org)
“Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decisions,” the group said.
The FDA citizen petition process, described in Title 21 of the Code of Federal Regulations (21 CFR Part 10), allows individuals and community organizations to request the agency make changes to health policy. At any time, any “interested person” can request the FDA “issue, amend or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”
In their petition, the group outlined many unanswered questions surrounding the efficacy and safety of COVID vaccines, and detailed how data must be collected before the FDA considers granting any vaccine full approval.
“We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure,” petitioners wrote.
In an op-ed published today in The BMJ, four of the petition’s signatories, writing on behalf of the group, said:
“The message of our petition is ‘slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”
The petition states a COVID vaccine should be fully approved only when substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient population. The petitioners “respectfully” requested the FDA act on the petition by June 11. They plan to seek judicial relief if the petition is denied.
The FDA granted Emergency Use Authorization (EUA) to three COVID vaccines — Pfizer, Moderna and Johnson & Johnson (J&J) — allowing rapid and widespread vaccine rollout across the U.S. However, the EUAs were granted without a built-in expiration date, which means they can lawfully be distributed even after a “public health emergency” no longer exists.
The 20-page citizen petition and supporting documents are filed under Docket ID FDA-2021-P-0521 on regulations.gov. Anyone can comment on the petition, or read others’ comments, including the FDA’s official reply once it arrives.
Petitioners ask the FDA to implement eight efficacy and safety measures before granting a COVID vaccine full FDA approval:
The petitioners provided a rationale for each requested action and a list of what they said were invalid reasons for rushing full approval of COVID vaccines. They explained that approving COVID vaccines for the purpose of ensuring they are accessible after the public health emergency has ended, or in an effort to ensure adequate access to vaccines across the population, are two objectives that can be accomplished with current EUAs.
The group also said giving full approval to a COVID vaccine in an effort to pave the way for vaccine mandates or to bolster public confidence were outside the scope of the FDA’s purview.
“Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decisions,” the group said.
The petition author and co-authors include:
Earlier this month, Children’s Health Defense Chairman (CHD) Robert F. Kennedy, Jr. and Dr. Meryl Nass, on behalf of CHD, filed a Citizen Petition with the FDA requesting the agency not only refrain from licensing COVID vaccines, but also immediately revoke the vaccines’ EUAs.
CHD submitted 72 references supporting the request for revocation and restraint. To read the full CHD petition text, download it from the FDA website or read the full petition here — then submit your comments using this form.
Embed tweet:
We invite parents, healthcare practitioners, military members and others to comment on our petition to the FDA calling on the agency to immediately remove COVID vaccines from the market.https://t.co/qRyByqdAL7
— Robert F. Kennedy Jr (@RobertKennedyJr) June 8, 2021
Read more at: ChildrensHealthDefense.org and FDA.news