Support the Citizen Petition to the FDA to Revoke BLA Approval for mRNA Countermeasures
Please support the petition filed by Children's Health Defense with input from Sasha Latypova
This is a reprint of Sasha Latypova’s December 10, 2025 Substack post. In case you haven’t seen it, please read about the petition and submit a comment to the FDA (link below). As of right now, it looks like there are already over 100,000 comments submitted. Let’s get it up to a million!
Although I do not expect the FDA to act upon the petition, I think it’s an important document because it contains all the information and links to primary source material demonstrating in purely legal terms (no “science” or “medicine” involved) that the mRNA Covid vaccines are unregulated countermeasures.
This is also a great way for citizens to express their disapproval. Even if the FDA fails to act, it cannot erase our input. And we can publicize this far and wide, with your help.
If anyone — I’m thinking especially of the corporate and alternative press — wants the facts about how mRNA Covid vaccines were never subject to any non-emergency legal or regulatory oversight, it’s all there.
Bottom line is that the “full FDA approval” of the Covid mRNA products as biologics was a legal travesty: Not a single one of the legal requirements for such approval was ever satisfied.
December 8, 2025: Children’s Health Defense (CHD) has formally filed a comprehensive Citizen Petition with the Food and Drug Administration (FDA). This petition is drawing heavily on my research into misuse and abuse of the PREP Act law and subversion of pharmaceutical law and regulatory practices for mRNA covid shots marketed by Pfizer and Moderna as BLA vaccine platforms. Read The Defender article about this major development here.
The core argument is not focused on the safety or efficacy of the vaccines, but rather on fundamental, ongoing violations of the legal and regulatory standards required for full Biologics License Application (BLA) approval.
Link to the Citizen Petition Here
We need thousands of comments! I am shadow banned everywhere. I cannot do it alone and I need your help. I rarely ask for anything but this is the time I am asking you to support our effort. We need to flood the FDA with comments.
Instructions: When you submit a comment (follow the red button below), please read “Commenter’s Checklist link on the comment page. It will describe how to effectively write a comment. The comment can be simply that you support this petition. Alternatively, you can provide a more detailed comment and even submit attachments if you wish. If you have friends or family injured by these shots I encourage you to make a more extensive comment. The comment form will ask to designate a category to your comment. You can chose “Drug Industry” or “Federal Government”.
Please Please Please!! Share and submit a comment to the FDA in support of this petition:
More details about this petition below.
The Core Violation: EUA Products Cannot Simply Be Rebranded as “BLA Licensed”
The petition highlights the critical difference between the two regulatory pathways: the non-investigational Emergency Use Authorization (EUA) and the investigational Biologics License Application (BLA).
When the FDA initially granted EUA status to the mRNA COVID-19 vaccines in December 2020, it waived strict BLA legal requirements, such as Institutional Review Board (IRB) oversight, clinical trials, and adherence to current Good Manufacturing and Laboratory Practices (cGxP). This is allowed by the PREP Act during an HHS Scy declared emergency.
However, when the FDA granted full BLA approval (Pfizer’s Comirnaty on August 23, 2021, and Moderna’s SPIKEVAX on January 31, 2022), it failed to enforce the requisite BLA licensing standards that exist in the US law. By law, manufacturing practices and data collected solely under EUA status cannot retroactively satisfy the BLA standards because these standards are explicitly made inapplicable to the PREP Act/EUA uses.
The Requested FDA Action
1. Petitioners ask the FDA to revoke all BLA’s for every mRNA COVID-19 vaccine for all demographic groups because manufacturers do not and have never met BLA standards. Further, in granting licensure, FDA failed to enforce these standards.
2. Petitioners ask the FDA to find Comirnaty (all versions) and SPIKEVAX (including MNEXSPIKE) mislabeled/misbranded.
3. Petitioners ask the FDA to find Comirnaty (all versions) and SPIKEVAX (including MNEXSPIKE) adulterated or potentially adulterated.
4. Petitioners ask the FDA to properly designate every mRNA COVID-19 vaccine as an Emergency Use Authorization biologic as long as the HHS Secretary’s Declaration of Emergency is in effect. 21 U.S. Code § 360bbb-3(c)).
Awesome how many comments the petition already received :))
A comment can be as simple and brief as this one here:
“I fully support the petition filed on behalf of Children’s Health Defense by Mary S. Holland, Brian Hooker, Kim Mack Rosenberg and Ray L. Flores II requesting that FDA revoke all licensure for COVID-19 mRNA vaccines as improperly granted.”
You can submit your comment under your personal name, under the name of an organization or anonymously.
You can also attach files and docs etc. to your comment if you want.
Here is the link again to leave a comment: https://www.regulations.gov/commenton/FDA-2025-P-6831-0001
Thank you Debbie and Sasha! This post contains the important categories to submit your comment for, which CHD neglected to do in their call to action!