Biologics

Revoke All mRNA Covid Vaccine BLAs: CHD Petition

David McFarland

— 2 min read
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Children’s Health Defense (CHD), which was co-founded by now-HHS secretary Robert F. Kennedy, Jr., is petitioning FDA to take several actions against the mRNA Covid-19 vaccines produced by Moderna and Pfizer/BioNTech. The petition specifically asks that the agency:

  • revoke all BLAs for every mRNA Covid-19 vaccine for all demographic groups because manufacturers do not and have never met BLA standards, and in granting licensure FDA failed to enforce the standards;
  • find Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax mislabeled and misbranded;
  • find Comirnaty and Spikevax adulterated or potentially adulterated; and
  • properly designate every mRNA Covid-19 vaccine as an emergency use authorization (EUA) biologic as long as the HHS secretary’s declaration of emergency is in effect.

Children’s Health Defense says that during Operation Warp Speed, FDA granted Covid-19 mRNA vaccines EUA status in 12/2020 by correctly (under EUA standards) waiving the legal requirements of institutional review board (IRB) oversight, clinical trials, and current good manufacturing and laboratory practices compliance that are strictly required for the IND and BLA pathways.

However, it continues, “FDA allowed Pfizer to follow the non-investigational EUA pathway even when it unlawfully granted Pfizer’s Comirnaty Covid-19 vaccine BLA licensure on 8/23/2021, while leaving its ‘interchangeable’ EUA Pfizer/BioNTech version on the market. Then, on 1/31/2022, the agency granted full BLA approval of Moderna’s Spikevax Covid-19 vaccine even though it continuously followed a non-investigational EUA pathway.”

The petition says there is no evidence that the current mRNA Covid-19 vaccine licensures comply with the legal standards of BLA labeling. “In fact,” it says, “it is quite the contrary. The most egregious of FDA’s violations is that the only human clinical studies for Covid-19 vaccines were conducted under an EUA pathway that lacked IRB oversight and were not legally compliant clinical investigations. In addition, ample evidence points to FDA’s continual waiver of most, if not all, normally applicable BLA standards, such as current good manufacturing practice/current good laboratory practice compliance in research and development and manufacture of these products.”

Children’s Health Defense says the burden is on FDA to prove that all BLA standards were satisfied when it fully licensed the Pfizer and Moderna vaccines, which it cannot do.

“We ask FDA to be cognizant of its longstanding, statutory mission and duty to protect the public health and to ensure that the American public receives only safe and effective vaccines,” the petition concludes. “Most Americans are not aware of the strict compliance requirements for licensed (BLA) Covid-19 vaccines and the numerous violations of the BLA standards that are currently allowed for the marketed Covid-19 vaccines, as described in this petition…. Acting on this citizen petition will enhance FDA’s credibility with the public. Given the obvious safety, effectiveness, labeling, and branding concerns over mRNA Covid-19 vaccines detailed [in the petition], along with anticipated comments on this docket, we respectfully appeal to FDA to implement the actions requested in this citizen petition.”

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