On Aug. 31, nonprofit Children’s Health Defense (CHD) filed a lawsuit against the U.S. Food and Drug Administration (FDA) and the agency’s acting director, Dr. Janet Woodcock. The lawsuit accused the agency of deception and rushed the licensure of Pfizer’s Comirnaty Coronavirus Disease 2019 (COVID-19) vaccine.
On Aug. 23, the FDA approved the Comirnaty vaccine while retaining Pfizer’s existing vaccines under Emergency Use Authorization (EUA). In its lawsuit, CHD argued that the licensure was a “bait and switch” performed by the FDA, which allows Pfizer, the U.S. military, Biden administrators, and employers to urge people to take “licensed vaccines” even though the only Pfizer vaccines available to the public right now are under EUA.
By simultaneously licensing Comirnaty and extending the EUA for existing Pfizer vaccines, the FDA violated federal law. The agency claimed that both vaccines have the “same formulation” and can thus be used “interchangeably.”
Citing law “21 U.S. Code § 360bbb–3” on the authorization of medical products for use in emergencies, CHD pointed out that the EUA designation is only allowed when there is no approved alternative product for preventing or treating the disease. As such, once the FDA approved the Comirnaty vaccine, there was no basis for continuing the EUA for existing Pfizer vaccines and other COVID-19 shots.
CHD also rebutted a possible argument by the FDA that since Comirnaty is currently unavailable in the United States, the agency has not violated the law of approving a vaccine while allowing a EUA for another alternative vaccine to continue.
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Calling such an argument “specious,” CHD notes in the lawsuit that the FDA has already said that existing EUA vaccines can be used “interchangeably” with the Comirnaty vaccine. This means that Pfizer can simply change the labels of EUA vaccines to reflect the Comirnaty brand name, and sell them in the market. Comirnaty is already being sold in Europe.
“The FDA must justify its actions in open court… The language of its licensure is nearly incomprehensible, and the result of licensed and unlicensed vaccines for the same indication is arbitrary,” Mary Holland, CHD president, and general counsel said to The Defender.
The lawsuit goes on to state that the FDA failed to consult with outside experts regarding licensing for the Comirnaty vaccine. In its letter to Pfizer, the agency claims to have done this as their review of the company’s vaccine “did not raise concerns or controversial issues.” CHD calls this claim “transparently false.”
The EUA classification shields the vaccine’s manufacturer from liability. CHD blamed the FDA for indulging Pfizer by allowing it to enjoy the benefits of having an approved vaccine while “retaining the blanket liability shield” of a EUA product.
“It has tried to please two masters: the Executive Branch, which has insisted on licensed vaccines for pervasive mandates, and Pfizer, which demanded indemnification from any vaccine-related injuries and deaths. But the FDA seems to have forgotten its one true client: the American public,” the lawsuit states.
The lawsuit also states that the FDA issued a EUA for the Pfizer vaccine even though the product continues to be in Phase III clinical trials. The Estimated Primary Completion Date of the trial is set for Nov. 2, 2022, while the Estimated Study Completion Date is scheduled for May 2, 2023. CHD asked the court to remand and vacate the FDA’s decision and to extend the EUA license for the existing Pfizer vaccine.
CHD’s lawsuit comes as Pfizer, which has already made billions from its COVID-19 vaccine, is developing a pill that is to be taken alongside the jab. The new pill, which needs to be taken twice per day, is expected to hit the market by the end of this year.
Albert Bourla, Chairman and CEO of Pfizer, stated that the company has begun Phase 2/3 studies of the oral antiviral candidate. “Success against #COVID19 will likely require both vaccines & treatments,” Bourla said in a tweet.