Why the FDA’s Pfizer Vaccine Approval Is Controversial, Disingenuous and Facing A Lawsuit

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FDA is facing criticism for the confusion created by approving Pfizer's Comirnaty vaccine.
FDA is facing criticism for the confusion created by approving Pfizer's Comirnaty vaccine. (Image: JFCfilms via Pixabay)

On Aug. 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer COVID-19 vaccine. Until then, the vaccine was used solely under the Emergency Use Authorization (EUA). The jab, known as the Pfizer-BioNTech COVID-19 Vaccine, “will now be marketed as Comirnaty,” the FDA said. This is the first COVID-19 vaccine to be approved by the agency. 

The FDA had issued two letters on Aug. 23 for two separate injections. The first letter is regarding the FDA approval of the Pfizer Inc/BioNTech COVID-19, which was renamed as Comirnaty. The company has not begun manufacturing the drug for the U.S. market. The letter also makes it clear that Comirnaty is not approved for those below the age of 16. In another letter, the FDA confirmed that existing Pfizer vaccine doses, which number in millions, continue to remain under EUA and people have the right to refuse them.

FDA acknowledges that Pfizer has “insufficient supplies” of the Comirnaty vaccine. Although the existing vaccines remain under EUA, they can be used “interchangeably” with the Comirnaty product, according to the FDA. Though these two vaccines are “legally distinct,” they are similar regarding “safety or effectiveness.”  

The existing EUA Pfizer vaccines have a liability shield which means that everyone involved with the product is protected from being sued. People who take a EUA vaccine and end up suffering injuries can only obtain compensation after applying to the Countermeasures Injury Compensation Program (CICP). The program has only awarded compensation to three percent of the claims made. On the other hand, people have the right to not take the vaccine. For instance, no business can force employees to take EUA vaccine injections. This right is protected under federal laws.

“The FDA has apparently tried to deceive people by issuing its two confusing letters without proper explanation. Despite the FDA’s sleight of hand, there is currently no FDA-approved COVID shot available in the United States. Even if there were an FDA-approved COVID shot available, people still may request that employers, schools, and the military accommodate their sincerely held religious beliefs,” Liberty Counsel Founder and Chairman Mat Staver said in a statement.

On Aug. 31, Children’s Health Defense (CHD) filed a lawsuit against the FDA and its acting director, alleging deceptive and rushed approval of the Comirnaty vaccine. Arguing that the licensure was classic “bait and switch,” CHD said that the move allows the Biden administration, military, and employers to urge people to take “licensed” vaccines even though all Pfizer vaccines currently, administered in the U.S. are under EUA.

“FDA’s actions to simultaneously license Pfizer’s ‘Comirnaty’ vaccine and to extend Pfizer’s EUA for its vaccine that has the ‘same formulation’ and that ‘can be used interchangeably’ violates federal law… Once FDA approved and licensed Pfizer’s Comirnaty vaccine, there was no further basis for the FDA to preserve the EUA status for the Pfizer-BioNTech vaccine,” the lawsuit states.

The law cited in the suit is 21 U.S. Code § 360bbb–3 which concerns “Authorization for medical products for use in emergencies.” The code states that a EUA designation must only be used when there is no “approved” alternative for preventing or treating the specific disease. Granting approval to Comirnaty should naturally make the EUA licenses of existing Pfizer vaccines void. In addition, the EUA status for other COVID-19 vaccines should also not be preserved.

“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 in a statement. CHD has asked the court to remand the FDA’s decision to license the Comirnaty vaccine and to extend the EUA status of the existing Pfizer vaccine.

The lawsuit comes as a study published at medRxiv on Aug. 24 warns of vaccinated individuals being at higher risk of contracting COVID-19. Researchers in the study looked at medical records of 673,676 Israelis 16 years and older, analyzing their infections, symptoms, and hospitalizations between June 1 and Aug 14 when the Delta variant was predominant in the country.

The study found that those who were never infected but were vaccinated between January and February this year had a 13 times higher chance of getting infected by the COVID-19 Delta variant than those who previously contracted the virus and remained unvaccinated.

“Natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity,” the study said.

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