A civil liberties group has registered a strong objection to the wisdom of the U.S. Food and Drug Administration’s (FDA) approval on Aug. 23 of the two-shot regimen of the Pfizer COVID-19 vaccine, while seeking to protect people’s right to refuse the vaccine.
The group points out that more than 3,000 individuals have died in the United States after getting the second Pfizer vaccination.
The Pfizer vaccine is the first to be approved for general use in people 16 years of age or older and will be marketed under the brand name “Comirnaty,” according to the FDA. The Pfizer vaccine remains available under the agency’s emergency use authorization for individuals 12 to 16 years old.
COVID-19 has reportedly killed more than 660,000 Americans since January 2020.
But the FDA’s decision to approve the Pfizer vaccine in record time may jeopardize public health, according to Liberty Counsel, which has been asked to help thousands of federal, health care, airline, and other employees, as well as medical and dental students who oppose mandatory COVID-19 vaccinations.
“Expediting an experimental injection in months without years of clinical studies and testing is irresponsible and deadly. The FDA has a terrible track record approving drugs that had to be recalled and removed from the market,” Liberty Counsel co-founder and CEO Mat Staver said in a statement made public on Aug. 24.
“I fear this unsound rush to approve the Pfizer two-shot dosage will be added to the FDA’s long list of failed and harmful drugs,” said Staver, whose Florida-based public interest law firm specializes in First Amendment and religious freedom litigation.
“Notwithstanding this FDA approval, people may still claim medical and religious exemptions,” Staver added.
Staver’s group pointed to data compiled for the Centers for Diseases Control and Prevention (CDC) in its Vaccine Adverse Event Reporting System (VAERS), which includes 3,079 individuals who died after receiving the second Pfizer shot.
Overall, there have been nearly 600,000 “adverse events” reported to VAERS concerning individuals who have received the Pfizer vaccine or its two main rivals from Moderna and Johnson & Johnson. Deaths total 13,068 after receiving one of the three vaccines.
Other adverse reactions reported to VAERS following receiving one of the three vaccines include 5,617 cases of anaphylaxis, 5,882 heart attacks, 17,228 permanently disabled individuals, and 25,169 severe allergic reactions.
The CDC includes with VAERS a disclaimer statement that includes the following:
“VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.
“The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.”
Liberty Counsel emphasized in its statement that federal “regulators also said they determined there are increased risks of myocarditis and pericarditis, or heart inflammation, following administration of the shot, particularly within the seven days following the second dose of the two-dose regimen.”
In a letter to Pfizer officials, FDA Chief Scientist Denise Hinton said she concluded the firm’s vaccine should be approved for regular use, subject to certain limitations, because:
“I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine, when used to prevent COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its known and potential risks.
“I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.”
Liberty Counsel also pointed out that FDA approval of a drug doesn’t preclude withdrawal of it from the market at a later date when problems are documented.
Among the examples noted by Liberty Counsel were these:
- In 1985, Seldane (Terfenadine) was an antihistamine that didn’t cause drowsiness. It had been on the market for 13 years before being recalled due to life-threatening heart problems when taken in combination with other drugs.
- Zantac was withdrawn from the United States in 2020 due to serious side effects that include liver problems, a slow heart rate, pneumonia, and the potential of masking stomach cancer.
- Darvocet first came on the U.S. market in 1955 and it wasn’t withdrawn until 2010 when it was found to have serious toxicity to the heart. Between 1981 and 1999, there were over 2,110 deaths reported. The UK banned it five years earlier, in 2005.
- Meridia was taken off the market in 2010 due to an increased cardiovascular and stroke risk. Six years earlier, the Senate was told by an FDA reviewer that Meridia, Crestor, Accutane, Bextra, and Serevent should all be taken off the market.
- Accutane was pulled from the market in 2009 after being sold for 27 years. Reasons cited for the withdrawal were increased risk of birth defects, miscarriages, and premature births, as well as inflammatory bowel disease and suicidal tendencies.