On Monday, the U.S. Food and Drug Administration approved the Pfizer COVID vaccine for general delivery to Americans aged 16 years old and above. It is the first COVID vaccine to move from Emergency Use Authorization (EUA) to full approval by the governing body. It was also the first COVID jab to get EUA approval back in December of 2020.
Now, the drug, which was given to millions of Americans across the country and people around the world, is no longer considered "experimental." However, a legal team that specializes in religious and human rights cases argued that despite having full approval, the Pfizer COVID vaccine still poses a threat to some because of its side effects.
Liberty Counsel, a religious liberty organization, argued that the Pfizer COVID vaccine is not "safe" despite being given FDA approval. According to WND, the organization cited the U.S. Department of Health and Human Services' Vaccine Adverse Event Reporting System or VAERS, a database of reported cases on negative results and reactions from different types of medications, such as the Pfizer COVID vaccine. According to the database, "595,620 adverse events, including 13,608 deaths as of August 13, 2021, from the COVID injections."
Liberty Counsel argued in a new report that the VAERS database showed "approximately 3,079 deaths after receiving the Pfizer shot." The religious liberty organization, which stands firmly against corporate vaccine mandates, added that health officials themselves admitted that "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."
Back in June, the FDA added a warning to patient and provider fact sheets for the mRNA vaccines from Pfizer and Moderna to indicate that it may cause a rare risk of heart inflammation, CNBC reported. Both jabs' information sheet was revised to include a warning abou myocarditis and pericarditis following its second dose and the onset of symptoms a few days after getting the jab.
The warnings said that the risk is "higher among males under 40 years of age compared to females and older males" and highest among boys aged 12 to 17. While data showed that the side effects were resolved, some patients "required intensive care support" and that "information is not yet available about potential long-term health outcomes.
Liberty Counsel also took aim at Pfizer, which in 2009 was embroiled in the largest health care fraud settlement in history against a pharmaceutical company. In the case, Pfizer presented a guilty plea to a felony violation of the Food, Drug and Cosmetic Act for illegally promoting the use of up to four of its drugs. A similar case of illegally marketing drugs occurred in 2004.
To add to their argument, Liberty Counsel also presented several drugs that have been approved by the U.S. FDA but caused problems and had to be recalled, including medications for treating stomach acids, an opioid pain reliever, and more.
"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," Mat Staver, Liberty Counsel's chief lamented.
"I fear this unsound rush to approve the Pfizer two-shot dosage will be added to the FDA long list of failed and harmful drugs. Notwithstanding this FDA approval, people may still claim medical and religious exemptions."
