The now-FDA-licensed Pfizer-BioNTech COVID-19 vaccine, first certified under the emergency use authorization (EUA) in December, will be sold as "Comirnaty" for those aged 16 and above.
Dr. Janet Woodcock, interim FDA Commissioner, said the licensing was "a milestone as we continue to battle the COVID-19 pandemic," the Christian Post reported.
The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," Woodcock maintained.
"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today's milestone puts us one step closer to altering the course of this pandemic in the U.S," she added.
Lifesite News, on the other hand, reported that the full authorization has been granted despite the National Institutes of Health (NIH) predicting that the Pfizer vaccine's effectiveness and safety trials would be completed by May 2, 2023.
The FDA initially approved the mRNA shot for emergency use in December 2020, making it the second "vaccine" of its type to be approved for emergency use in the United States.
Lifesite also noted that, although Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, acknowledged that "we approved this vaccine expeditiously," he insisted that the final approval "was fully in keeping with our existing high standards for vaccines in the U.S."
According to the FDA's news release, the safety of Comirnaty was assessed in roughly 22,000 individuals who got the vaccination and in 22,000 people who received a "placebo" aged 16 years and above.
"The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death," the FDA claimed in their release.
The FDA also said that the manufacturer will be required to perform "post marketing studies" to better evaluate the "risks of myocarditis and pericarditis" after Comirnaty vaccination.
Recorded adverse reactions after the Pfizer jabs
According to the Centers for Disease Control and Prevention (CDC), 92,002,656 people have gotten both doses of the Pfizer vaccine.
The CDC-managed Vaccine Adverse Event Reporting System (VAERS) has received reports of 326,535 adverse reactions associated with the administration of the mRNA injection.
Per the VAERS data, the use of Pfizer's newly approved vaccine from December 14, 2020 to August 13,2021 resulted in "9,027 deaths, 12,358 permanent disabilities, and 36,665 hospitalizations."
The Pfizer vaccine has also been linked to 2,986 cases of myocarditis or pericarditis, 348 of which were in children aged 12 to 17.
Furthermore, the VAERS also documented 504 cases Guillain-Barré syndrome after Pfizer vaccine shot, a muscular disorder that the NIH explains as causing weakness and occasionally "devastating paralysis."
According to system records, 887 cases of Guillain-Barré disease have been documented after receiving a COVID "vaccine," implying that Pfizer's vaccine is responsible for nearly 57% of all cases of Guillain-Barré syndrome.
Anaphylactic responses, a potentially fatal kind of allergic reaction, were reported 85,655 times on VAERS, as were 11,100 occurrences of blood clotting problems, accounting for about 65% of all blood clot reports after COVID shots.
Pfizer's injection has also been linked to 812 miscarriages or premature births.
