On Monday, the Food and Drug Administration fully approved the Pfizer Covid-19 vaccine for people 16 years and older.
Pfizer, Moderna and Johnson & Johnson vaccines were previously granted emergency use authorization after meeting safety requirements from the FDA. The full approval comes from a biologics license application consisting of clinical data, vaccine quality data, site inspections, and information relating to the manufacturing process.
Acting FDA Commissioner Janet Woodcock sated, “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, 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”.
The director of FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, said “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine”, and added “although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.’.
While the FDA reviewed the vaccine, 40,000 participants aged 16 years and older were used to test vaccine efficacy. Half of the participants received a placebo and trial results concluded the vaccine was 91% effective in preventing COVID-19. They also evaluated the vaccine’s safety, with the most common side effects being pain, redness and swelling, fatigue, headache, muscle pain, chills and fever.
Now that Pfizer has been granted full FDA approval, the Pentagon has announced it will mandate vaccines for 1.3 million active-duty service members. New York City is also requiring all teachers to have at least one dose by September 27 and there will be no regular testing option.