FDA Research Finds Pfizer COVID-19 Vaccine Effective And Safe

A thorough review of the COVID-19 vaccine by Pfizer and its partner BioNTech was published by the Food and Drug Administration on December 8. 

The review of the department found “no specific safety issues identified that would prohibit approval of an emergency use authorization (EUA).” There were rare severe reactions. However, side effects are common, with most research participants suffering injection site reactions, headaches, and fatigue.

The study further supports the 95% vaccine efficacy previously reported, measured a week after two vaccine doses. The doses of the vaccine are administered 21 days apart.

The clinical data also suggest that after the first dose, the vaccine may be able to prevent COVID-19, although the FDA analysis says the data presented does not allow a firm conclusion on that possible effect.

The vaccine approval under review is for effective COVID-19 preventive immunization caused by SARS-CoV-2 in people 16 years and older.

A EUA will allow companies to start selling their vaccine in the United States even while continuing research on its safety and efficacy. The EUA allows Pfizer/Biotech to carry out a two-month follow-up of a subset (38,000) of the more than 44,000 individuals who have enrolled in Phase 3 trials; Pfizer/BioNTech intends to continue to follow the volunteers for two years and then submit their vaccine for standard approval once they have longer-term records.

The two firms sent a 92-page submission to the FDA, which included results from a Phase 3 trial demonstrating that the vaccine was 95% successful in shielding people from the COVID-19 disease, with only minor side effects being observed in most vaccinated persons. FDA scientists analyzed the data and found that the findings of the analysis fulfilled the criteria of the EUA for a safe and efficient vaccine.