FDA Analysis Confirms Pfizer-BioNTech COVID-19 Vaccine Meets Emergency Use Authorization Criteria

Pfizer’s COVID-19 Vaccine Is One Step Away from FDA Emergency Approval.

On December 8, the U.S. Food and Drug Administration (FDA) released an analytical report stating that,Clinical study results show that the BNT162b2 COVID-19 vaccine, co-developed by Pfizer and BioNTech, meets the FDA's criteria for Emergency Use Authorization.

According to The Wall Street Journal, the 53-page report released by the FDA on that day confirmed the trial results disclosed by Pfizer in November: the COVID-19 vaccine co-developed with its partner demonstrated 95% efficacy in preventing symptomatic SARS-CoV-2 infection. The report stated that the COVID-19 vaccine met the criteria for Emergency Use Authorization.

The Phase 3 clinical trial of this vaccine was launched on July 27 this year, and has so far recruited 44,000 participants worldwide. This FDA report analyzed the health data of 19,000 of these participants.

The report stated that there is evidence indicating that the COVID-19 vaccine, administered in two doses with a three-week interval, begins to provide protection in humans after the first dose.

The report indicated that 70% of participants experienced side effects for one to two days after vaccination, including symptoms such as soreness at the injection site, fatigue, headache, joint pain, and fever.

The report also stated that the vaccine was effective across different ages, weights, and ethnicities. However, data from the report showed that most participants were White, and the majority were under the age of 55.

The Washington Post stated that this report contains preliminary information provided by the FDA prior to its approval of the COVID-19 vaccine. The FDA will convene a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on the 10th to vote on whether the vaccine is effective in preventing SARS-CoV-2 infection in individuals aged 16 years and older. Following the meeting, the FDA will decide whether to grant Emergency Use Authorization for the vaccine.

According to Reuters, Pfizer and Moderna submitted applications for emergency use authorization of their COVID-19 vaccines in the United States in late November. Both vaccines are mRNA (messenger RNA) vaccines. The latter’s COVID-19 vaccine will undergo FDA review next week.

It was also reported that UK regulators approved the COVID-19 vaccine jointly developed by German and U.S. companies last week, with vaccinations commencing on the 8th. The vaccine is currently under review in the European Union.