FDA Grants Historic Emergency Use Authorization to COVID-19 Vaccine From Pfizer and BioNTech

Distribution of the first 2.9 million doses of the COVID--19 vaccine jointly developed by Pfizer and BioNTech are expected to begin within hours of the FDA’s decision.

The FDA has approved an Emergency Use Authorization (EUA) application for the first coronavirus disease 2019 (COVID-19) vaccine to be distributed in the United States. Federal officials have said distribution of the first 2.9 million doses of BNT162b2, jointly developed by Pfizer and BioNTech, are expected to begin within hours of the FDA’s decision and the first vaccinations could follow soon thereafter.

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, MD, in a press release. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

An advisory committee for the US Centers for Disease Control and Prevention is expected to greenlight the vaccine on Saturday, The Washington Post reported. Initial doses of the mRNA vaccine have been earmarked for frontline health care workers and patients in high-risk categories.

On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 in support of granting an EUA for BNT162b2.

“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release issued Friday evening.

The vaccine was previously granted a temporary authorization for emergency use against COVID-19 by the Medicines & Healthcare Products Regulatory Agency in the United Kingdom. This was the first EUA for a COVID-19 vaccine to be issued following an international phase 3 trial testing the safety and efficacy of the vaccine.

The phase 3 trial demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, which was the first primary objective, and also in participants with and without prior SARS-CoV-2 infection, which was the second. For both study objectives, the efficacy rate was measured from 7 days after the second dose of the vaccine.

For the first primary objective, the analysis was based on 170 cases of COVID-19. The observed efficacy in adults aged 65 years and over was more than 94%, with consistency in the efficacy rate across age, gender, race, and ethnicity demographics.

During the trial, BNT162b2 was found to be well tolerated by patients. Additionally, there have been no serious safety concerns reported to date by the Data Monitoring Committee.

The FDA said the trial data indicate that the known and potential benefits of the vaccine outweigh the known and potential risks, which supports it use in millions of people 16 years of age and older.

“In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information,” the agency wrote in a press release.

The Department of Health and Human Services (HHS) has recognized the importance of pharmacists in COVID-19 relief and vaccine distribution. Earlier this year, HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP) authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations to patients 3 years of age and older, preempting any state and local laws that prohibit ordering or administering vaccines.

“Invoking pharmacists as a covered person for the purposes of administering a COVID-19 vaccine represents an opportunity for the federal government to recognize pharmacists and pharmacy staff members as front-line health care workers who can make a meaningful difference in combating the disease,” wrote Pharmacy Times Editorial Board member Ned Milenkovich, PharmD, JD, in an article from November.

A recent nationwide survey of 400 pharmacists conducted by the American Pharmacists Association (APhA) found that 60% plan to be set up and ready to vaccinate patients as soon as the COVID-19 vaccine becomes available or in the second wave of vaccinations. The November survey found that 37% of pharmacists said they are currently ready to receive the vaccine and vaccinate patients as soon as the vaccine is available and 23% said they were in the final preparation stages and will be ready to vaccinate patients as soon as the vaccine is available.

Following the historic approval, pharmacists are expected to serve a vital role on the frontlines in addressing public concerns regarding the vaccine’s safety and efficacy.

“Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee,” Marks said. “Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”