Pfizer, BioNTech submit for emergency use authorization of COVID-19 vaccine with FDA

After displaying 95 percent efficacy in their COVID-19 vaccine candidate, Pfizer and BioNTeach have filed a request to the U.S. Food and Drug Administration (FDA) to grant them an emergency use authorization (EUA) that would allow its rollout next month.

High-risk populations will be the first eyed for the vaccine, known as BNT162b2, if the FDA and independent experts from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) find the drug acceptable, based on its safety and efficacy data.

In the phase three trial of the drug, 170 confirmed cases of COVID-19 accrued from among more than 43,000 volunteers since the trial began in July. Efficacy was similar across age, race, and ethnicity demographics.

The vaccine requires two doses several weeks apart. Protection is provided approximately 28 days after the first shot, and so far, no major side effects have emerged. The corporate creators have already ramped up manufacturing capabilities in preparation for its dispersal, expecting to produce up to 50 million doses this year and up to 1.3 billion doses by the end of 2021. They have also developed a specially designed temperature controlled thermal shipper to accompany these vaccines that would allow them to be stored for up to 15 days by refilling them with dry ice.

The VRBPAC will recommend to the FDA whether or not to authorize the vaccine candidate, which the FDA will consider during its own deliberation. The FDA may issue an EUA if it is determined that the vaccine may effectively prevent, diagnose, or treat the disease or conditions caused by SARS-CoV-2, and potential benefits outweigh the risks.