Pfizer and BioNTech announced that they would be submitting an application for an emergency use authorization for their coronavirus vaccine to the US Food and Drug Administration (FDA) today. This is the first vaccine to seek a regulatory seal of approval in the United States.
Pfizer said in a statement that their vaccine candidate, known as BNT162b2, will potentially be available for high-risk groups in the US by the end of December. The vaccine itself requires two doses that will be administered a few weeks apart, and full protection is achieved 28 days after the initial shot.
The submission to the FDA is based on the clinical trial results Pfizer finalized this week for their vaccine. The trial began in the US on July 27th and enrolled more than 43,000 volunteers worldwide. The final analysis of the vaccine showed that it was 95% effective in preventing infections with no serious safety concerns appearing, even in older adults.
42% of the global participants and 30% of US participants in the Phase 3 portion of the study come from racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants were ages 56 to 85. Pfizer CEO Albert Bourla recently released a statement about his company’s excitement over their filing.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”
Moderna is another pharmaceutical company who also recently released early clinical trial data that showed their Covid-19 vaccine as being 94.5% effective. Moderna is also projected to apply for EUA with the FDA later this month after it finalizes its safety data for the trial.
An EUA won’t give the vaccine a full approval for public distribution, but instead allows the vaccine to be used under certain circumstances before all of the evidence is available for approval. The FDA has scheduled a meeting with its Vaccines and Related biological Products Advisory Committee, a group of outside experts, for December 8-10th, which is likely when an EUA decision will occur.
According to the US Centers for Disease Control and Prevention (CDC), if the FDA authorizes the vaccines, they will be immediately distributed throughout the US, however, no one will be injected until a CDC advisory committee reviews the data and creates a plan for distribution/who will receive the vaccine first.
The CDC advisory committee will have 48 hours to make a decision which will likely show healthcare professionals, doctors, nurses, and other workers that are directly on the frontlines of this pandemic receiving their immunizations first, and then higher risk immunocompromised individuals next.
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at firstname.lastname@example.org.