Pfizer and BioNTech planning for FDA approval for COVID-19 vaccine

Pfizer and BioNTech apply for emergency use authorization of their potential coronavirus (COVID-19) vaccine with the FDA. The Food and Drug Administration will process the request over the next couple of weeks with a scheduled advisory committee meeting to review the vaccine.

The COVID-19 vaccine by Pfizer and BioNTech has proven to prevent 95 percent of cases in initial studies and there is already a distribution plan if the FDA approves the COVID-19 vaccine. If the FDA approves this vaccine production initially be limited and rolled out in phases.

#COVID19 UPDATE: We will submit a request today to the @US_FDA for Emergency Use Authorization (EUA) of our mRNA vaccine candidate with @BioNTech_Group.

— Pfizer Inc. (@pfizer) November 20, 2020

The vaccine will be available starting with healthcare workers and the elderly with underlying health conditions will be the next phase of people to receive the vaccine. The following groups to receive the vaccine will be essential workers, teachers, people in homeless shelters, prisons, and children.

The late-stage trial of the COVID-19 vaccine involved more than 43,000 participants with the results of 170 confirmed COVID-19 infections. The study concluded that 162 infection cases were observed in the placebo group and the remaining eight cases were in the study group that received the two-dose vaccine.

Though the results of the studies are promising the storage conditions for the vaccine could prove a problem in widespread distribution. The vaccine requires special refrigeration of minus 94 °F and the competition vaccine by Moderna can be stored easily at minus 4°F.

The U.S. agreed to buy 100 million doses of the Pfizer and BioNTech vaccine that is apart of Operation Warp Speed for $1.95 billion in July. If approved, the vaccine would be on track to produce 50 million doses this year and nearly 1.3 billion doses for 2021.

We are submitting our first request for an #EUA in the U.S. for vaccine candidate #BNT162b2 against #covid19. We look forward to continuously providing data to various regulatory authorities as part of our rolling review process – including the @EMA_News. https://t.co/Lk7MTlwE5R pic.twitter.com/OjZ2IxiU3a

— BioNTech SE (@BioNTech_Group) November 20, 2020

This vaccine is also submitting proposals for regulatory agencies around the world including the Medicines & Healthcare Products Regulatory Agency in the United Kingdom and the European Medicines Agency. The leading disease expert in America, Dr. Anthony Fauci, believes the vaccine should be available to all Americans by April or July.