Pfizer And BioNTech to Submit Emergency Use Authorization Request to FDA For COVID-19 Vaccine

Pfizer and BioNTech announced on Friday that they will be submitting an emergency use authorization request to the US Food and Drug Administration (FDA) on Friday.

The shares of BioNTech and Pfizer increased by 6.3% and 1.5%, respectively, in the pre-opening trade on Wall Street.

Today’s announcement came two days after Pfizer announced that its final analysis of the data found that its coronavirus vaccine with BioNTech was 95% effective in preventing Covid-19, was safe and appeared to prevent serious diseases.

The drugmakers said the vaccine, called BNT162b2, was highly effective against the virus 28 days after the first dose, and its effectiveness was consistent across all ages, races and ethnicities.

Additionally, elderly people, who are seen to be at high risk of contracting severe disease from Covid-19, have seen the vaccine efficacy of more than 94%, they added.

And if the request is approved by the Food and Drug Administration, the vaccine will likely be limited and roll out in several phases, with health care workers, the elderly, and people with underlying health conditions vaccinated first.

Primary workers, teachers and people in shelters, as well as people in prisons, are likely to rank next on the list, followed by children and youth.

The FDA process is expected to take a few weeks, and a vaccine review advisory committee meeting is tentatively scheduled for early December.