Policy & Regulation
Correction - Pfizer and BioNTech to submit emergency authorisation for their COVID-19 to US FDA on 20 November 2020
20 November 2020 -

CNN reported on Friday that US pharmaceutical company Pfizer Inc and its German partner BioNTech will request an emergency use authorisation for their COVID-19 vaccine from the US Food and Drug Administration on 20 November 2020.

This is the first COVID-19 vaccine to seek a regulatory approval in the US.

In a statement, the companies said that their vaccine candidate, known as BNT162b2, will potentially be available for use in high-risk populations in the US by the middle to end of December.

Pfizer CEO, Albert Bourla, said in a statement : "Filing in the US 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."

Reportedly, this submission to the US FDA is based on results from the Phase 3 clinical trial of Pfizer's vaccine, which began in the US on 27 July 2020 and enrolled more than 43,000 volunteers.

The final analysis from the trial found that the COVID-19 vaccine was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, as announced by the companies this week.

This submission also includes safety data on about 100 children ages 12 to 15.

Also, in a news release, the companies said that about 42% of global participants and 30% of US participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants are ages 56 to 85.

Correction to date in headline

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