Pfizer, BioNtech to submit to FDA for EUA for their COVID vax candidate

American drug giant Pfizer and German laboratory BioNTech on Friday (November 20) said that they will be submitting to the US Food and Drug Administration (FDA) for emergency use authorisation for their COVID-19 vaccine candidate. Citing an official statement by the companies, CNN reported that their vaccine candidate, known as BNT162b2, will potentially be available for use in high-risk populations in the United States by the middle to end of December. According to the companies, the vaccine requires two doses a few weeks apart and the protection is achieved 28 days after the first shot.

The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer’s vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers, CNN reported.

On November 18, Pfizer had said that final results from the late-stage trial of its coronavirus vaccine was found to be 95 per cent effective and had no serious side effects on older people.

The findings are based on two doses given to more than 41,000 people around the world, said the US drugmaker adding that it would apply for emergency US authorisation soon, raising hopes that a working vaccine could soon become a reality.

This comes after Pfizer and its partner German biotechnology firm BioNTech had last week published data that their vaccine offered 90 per cent protection from the infection as compared to placebo saline shot.

In a statement, Pfizer and BioNTech said they expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. NDTV