Shares of German drug maker BioNTech SE rallied 24 per cent, while US-based Pfizer Inc. stock jumped over 14 per cent in pre-market trading on Monday after their COVID-19 vaccine candidate achieved positive results in first interim analysis from Phase 3 study. Pfizer Inc and BioNTech SE said their BNT162b2 vaccine candidate was more than 90 per cent effective in preventing COVID-19.
Boosted by the development, Futures for the Dow Jones Industrial Average rallied 1,521 points, or 5.4 per cent, to 29,720. S&P 500 index futures rallied 130.80 points, or 3.7 per cent, to 3,632, while Nasdaq -100 Futures gained 0.8 per cent or 102.25 points at 12,177. The US stock-index futures rally was also fuelled by the presidential election results in which Joe Biden defeated President Donald Trump in a close contest.
The COVID-19 vaccine, BNT162b2, being developed by Pfizer Inc. and BioNTech are in late-stage vaccine trial. The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
Based on success achieved in first interim analysis from Phase 3 study, the drug makers plan to soon apply for Emergency Use Authorisation (EUA) before the US Food and Drug Administration (FDA) after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
Based on current projections, the drug makers expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine produced.
By Chitranjan Kumar