The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he further said. "If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively," he said.
American pharmaceutical giant Pfizer and its German partner BioNTech have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy end points. Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2021 and up to 1.3 billion doses by the end of 2021. The major announcement came just two days after leading biotechnology firm Moderna said that its virus vaccine had an efficacy rate of 94.5 per cent.
Of the 170 volunteers who had contracted COVID-19 in Pfizer's involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95 per cent effective. Of the 10 people who had severe COVID-19, one had received the vaccine, the Reuters report said.
According to an analysis of the data, the Pfizer vaccine has an efficacy rate of 95 per cent in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose. The companies said the first primary objective analysis is based on 170 cases of COVID-19, of which 162 cases of coronavirus were observed in placebo group while 8 cases in the BNT162b2 group. The companies said that the vaccine efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent.