In a joint press release, the two partners said the vaccine met all of its primary efficacy endpoints. Better still, it had an efficacy rate of 95% in participants both with and without prior coronavirus infection (mild or severe). Also, the vaccine's efficacy was consistent across key demographics such as age, gender, and ethnicity. No serious safety concerns were reported.
That rate, meanwhile, is higher than the 90%-plus demonstrated in the interim analysis of trial data published last week by Pfizer and BioNTech.
With this fresh data, the two companies can now submit BNT162b2 to the Food and Drug Administration for Emergency Use Authorization (EUA), which Pfizer said they plan to do "within days." The vaccine would be cleared for use with an EUA.
"Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages," BioNTech CEO Ugur Sahin was quoted as saying.
"We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities," he added.
The two companies say they expect to be able to produce up to 50 million doses of their vaccine by the end of this year, and as many as 1.3 billion by the close of 2021.
Both Pfizer and BioNTech's stocks were on the rise in late-morning trading Wednesday. Pfizer was up 1.7%, outpacing the S&P 500 index's 0.2% gain, and BioNTech had leaped ahead by 4.5%.