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Pfizer says its Covid vaccine 90 per cent effective
Eight months into the crisis, the preliminary results pave the way for the companies to seek an emergency-use authorisation from regulators if further research shows the shot is also safe. The vaccine may be available by the end of the month.
The Covid-19 vaccine being developed by Pfizer Inc and BioNTech SE prevented more than 90% of infections in a study of tens of thousands of volunteers, the most encouraging scientific advance so far in the battle against the pandemic that has infected over 50 million people, of whom 1.2 million have died.
Eight months into the crisis, the preliminary results pave the way for the companies to seek an emergency-use authorisation from regulators if further research shows the shot is also safe. The vaccine may be available by the end of the month.
The disclosure ends the suspense over the release of interim analysis of the company’s Phase 3 clinical trials that was initially expected by the end of October. The data (the first interim efficacy analysis as it is called of late stage trial data) was released after being vetted by independent experts.
Interim efficacy data presents the first significant evidence that a vaccine has been able to prevent disease, and not just trigger an immune response. Pfizer and BioNTech’s announcement that the messenger RNA, or mRNA, vaccine had at least 90% efficacy among 94 confirmed cases means that at least 84 of the people who developed symptomatic Covid from over 43,000 trial volunteers had received the placebo.
This includes people who got two doses of the vaccine as well as those who received a placebo shot. According to Pfizer’s trial protocol released previously, this number falls closer to what would have been the third interim analysis checkpoint, for which it had set a 62.7% efficacy target – the 90% number far exceeds this target.
“The first set of results from our Phase 3 Covid-19 vaccine trials provides the initial evidence of our vaccine’s ability to prevent Covid-19,” Pfizer CEO Albert Bourla said in a statement. He termed it “a great day for science and humanity.”
The companies’ findings do not include details on safety because the US Food and Drug Administration requires at least two months of safety data and the company is in the process of collating that for the trial that began in late July and involves almost 44,000 participants. In a statement, Pfizer said it will “have the required safety data by late November. Submission for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) will be planned soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.”
If approved, the companies expect to produce around 50 million doses of the vaccine this year itself. “With today’s news, we are a significant step closer to providing people around the world with a much needed breakthrough to help bring an end to this global health crisis,” Bourla added.
According to science informatics and analytics company Airfinity, Pfizer’s positive results mean they could have enough cases for EUA in the US following the safety readouts in less than two weeks. “We also expect EU and UK to approve quickly,” said Airfinity’s CEO Rasmus Bech Hansen, in an email to HT.
“These results increase the likelihood of a positive readout for Moderna, whose vaccine follows similar technology and had comparable phase I data,” Hansen said, adding that “US, EU, and Japan stand as biggest winners as they have pre-purchased the most doses from Pfizer”.
Pfizer-BioNTech have secured supply deals with multiple countries for a little over 1 billion doses till the end of 2021. In all, its production capacity till the end of 2021, based on deals with vaccine makers, is estimated at 1.8 billion doses, according to Airfinity data.
To be sure, one of the fundamental questions about any vaccine for Covid-19 remains unanswered by this data (although that was never meant to be answered rightaway): the length of immunity provided by the vaccine.
Pfizer and BioNTech are among the frontrunners in the race to develop a vaccine for Covid-19. Others that are in the midst of late-stage human trials include Moderna Inc, Johnson & Johnson, and AstraZeneca-Oxford.
The interim data from the Pfizer vaccine was to be initially reviewed after 32 volunteers in the trial contracted the infection; this was subsequently increased to 62; but eventually, the data for 94 participants who were infected and symptomatic was analysed.
If successfully tested and launched, the Pfizer-BioNTech vaccine will be the world’s first mRNA one. Its vaccine carries a piece of genetic instruction code (mRNA) that activates human cells to themselves make a version of the spike protein of SARS-COV2, the virus that causes Covid-19. This spike protein then activates the body’s immune system, producing an immune reaction. Moderna’s vaccine candidate is also based on the same technology.
The Pfizer-BioNTech vaccine will require two shots. According to the companies, the data indicates that the efficacy rate is in excess of 90%, seven days after participants received their second shot.
News of the vaccine’s efficacy breaks amidst a surge in cases in the US, with the 7-day average crossing 100,000 over the weekend.
