In early January, Ugur Sahin, a Turkish-born immunology professor, told the board of the German biotech group he co-founded to devote the small company’s resources to tackling a new virus that had emerged in China.
Eleven months later, BioNTech’s Covid-19 vaccine — developed with the help of US partner Pfizer and China’s Fosun — is on course to become the first approved vaccination in the US and EU for the disease that has killed 1.25m people and battered the world economy.
The inoculation, based on mRNA technology that has never been used before, was found to be 90 per cent effective in phase 3 trials involving more than 43,000 participants, the companies said on Monday, far exceeding the threshold required by regulators.
Anthony Fauci, the head of the US National Institutes of Health, described the results as “just extraordinary” and global markets soared at the prospect that coronavirus vaccines will be effective.
“This is an important step for science, the data showed that a vaccine can work,” Mr Sahin told the FT. “The likelihood that other vaccines are going to be also successful increased today.”
The S&P 500 opened at a new record high in New York. Shares in Pfizer rose 7.6 per cent and BioNTech increased 7.9 per cent.
Pfizer and BioNTech were already working on a flu vaccine together when the Covid-19 pandemic began at the start of the year. In mid-March, the pair agreed a deal to work together on a vaccine, with BioNTech contributing the vaccine technology, and Pfizer deploying its capacity to run large clinical trials and scale up manufacturing.
The positive data from the trial has now lifted hopes that several other vaccines that rely on the same mRNA technology could also yield encouraging results. Instead of introducing antigens into the body to produce an immune response, it sends genetic information to a cell that can be translated into proteins that fight disease.
“It validates the mRNA platform [and] it validates greatly the spike protein as the target of the anti-coronavirus response,” Mr Fauci said.
Anita McElroy, an infectious disease specialist at the University of Pittsburgh’s Center for Vaccine Research, said it was “fantastic news” and that the effectiveness far surpassed that of a flu vaccine, which are generally between 30 per cent and 60 per cent effective. “This is the first one to show efficacy but it has a lot of promise for all the other vaccines.”
Pfizer and BioNTech said they expect to have complete safety data from the trial ready to submit to US and EU regulators by the third week of November. Analysts expect the US regulator to move quickly, perhaps approving a vaccine on an emergency basis in December.
Although no significant side-effects have been discovered, Pfizer and BioNTech will still have to pass safety thresholds set by the US Food and Drug Administration and the European Medicines Agency to receive approval. Subsequent, larger data sets could also alter the vaccine’s overall efficacy.
The companies — which have been ramping up production over the past few months — say they have the capacity to produce 50m doses of the vaccine this year and 1.3bn doses in 2021.
Early batches have been earmarked by the US, which secured 100m doses and the option to purchase 500m more, and the UK, which said it has bought 40m doses.
Although BioNTech received €375m from the German government and a €100m loan from the European Investment Bank, Pfizer was among the only vaccine developers not to take funding from Operation Warp Speed, the US government’s vaccine programme.
The companies have priced the vaccine in the US at about $19.50 a dose, for a two-dose course, and not promised — like AstraZeneca and Johnson & Johnson — to make the vaccine available on a not-for-profit basis, provoking criticism from advocacy groups.
Oxfam said the vaccine would be “zero per cent effective to the people who can’t access or afford it”, and urged the companies to share their vaccine with other developers.
Geoffrey Porges, an analyst at SVB Leerink, estimated the shot could generate about $3.5bn next year, split between Pfizer and BioNTech.
Mr Porges added that the timing of the announcement, after the conclusion of the US presidential vote, suggested the companies “wanted to avoid making themselves part of the election process”.
Donald Trump, US president, had pushed vaccine makers to deliver good news before the November 3 election and by late October Pfizer and BioNTech had been the only companies in a position to possibly deliver efficacy data before the vote.
BioNTech said the companies, in collaboration with the FDA, which was nervous about rushing through a drug with only a small sample, had waited to see a higher number of infections within the 43,000 trial participants before making an announcement. Pfizer’s independence was a “precious asset”, chief executive Albert Bourla said last month.
In Mainz, Mr Sahin said BioNTech’s staff — who have almost doubled in number since the start of the year — are now focused on ensuring that there are no hiccups as the vaccine enters the final straight.
“I told our team in January that we might have a vaccine by the end of this year,” he said. “We are a bit lucky that we did not run into any major problems.”
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