Pfizer and BioNTech submitted their Covid-19 shot for emergency authorisation in the US on Friday, becoming the first pharmaceutical companies to apply for regulatory approval of a coronavirus vaccine.
In a joint statement, the companies said they had gathered enough safety data to satisfy the US regulator and that doses of the vaccine would be ready to be shipped within hours of authorisation, which could happen by the middle of December.
The US Food and Drug Administration moved quickly, announcing late in the day that an advisory group of independent experts will meet to discuss the submission on December 10, a crucial step on the road to a so-called emergency use authorisation.
Stephen Hahn, the FDA commissioner, said the agency is committed to making the approval process “as open and transparent as possible”.
If approved, the shot will be the fastest to market in history, and the first to use mRNA technology, which sends genetic instructions to cells to provoke an immune response rather than using a weakened form of the virus.
On Wednesday, data from the companies’ phase-3 trial, involving more than 43,000 people, showed the vaccine had an efficacy rate of 95 per cent, far above the threshold required by the FDA, and higher than many common jabs, such as those for flu or rabies. The study also found that the vaccine, which requires a booster shot, caused no serious side-effects, and was almost as effective in people over 65.
Albert Bourla, Pfizer chief executive, said the FDA submission marked a “critical milestone” in efforts to deliver a Covid-19 vaccine to the world. “We now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” he added.
The FDA submission will also include safety data from about 100 children aged 12 to 15. The Pfizer-BioNTech shot is one of the only Covid-19 vaccines to have been tested on children. But experts have cautioned there needs to be more research before giving the shot to kids.
A full submission to the European Medicines Agency, which was also expected this week, has been postponed because the EU regulator has asked for more trial data than its US counterpart, according to people familiar with the process.
Ugur Sahin, chief executive of Mainz-based BioNTech, said that interactions with the EMA were of “particular importance” to the German company, and that it had provided regular data to the EMA using its “rolling review process”.
The companies have also started to feed some data to regulators in Australia, Canada, Japan and the UK.
Shares in BioNTech rose 5.6 per cent to $100.52, while Pfizer closed up 1.4 per cent to $36.70 in New York.
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Pfizer and BioNTech have the capacity to produce 1.35bn doses of their vaccine by the end of 2021, including 50m doses by the end of the year.
The vast majority of those doses have been reserved by the US, EU, UK and Japan. Deliveries to developing countries could be initially complicated by the need to store the vaccine at approximately minus 75C during transportation.
Pfizer and BioNTech’s submission to the FDA is likely to be quickly followed by a filing from US biotech Moderna. Moderna’s mRNA vaccine was also found to be almost 95 per cent effective in phase-3 trials. The company said on Monday that it would apply for regulatory approval in the US “in the coming weeks”.
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