Regulators on both sides of the Atlantic ocean are working to speed a review of the shot’s safety and effectiveness after the data showed it prevented more than 90% of infections. Monday’s release placed the two drugmakers firmly in the lead of the vaccine race, ahead of Moderna and AstraZeneca.
If the results hold up, they will leave Pfizer and Biontech with commitments to supply hundreds of millions of doses of a vaccine to competing customers battling a virus resurgence and eager to start vaccination campaigns as soon as possible.
The companies have signed advance purchase agreements for 100 million doses with the U.S. and double that with the European Union, with options for more. Supply will fall far short at the beginning.
The partners said they’ll be able to produce enough to inoculate 25 million people this year, less than a third of the population of Germany, where Biontech is based.
“We will need to find a way to distribute that in a fair fashion,” Biontech Chief Executive Officer Ugur Sahin said in an interview. While approval timelines depend on local regulators, there’s no reason that one would significantly lag the other, Sahin said.
Pfizer has said it will submit the vaccine to the U.S. Food and Drug Administration for emergency clearance once it gets an average of two months of follow-up data on safety, which will most likely happen next week. The European Medicines Agency already began a rolling review of the experimental vaccine last month.
Europeans will probably be able to get their shots starting early next year, German Health Minister Jens Spahn said Monday, adding that his calculation factors in a buffer in case of any potential setbacks. Health workers and high-risk groups will be first in line, he said.
“There could be a difference in timing between American and European approvals,” Spahn said. “Still, I’m very confident it will be a relatively short one.”
The partners expect to ramp up production significantly next year, with capacity for as many as 1.3 billion doses. Most of that would be exhausted if the U.S. and the EU exercise their options.
The vaccine requires extreme freezing for long-term storage, which could complicate distribution, although it can stay at refrigerator temperatures for at least five days.
Biontech is working with Shanghai Fosun Pharmaceutical Group on bringing the vaccine to China. An early-stage patient trial started there in August. The company is in talks with the country’s drugs regulator about using some of the data from the existing late-stage trial to support a regulatory filing in China, according to Biontech.
The U.K. struck its own supply agreement for 30 million doses. Japan also has an accord with the drugmakers, as does Canada.