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 Inc. and AstraZeneca Plc.
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 US 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.
Meanwhile, BioNTech's co-founder and chief executive said he was optimistic that the protective effect of its experimental COVID-19 vaccine, co-developed with Pfizer, would last for at least a year.
"We should be more optimistic that the immunisation effect can last for at least a year," CEO Ugur Sahin told Reuters.
European Union, 200 million doses (option: 100 million)
Japan 120 million doses
US, 100 million doses (option: 500 million)
UK 30 million doses
Pfizer has said it will submit the vaccine to the US 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.
The preliminary results pave the way for the companies to seek an emergency-use authorization from regulators if further research shows the shot is also safe.
Commenting on the success of the vaccine in the interim phase, Dr. Albert Bourla, Pfizer Chairman and CEO said, “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19."
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 US 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 Co. 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 UK struck its own supply agreement for 30 million doses. Japan also has an accord with the drugmakers, as does Canada.
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