stated that it could be prepared to apply for an authorization for the emergency use of its Covid-19 vaccine by the end of November if it accepts that it has received positive efficacy and safety data from late-stage human trials, for the first time or and any other leading developer of Western vaccines has provided such a specific timeline.
The drug, which is developing its vaccine candidate with German partner BioNTech SE,,
said he continued to expect data on the effectiveness of the vaccine – whether or not it protected at least most vaccinated people from the disease ̵
Accepting positive results with both datasets, Pfizer said it then plans to submit a permit for emergency use of the vaccine in the United States from the Food and Drug Administration shortly after receiving the safety data. He did not reveal time for such applications anywhere else in the world.
A third set of data – to ensure that the drug can be manufactured on a large scale with the right quality and consistency – will be ready to send before Pfizer expects to receive the safety data.
Pfizer said it had set the timeline in an attempt to clear up any confusion about the complex process. “To ensure public confidence and clear up a great deal of confusion, I believe it is essential that the public understands our projected deadlines,” Pfizer CEO Albert Burla said in an open letter published early Friday.
Pfizer has long given a final schedule for the end of October to have enough data to determine if the vaccine is effective, increasing the likelihood of an emergency authorization shortly thereafter – and possibly even before the presidential election. President Trump said last month in a debate with former Vice President Joe Biden that the vaccine is weeks away. Pfizer’s new schedule puts pre-election approval for its candidate out of reach.
Other Western vaccine development programs, including one from the University of Oxford and AstraZeneca PLC and another from Moderna Inc.,
they are also in the late stages of human trials. Trials of the Oxford vaccine have been halted in Britain and the United States after the subject became ill in Britain. They were resumed in the UK, but the FDA has not yet authorized them to resume in the US
As the West is largely awaiting data from these human experiments, China and Russia have launched their own vaccines and allowed limited use for parts of their populations and beyond.
While Pfizer’s schedule on Friday is limited to its application for an emergency use permit in the United States, the best regulator in Europe could act quickly when submitting such data from Pfizer and partner BioNTech. BioNTech said on Friday that a European emergency application would soon follow a submission to the FDA.
Such data will be reviewed immediately by the European Medicines Agency, a senior EMA official said. The EMA, which regulates medicines in the European Union, could then issue a conditional marketing authorization, similar to the US emergency marketing authorization.
Pfizer and BioNTech are vying to increase production of their vaccine candidate to meet global needs, assuming the shot wins a regulatory green light. The two have pledged to deliver more than 450 million doses this year and next, depending on late-stage trials that show the vaccine is safe and effective, and governments that are giving the green light to use it.
The US government has placed an initial order of 100 million doses, with the option to purchase an additional 500 million doses. The EU has ordered 200 million doses with the possibility of another 100 million. The Japanese government has ordered 120 million doses and Britain 30 million. All orders are subject to regulatory approval and so far only the price of the deal in the US has been announced – 1.95 billion dollars.
BioNTech and Pfizer have previously set a goal of producing up to 100 million vaccines worldwide by the end of this year. This initial batch would be enough for only 50 million people, as the vaccine, known as BNT162, consists of two shots, the so-called primary vaccination and a booster. The two companies did not disclose how many doses they had already taken.
“Drew Hinshaw contributed to this article.”
Write to Boyan Panchevski at email@example.com
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