said it could be ready to apply for Covid-19 vaccine-use emergency permit by the end of November, assuming it receives positive validity and safety data from the final stages of trials. man, for the first time this or any other leading vaccine developer in the West has provided such a specific timeline.
Drug giant, forming vaccine candidate with German partner BioNTech SE,
said it is expected to continue to have data on the effectiveness of the vaccine – if it protects at least most of those vaccinated from the disease – later this month. It expects drug safety data to be available in the third week of November.
Assuming a positive result in the same set of data, Pfizer said it plans to file for emergency-use approval for the U.S. vaccine from the Food and Drug Administration immediately after receiving safety data. It does not disclose the timing for similar applications anywhere in the world.
A third set of data — to ensure that the drug can be developed on a large scale with proper quality and consistency — is ready for submission before Pfizer expects to receive safety data.
Pfizer said it laid out the timeline in an effort to clear up any confusion about the complex process. “To ensure public confidence and clean up the confusion, I believe it is important for the public to understand our estimated deadlines,”; Pfizer Chief Executive Albert Bourla said in an open letter released Friday.
Pfizer has long provided a timeline in late October for having enough data to establish whether the vaccine is effective, which increases the likelihood of an emergency use permit shortly thereafter — and may be before the election. presidential. Pfizer’s new timeline has set unreachable for its candidate.
Other Western vaccine development programs, including one at the University of Oxford and AstraZeneca PLC and another by Moderna Inc.,
is in the final stages of human trials. Oxford vaccine tests stopped in the UK and US after a test subject got sick in Britain. They were continued in the UK, but the FDA has not yet allowed them to continue in the US
While the West is increasingly waiting for data from human trials, China and Russia have released their own vaccines and allowed their limited use for some parts of their population and so on.
While the timeline laid down by Pfizer on Friday was limited to its application for emergency use permits in the US, Europe’s leading regulator could act quickly on similar data submissions from Pfizer and partner BioNTech. BioNTech said on Friday that an application in Europe for emergency use would soon be followed by an FDA-approved one.
Such data will be immediately reviewed by the European Medicines Agency, a senior Ema official said. The EMA, which regulates drugs throughout the European Union, may issue what it calls a conditional marketing permit, similar to a U.S. emergency use permit.
Pfizer and BioNTech are racing to increase the production of vaccine candidates to meet the needs of the world, assuming the shot wins a green light regulation. The two are committed to providing more than 450 million doses this year and next year, depending on the final stages of testing that shows the vaccine is safe and effective, and the governments that are providing forward for its use.
The U.S. 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 option for another 100 million. The Japanese government ordered 120 million doses and Britain ordered 30 million. All orders are subject to regulatory approval, and only the price of the US deal — $ 1.95 billion — has been disclosed so far.
BioNTech and Pfizer previously set a target to produce up to 100 million vaccines worldwide by the end of this year. That initial group would only be enough for 50 million people, however, because the vaccine, known as BNT162, consists of two shots, one called primary vaccination and one booster. The two companies have not yet disclosed how many doses have been taken.
Write to Bojan Pancevski at [email protected]
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