Pfizer will be able to apply for emergency use of the Covid-19 vaccine in late November

Pfizer Inc.

P.F.E. -0.84%

Said it may be ready to apply for emergency-use authorization of its Covid-19 vaccine by the end of November, believing that in late-stage human trials will yield positive efficacy and safety data, the first time it or any other leading Western vaccine developer This kind of provided. Exact timeline.

Drug giant, developing its vaccine candidate with German partner Bioentech SE,

BNTX 4.05%

That said, earlier this month, the effectiveness of the vaccine – it continues to be expected – is to protect at least the majority of vaccinators from the disease. He then expects to have information on the safety of the drug by the third week of November.

Assuming positive results with both sets of data, Pfizer said it would immediately return to the U.S. after receiving security data. There are plans to file for emergency-use authorization for the vaccine by the Food and Drug Administration. It doesn’t reveal time anywhere in the world for the same app.

A third set of data – to ensure that the drug can be mass-produced at appropriate quality and consistency – will be ready to be submitted before Pfizer expects to receive safety data.

Pfizer said it set a timeline in an effort to remove any confusion about the complex process. “I believe the public needs to understand our projected timeline in order to ensure public confidence and eliminate major confusion,” Pfizer chief executive Albert Borla said in an open letter released early Friday morning.

Pfizer has long given a deadline of late October-October, so there is enough data to establish whether the vaccine is effective, raising the possibility of authorization of emergency use soon after – possibly even before the presidential election. Pfizer’s new timeline is beyond the reach of its candidate.

Other Western vaccine development programs, including those by Western Xford University and AstraZeneca plc and other moderns Inc.,

There is also a late stage human trial. Trial of UK XF vaccine after trial subject fell ill in UK UK and US. Were stuck in. They were reintroduced to the UK, but the FDA approved them in the US. Has not yet given the authority to resume in

As the West largely awaits data from these human tests, China and Russia have vaccinated their own and authorized the limited use of some parts of their populations and so on.

The timeline set by Pfizer on Friday is U.S. Its application for emergency-access authorization is limited, while Europe’s top regulator could act quickly on similar data submissions from Pfizer and partner Bioentech. Bioentech said Friday that the European application for emergency use would quickly follow the one the FDA did.

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Such data will be immediately reviewed by the European Medicines Agency, a senior MMA official said. The EMA, which regulates drugs in the European Union, can then issue what it calls conditional marketing author authorization, similar to the authorization of emergency use in the US.

Pfizer and Bioentech are scrambling to increase the production of its vaccine candidate to meet the needs of the world, assuming the shot-winning regulatory green light. Both have pledged to supply 5050 million doses this year and next, contingent on late-stage trials showing the vaccine to be safe and effective, and governments will move forward with 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 ordered 200 million doses with another 100 million option. The Japanese government ordered 120 million doses and ordered Britain 30 million. All orders are subject to regulatory approval, and only કિંમત 1.95 billion has been valued in the US.

Bayonet Tech and Pfizer had earlier set a target of producing 100 million vaccines globally by the end of this year. That initial batch will only be enough for a million people, however, the vaccine known as BNT 1862 has two shots, the so-called prime vaccine and a booster. Both companies have not yet disclosed how many doses they have made.

Write to Bojan Pensowski at [email protected]

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