Pfizer could request emergency use of Covid-19 vaccine by end of November

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Pfizer Inc.

said he may be ready to seek emergency authorization for his Covid-19 vaccine by the end of November, assuming he receives positive efficacy and safety data from ‘late-stage human trials, the first time he or any other leading Western vaccine developer has provided such a specific schedule.

The drug giant, which is developing its vaccine candidate with its German partner BioNTech SE,

said he continues to expect to have data on the vaccine’s effectiveness – whether it protects at least a majority of those vaccinated against the disease – later this month. He then expects to have data on the safety of the drug by the third week of November.

Assuming positive results with both datasets, Pfizer said it then plans to file an application for emergency use of the vaccine in the United States with the Food and Drug Administration shortly thereafter. have received the security data. He has not revealed any time for similar applications elsewhere in the world. A third set of data – to ensure the drug can be manufactured on a large scale with the right quality and consistency – will be ready to be submitted before Pfizer expects to receive the safety data.

Pfizer said it established the timeline in an effort to eliminate confusion over the complex process. “To ensure public confidence and clear up much confusion, I think it is essential that the public understand our estimated timelines,” Pfizer chief executive Albert Bourla said in an open letter published Friday morning.

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

Other western vaccine development programs, including one by the University of Oxford and AstraZeneca PLC and another by Moderna Inc.,

are also in the phase of human trials. Trials of the Oxford vaccine have been halted in the UK and US after a test subject in Britain fell ill. They have taken over in the UK, but the FDA has not yet cleared them to take back in the US

While the West widely awaits data from these human trials, China and Russia have rolled out their own vaccines and authorized their limited use for parts of their populations and beyond.

While the timeline Pfizer set on Friday is limited to its emergency use authorization application in the United States, Europe’s main regulator could act quickly on similar data submissions from Pfizer and its partner BioNTech. BioNTech said on Friday that a European application for emergency use would quickly follow one presented to the FDA.

The data would be immediately reviewed by the European Medicines Agency, a senior EMA official said. The EMA, which regulates medicines across the European Union, could then issue what it calls a conditional marketing authorization, similar to the emergency use authorization in the United States.

Pfizer and BioNTech have been battling to increase production of its vaccine candidate to meet global needs, assuming the shot wins the regulatory green light. The two have pledged to deliver more than 450 million doses this year and next, subject to late stage trials showing the vaccine to be safe and effective, and governments are giving the green light for its use.

The US government has placed an initial order for 100 million doses, with the possibility of purchasing an additional 500 million doses. The EU has ordered 200 million doses with an option for another 100 million. The Japanese government has ordered 120 million doses and Britain has 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 goal of producing up to 100 million vaccines globally by the end of this year. This initial batch would only suffice for 50 million people, however, because the vaccine, known as BNT162, consists of two injections, a so-called primary series and a booster. The two companies did not disclose how many doses they have already taken.

Write to Bojan Pancevski à [email protected]

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