Pfizer sees emergency use filing for Covid-19 vaccine after U.S. election

Суббота, 17 Окт, 2020

Pfizer Inc. said Friday it could apply for emergency use authorization in the United States of its COVID-19 vaccine by late November.

An advanced study involving tens of thousands of volunteers that is necessary to establish safety and effectiveness of the vaccine is scheduled to start in November or December.

The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore received an injection in May. During a digital event in September, he also said the company expected initial results in late October and would seek FDA authorization as soon as possible.

At least half of 44,000 participants in the study must have been tested without showing side effects by then. Moderna's first look at data is more likely to come next month.

Faust was among a group of leading scientists who previously urged Pfizer to wait until at least late November before seeking emergency authorization.

The CDC has said that if supplies are limited, the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, people aged 65 years and older and essential workers.

Regulators for Europe and Canada are considering data on a rolling basis, as it becomes available.

Health officials told a press conference last month that the country expects to be able to produce 610 million vaccine doses annually by year-end, stressing it would be affordable.

The plan also prioritizes which groups will receive the vaccine first, although at this point it's unknown how long it would take to move through each of the four phases. Russian authorities say the "conditional" registration is similar to fast-track programmes in the West and China and will allow them to ramp up production while testing continues.

"I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer's and our partner BioNTech's COVID-19 vaccine", Bourla said. Russian Federation has also given the vaccine to at least hundreds of "high-risk" members of the general population.

The FDA must make sure that the benefits of a vaccine outweigh the risks before authorization since they are meant to be given to hundreds of millions of healthy people.

That's a clear shift from Bourla's previous comments, which constantly featured "October" as the key word-at a time when President Donald Trump was touting a vaccine before the November 3 election, and mentioning Pfizer by name.