Pfizer Sees Emergency Use Filing For COVID-19 Vaccine After US Election.

Pfizer Sees Emergency Use Filing For COVID-19 Vaccine After US Election

The timeline now allows for a possible US authorization of a coronavirus vaccine this year

Pfizer Inc said on Friday it may file for authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before US elections as President Donald Trump has promised.

The regulatory filing for the vaccine could come as soon as safety data is available, possibly in the third week of November, Pfizer said, lifting the company's shares and the broader US stock market.

The timeline now allows for a possible US authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

The US Food and Drug Administration said earlier this month it wants at least two months of safety data on half of the trial participants before authorizing emergency use of any experimental coronavirus vaccine.

While the White House cleared the guidance, Trump has called the new rules a 'political hit job' as they undercut hopes of getting a vaccine before voters go to polls on November 3.

Based on current trial enrollment and dosing in a late-stage trial, Pfizer expects to have that safety data in the third week of November, Chief Executive Officer Albert Bourla said in an open letter posted on the company's website.

Newsbeep


Bourla noted in the letter that the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical.

Pfizer's shares rose 2.4% in premarket trading, while BioNTech's U.S-listed shares were up 3.3% before the opening bell.

(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)

NDTV News

NDTV.com provides latest news from India and the world. Get today’s news headlines from Business, Technology, Bollywood, Cricket, videos, photos, live news coverage and exclusive breaking news from India.

https://www.ndtv.com/

Related news
UK floods: Residents in tears as barriers breached in Worcestershire town.

UK floods: Residents in tears as barriers breached in Worcestershire town.

Homes have been flooded and residents left in tears after defence barriers were breached in a town previously hit by flooding last year. Bewdley in Worcestershire, which was also devastated by heavy rainfall last February, saw its temporary storm ...

Stormy weather pattern setting up across the U.S.

Stormy weather pattern setting up across the U.S.

A stormy jet stream is slamming into the West next week, setting up storm patterns across the U.S. CBS News meteorologist and climate specialist Jeff Berardelli joins "CBS This Morning: Saturday" to discuss what to expect next week. CBSN is CBS Ne...

Previewing the NFL's conference championship Sunday.

Previewing the NFL's conference championship Sunday.

We are just hours away from finding out who will be playing in Super Bowl LV in Tampa, Florida. Championship Sunday kicks off with the Tampa Bay Buccaneers heading to Green Bay to take on Aaron Rodgers and the Packers. In the evening, the Buffalo ...

Washington has the 'inability beyond belief of getting anything done': WV Gov.

Washington has the 'inability beyond belief of getting anything done': WV Gov.

West Virginia Gov. Jim Justice (R) provides insight into President Biden halting new oil and gas leases on federal land. Subscribe to Fox News! Watch more Fox News Video: Watch Fox News Channel Live: FOX News Channel (FNC) is a 24-hour all-encompa...

What can we expect from Biden's first 100 days in office?.

What can we expect from Biden's first 100 days in office?.

The Hill editor-in-chief Bob Cusack talks to Fox News' Eric Shawn about what President Joe Biden will accomplish during his first 100 days in office. Subscribe to Fox News! Watch more Fox News Video: Watch Fox News Channel Live: FOX News Channel (...

Vaccine Supply Issues Leave Officials And Residents Frustrated - NBC Nightly News.

Vaccine Supply Issues Leave Officials And Residents Frustrated - NBC Nightly News.

Health officials across the country say the demand for vaccine doses far outpaces the supply they’re receiving. Some sites have stopped giving doses.» Subscribe to NBC News: » Watch more NBC video: NBC News Digital is a collection of innovative an...