Coronavirus vaccine: Pfizer may ask for emergency approval in late November.

Click to play video 'Coronavirus: FDA working to implement strict guidelines for emergency release of vaccine'

watch: FDA working to implement strict guidelines for emergency release of vaccine.

Pfizer 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 U.S. 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 U.S. stock market.

READ MORE: Pfizer to include participants as young as 12 in coronavirus vaccine trials

The timeline now allows for a possible U.S. 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.

[ Sign up for our Health IQ newsletter for the latest coronavirus updates ]

The U.S. 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.

Trending Stories

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 Nov. 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.

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 per cent in premarket trading, while BioNTech’s U.S-listed shares were up 3.3 per cent before the opening bell.

View link »

© 2020 Reuters

Related news

China says Britain ‘violated promises,’ may not recognize Hong Kong passports.

Britain accuses China of failing to live up to its pledges to maintain freedoms in the special administrative region, while Beijing says London is interfering in its internal affairs.

Ukraine is key country in global geopolitics - Fukuyama.

Ukraine is a key country in global geopolitics today and for the future of democracy around the world, according to Francis Fukuyama, professor at Stanford University.

Joe Biden Warns Of «Dark Winter» Of Covid In Final Presidential Debate.

A second debate planned for October 15 was cancelled after Trump came down with Covid-19 and declined to take part in a virtual debate.

Tusk: West should guarantee Eastern European countries EU, NATO membership.

The Western community must guarantee all concerned Eastern European countries the prospect of EU and NATO membership.

«Eating Rats And Snakes» : Myanmar Slums Look For Food In Open Drains.

With more than 40,000 cases and 1,000 deaths, Myanmar is facing one of Southeast Asia's worst coronavirus outbreaks, and the lockdown in Yangon has left hundreds of thousands of people without work...

New epidemic zoning from Oct 26: Ivano-Frankivsk, Mykolaiv, Poltava, Rivne, Sumy, Ternopil, Kharkiv, Khmelnytsky, Chernivtsi, Chernihiv in 'red' zone.

The city of Kyiv and all regions of Ukraine are not ready to ease quarantine measures introduced to prevent the spread of COVID-19, according to data provided by the Health Ministry on October 23.

US Bullying Countries To Pick Sides, Attempt Will Not Succeed: China.

The United States is bullying countries to pick sides over their ties to China, but such efforts will not succeed, Chinese foreign ministry spokesman Zhao Lijian told a news briefing on Friday.

Ukrainian army reports 143 new coronavirus cases

The Ukrainian Armed Forces have confirmed 143 new coronavirus cases in the past 24 hours, the press service of the Medical Forces Command of the Armed Forces reports.

Sri Lanka Parliament Strengthens Presidential Powers.

Sri Lankan lawmakers approved amendments to the constitution that strengthened the powers of President Gotabaya Rajapaksa and took away parliament's role in making key appointments such as judges and...

Make «Difficult» Decisions For Economic Independence: US To Sri Lanka.

The United States on Thursday urged Sri Lanka to make "difficult but necessary" decisions to secure its economic independence for long-term prosperity.

By continuing to browse World News (UAZMI), you acknowledge that you have read the Terms of Use and agree to the use of cookies