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US Pfizer to seek approval from FDA 'within days' after further analysis finds COVID-19 vaccine 95% effective

15:25  18 november  2020
15:25  18 november  2020 Source:   usatoday.com

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Pfizer and BioNTech said final analysis found coronavirus vaccine was 95 % effective in Pfizer says final data analysis shows Covid vaccine is 95 % effective – plans Pfizer said it plans to submit an application for emergency use authorization to the Food and Drug Administration " within days ."

BREAKING: Pfizer says final analysis shows its vaccine is 95 percent effective , to seek approval ' within days '. The U.S. pharma giant and its German partner said their Phase 3 trial was now complete and that it found the vaccine was 95 percent effective at preventing symptomatic Covid - 19

Pfizer and its collaborator BioNTech announced early Wednesday it plans to start the Food and Drug Administration approval process “within days” for its candidate vaccine, BNT162b2, after further analysis showed it’s 95% effective.

a close up of a sign: A sign with the Pfizer logo stands outside the corporate headquarters of Pfizer Canada in Montreal, on Monday, Nov. 9, 2020. On Monday, the company says an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19, but it doesn't mean a vaccine is imminent. (Ryan Remiorz/The Canadian Press via AP) © The Associated Press A sign with the Pfizer logo stands outside the corporate headquarters of Pfizer Canada in Montreal, on Monday, Nov. 9, 2020. On Monday, the company says an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19, but it doesn't mean a vaccine is imminent. (Ryan Remiorz/The Canadian Press via AP)

Newly released data found the candidate vaccine prevented 95% of infections from the virus that causes COVID-19 after evaluating 170 people who were infected, 162 of which took the placebo, the company said in a news release.

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Pfizer will apply for emergency use authorization from the FDA within days after final results from its late-stage trial of its COVID - 19 vaccine showed it was 95 percent effective . The drugmaker said efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and

The Pfizer -BioNTech data shows 170 trial participants contracted Covid - 19 overall. Eight participants who got the vaccine fell ill, while 162 cases were Pfizer and BioNTech plan to seek U.S. emergency authorization “ within days ,” according to the release. On Tuesday, Pfizer Chief Executive Officer

There were 10 severe cases of COVID-19 in the trial, with nine of them occurring in the placebo group.

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According to the news release, the candidate vaccine was 94% effective in adults over 65 years of age, but maintained efficacy across gender, race and ethnicity demographics.

Researchers also found the vaccine was “well tolerated” across the 43,000 study participants who were enrolled with no serious safety concerns. The participants reported mild to moderate side effects, mostly fatigue and headache.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

Pfizer vaccine news 'as good as you could hope for'

  Pfizer vaccine news 'as good as you could hope for' Scientists and doctors are encouraged by 90% efficacy but caution a long road ahead. More safety data is needed before the pharmaceutical company will ask the Food and Drug Administration for authorization, but 90% efficacy is "about as good as you could hope for at this point," said David Benkeser, assistant professor of biostatistics and bioinformatics at Emory University Rollins School of Public Health. "Obviously, the full data aren't available yet to answer all the questions we're interested in, but a 90% efficacy estimate after that many events is a very good sign.

A vaccine developed by Pfizer Inc. and BioNTech SE protects most people from Covid - 19 Pfizer has found itself drawn into a contentious political debate about how quickly regulators in the U.S 16, Pfizer Chief Executive Officer Albert Bourla said the companies could seek an emergency use

Final analysis of the vaccine developed by Pfizer and BioNTech has shown that it is safe and 95 per cent effective in preventing Covid - 19 disease Protection is achieved 28 days after the initiation of the vaccination , which consists of two doses, meaning up to five million Britons could be inoculated

By reaching this safety milestone, the companies say they plan to submit a request to the FDA for emergency use authorization “within days.”

Pfizer and BioNTech are expected to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021.

The news comes days after Moderna, a Cambridge, Massachusetts-based biotechnology company, announced early Monday its candidate vaccine, mRNA-1273, developed in collaboration with the U.S. government, appeared to be 94.5% effective against COVID-19.

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Both the Moderna and the Pfizer/BioNTech candidate vaccines depend on a technology called mRNA that uses the body's natural processes to turn cells into factories producing a protein found on the outside of the virus that causes COVID-19. The immune system then learns to recognize that protein and attack the virus if it appears.

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WATCH: COVID - 19 : Pfizer -BioNTech vaccine now 95 % effective and will be submitted for authorisation ' within days '. The UK’s drug regulator NIO is trading down about 3% in after hours following the Chinese electric vehicle startup’s third quarter results. This comes on the same day rival

Pfizer says early analysis shows its Covid - 19 vaccine is more than 90% effective . In a news release, the pharmaceutical giant said it plans to seek emergency use authorization from the FDA soon after volunteers have been monitored for two months after getting their second dose of vaccine , as

While Pfizer has passed the safety milestone, Moderna will likely take longer to do this because it enrolled its trial participants at a slightly slower pace.

Both companies will have to show they can safely produce their vaccine at scale. Pfizer said it would provide the FDA with all necessary information in its emergency use application. It's not clear when Moderna will complete that process, but it is not expected to slow its application.

Once receiving each application, the FDA will review them, as will the independent Vaccines and Related Biological Products Advisory Committee.

It's not known how long that process will take, but the regulatory agency is expected to issue an emergency use authorization for the Pfizer/BioNTech vaccine before the end of the year.

Contributing: Karen Weintraub, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

Donald Trump and Trump Jr. spread a conspiracy theory that Pfizer deliberately waited until after Election Day to release its COVID-19 vaccine trial results

  Donald Trump and Trump Jr. spread a conspiracy theory that Pfizer deliberately waited until after Election Day to release its COVID-19 vaccine trial results Trump claimed Pfizer's COVID-19 vaccine results came out after the election because the FDA "didn't want to have me get a Vaccine WIN."They offered no evidence for their claims.

This article originally appeared on USA TODAY: Pfizer to seek approval from FDA 'within days' after further analysis finds COVID-19 vaccine 95% effective

When could the first COVID-19 vaccines be given in the US? .
Given the regulatory timeline, Dec. 13 is the earliest the first round of vaccine against the coronavirus could start to be given to select Americans.Pfizer and its German collaborator BioNTech applied for emergency use authorization for their COVID-19 vaccine from the Food and Drug Administration.

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