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

15:26  18 november  2020
15:26  18 november  2020 Source:   msn.com

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.

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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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.”

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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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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.

Pfizer, Moderna have delivered 'best news so far' in COVID-19 fight, but USA TODAY's vaccine panel warns of logistical challenges

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

Ravens WR Willie Snead tests positive for COVID-19 Sunday .
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