TOP News

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

Pfizer's ultra-cold vaccine, a 'very complex' distribution plan, and an exploding head emoji

  Pfizer's ultra-cold vaccine, a 'very complex' distribution plan, and an exploding head emoji As Molly Howell, a state health official in North Dakota, watched a webinar on how to distribute what's expected to be the first Covid-19 vaccine, her head began to spin. © David Dee Delgado/Getty Images North America/Getty Images NEW YORK, NY - NOVEMBER 09: People walk by the Pfizer headquarters on November 9, 2020 in New York City. Pharmaceutical company Pfizer announced positive early results on its COVID-19 vaccine trial and has proven to be 90% effective in preventing infection of the virus.

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.

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

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

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

Start the day smarter. Get all the news you need in your inbox each morning.

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.”

Fact check: Pfizer received COVID-19 vaccine data after Election Day, released within days

  Fact check: Pfizer received COVID-19 vaccine data after Election Day, released within days Claims that Pfizer withheld positive news about its COVID-19 vaccine until after Joe Biden became president-elect are false.Charlie Kirk, a conservative activist, claimed in a video posted to Facebook on Nov. 11 that Pfizer withheld the news until after Joe Biden secured enough electoral votes to become president-elect on Nov. 7.

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.

6 lawmakers in 5 days: New COVID-19 infections put spotlight on Congress’ loose guidelines

Demand for dry ice: COVID vaccine candidate from Pfizer must be stored at minus 112, prompting a rush on dry ice

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.

Broncos DC Ed Donatell back home recovering after COVID-related hospitalization

  Broncos DC Ed Donatell back home recovering after COVID-related hospitalization Broncos defensive coordinator Ed Donatell required hospitalization after contracting the coronavirus, according to the team. The second-year Denver DC was hospitalized last week but discharged Sunday. Donatell, 63, has been battling COVID-19 symptoms since Oct. 31 and has missed the past three games. Donatell, who is in his third stint with the franchise, is one of a few Broncos staffers to have contracted the virus. Running backs coach Curtis Modkins did so in October, and offensive line coach Mike Munchak was in the team’s COVID protocol.

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.

Doctors and nurses want more data before championing vaccines to end the pandemic

  Doctors and nurses want more data before championing vaccines to end the pandemic Health-care leaders say they are finding unexpected wariness among medical workers about taking the novel vaccines, based on concerns about President Trump’s politicization of the government’s reviews, their rapid development under Operation Warp Speed, and a lack of information about longer-term safety and effectiveness. Large health systems, medical societies and the federal government are launching an effort to persuade front-line health care providers to take novel vaccines that were developed, and are likely to be granted emergency approval, in record time.

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 .
Watch some quick efficient passing by Louisville. As soon as David Johnson catches the ball he tosses it up to the hoop for Jae'Lyn Withers to throw it down for the ACC Must See Moment.

See also