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Pfizer to seek COVID-19 vaccine approval after reporting 95% effectiveness

Last Updated Nov 18, 2020 at 9:42 am EST

FILE - This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. (Courtesy of University of Maryland School of Medicine via AP, File)
Summary

Pfizer says it plans to submit a request to the U.S. FDA for emergency use approval of its COVID-19 vaccine


Pfizer says its COVID-19 vaccine candidate is 95 per cent effective against the virus


Pfizer says data from its COVID-19 Phase 3 vaccine trials will also be submitted to agencies around the world


WASHINGTON (NEWS 1130) – Pharmaceutical giant Pfizer says it now has enough data on its COVID-19 vaccine candidate to ask U.S. federal regulators for emergency use approval.

Pfizer says new data suggests its vaccine is 95 per cent effective against the virus, and that its shot protects older people most at risk of dying from COVID-19.

“Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%,” the company says.

Pfizer says it and German-based BioNTech, with which it’s developing its vaccine, plan to submit a request to the FDA within days, “based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine.”

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The company says data from its Phase 3 trials will also be submitted to other agencies globally.

“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. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Dr. Albert Bourla, Pfizer Chairman and CEO, says.

“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 and BioNTech’s vaccine, if approved for use, would require people to get two shots over three weeks. The candidate began its Phase 3 trials in late July. Of the participants who enrolled in the trial, more than 41,000 received a second dose of its vaccine candidate.

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Just two weeks ago, data verified by an independent monitor suggests Pfizer’s drug was 90 per cent effective in stopping transmission of COVID-19 among people who have not been previously infected.

Canada currently has deals with a number of companies, including Pfizer, to secure millions of doses of potential vaccines against COVID-19.

Pfizer’s vaccine candidate also has a Vancouver connection; the biotech firm, Acuitas Therapeutics, that ensures the shot is effectively delivered is based in the city. Acuitas has been working on this since February.

To date, Canada has recorded 300,000 cases of COVID-19. Worldwide, there have been more than 55 million cases.

-With files from Marcella Bernardo, The Associated Press