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Pfizer Says Coronavirus Vaccine Reaches 95% Efficacy Rate; Shares Leap

Pfizer said the final analysis of its late-stage coronavirus vaccine study showed a 95% efficacy rate, with the drugmaker planning to file for emergency FDA approval in the coming days.

Pfizer Inc.  (PFE) - Get Pfizer Inc. Report said Wednesday that it's developing coronavirus vaccine reached a 95% efficacy rate, topping that of Moderna  (MRNA) - Get Moderna, Inc. Report, following final analysis of its late stage trials.

Pfizer and its German partner, BioNTech BNTX, said the efficacy rate of the vaccine, known as BNT162b2, was consistent across all age and race demographics and based on a total case cohort of 170. Interim results published last week indicated an efficacy rate of 90% from a cohort of around 94 patients.

The pair said the will apply for Emergency Use Authorization from the U.S. Food & Drug Administration in the coming days. They also reiterated their aim of having 1.3 billion doses available next year.

“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,” said CEO Albert Bourla. “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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Pfizer shares were marked 2.9% higher in early trading immediately following the vaccine trial results at $37.07 each. BioNTech's U.S.-listed shares, meanwhile, rose 5.5% on the Nasdaq to $91.70 each. 

Moderna said Monday that its messenger RNA-based vaccine hit a 94.5% efficacy rate and noted that it can last for up to six months when stored at standard freezer temperatures of -4 degrees Fahrenheit, compared to the -94 degree temperatures required for the Pfizer vaccine. 

Pfizer and BioNTech dosed half of their 43,538 trial participants with a placebo, and the other half with their vaccine candidate, on two separate occasions as part of their three-stage study. Of the 170 confirmed cases of COVID-19 that resulted from the blinded trial, the pair said, more than 95%  -- or 162 -- came from the placebo group. 

Pfizer received 'fast track' designation from the FDA in July based on preliminary data from Phase 1 and Phase 2 studies. Its Phase III trial should be concluded in early December, Pfizer said, with analysis from around 164 infections. 

Pfizer said it saw no serious safety concerns from its ongoing trial, the only major study not linked to the U.S. government's 'Operation Warp Speed' program, and expects to have as many as 1.3 billion doses produced next year if and when the drug is ultimately approved by regulators.