Pfizer COVID-19 Vaccine 95% Effective, Plans to Seek Approval From FDA 'Within Days'

(Photo : Jeenah Moon/Getty Images) Pfizer Makes $1.95 Billion Deal With U.S. For Future COVID-19 Vaccine NEW YORK, NY - JULY 22: Pfizer Inc. signage is seen on July 22, 2020 in New York City.

Pfizer announced on Wednesday that its coronavirus vaccine developed with partner BioNTech is more than 95 percent effective during the final analysis of its Phase 3 trial.

According to the Associated Press, the Pfizer coronavirus vaccine is safe and also offers protection for older people who are most at risk of dying from the virus.

BBC added in a report that the Pfizer vaccine also appears to work in people of all ages and ethnicities.

Alongside the news of their coronavirus vaccine's efficacy, the drugmaker also said it would apply for authorization from the U.S. Food and Drug Administration (FDA) "within days," ABC News reported.

In another report, BioNTech CEO Ugur Sahin told CNN that Pfizer and BioNTech would file paperwork for the emergency use of the vaccine with the U.S. FDA on Friday. 

The FDA advisory panel may be ready to review the data from Pfizer's study in early December. The late-stage trial involved some 41,000 people from all parts of the world. Half of the volunteers were given a vaccine, and others were given a placebo.

As announced last week, Pfizer and BioNTech's initial data showed that the vaccine offered 90 percent protection. The companies have not yet released full trial data but assured that there were no serious safety concerns.

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However, the researchers did notice headaches and fatigue in about two percent of volunteers given the vaccine.

There was no evidence that severe COVID-19 cases can be protected, but this is only based on 10 severe cases during the course of the study.

They drew the current data from this initial observation, suggesting that the vaccine is now more effective based on 170 cases that developed in their volunteers.

Following the release of this data, U.S. drugmaker Moderna suggested that their vaccine candidate was nearly 95 percent effective. Similar promising results were also seen in trials from another vaccine candidate in Russia, called Sputnik V. 

Pfizer Could Be First Coronavirus Vaccine Maker

If the FDA finds that the vaccine is safe and effective, Pfizer will be making history as the first company to get the FDA green light for a COVID-19 vaccine.

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Prof. Trudie Lang of the University of Oxford described the developments as "a remarkable and very reassuring situation," along with other scientists that said the data was further encouraging.

Lang was particularly optimistic about multiple vaccines lined up for regulatory approval.

"To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science," she said.

It is unclear how long the Pfizer vaccine's protection would last and if it can stop transmission of the virus from person to person.

Distributing Pfizer's Coronavirus Vaccine 'Overnight'

According to Pfizer, it plans to deliver millions of doses of its vaccine to most of the vulnerable sectors overnight once the FDA gives its approval.It is hoping for a possible green light before the end of the year.

As per FDA's requirements, at least two months of safety data among at least half of the trial volunteers have to be met before it can consider a limited emergency authorization.

Pfizer announced that it did hit this key milestone on Wednesday.But the problem might not end with just the trials and the logistics that come with storing the vaccines.

Pfizer's shot, unlike Moderna's, has to be store in ultra-cold temperatures of minus 94 degrees Fahrenheit but can be refrigerated for five days.

Still, the U.S. needs all the vaccines it can get can, and the manufacturing capacity of Moderna's vaccine is not as robust as Pfizer, said USA Today.

The need for cold storage may be an issue for health departments for months. Moderna also plans to ask the European Medicines Agency - Europe's regulatory body - to distribute.