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Pfizer seeks permission for emergency use of COVID-19 vaccine; 95% effective

The drug maker says its vaccine is 95% effective and ready to be deployed.

The race for a COVID-19 vaccine may be nearing an end as Pfizer announced Wednesday that it will ask the Food and Drug Administration to grant permission for emergency use of its vaccine, which the company says has safely completed a Phase 3 trial and is 95% effective. 

The Wednesday announcement comes about a week after Pfizer said its vaccine was showing promising results, and the latest efficacy analysis revealed that the vaccine was consistently effective across age, gender, race and ethnicity demographics – and was "over 94%" effective in adults over 65 years of age. 

More than 43,000 people participated in the vaccine trial and there were no serious safety concerns observed, Pfizer said. Side effects from the vaccine included fatigue and headache, although only at very minor levels of less than 4%. 

If granted permission for emergency use, Pfizer and drug-maker BioNTech are aiming to produce 50 million vaccine doses before the end of the year and up to 1.3 billion doses by the end of 2021, with the companies confident they can distribute it around the world. 

“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 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.”

Although the vaccine needs to be kept at temperatures of around -70°C (-94°F), Pfizer and BioNTech have developed temperatures-controlled thermal shippers that use dry ice to keep the vaccines at a proper temperature. 

It should be noted that Pfizer's vaccine has not been independently reviewed, nor has a vaccine being developed by Moderna that is 94.5% effective. Moderna said earlier this week that its goal is to have 20 million doses of the two-dose vaccine available by the end of the year and 500 million to 1 billion available in 2021.

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