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Pfizer formally asked U.S. regulators Friday to allow emergency use of its COVID-19 vaccine

Pfizer formally asked U.S. regulators Friday to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic — but not until after a long, hard winter..In this Wednesday, April 8, 2020 photo provided by the Center for Pharmaceutical Research, a pharmacy technologist using a biosafety level 2 hood prepares a COVID-19 coronavirus vaccine candidate for testing in Kansas City, Mo. This early safety study, called a Phase 1 trial, is using a vaccine candidate developed by Inovio Pharmaceuticals. (Center for Pharmaceutical Research via AP)

 

The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to the FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.

With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.

Sandesh Ilhe
Sandesh Ilhe
With an Engineers degree in Advanced Database Management and Information Security, Sandesh brings the deep understanding of the digital world to the table. His articles reflect the challenges and the complexities that come along with every disruption in the industry. He carries over six years of experience on working with websites and ensuring that the right article reaches the right reader.