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Pfizer applies for US emergency use for Covaxin

NEW YORK, NOV 20 (AGENCIES) | Publish Date: 11/20/2020 12:03:20 PM IST

Pfizer Inc said it will apply to U.S. health regulators on Friday for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus.

The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.

Pfizer’s shares rose 1.6% and BioNTech climbed 6% on the news that a vaccine could soon be available, raising hopes for the end of a pandemic that has claimed more than a quarter of a million lives in the United States and over 1.3 million worldwide.

The application also includes safety data on about 100 children 12-15 years of age. The company said 45% of U.S. trial participants are 56-85 years old.

If the data is solid, “we literally could be weeks away from the authorization of a 95% effective vaccine,” U.S. Health Secretary Alex Azar said on CBS’ “This Morning”.

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