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Pfizer-BioNTech Covid Shot Gains U S Clearance for Young Teens

May 11 2021, 4:55 PM May 11 2021, 2:45 AM May 11 2021, 4:55 PM (Bloomberg) (Bloomberg) Pfizer Inc. and BioNTech SE’s Covid-19 vaccine was cleared for use in younger teens in the U.S., paving the way for the mass vaccination of middle- and high-school students before the start of summer camps and the next school year. The Food and Drug Administration said in a statement Monday that it had expanded the shot’s original emergency use authorization to include adolescents 12 to 15 years of age. “It was a relatively straightforward decision,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, at a news conference. The vaccine generated a strong immune response, there were no cases of Covid in the vaccinated group, and there were no signs of any new or worrisome side effects, he said.

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The Latest: Romanians protest restrictions as cases top 1M

The Latest: Romanians protest restrictions as cases top 1M
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Pfizer asks US government to allow more kids to get Covid-19 vaccine

Drug giant Pfizer and its partner in developing the first COVID-19 vaccine that received emergency authorisation in the US want to allow more adolescents to receive the vaccine. New York-based Pfizer and BioNTech SE of Germany have asked the US Food and Drug Administration to expand the emergency use authorisation for their vaccine to include adolescents ages 12 through 15. Back in mid-December, the two-dose shot received emergency clearance for vaccinating people ages 16 and up. Pfizer and BioNTech said they are working closely with the FDA and regulators in other countries to get emergency or conditional authorization as quickly as possible for kids ages 12 through 15.

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