Moderna requests FDA authorization to give adolescents COVID-19 vaccine

·2 min read

Moderna has petitioned federal regulators to clear its COVID-19 vaccine for use in adolescents between the ages of 12 and 17, the company announced Thursday.

“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” said Moderna CEO Stephane Bancel. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. ... We remain committed to helping to end the COVID-19 pandemic.”

The Food and Drug Administration will debate whether to expand the company's emergency use authorization to cover people younger than 18. The two-shot vaccine has been authorized for use in adults since December 2020. The company announced in late May that the vaccine was shown to be 100% effective in protecting against infection during a study of 3,732 adolescents 12 to 18.

MODERNA APPLIES FOR FULL FDA VACCINE APPROVAL

Moderna filed for full FDA approval for its vaccine last week, the second company to do so after Pfizer, the maker of another two-dose mRNA vaccine. Pfizer was also first to have its vaccine authorized for children 12-15, with the FDA granting the company an expanded use authorization about a month ago.

No COVID-19 infections were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, according to a statement from Moderna. The most common adverse effects were headache, fatigue, muscle aches, and chills, the same negative effects expected in adults who receive the mRNA shots.

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The expanded authorization process for the Pfizer vaccine was quick. The request was sent to the FDA on April 9 and was granted about a month later. The debate over authorizing Moderna's shots in teenagers is likely to take about the same amount of time.

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Tags: Healthcare, News, Coronavirus, Vaccination, FDA, Pfizer, Pharmaceutical Industry, Regulation

Original Author: Cassidy Morrison

Original Location: Moderna requests FDA authorization to give adolescents COVID-19 vaccine

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