Pfizer and BioNTech say COVID-19 vaccine safe and effective in children aged 5 to 11

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Pfizer and BioNTech say COVID-19 vaccine safe and effective in children aged 5 to 11
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Pfizer says COVID-19 vaccine safe and effective for children as young as five

Pfizer Inc. PFE, -1.30% and German partner BioNTech SE BNTX, -3.61% on Monday announced positive results in a Phase 2/3 trial of their COVID-19 vaccine in children aged 5 to 11, and said the vaccine was safe, well tolerated and produced"robust" neutralizing antibody response. The companies said participants in the trial were given a two-dose regimen of 10 ug administered 21 days apart, a smaller dose than the 30 ug given to people aged 12 and older.

These are the first results from a pivotal trial of a COVID-19 vaccine in this age group." The companies are planning to submit the data to the Food and Drug Administration and the European Medicines Agency, as well as to other regulators around the world as soon as possible. Results from a trial involving children younger than 5 are expected"as soon as later this year," said the statement. "Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S.

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