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Sept. 20, 2021, 7:16 a.m. EDT

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

Pfizer Inc. (NYS:PFE) and German partner BioNTech SE (NAS:BNTX) 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. "The antibody responses in the participants given 10 ug doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 ug doses," the companies said in a joint statement. "The 10 ug dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. 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. -- underscoring the public health need for vaccination," said Pfizer CEO Albert Bourla in the statement. There were 2,268 participants in the trial. Shares of both companies were lower premarket, caught up in a broad market rout sparked by fears of a default by Chinese property developer China Evergrande. Pfizer shares have gained 19% in the year to date, while BioNTech has gained 341%. The SPDR S&P Biotech ETF (PSE:XBI) has fallen 6% and the S&P 500 (S&P:SPX) has gained 18%.

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