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Pfizer and BioNTech said Monday that three doses of their COVID-19 vaccine offer strong protection for children ranging from 6 months old to under 5 years old, The Associated Press is reporting.

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In a news release, the drugmakers said preliminary data from a Phase 2/3 clinical trial of 1,678 young children showed that three 3-microgram doses of the vaccine were safe and 80.3% effective in preventing symptomatic COVID-19. Only 10 COVID-19 infections have been identified so far among study participants; the companies said they won’t perform a formal analysis until researchers log 21 cases, the companies said.

“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well-tolerated and produced a strong immune response,” Albert Bourla, Pfizer’s chairman and CEO, said in a statement. “These topline safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization.”

BioNTech Co-founder and CEO Ugur Sahin added that the companies are “preparing the relevant documents and expect completing the submission process” to the U.S. Food and Drug Administration this week.

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The news comes less than a month after rival Moderna announced it was seeking approval from the FDA for emergency use of its COVID-19 vaccine in children younger than 6.

The rate of new COVID-19 cases appears to be rising domestically and globally, according to The New York Times. As of Sunday, the U.S. was averaging 108,065 new cases per day, up 53% from two weeks earlier, the newspaper reported. Meanwhile, the worldwide average was 581,351 new cases per day, up 12% from 14 days earlier.

As for fatalities, the U.S. averaged 309 deaths per day – a decrease of 16% from two weeks earlier, the newspaper reported. The global average was 1,696 daily deaths, down 23% from 14 days earlier.

The Centers for Disease Control and Prevention reported Sunday that 66.5% of the U.S. population is considered fully vaccinated against COVID-19. About 46.5% of fully vaccinated residents have received a booster dose of a coronavirus vaccine, the agency said.

The Associated Press contributed to this report.