Drugmakers Pfizer Inc and BioNTech SE said on May 23 that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.
The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc.’s emergency authorization request for the company’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc.’s vaccine for those aged 6 months through 4 years.
The U.S. Food and Drug Administration on May 17 authorized the use of a booster shot of Pfizer and BioNTech’s COVID-19 vaccine for children aged 5 to 11, making everyone in the United States over the age of 5 eligible for a third shot.
Moderna Inc. asked U.S. regulators to authorize the company’s COVID-19 vaccine for children under the age of 6, which would make it the first shot against the coronavirus available for those under 5-years-old.
Child vaccination rates in the United States fell during the COVID-19 pandemic as many children skipped doctors appointments and states eased vaccine requirements during remote learning, according to a government study released on April 21.
The U.S. Food and Drug Administration approved Sanofi’s new pediatric vaccine immunizing children against six diseases.