COVID-19 Vaccine Safe For 5-11-Year-Olds: Pfizer

CONNECTICUT — The state Department of Public Health has called Pfizer's declaration that their COVID-19 vaccine is safe for young children "a step in the right direction."

The Groton-based drug manufacturer announced Monday a Phase 2/3 trial of its vaccine yielded safe and "robust" results for 5-to-11-year-olds. Pfizer's data has not been peer-reviewed or published.

In its statement, DPH said that Pfizer plans to submit for an emergency use authorization to the Food and Drug Administration. FDA officials have said that once data is submitted, the agency could authorize a vaccine for young children in a matter of weeks.

Pfizer's COVID-19 vaccine, now marketed as Comirnaty, was approved by the FDA for people 16 years of age and older last month. It is available under emergency use authorization for children age 12 through 15, and for the administration of a third dose in certain immunocompromised people.

The trial included 2,268 children, ages 5 to 11, and used a two-dose regimen of the vaccine administered 21 days apart, according to a news release from Pfizer. The 10-microgram dose was smaller than the 30-microgram dose that is currently being administered to those 12 and older.

Connecticut health officials will continue to closely monitor the updates from the FDA and the guidance provided by the Advisory Committee on Immunization Practices, DPH said in its release.