Adolescents Gain COVID-19 Protection From Comirnaty
New York-based Pfizer Inc. and its co-development partner BioNTech SE announced on November 22, 2021, positive topline results from the safety and efficacy analysis of their Comirnaty COVID-19 vaccine when used in adolescents.
The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of the Comirnaty Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.
And the adverse event profile was generally consistent with other clinical safety data for the vaccine.
Furthermore, no serious safety concerns were observed in individuals with at least six months of safety follow-up after the second dose.
“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age,” said Ugur Sahin, CEO, and Co-founder of BioNTech.
These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application to be submitted to the FDA to expand approval of the vaccine for use in individuals 12 years and older. The vaccine is currently available for individuals 12 to 15 years of age under emergency authorization.
In individuals 12 years of age and older, a third primary series dose may be administered at least four weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.
And a single booster dose of the vaccine may be administered at least six months after completion of a primary series to individuals 18 years of age and older.
Moreover, myocarditis and pericarditis have occurred in some people who have received the vaccine, more commonly in males under 40. In most of these people, symptoms began within a few days following receipt of the second dose of the Comirnaty vaccine. The chance of having this occur is very low, says Pfizer.