On the same day the Centers for Disease Control and Prevention said it was aware of eight cases of heart inflammation in 5- to 11-year-olds vaccinated with Pfizer’s COVID vaccine, Pfizer and BioNTech announced they would seek full approval for their Comirnaty COVID vaccine for children 12 through 15.
At least eight cases of myocarditis, or heart inflammation, in children 5 to 11 years old who got the Pfizer-BioNTech COVID vaccine were reported to the Centers for Disease Control and Prevention (CDC), the agency said during a Dec. 16 meeting.
The cases were reported in the Vaccine Adverse Event Reporting System (VAERS) and presented by a CDC official to a panel of its vaccine advisers.
The CDC acknowledged the reports on the same day Pfizer and BioNTech announced they had submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) to expand the approval of their Comirnaty vaccine — not yet available in the U.S. — to include individuals ages 12 through 15 years.
During the Dec. 16 meeting of the CDC’s vaccine advisory panel, the CDC said there had been more than 7 million vaccine doses administered in the 5 to 11 age group at the time the agency examined the data, including 5.1 million first doses and 2 million second doses.
The CDC said there had been 3,233 reports to VAERS of adverse events among 5- to 11-year-olds, including 14 reports of myocarditis, five reports with follow-up in progress, nine reports with follow-up information obtained and eight reports of myocarditis that met the CDC’s working case definition, including four males and five females.