May 10, 2021
The U.S. Food and Drug Administration (FDA) on Monday granted the highly anticipated approval of the first COVID-19 vaccine authorized for emergency use in children aged 12 to 15. The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech vaccine originally issued on Dec. 11, 2020, which authorized administration in individuals 16 years of age and older.
The FDA reviewed safety data from an ongoing randomized, placebo-controlled clinical trial of more than 2,000 participants ages 12 through 15 years old in the United States. In this analysis, the Pfizer-BioNTech vaccine was 100% effective at preventing COVID-19—zero cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients.
During the clinical trial, the Pfizer-BioNTech COVID-19 vaccine for 12-15 year-olds was administered as a series of two doses, three weeks apart, with the same dosage and dosing regimen for 16 years of age and older. Shots could begin as soon as the federal Advisory Committee on Immunization Practices issues its recommendations, which is expected Wednesday. The vaccine will undergo one more review by the Western States Scientific Safety Review Workgroup before the vaccine becomes available in California. The western states workgroup is expected to issue its recommendation as early as Friday.
In anticipation of the imminent availability of the vaccine for 12-15 year olds, the California Department of Public Health (CDPH) and California Medical Association (CMA) are hosting an informational webinar on the enrollment process and requirements for physicians who provide pediatric services and are interested in participating in the state's COVID-19 vaccination program.
The one-hour webinar will be 5-6 p.m. on Tuesday, May 11, 2021. Space is limited, so register as soon as possible to ensure your spot. If you're unable to attend the live webinar, the session will be recorded and posted to CMA's on-demand webinar library and to eziz.org/covid.