The U.S. Food and Drug Administration (FDA) this week expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age.
The FDA amended the EUA for the vaccine originally issued on Dec. 11, 2020, for use in those 16 years of age and older.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” acting FDA Commissioner Dr. Janet Woodcock said Monday. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC).
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
The available safety data to support the EUA in adolescents down to 12 years of age, include 2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States.
Dallas County Judge Clay Jenkins said Tuesday that he expected the county could administer the first vaccine doses to people in the 12-15 age group as soon as Friday.
“Their parent or legal guardian must be with them to sign forms in order for a child to get a vaccine,” he added.
In other news:
- Dallas County Tuesday reported 159 more COVID-19 cases and eight additional deaths, including a Dallas man in his 20s who was found dead at his home and a Dallas man in his 30s who died in an emergency room. The county also reported eight more cases of the B.1.1.7 variant first identified in the U.K., one case of a B.1.429 variant first identified in California, and one case of a P.1 variant first identified in Brazil. To date, the county’s reported 69 cases of variant B.1.1.7, seven B.1.429 cases, two B.1.526 cases, two P.1 cases, and one P.2 case. Monday, the county reported 188 more cases and six deaths.
- The county is partnering with Dallas ISD to bus students aged 16-18 to vaccine sites as soon as next week, the Dallas Morning News reported. “The parent does need to attend if the school brings the student in a bus with the appropriate consent form,” Jenkins said Tuesday.
- Ahead of the FDA expanding emergency use of the Pfizer vaccine to adolescents, the Texas Department of State Health Services late last week sent a letter to more than 3,000 pediatric health care providers enrolled in the Texas Vaccines for Children Program as well as to the Texas Medical Association, Texas Pediatric Society and other provider groups inviting them to enroll in the COVID-19 vaccine program.