The FDA approved the Pfizer vaccine on Monday for children aged 12 to 15, paving the way for teenagers to start receiving vaccines as soon as this week.
The vaccine would also need to be approved by a CDC vaccine advisory committee for youths in that age group, with approval anticipated on Wednesday.
Acting FDA Commissioner Janet Woodcock said in a statement: “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.” She said, “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data.”
Last week, the FDA revealed its plan to make vaccines available to children, allowing millions of young Americans to be immunized.
The FDA announced on Monday that the Pfizer-BioNTech vaccine has met “the regulatory requirements” to be approved for children as young as 12 years old, claiming that the benefits “outweigh the known and possible risks.”
Even though children’s symptoms are milder than those of adults, the CDC recorded 1.5 million COVID-19 cases among 11- to 17-year-olds between March 1 and April 30 this year.
Peter Marks, head of the FDA Center for Biologics Evaluation and Research, said in a statement: “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.” He said, “With science guiding our evaluation and decision-making process, the FDA can assure the public and the 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 vaccines had previously been licensed for people aged 16 and up.
However, some opponents have challenged the wisdom of using the vaccines on a low-risk population, given that parts of the world are already scrambling to inoculate more vulnerable adults.