The US Food and Drug Administration (FDA) expanded the emergency use authorization of Pfizer/BioNTech's COVID-19 vaccine for children ages 12 to 15 years. With this, Pfizer became the first vaccine in the United States to be authorized for use in younger teens and adolescents; the vaccine had previously been authorized for people age 16 and older.
The FDA has described it as an important decision. FDA Executive Commissioner Dr. Janet Woodcock said, "The expansion brings us closer to returning to a sense of normalcy. 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.
At the same time, Pfizer-BioNTech's COVID-19 vaccine currently used by adults in many countries. Pfizer released the data in March and said that 2,260 volunteers of 12-15 years given the vaccine. Meanwhile, the clinical trials found "100% efficacy and robust antibody responses" in study participants who were 12 to 15.
In December 2020, the US FDA granted Pfizer's request for an emergency use authorization for its COVID-19 vaccine. However, the company received federal approval to include children as young as 12 in its vaccine trial in October. Meanwhile, Pfizer, Moderna and Johnson & Johnson are currently assessing the safety and effectiveness of their vaccines in children.
Meanwhile, Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research, said, "The response to the vaccine was excellent and in fact, it was even better, really, in the younger age group than it was in the 16-25 age group. The safety profile was very similar in 12-15-year-olds as in 16-25-year-olds."
