FDA Approves Vaccine for Kids 12 to 15

The U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNtech COVID-19 vaccine for emergency use in adolescents aged 12 to 15 Monday.

While the FDA has given approval for emergency use, this does not mean that the vaccine can be administered to children in this age group yet, said Elizabeth Goodsitt, communications officer for the state Department of Health Services.

“There are more steps that must be taken to ensure the Pfizer [vaccine] meets the high safety standards of the Centers for Disease Control and Prevention (CDC),” Goodsitt said in an email.

The CDC’s Advisory Committee on Immunization Practices is meeting Wednesday to review the vaccine for expanded authorization and will vote on recommendations and guidance for its use with this age group. CDC director Rochelle Walensky will then decide whether to adopt the recommendations of the committee.

Dr. Janet Woodcock, acting FDA commissioner, said the new authorization is a “significant step in the fight against the COVID-19 pandemic,” in a statement released Monday. She also said, “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.”

The data supporting the decision, according to the FDA, comes from a placebo-controlled study with 2,260 participants, 50% of whom were given the saline-placebo.

The vaccine proved 100% effective at preventing COVID-19 among the group of adolescents who received the vaccine. The most common side effects from the study lasted one to three days and were also the same as those that occurred among people 16 years and older. They included pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain.

More than half the participants in the study were followed for two months following their second injection to monitor potential side effects and the safety of the vaccine.

In the FDA’s announcement of the expanded use, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said “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.”

The FDA said approximately 1.5 million cases of COVID-19 have been reported to the Centers for Disease and Control and Prevention among children aged 11 to 17. In Milwaukee County, cases have been rising sharply for teenagers aged 15 to 17 in recent weeks, with most of the transmission occurring in the city of Milwaukee.