FDA Approves Pfizer-BioNTech Booster Shot for Children 5 and Older

Today, the US Food and Drug Administration (FDA) approved booster doses of the Pfizer-BioNTech COVID-19 vaccine for children 5-11 years of age.

Now, children as young as 5 can receive a third dose of the vaccine at 5 or more months after their initial 2-dose Pfizer-BioNTech vaccination series.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalized,” Robert M. Califf, MD, the FDA Commissioner, said in a statement explaining the expanded recommendation. “Children may also experience longer term effects, even following initially mild disease.”

There has been a growing push for approval of boosters in children. “Emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.”

On January 3, the FDA recommended Pfizer-BioNTech booster shots for children 12 years and older. Simultaneous with this expansion to adolescents, the FDA shortened the time in between second and third doses from 6 months to 5 months.

Pfizer-BioNTech is currently the only COVID-19 vaccine approved for children and adolescents (5-17 years of age). Moderna previously announced filing for EUA of its mRNA COVID-19 vaccine for children as young as 6 months, but Pfizer-BioNTech is still the only COVID-19 vaccine FDA- and CDC-approved for primary vaccination and booster vaccination in children.

The efficacy of COVID-19 booster vaccination in pediatric populations was based on results from an ongoing, randomized, placebo-controlled study. Data from this trial contributed to the initial FDA decision to approve Pfizer-BioNTech COVID-19 vaccine for children 5-11 years.

Investigators monitored the safety and antibody responses of 67 children who received a booster dose 7-9 months after their initial 2-dose Pfizer-BioNTech vaccine series. Comparatively, COVID-19 antibody titers increased significantly after a booster dose.

Another study of approximately 400 children in this age group assessed the safety of receiving a booster 5-9 months after primary vaccination. The most common adverse events were pain, injection site reactions (redness and swelling), fatigue, headache, muscle or joint pain, chills, and fever.

“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” Califf said. “If your child is eligible for the Pfizer-BioNTech COVID-19 vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”