The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.
The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.
While “COVID-19 tends to be less severe in children than adults,” Califf noted that the omicron wave has resulted in more children getting infected and hospitalized with COVID-19 infections. “Children may also experience longer-term effects, even following initially mild disease,” he added.
The FDA has determined that vaccine effectiveness in all authorized populations wanes in the weeks and months following administration of a second dose.
“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,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
To arrive at its most recent decision, the FDA reviewed data from an ongoing placebo-controlled study involving children between 5 and 11.
At present, no COVID-19 vaccines are authorized for children under 5. Media reports suggest that, in June, FDA could allow the use of the Pfizer-BioNTech and Moderna vaccines in children aged six months to four years of age.
In making its most recent decision, FDA did not convene an additional meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), concluding that it had sufficient information to expand authorization.
The VRBPAC will gather for a string of meetings in June to discuss authorizing COVID-19 vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech in young children. Also that month, the committee will consider recommending authorization of the COVID-19 vaccine from Novavax (Nasdaq:NVAX).