The U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include the use of a single booster dose use in youth 12-15 years of age.
The amended EUA also shortens the time between the completion of a primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months, down from six months, for all approved age groups. The amended EUA also allows for a third primary series dose for immunocompromised children 5-11 years of age.
Acting FDA Commissioner Janet Woodcock, MD, said, “With the current wave of the Omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19.”
To reach the decision in allowing boosters for youth, the FDA said it “reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination.”
As Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, explained, “Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants. In particular, the Omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines. With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”
