FDA Authorizes Pfizer-BioNTech Booster Shots for 16- and 17-Year-Olds
Faced with the growing threat of the Delta and Omicron variants, the FDA authorized Pfizer-BioNTech booster doses for 16- and 17-year-olds.
Today, the US Food and Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 “booster” vaccines for 16- and 17-year-olds.
The FDA decided that 16- and 17-year-olds who received a 2-dose regimen of the Pzifer-BioNTech vaccine can now receive a third booster dose 6 months after their original series.
The emergence of new, potentially more infectious, variants of concern Delta and Omicron motivated the FDA to act quickly to keep breakthrough infections at a minimum and prevent the SARS-CoV-2 virus from continuing to mutate.
The decision will be reviewed by the Centers for Disease Control and Prevention Director Rochelle Walensky, and if endorsed, could go into effect as soon as this week.
The Moderna and Janssen (Johnson & Johnson) booster doses remain available only to Americans over the age of 18.
The authorization is likely to cause controversy in the infectious disease community, as experts are divided on whether adolescents should receive boosters, as they are less likely to experience severe or fatal COVID-19 disease than older persons.
Additionally, many argue that herd immunity and stopping the spread of COVID-19 can only be achieved if these extra doses are redistributed among persons that have yet to receive any vaccination.
The outbreak of the Omicron variant has been the impetus for many health officials and the Biden Administration to strongly encourage all eligible persons to receive an additional booster dose.
Pfizer-BioNTech originally submitted a request for Emergency Use Authorization (EUA) to administer its booster to all adults on November 9. On November 19, the Moderna and Pfizer-BioNTech booster doses were FDA-authorized for all adults 18 years and older.