HealthDay News — The US Food and Drug Administration on Monday approved the emergency use of the Pfizer booster shot against COVID-19 for youths aged 12 to 15 years.
The move comes as the Omicron variant spreads across the country and students return to classrooms following the holiday break.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” Acting FDA Commissioner Janet Woodcock, MD, said in an agency news release announcing the approval. “With the current wave of the Omicron variant, it’s critical that we continue to take effective, lifesaving preventative measures such as primary vaccination and boosters, mask wearing, and social distancing in order to effectively fight COVID-19.”
The FDA also reduced the period that people must wait between their second dose and their booster shot to 5 months, down from the current 6 months. At the same time, regulators authorized the Pfizer booster shot for a select group of younger children, those aged 5 to 11 years who have immune deficiencies and are therefore more vulnerable to severe COVID-19.
“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the emergency use authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” Pfizer Chairman and CEO Albert Bourla said in a company statement. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”
Approximately 70% of Americans 12 years and older are now fully vaccinated, according to the US Centers for Disease Control and Prevention, but about 1.8 million adolescents in the 12- to 15-year-old demographic have already tested positive for the virus.