Pfizer-BioNTech submits data to US FDA for COVID-19 vaccine in young children
Pfizer Inc. and BioNTech SE on Tuesday submitted the first trial data for their COVID-19 vaccine in children aged 5 to 11 to U.S. regulators and announced that they would make a formal request for authorization to proceed. emergency use in the coming weeks.
Coronavirus infections have skyrocketed in children and peaked in early September, according to data from the American Academy of Pediatrics.
The vaccine, which is already licensed in adolescents aged 12 to 15 and fully approved for ages 16 and over in the United States, was shown to induce a strong immune response in the target age group in a clinical trial of 2,268 attendees, the companies said. September 20.
The Pfizer-BioNTech vaccine was approved for use in children between the ages of 12 and 15 approximately one month after the companies applied for approval. If the same schedule is followed for this app, children could start receiving their snaps as early as the end of October.
Early clearance could help mitigate a potential increase in cases this fall, with schools already open across the country.
While children are less susceptible to severe COVID-19, they can pass the virus to others, including vulnerable populations who are at greater risk for serious illness.