The US Food and Drug Administration (FDA) may approve the use of the coronavirus vaccine from Pfizer and BioNTech among adolescents aged 12-15 years by next week, the New York Times reports, citing sources.
The companies sent a request to the US regulator for approval for the emergency use of the COVID-19 vaccine for this age group in early April. Earlier, they said that their coronavirus vaccine showed 100% effectiveness when used among adolescents aged 12 to 15 years.
As the newspaper notes, the regulator can approve the application of the companies by the end of this week. If approved, the advisory committee of the Centers for Disease Control and Prevention (CDC) will analyze data from clinical trials and make recommendations for the use of the drug among adolescents.
Earlier it was reported that Pfizer and BioNTech have applied to the European Medicines Agency (EMA) for approval of their coronavirus vaccine for use among adolescents aged 12-15 years. The EU regulator said it would explore the possibility of expanding the recommendations for the use of the drug.