US Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech's COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years.
A vial of the BioNTech-Pfizer vaccine Comirnaty in the pediatric dosage is on display in a pediatrician's office in Berlin on December 14, 2021, at the start of COVID-19 vaccination campaign for children under 12 years in Germany. The US Food and Drug Administration says Pfizer's COVID-19 vaccine is safe for children aged 6 months to 4 years. Tobias Schwarz/AFP
The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children. "Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years," FDA staff said in the review.
COVID-19 shots for children under the age of 6 are yet not approved in most parts of the world. It remains unclear how many parents will get their young ones vaccinated as demand has been low for kids aged 5 to 11.