BioNTech’s COVID-19 vaccine has been found to be safe and effective in children aged 5 to 11, according to a study involving 4,500 participants. The mRNA vaccine, Comirnaty (BNT162b2), was well-tolerated by children in this age group, with an immune response against the SARS-CoV-2 virus similar to that seen in 12- to 18-year-olds. The observed side effects were comparable to those seen in older participants. The study was conducted on children aged between six months and 11 years, with the results based on data from 2,268 children. BioNTech plans to publish results from studies on infants aged six months to two years and toddlers aged two to five years in the fourth quarter of 2021.
BioNTech CEO Ugur Sahin expressed his satisfaction with the results, stating that the company is pleased to be able to present the data to regulatory authorities before the start of the winter season. The company now plans to submit the results to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the hopes of getting approval for vaccinating children as soon as possible. However, even if the EMA approves the vaccine promptly, it is unlikely that the first children in Germany will be vaccinated for several months. Federal Health Minister Jens Spahn has stated that approval for this age group in Germany is realistic only in the first quarter of 2022, with a recommendation from the Standing Committee on Vaccination (Stiko) likely to come later.
The results of this study are a significant development in the fight against COVID-19, as vaccinating children is crucial to achieving herd immunity and reducing the spread of the virus. The safety and efficacy of the vaccine in this age group will provide reassurance to parents and caregivers, and the data will be closely scrutinized by regulatory authorities before approval is granted. The success of the vaccine in children aged 5 to 11 is a testament to the hard work and dedication of the scientists and researchers involved in its development, and it is hoped that this will pave the way for further progress in the fight against the pandemic.
