EMA approves Pfizer-BioNTech COVID-19 vaccine for young children

The Food and Drug Administration (FDA) granted approval for emergency use of the Comirnaty vaccine in children in October 2021.

The European Medicines Agency (EMA) have approved the use of the Pfizer-BioNTech coronavirus vaccine Comirnaty for children aged 5 to 11-years-old. This news comes as Europe faces a resurgence of COVID-19 cases, accounting for over half of global figures. The mRNA-based vaccine is already authorised for those aged 12 and over as of May 2021. The recommendation will be sent to the European Commission for final approval.

Pfizer and BioNTech submitted data supporting the use of Comirnaty in those over 5 years, including data from a Phase 2 and Phase 3 study. The formula has an efficacy rate of 90.7% in preventing symptomatic COVID-19, according to data from the trial in which nearly 2000 children participated. The FDA authorised emergency use of the vaccine in children in October 2021.

The Committee for Medicinal Products for Human Use (CHMP) has shared that the dose of Comirnaty in this age bracket will be lower than that used in people aged 12 years and above – a dose of 10μg in comparison to the 30μg dose for those 12 and over. Of the 1305 children who received the vaccine in the clinical trial, only three developed COVID-19. This compares to 16 out of the 663 children who received a placebo.

“The benefits of Comirnaty in children aged 5 to 11 outweighs the risks, particularly in those with conditions that increase the risk of severe COVID-19,” said the EMA in a statement. This news accompanies Austria’s implementation of a fourth national lockdown and the announcement that vaccination against COVID-19 will be legally mandatory from February 2022.

Germany, also facing a fourth wave of COVID-19, will receive 2.4 million doses with the shipment. This is estimated to be enough to inoculate about half of the country’s children within the age bracket. Tens of millions of children in the age group will also be eligible for the shot in the EU.