Europe Recommends mRNA Vaccinations for Children
The European Medicines Agency (EMA) announced today its vaccine advisory committee had recommended the Comirnaty COVID-19 vaccine for children between the ages of 5 and 11.
The EMA's recommendation has been sent to the European Commission for a final decision.
The mRNA-based vaccine, co-developed by Germany-based BioNTech SE and New York-based Pfizer Inc., is already approved for use in adults and children aged 12 and above.
For children in this age group, Comirnaty will be a lower dose (10 µg compared with 30 µg).
As in the older age groups, Comirnaty is given as two injections in the upper arm muscles, three weeks apart.
The primary study in children showed that the immune response to Comirnaty given at a lower dose (10 µg) in this age group was comparable to that seen with the higher dose (30 µg) in 16- to 25-year-olds (as measured by the level of antibodies against the SARS-CoV-2 betacoronavirus).
The efficacy of Comirnaty was calculated in almost 2,000 children who had no sign of a previous COVID-19 infection.
Of the 1,305 children receiving the mRNA vaccine, three developed COVID-19 compared with 16 out of the 663 children who received placebo.
This data indicates that, in this short-term study, the vaccine was 90.7% effective at preventing symptomatic COVID-19 (although the actual rate could be between 67.7% and 98.3%).
The most common side effects in children aged 5 to 11 are similar to those aged 12 and above.
They include pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain, and chills.
Based on this information, the EMA concluded that the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19.
BioNTech, the company that markets this vaccine in Europe, is required to provide regular updates and conduct studies to monitor the safety and effectiveness of the vaccine as the public uses it. Authorities also conduct additional studies to monitor the vaccine.