The Pfizer/BioNTech coronavirus vaccine is “safe and effective” for use in children between the ages of five and 11, according to the latest clinical trial results.
On Monday, the companies announced that they plan to submit the research results to the European Medicines Agency (EMA), which will review the case before European countries can decide on lowering the minimum age limit for the shot to be administered.
“Now the EMA will check whether the benefits outweigh the risks for those children and whether it is safe to use,” Belgium’s vaccination taskforce spokesperson, Gudrun Briat, told The Brussels Times.
A study of 2,268 children between the ages of five and 11 showed that the vaccine – in a lighter dose – is effective against the virus and that it does not have any major side effects, adding that the findings are consistent with those observed in older populations at a higher dose.
Today with @BioNTech_Group, we are proud to announce positive topline results from the pivotal trial of our #COVID19 vaccine in children 5-11 years of age. https://t.co/a1mSEgxNHQ pic.twitter.com/9xGfYEzFuy
— Pfizer Inc. (@pfizer) September 20, 2021
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech.
Impact on Belgium’s vaccination campaign
Briat explained that this announcement “does not mean we will start vaccinating young children next week,” as Belgium has to wait for the EMA’s approval first before the relevant data can be revealed.
“Then the file will be submitted for advice to the Superior Health Council in Belgium, and based on their advice, the Ministers of Health will decide whether to start vaccinating this age group,” Briat added.
She stressed that it is a good sign that the companies have submitted this file to the EMA, “because that shows that they feel confident about their case.”
Currently, the vaccine has received approval in Europe to be administered to young people aged over 12. But in Belgium, children between the ages of 12 and 15 can only get vaccinated if a parent accompanies them to the vaccination centre or if they have been given written consent for the vaccination.
The results announced on Monday are part of the Phase 2/3 study, which is enrolling children 6 months to 11 years of age. Results in children under the age of five are expected sometime later this year.