European Medicines Agency approves Pfizer jab for 12 to 15-year-olds
The European Medicines Agency has authorised the use of the BioNTech/Pfizer vaccine in adolescents aged between 12 and 15, paving the way for EU countries to start vaccinating school-age children.
The approval widens the EU’s authorisation of the vaccine, produced in a joint venture between the German biotech start-up BioNTech and the US pharmaceutical company Pfizer, and applies across the bloc.
The EMA said that the benefits of the BioNTech/Pfizer vaccine in children aged 12 to 15 outweighed the risks, “in particular in children with conditions that increase the risk of severe Covid-19.”
Speaking on Friday, Marco Cavaleri, head of biological health threats and vaccines strategy at the EMA, said it would be up to each member state to decide “if and when” to use the vaccine on adolescents in the future.
“It is up to them to decide whether they want to restrict the use just in adolescents who are at higher risk of Covid-19 because of comorbidities or other factors, versus using this vaccine in a broader population,” he added.
The BioNTech/Pfizer jab given to children will be the same dose — 30mg — as that given to adults, and the EMA said that no significant side-effects were seen in children during clinical studies.
“Pretty much what we see in young adults is also seen in adolescents . . . We don’t think at this point in time that something different will happen,” Cavaleri said.
The EU says it is up to its 27 member states to devise vaccination strategies and define target groups, and most member countries have yet to give a timeline for vaccinating young people.
Germany on Thursday announced plans to allow children aged 12 and over to receive the jab once vaccine priorities are lifted on June 7. However, German authorities said they were not providing additional doses.
The EU has said the new contract it has signed with BioNTech/Pfizer for the purchase of up to 1.8bn doses through to 2023 took into account the potential need to vaccinate children.
The US Food and Drug Administration approved use of the Pfizer jab in children aged over 12 in May.
BioNTech/Pfizer is carrying out paediatric studies into the potential use of the vaccine in children aged six months to 11 and depending on results, could request authorisation for that group in September. It expects initial results from the trial in the fourth quarter.
Additional reporting by Michael Peel in Brussels