The approval was enforced over a month later than it was expected earlier, causing a patchwork of travelling conditions in the European Union in the run-up to the carnival break: some countries required teenagers to have booster shots to ensure entry, even though they had not been officially approved for that age group.
The EMA made the declaration in a press release, “The available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.”
The opinion that is issued was based on the data from a clinical trial of the Pfizer booster shot in between the people of the age 16 and more than that was published literature and post-authorisation data and the real-world evidence from the use of the booster dose in the teenagers in Israel.
Along with this, it is now up to the European Commission to issue a final plan on whether the booster shot can be provided to young ones.
On the other hand, the Brussels-Capital Region, Belgium and Wallonia were waiting for the official EMA to roll out their booster campaign for the teenagers at the beginning of February. Flanders has already been made the decision to go further.
Furthermore, the teenagers aged 12 and 17 in Flanders could already get a booster vaccine without getting any invitation. They first signed an ‘informed consent form, which gives the clarification that the shot was offered instead of officially recommended.