The European Medicines Agency (EMA) recommended on Friday (28.05.2021) that the vaccine of the German pharmaceutical company BioNTech, distributed worldwide by Pfizer, should also be used in young people between the age of 12 and 15, which opens the door for these age groups to also be inoculated with a coronavirus vaccine for the first time since the onset of the pandemic.
Marco Cavaleri, team manager who analyzed the background to the drug, noted that he had received all the information needed to authorize the vaccine and that it was a very effective formula to prevent COVID-19 infections. Cavaleri added that the decision should now be approved by the European Commission and the respective national regulators.
The recommendation follows shortly after the entities responsible for these issues in Canada and the United States also gave their approval to the BioNTech vaccine. Precisely in the United States, a study conducted to analyze the potential risks in dose use showed that it was safe and effective. In Europe it is already used in young people over the age of 16.
However, specialists will continue to review information that emerges over the next two years on possible long-term effects. Pfizer and BioNTech tested their formula in Phase III on 2,260 adolescents and ensured that its effectiveness was 100 percent and with a «solid» immune response. In the tests, they add, the vaccine was «generally well tolerated.»
Most SARS-CoV-2 vaccines have been authorized for over-18s worldwide, who are most at risk if the virus is contracted and developed. But by vaccinating children, countries could make sure to stop outbreaks, as some studies have shown that older children play a role as spreaders of the virus, even if they do not develop COVID-19.