Europe approves Pfizer vaccine for adolescents
The European Medicines Agency concludes that it is safe for children aged 12 to 15, as the U.S. and Canada have already done
BrusselsAdolescents aged 12 to 15 can also receive the Pfizer/BioNTech vaccine in Europe. This was decided on Friday by the European Medicines Agency (EMA). Its experts have been examining clinical trials on the efficacy of the Pfizer/BioNTech vaccine since May in order to be able to deliver this verdict in an accelerated manner. The pharmaceutical company had already argued that tests had been carried out on more than 2,260 adolescents showing 100% effectiveness and "good tolerance". The European Commission now has to take the final step to approve it, but each EU member state has the power to decide how and when it wants to start using it with this age group.
The EMA recommends that in adolescents the Pfizer vaccine should be given as it is being given to those over 16 years of age, i.e. two doses at an interval of three weeks. Until Friday, the Pfizer vaccine was only authorised for those over 16, like the rest of the vaccines the European Union had given a green light to. Even so, at the beginning of May, Canada was already the first country to authorise the use of this drug in people over 12 years of age. A few days later the United States also authorised the use of the vaccine of this pharmaceutical company to those between 12 and 15 years old.
The EMA has a committee of paediatric experts to take this type of decision and to continue analysing the data corresponding to this age group. According to Marco Cavalieri, head of vaccines at the European agency, Pfizer is equally or more effective in this age group, and behaves in a "very similar" way to how it does with young adults (16 to 25) who were already being immunised with this drug. This means that the efficacy is similar in both age groups (around 75%) and also that the side effects it can cause are similar: in most cases moderate pain at the injection site, headache or muscle pain and fever. Among the more than 2,000 adolescents who participated in the study, no rare side effects have been detected, but the EMA expert committee is studying rare cases of myocarditis and pericarditis (inflammation of the heart muscles) that have occurred after vaccination with Pfizer mainly in people under 30 years of age. "There is currently no indication that these cases are caused by the vaccine and the EMA is looking into it", says the regulator.
At the moment, only this pharmaceutical company has requested authorisation from Europe to immunise children between 12 and 15 years old, despite the fact that Moderna presented favorable results a few days ago. "We are waiting for an application to be submitted and to be able to analyse the data", EMA sources explain.
Starting to lower the age of vaccination is key to achieving herd immunity. Children under 19 years of age account for about 20% of the European population, so it is necessary that this age group is also immunised to achieve herd immunity. In Europe, Germany has been one of the first governments to support starting to vaccinate adolescents with Pfizer and, in fact, the German federal government was waiting for this EMA opinion to start offering appointments to this age group from 7 June.
When asked whether it is appropriate to start vaccinating adolescents in advanced countries while many others have not yet been able to vaccinate a significant percentage of their population at risk, EMA experts have recalled that their job is to issue scientific verdicts and analyse the data.
According to official data collected by the European Centre for Disease Control and Prevention (ECDC), as of 28 May, more than 48% of the European population over 18 years of age had been vaccinated with one dose and 19.5% had received two doses or the full course in the case of the Janssen single-dose vaccine. The most advanced country in Europe is Hungary, which started vaccinating with the Russian Sputnik and has administered the first dose to 61.5% of its population. It is followed by Finland, which already exceeds 50% of the adult population with the first dose, and then Belgium and Germany, which exceed 48%