The European Medicines Agency (EMA) approved this Friday the use of the Pfizer / BioNTech anticovid vaccine in children between 12 and 15 years old, the first of these drugs for adolescents in the 27 countries of the European Union
“As planned, the EMA’s Committee on Medicines for Human Use approved today (this Friday) the use of the Pfizer / BioNTech vaccine for adolescents between 12 and 15 years of age,” said Marco Cavaleri, head of the vaccination strategy. of the EMA, at a press conference.
Cavaleri confirmed this “pediatric indication” agreed this Friday at an extraordinary meeting of the committee for drugs for human use (CHMP), which has concluded that the vaccine is “safe” and effective in children of that age group.
Pfizer and BioNTech tested their formula against coronavirus in phase III in 2,260 adolescents and ensured that it was 100% effective and with a “strong” immune response.
In testing, they add, the vaccine was “generally well tolerated.”
Germany already announced this week that it was willing to start vaccination for young people from 12 years old on June 7, once the EMA gave its green light.
The United States and Canada have already authorized this extension of the vaccination campaign for adolescents.
The vaccine, which has been approved in the EU since December for people over 16 years of age, will have the same application in children between 12 and 15 years of age as the one currently being given to adults: it will be administered in two injections in the upper arm muscles, “three weeks” apart between the first and second doses.
On the other hand, the EMA assured that it maintains its recommendation to inject a second dose of the AstraZeneca vaccine to those who received a first one without showing adverse effects of blood clotting because there is no evidence that the second injection increases the risk of developing thrombocytopenia with respect to at the first dose.
The European regulator stressed that there is evidence offered by some studies, which have yet to be analyzed by the EMA, on the effectiveness of the use of a second dose of an mRNA vaccine, the result of which shows that “there is no concern from a safety perspective” and that this is “a really effective approach” from an immunological point of view.
With information from AFP and EFE
