EMA recommends approval of BioNTech vaccine for children

style="float: right; margin-bottom: 10px; font-weight: 600;"Thu 25th Nov, 2021

The European Medicines Agency (EMA) has given the green light for the use of BioNTech and Pfizer's Corona vaccine in children aged five to eleven. The responsible EMA committee recommended an extension of the approval on Thursday. The final decision still has to be made by the European Commission. However, this is considered a formality.

According to the EMA, the dose for this age group will be lower than for patients aged twelve and older. However, it will also be administered as two injections in the upper arm at intervals of three weeks. The vaccine, called Comirnaty, was the first of four vaccines now approved across the EU on Dec. 21, 2020, initially for people 16 and older. At the end of May, approval was extended to children aged twelve and older.

The EMA emphasized that the vaccine is safe and effective according to studies. So far, no severe side effects had been observed, at most mild reactions such as fever, pain at the injection site, fatigue or headache. The experts had been reviewing studies by manufacturers since October. So far, this vaccine has only been approved in the EU for people 12 years and older. But in Israel and also the United States, children as young as five may be vaccinated with it.

German Health Minister Jens Spahn had said Monday that the entire EU would receive deliveries of the pediatric vaccine on Dec. 20, with Germany getting 2.4 million doses in one fell swoop. BioNTech confirmed the schedule. "Pfizer and BioNTech still expect that the first doses can be delivered to all EU member states on Dec. 20. With the delivery to Germany, about half of the children between five and under twelve years living in Germany can be vaccinated," a spokeswoman for the Mainz-based manufacturer expressed. The schedule was repeatedly discussed with representatives of the EU Commission and finally confirmed last week. An earlier delivery is not to be expected, she said: "All upstream processes have been aligned with this deadline."

In Germany, the Standing Commission on Vaccination (STIKO) plans to issue its recommendation on Corona vaccination for children aged five to eleven before the end of the year. The chairman of the STIKO, Thomas Mertens, had said he could understand if parents were skeptical about vaccinating their children. "I can understand that very well, and it basically also corresponds to the problem that the STIKO faces with its recommendation - namely, weighing up the benefits and possible "residual risks" for children in this age group," Mertens told the Swabian newspaper about the vaccination of children aged five to eleven.

No serious vaccine reactions or side effects were documented in an approval study by BioNTech/Pfizer, Mertens said. Moreover, the vaccine's efficacy in children was about the same as in adults after a relatively short observation period, he added. However, figures from the current studies were not sufficient to rule out rare side effects. The results of previous studies and application data must be taken into account. A decision on a recommendation is being prepared, Mertens said.

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