EMA approves BioNTech vaccine for children aged five and over

Status: 25.11.2021 4:59 p.m.

The EMA gives the green light for the approval of the corona vaccine from the manufacturer Pfizer / BioNTech for children from the age of five. It is the first corona vaccine that can be approved in the EU for children under the age of twelve.

The European Medicines Agency (EMA) paves the way for vaccinations of children with the Covid-19 vaccine from BioNTech and Pfizer. The responsible EMA committee recommended that the approval be extended to children between the ages of five and eleven. The final decision still has to be made by the European Commission, but this is a matter of form. So far, the vaccine has only been approved in the European Union from the age of twelve.

“So far only the tip of the iceberg”

Since the summer, the number of infections has skyrocketed in many EU countries, especially among younger people. Serious disease courses rarely occur in children, but there is no reason to be carefree when dealing with the younger age groups, says Marco Cavaleri. He heads the vaccine strategy of the European Medicines Agency: “Children can also be affected by long-term health effects after contracting Covid-19. That has been proven, but we believe that we are only seeing the tip of the iceberg and very little about it Long know Covid in children and adolescents. Therefore, I am very happy that the BioNTech / Pfizer vaccine is now also approved for children between the ages of five and eleven. ”

2.4 million cans for Germany

The vaccination for children contains a third of an adult dose and is vaccinated twice in the upper arm with an interval of three weeks. Federal Minister of Health Jens Spahn announced on Monday that the entire EU would receive delivery of the children’s vaccine on December 20, and that Germany would then receive 2.4 million doses in one fell swoop. BioNTech confirmed the schedule.

“Pfizer and BioNTech still assume that the first doses can be delivered to all EU member states on December 20th. With delivery to Germany, around half of the children between the ages of five and under twelve living in Germany can be vaccinated “, said a spokeswoman for the Mainz manufacturer. The schedule was discussed repeatedly with representatives of the EU Commission and was finally confirmed last week. An earlier delivery is not to be expected: “All upstream processes were aligned to this deadline.”

“Many doctors are waiting for a STIKO recommendation”

In any case, the decision of the EMA brings more security, says Peter Liese. The CDU politician is the health policy spokesman for the EPP, the largest group in the EU Parliament. “This is very good news for parents and children,” says Liese. “Especially children who suffer from previous illnesses such as Down syndrome, heart defects or lung diseases, it is urgently necessary to get a vaccination as soon as possible with the current high numbers.”

However, the decision of the EMA does not mean that vaccination of children is now also recommended. Only the national governments or health authorities can decide that. This is why the Standing Vaccination Commission (STIKO) is now in demand in Germany. “The approval takes place because the vaccine is safe and tested,” says Tiemo Wölken, the health policy spokesman for the SPD MEPs. “That’s why I expect the STIKO to quickly issue a recommendation for Germany, because many doctors are waiting for this recommendation.”

STIKO intends to give its recommendation by the end of December

The STIKO is currently preparing a recommendation to vaccinate children at the start of the first vaccine delivery. “Our goal is to have this recommendation ready by the end of December, if possible by the start of delivery of the children’s vaccine to the federal states,” STIKO boss Thomas Mertens recently said. When the vaccine was approved by the EU for those aged twelve and over in May, the STIKO initially only recommended vaccinations for adolescents with previous illnesses. It was only in August that she recommended this to everyone aged twelve and over and referred to a broader database, especially from the US vaccination program with millions of vaccinated young people.

Following approval by the FDA at the end of October, around three million children aged five and over in the USA were vaccinated with BioNTech, and vaccinations started this week in Israel and Canada. According to data from the Robert Koch Institute, the seven-day incidence in Germany is currently by far the highest in the age group of five to 14 year olds at 882.9, followed by 15 to 34 year olds with an incidence of 468 Overall, the incidence rose to a high of 419.7 on Thursday.

With information from Matthias Reiche, ARD-Studio Brussels

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EMA approves BioNTech vaccine for children aged five and over