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Coronavirus: Biontech and Pfizer apply for vaccine approval for five to eleven year olds in Europe

2021-10-15T15:51:33.859Z


So far, only children from the age of twelve can be vaccinated against Covid-19 in Germany. The first vaccine manufacturers to seek approval for younger children are now Biontech and Pfizer.


Enlarge image

A vial of the vaccine from Biontech and Pfizer

Photo: Wundrig / Photo booth / IMAGO

The Mainz-based pharmaceutical company Biontech and its US partner Pfizer have now also applied for approval of their corona vaccine for children aged five to eleven in the EU.

Both announced on Friday in Mainz and New York that they had submitted the relevant data on the clinical investigations to the EU medicines agency Ema.

The same data has already been submitted to the US FDA.

There, Biontech and Pfizer applied for emergency approval of the corona vaccine for children aged five to eleven on October 7th.

Good tolerance in studies

According to Biontech and Pfizer, the clinical studies show that the vaccine is well tolerated by children and elicits a stable immune response.

In contrast to those aged twelve and over, only one third of the dose was given to children in this age group.

According to the companies, a total of 4500 children aged between six and eleven are taking part in the study; the data on five to eleven year olds are based on 2268 participants.

More than 90 clinics in the USA, Finland, Poland and Spain were involved.

more on the subject

  • Coronavirus: vaccination for children aged five and over - Biontech presents positive study results

  • Off-Label Childhood Vaccinations: "I've been looking forward to this since the pandemic began" By Katherine Rydlink

In Germany, no vaccine has yet been approved for children between the ages of five and eleven.

The Standing Vaccination Commission (Stiko) decided in August to recommend corona vaccinations for all children and adolescents from the age of twelve - after long deliberations.

From the Stiko's point of view, a possible vaccination recommendation for five to eleven year olds is even more difficult than that for 12 to 17 year olds.

In Germany, no child under 17 died exclusively of Covid-19, Stiko chairman Thomas Mertens recently told the Stuttgarter Zeitung and the Stuttgarter Nachrichten.

Because the burden of disease was so low among 12 to 17-year-olds, the decision to vaccinate was so difficult in the balance of benefits and harm.

"It will be even more difficult with the younger ones," says Mertens.

mar / dpa

Source: spiegel

All tech articles on 2021-10-15

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