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Biontech applies for approval of its corona vaccine for children: Stiko member with prognosis for recommendation

2021-10-15T17:39:37.974Z

Biontech and Pfizer have applied to the EMA for approval of their corona vaccine for children ages five to eleven. Severe gradients should be prevented.



Biontech and Pfizer have applied to the EMA for approval of their corona vaccine for children ages five to eleven.

Severe gradients should be prevented.

Mainz - The corona vaccination rate in Germany is increasing slowly but steadily.

In Germany, 65.6 percent of the population are now fully vaccinated against the coronavirus *.

This comes from the data from the Robert Koch Institute (RKI) * from Friday (October 15).

Corona vaccines have not yet been approved for children under the age of twelve.

This could change soon.

Corona vaccination: Biontech applies for approval for children

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 Europe.

Both announced on Friday 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 7.

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

In contrast to adolescents, children in this age group were given only a third of the dose.

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.

Corona vaccination for children: Stiko member gives forecast for recommendation

Pediatrician Martin Terhardt does not yet assume that the approval study already provides sufficient data on rare vaccine side effects * in children. Because the test group is still too small for that, said the member of the Standing Vaccination Commission (Stiko) to the Berlin

daily mirror

. Such data will only be available after the vaccine has already been used. "This is different from the vaccine for those over twelve that was already being used in other countries when we made the first recommendation," explained Terhardt.

The pediatrician said he could imagine that the Stiko would initially make a recommendation for children with certain serious pre-existing illnesses until there was a sufficient database. "Most of all I think of the clearly overweight children and adolescents." They would definitely have a higher risk of developing Covid-19 *. As soon as the corona vaccine is approved in Europe, it can be used, said Terhardt. "Provided that the not yet easily assessable risk of vaccination is accepted by doctors and parents."

Overall, children have a significantly lower risk of developing severe Covid-19 * than adults.

"It is true that large outbreaks are much less common in day-care centers and schools, but it does happen that children pass the virus on," says Terhardt.

If the numbers increased, so would the severe courses.

“It's all about them.

We don't worry about the common cold caused by Corona, ”explained the Stiko member.

(ph / dpa) * Merkur.de is an offer from IPPEN.MEDIA

Source: merkur

All news articles on 2021-10-15

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