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Biontech Vaccine Receives Emergency Approval for Five to Eleven Year Olds from US Medicines Agency

2021-10-29T21:14:34.361Z


In the USA, children from the age of five will be allowed to be vaccinated with the vaccine from Biontech / Pfizer. In Europe, a decision on this should also be made before Christmas.


Enlarge image

A vaccination jar from Biontech / Pfizer (archive image)

Photo: BIONTECH SE / HANDOUT / EPA-EFE / Shutterstock

The vaccine from Biontech / Pfizer has now also received emergency approval in the USA for use in children between the ages of five and eleven. The US drug agency FDA announced on Friday after an advisory body to the agency had already spoken in favor of it on Tuesday. Afterwards, the CDC health authority has to deal with it formally. A decision is expected in the coming week.

This means that the vaccination campaign for the approximately 28 million affected children in the USA can now - as the White House already planned - start in November. Within the next few days, 15 million doses of the vaccine are to be delivered to paediatricians, clinics and pharmacies. The necessary accessories, such as smaller syringes, should also be delivered directly. The vaccine can be stored for up to ten weeks at normal refrigerator temperature, it said.

"As a mother and doctor, I know parents, childcare workers, school staff and children have been waiting for today's approval," said FDA executive Janet Woodcock.

"Vaccinating younger children against Covid-19 will bring us closer to a return to a certain normalcy." She emphasized that the vaccine from the Mainz manufacturer Biontech and its US partner Pfizer meet the "high standards" of the FDA.

Children receive a significantly lower dose than adults

The vaccine from the German manufacturer Biontech and its US partner Pfizer is already approved in the USA for children and adolescents from the age of twelve and for adults.

The active ingredients from Moderna and Johnson & Johnson have so far only been approved for use in adults.

Biontech and Pfizer have also applied for approval of their corona vaccine for children of this age group in Europe, as they announced in mid-October.

Accordingly, they transmitted the relevant data to the EU Medicines Agency Ema.

A decision by Ema is planned before Christmas.

According to Biontech / Pfizer, a clinical study showed that the vaccine was "well tolerated" for children of this age group and produced a "strong immune response" one month after the second dose.

Compared to adults and adolescents, the five to eleven year olds were given a significantly lower dose of the vaccine.

They received the second necessary spades after 21 days.

The study included 2,268 children of that age.

tfb / dpa / AFP / Reuters

Source: spiegel

All tech articles on 2021-10-29

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