Covid-19 vaccine safe and effective in five to eleven year olds

Biontech / Pfizer vaccine

In the study, Biontech and Pfizer tested a lower dose of their already approved vaccine.

(Photo: dpa)

Frankfurt / New York Biontech and Pfizer want to apply for approval of their Covid-19 vaccine for use in children as soon as possible after positive study results. In the crucial study with five to eleven year olds, the vaccine was well tolerated and generated a strong immune response, the two companies announced on Monday.

The data are now to be submitted to the European Medicines Agency Ema, the US FDA and other regulatory authorities worldwide. These are the first results from a pivotal study for a Covid-19 vaccine for children under the age of twelve.

In the study, Biontech and Pfizer tested a dosage of their already approved vaccine of ten micrograms. Two doses were given 21 days apart. The vaccination for over twelve years old provides a dose of 30 micrograms. The immune response in children at the lower dose was comparable to that observed in a previous study with 16- to 25-year-olds – as were the side effects. 2268 children between the ages of five and eleven took part in the study.

“Since July, Covid-19 cases among children in the United States have increased by around 240 percent. That underscores the need for vaccinations, ”said Pfizer CEO Albert Bourla. The study results are a strong basis for applying for approval of the vaccine in children aged five to eleven. “Our plan is to submit them to the FDA and other regulatory agencies as soon as possible.”

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Biontech and Pfizer plan to publish data on the use of the vaccine in children between the ages of six months and five years in the fourth quarter of this year. For children and adolescents aged twelve and over, the vaccine was approved in the US and the EU in May.

In the United States, corona hospital admissions and deaths have risen in recent months due to the highly contagious Delta variant. The number of cases among children has also increased. In Germany, the seven-day incidence was recently highest in the age group of 5 to 14 year olds.

According to the assessment of the Standing Vaccination Commission (Stiko), there is a significantly higher risk of infection for children and adolescents because of Delta. So far, however, there is no evidence that Delta is more dangerous for them and that it leads to more severe disease courses for them.

More: Cumulative vaccination breakthroughs at Johnson – & – Johnson – what’s behind it?

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