"Pfizer" confirms that its vaccine against Corona is effective and safe for young children
The German company "Biontech" and the American "Pfizer" announced that the vaccine they jointly developed against corona is effective and safe for children aged 5 to 11 years and provokes a stable immune response.
The two companies said in a statement today, Monday, that data for clinical trials will be submitted to the European Medicines Agency (EMA) and the US Food and Drug Administration as soon as possible.
"We are pleased to be able to provide the data of the school-age group of children to the relevant authorities for approval before the start of winter," said Ugur Sahin, president of Piontech, according to the statement.
In contrast to the twelve-year-old group, children aged five to eleven years were given only one-third of the dose during phase 2/3 of the clinical studies.
The two vaccinations were separated by three weeks.
"Antibody responses in subjects who received the 10-microgram dose were similar to those reported in a previous Biontech/Pfizer study among subjects aged 16 to 25 who received the 30-microgram dose," the statement read.
According to the data, side effects were also similar to those of the older group.
The companies announced that results for two additional groups of participants, aged between two and five years and between six months and two years, are expected to be presented in the last quarter of this year.
According to the data, a total of 4,500 children between the ages of 6 months and 11 years are participating in the study.
The data provided on children aged 5 to 11 years included 2,268 participants.
More than 90 hospitals in the USA, Finland, Poland and Spain are participating in the study.
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