Clinical studies on the effects of Pfizer vaccine on children over 5 years of age support the safety of the vaccine.
After completion of the study, the data is transferred to the US regulator. The company’s press service reported on September 20, quoting Pfizer Chairman of the Board Albert Burla:
“Since July, the incidence of COVID-19 among US children has risen by 240%, highlighting the need for vaccinations in the public health system. The findings provide a solid foundation for approval of our vaccine for children ages 5-11, and we plan to transfer their Food and Drug Administration (FDA) and other regulators as soon as possible. “
4500 children from six months to 11 years old participated in clinical studies, 2268 of them were over 5 years old. The vaccine schedule is similar to that used for adults – 2 doses with an interval of 21 days. Each child dose contains 10 mcg of the vaccine, which is one third of the adult dose. The immune response in children is the same as in young people aged 16-25 who receive 30 μg of the vaccine. Ugur Sahin, co-founder of BioNTech, says:
“We are pleased to report the results to school-age children before winter begins.”
The company is now embarking on vaccination research in the 2-5 and 0.5-2 age groups. The results are planned to be obtained by the end of this year, according to Bloomberg. Demands to vaccinate children have increased in the United States since the start of the school year, as the Delta mutation caused an increase in cases.
Currently, people at risk and over 65 years of age are recommended booster vaccination. Vaccination results for children will soon be submitted to the European Medicines Agency (EMA) and the US FDA.