In . – 23.05.2022 13:56 (act 23.05.2022 16:01)
BioNTech: Planned vaccine approval for young children. ©APA/Barbara Gindl (symbol image)
The topic of corona vaccination remains in the headlines: BioNTech is planning to approve its corona vaccine for young children.
“We hope to be able to complete the US emergency regulatory approval filing process this week,” BioNtech CEO Ugur Sahin said on Monday. Submissions to the EU Medicines Agency EMA and other authorities around the world are expected to follow in the coming weeks. So far, the vaccine has only been approved for use in children over five in the EU and US.
Children under five and the Corona vaccine from BioNTech and Pfizer
Children under five need three doses of BioNTech and Pfizer’s Covid-19 vaccine for adequate protection. Three vaccines generated strong immune responses and high efficacy, biotechnology company Biontech and US drugmaker Pfizer said on Monday.
The two partners have published the first results of their phase 2/3 clinical trial in children aged six months to less than five years. Accordingly, a good 80% efficacy against symptomatic Covid disease was observed after the third dose, while the highly contagious omicron variant prevailed. Vaccines were well tolerated and side effects were mild to moderate. If approved, it will be the first Covid vaccine available for children under five.
Vaccine approved in the EU for use in children five years and older
So far, the vaccine has only been approved for use in children over five in the EU and US. You will receive two doses as teenagers aged 12 and over and adults, but with a smaller dose of ten micrograms – one third of the adult dose. The dosage for children under five is again significantly lower by three micrograms. There are around four million children under the age of five in Germany.
The series of vaccines for infants and young children includes a total of three doses, as according to data from the first study, two doses were sufficient for children aged six to 24 months. However, they did not produce sufficient effectiveness in children aged two to four years. Biontech and Pfizer therefore decided in December to investigate a third dose – given at least two months after the second dose – to ensure a sufficiently high level of protection. Up to three partial vaccinations are also required for basic immunization of various childhood vaccines such as tetanus, diphtheria, polio, and whooping cough.
study data
“Study data indicate that our vaccine, at the carefully selected low dose of 3 μg, is effective enough to provide a high level of protection against the newest variants of Covid-19, even in the youngest,” Sahin said. Preliminary data from the study of 1,678 vaccinated children under the age of five are based on ten symptomatic Covid cases that emerged seven days after the third dose and were recorded through the end of April. A formal efficacy review is planned after at least 21 cases, after which final efficacy data will be published.
Also in adults, adolescents and children over five years of age, study data indicate that three doses improve protection compared to two doses of vaccine.
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