Status: 05/23/2022 2:02 p.m
According to studies, three doses of the Corona vaccine from BioNTech lead to a high level of protection in children under the age of five. The group now wants to apply for the first approval of a Covid vaccine for this age group in the USA and Europe.
The Mainz-based biotechnology company BioNTech and the US pharmaceutical company Pfizer also want to apply for approval of their corona vaccine Comirnaty for babies and toddlers up to five years of age. “We are currently preparing the relevant documentation and expect to be able to complete the US emergency use authorization filing process this week,” said BioNTech CEO Ugur Sahin. Submissions to the EU Medicines Agency EMA and other authorities worldwide are expected to follow in the coming weeks.
80 percent protection
Children under the age of five therefore need three doses of the Covid-19 vaccine from BioNTech and Pfizer for adequate protection. Three vaccinations generated strong immune responses and high efficacy, the two companies said.
The partners published initial results from their phase 2/3 clinical trial in children aged six months to less than five years. Thereafter, a good 80 percent efficacy against symptomatic Covid disease was observed after the third dose, while the highly contagious omicron variant predominated. The vaccinations were well tolerated and the side effects were mild to moderate. If approved, it would be the first available Covid vaccine for children under the age of five.
So far, the vaccine has only been approved for use in children over the age of five in the EU and the USA. You will receive two doses like adolescents aged 12 and over and adults, but at a lower dose of ten micrograms – a third of the adult dose. The dosage for children under the age of five is significantly lower at three micrograms. There are around four million children under the age of five in Germany.
Three vaccine doses the rule
The vaccination series for babies and small children comprises a total of three doses, since according to the first study data two doses were sufficient for children aged six to 24 months; however, they did not produce sufficient efficacy in two to four-year-olds. BioNTech and Pfizer therefore decided in December to investigate a third dose – administered at least two months after the second dose – to ensure that a sufficiently high level of protection was achieved.
Up to three partial vaccinations are also required for the basic immunization of various children’s vaccines, such as tetanus, diphtheria, polio and whooping cough. “The study data indicate that our vaccine, with the carefully selected, low dose of three micrograms, is effective enough to offer a high level of protection against the latest Covid-19 variants even in the youngest,” said Sahin.
response still unclear
The 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 registered by the end of April. A formal efficacy analysis is foreseen after at least 21 cases, after which final efficacy data will be published. Also in adults, adolescents and children over the age of five, study data indicate that three doses improve protection compared to two vaccine doses. In Germany, the Standing Vaccination Commission recommends a Covid booster vaccination for everyone over the age of twelve with a third dose at least three months after the previous vaccination.
However, it is not clear how many parents will have their toddlers vaccinated against Covid-19. Almost 20 percent of five- to eleven-year-olds in Germany are fully vaccinated, compared to 29 percent in the USA. For healthy children there is only a low risk of severe Covid disease, the infection is usually asymptomatic and usually milder than in adults.