Approval pending: BioNTech vaccine effective for young children

Status: 23.05.2022 14:02

According to studies, three doses of the Corona vaccine from BioNTech lead to a high level of protection in children under five years of age. The group now wants to apply for the first approval of a Covid vaccine for this age group in the US and Europe.

The Mainz-based biotechnology company BioNTech and the American pharmaceutical company Pfizer also want to apply for approval of their corona vaccine Comirnaty for babies and toddlers up to five years. “We are currently preparing the relevant documentation and expect to be able to complete the U.S. Emergency Use Application this week,” said BioNTech CEO Ugur Sahin. Submissions to the European 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 efficiency, the two companies said.

The partners published the first results from their Phase 2/3 clinical trials with children aged six months to under five years. Thereafter, a good 80 percent effect against symptomatic Covid disease was observed after the third dose, while the highly contagious omicron variant dominated. The vaccinations were well tolerated and the side effects were mild to moderate. If approved, it will be the first available Covid vaccine for children under five.

So far, the vaccine has only been approved for use in children over the age of five in the EU and the US. You will receive two doses such as adolescents 12 years of age and adults, but with a lower dose of ten micrograms – one third of the adult dose. The dosage for children under five is significantly lower at three micrograms. There are about four million children under the age of five in Germany.

Three vaccine doses rule

The vaccination series for infants and young children includes a total of three doses, as two doses according to the first study data were sufficient for children aged six to 24 months; however, they did not produce sufficient effect in two- to four-year-olds. Therefore, in December, BioNTech and Pfizer decided to investigate a third dose – given 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 childhood vaccines, such as tetanus, diphtheria, polio and pertussis. “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.

The answer is still unclear

Preliminary data from the study of 1,678 vaccinated children under the age of five are based on ten symptomatic Covid cases that appeared seven days after the third dose and were recorded at the end of April. A formal effect analysis is expected after at least 21 cases, after which final effect 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 doses of vaccine. In Germany, the Standing Vaccination Commission recommends a Covid booster vaccination for anyone over the age of 12 with a third dose at least three months after the previous vaccination.

However, it is not clear how many parents will have their young children vaccinated against Covid-19. Nearly 20 percent of five- to eleven-year-olds in Germany are fully vaccinated, compared to 29 percent in the United States. For healthy children, there is only a low risk of severe Covid disease, the infection is usually asymptomatic and usually milder than in adults.

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