Approval pending: BioNTech vaccine is effective in young children

Status: 23.05.2022 2:02 pm

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.

Maines-based biotechnology company BioNTech and US drugmaker Pfizer also want to apply for approval of the Corona Comirnaty vaccine for infants and young children up to the age of five. “We are currently preparing the relevant documentation and expect to be able to complete the emergency use authorization application process in the United States this week,” said Ugur Sahin, CEO of BioNTech. Applications are expected to be submitted to the European Union Medicines Agency (EMA) and other authorities around the world in the coming weeks.

80 percent protection

So children under five need three doses of the Covid-19 vaccine from BioNTech and Pfizer to get adequate protection. The two companies said that three vaccines generated strong and highly effective immune responses.

Partners have published preliminary results from phase 2/3 clinical trials for children aged six months to less than five years. Then, good efficacy of 80 percent against symptomatic COVID-19 was observed after the third dose, while the highly infectious omicron variant predominated. Vaccines were well tolerated and side effects were mild to moderate. If approved, the first Covid vaccine will be available for children under five years old.

So far, the vaccine has been approved for use in children over the age of five only in the European Union and the United States of America. You will receive two doses as in adolescents of 12 years or older and adults, but at a dose less than ten micrograms – one-third of the adult dose. The dose for children under five years of age is much lower at 3 mcg. In Germany there are about four million children under the age of five.

Three doses of the base vaccine

The vaccination series for infants and young children consisted of three doses in total, since according to the data of the first study, two doses were sufficient for children aged six to 24 months; However, they did not produce sufficient efficacy in children aged two to four years. So in December BioNTech and Pfizer decided to check a third dose – taken at least two months after the second – to ensure a high level of protection was achieved.

Up to three partial vaccinations for the primary immunization are also required for different childhood vaccines, such as tetanus, diphtheria, polio, and whooping cough. “The study data indicates that our vaccine, at a carefully selected low dose of three micrograms, is effective enough to provide a high level of protection against the latest Covid-19 even in the youngest,” Shaheen said.

The answer is still unclear

Preliminary data from a study of 1,678 vaccinated children under the age of five are based on ten asymptomatic cases of COVID that developed seven days after the third dose and were registered by the end of April. Formal efficacy analysis is expected 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 doses of the vaccine. In Germany, the Standing Committee on Immunization recommends a Covid booster vaccination for everyone 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 whose young children will be vaccinated against Covid-19. Nearly 20 percent of children aged 5-11 in Germany are fully immunized, compared to 29 percent in the USA. For healthy children, there is a low risk of developing severe COVID-19, and the infection is usually asymptomatic and usually milder than in adults.

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