RIO DE JANEIRO, BRAZIL – BioNTech is expected to apply for approval to use its Covid-19 vaccine in children as young as 5 years old across the globe in the coming weeks, and preparations for a launch are underway. The biotech company’s two top executives spoke to German newsmagazine ‘Der Spiegel’.
“Already in the course of the next few weeks, we will present the results of our test in 5- to 11-year-olds to regulatory agencies around the world and apply for approval of the vaccine in this age group, including here in Europe,” their chief medical officer, Oezlem Tuereci, told the weekly.
The confident statements underscore the lead that BioNTech, which has collaborated with Pfizer on a covid vaccine, holds in the race to gain comprehensive approval for the vaccination of children under 12 in Western countries.
BioNTech says it expects to submit its regulatory dossier on children aged five to 11 in September and also outlines plans to seek approval for children aged six months to two years by the end of the year.
They also told Der Spiegel that the final stages of production are being adjusted to package a smaller pediatric dose of its Comirnaty vaccine, already established and currently used in adults and children at least 12 years old.
The raw test data is now being prepared for regulatory submission, and “things are going well, everything is going according to plan,” chief executive Ugur Sahin told Spiegel.
On Thursday, 9, Moderna said that it is in the testing phase of an immunizer for children between 6 and 11. China is leading the way in lowering the age limit in its immunization campaign. In June, the country’s health authorities approved the emergency use of the Sinovac vaccine in children as young as three years old.
Chile, which has relied heavily on the Sinovac vaccine, approved the use of the vaccine in children over 6 years old this month.
In July, Israel’s Health Ministry said that children up to five years old could get the Pfizer-BioNTech vaccine if they suffer from conditions that make them particularly vulnerable to Covid-19.
STUDY DATA FOR CHILDREN AGED SIX MONTHS AND OLDER AT THE END OF THE YEAR
According to Jörg Dötsch, president of the German Society for Pediatrics and Adolescent Medicine, the dosage plays a vital role in five- to 11-year-olds, unlike in the 12- to 17-year-old age group.
“On the one hand, this is because the bodyweight of these children is nevertheless very different from that of an adult,” Dötsch explained. For another, he said, it’s all about the immune system.
“Medicine assumes that this system is fully developed from the age of about twelve.” In younger people, he said, it is still developing. “These are two special features that have to be taken into account and why you have to proceed very carefully,” Dötsch continued.
At BioNTech, production is already being prepared. “The vaccine is the same, but at a lower dose, and there is less filling to be done,” Türeci said.
According to BioNTech, the study results are available and only need to be prepared for regulatory authorities. The study data on younger children from six months of age is also expected by the end of the year.