FRANKFURT – BioNTech will apply for worldwide approval for the use of its Covid-19 vaccine in children as young as five in the next few weeks, and preparations for an introduction are well underway, the biotech company’s top two executives said the mirror.
“In the next few weeks we will be submitting the results of our study on five to 11 year olds to regulatory authorities around the world and applying for approval of the vaccine in this age group, including here in Europe,” said Chief Medical Officer Oezlem Tuereci said the German news weekly.
The confident statements underscore the lead BioNTech, who works with Pfizer, in the race for widespread approval of vaccinating children under the age of 12 in Western countries.
BioNTech has announced that it will submit its approval dossier for five to eleven year olds in September. It has also set out plans to seek approval in children aged 6 months to 2 years later this year.
Tuereci also told Spiegel that the final production steps would be adjusted to fill a lower-dose pediatric version of its established Comirnaty vaccine. It is currently approved for adults and adolescents aged 12 and over.
The raw data of the study are now being prepared for an application for approval and “it looks good, everything is going according to plan”, managing director Ugur Sahin told Der Spiegel.
Runner-up Moderna said Thursday that a study testing the vaccine in children between six and 11 years of age has now fully started and that another study in infants six months of age is working on the best dosage.
China has lowered the age limit for its vaccination campaign. The country’s health authorities approved the emergency use of the Sinovac vaccine in children aged three and over in June.
Chile, which has relied heavily on Sinovac’s vaccination, this month approved the use of the vaccine in children over the age of 6.
The Israeli Ministry of Health said in July that children as young as five can receive the Pfizer BioNTech injection if they suffer from conditions that make them particularly susceptible to Covid-19.