Drugmaker BioNTech is poised to apply worldwide for authorization to use its Covid-19 vaccine in children up to five years old, and preparations for the launch are on track, the biotech company’s two top executives told the German newspaper “Der Spiegel”.
“In the coming weeks, we will file the results of our study in children aged 5 to 11 years with regulatory bodies around the world and we will apply for vaccine approval in this age group also here in Europe,” said medical director Oezlem Tuereci.
The confident statements underscore the lead that BioNTech, which made the vaccine in partnership with Pfizer, holds in the race to gain widespread vaccination approval to vaccinate children under 12 in Western countries.
BioNTech said it expected to present its regulatory dossier on children ages 5-11 in September. The company also made plans to seek approval for children 6 months to 2 years later this year.
Tuereci also told the paper that final production steps were being adjusted to bottle a lower-dose pediatric version of the vaccine.
It is currently approved for adults and youth at least 12 years of age.
The raw test data was now being prepared for a regulatory record and “things seem to be going well, everything is going according to plan”, chief executive Ugur Sahin told “Der Spiegel”.
Moderna said on Thursday (09) that a trial testing its vaccine in children between 6 and 11 years old was now fully completed and that it was working on the best dosage in another study involving babies up to six months of age.
China is at the forefront in lowering the age limit in its immunization campaign. The country’s health authorities approved in June the emergency use of Sinovac vaccine in children up to three years of age.
Chile, which relied heavily on the Sinovac vaccine, this month approved the use of the vaccine in children over 6 years of age.
Israel’s Ministry of Health said in July that children as young as five years old can get the Pfizer-BioNTech vaccine if they suffer from conditions that make them particularly vulnerable to Covid-19.