FRANKFURT – BioNTech is set to seek worldwide approval to use its Covid-19 vaccine in children as young as five years old in the coming weeks and preparations for a launch are on track, said the two senior executives of the biotech company in Der Spiegel.
“Already in the next few weeks, we will be filing the results of our trial in children aged five to 11 with regulators around the world and seeking vaccine approval in this age group, also here in Europe,” he said. said Chief Medical Officer Oezlem. Tuereci told the German news weekly.
The confident statements underscore the lead that BioNTech, which works with Pfizer, has in the race to gain broad approval to vaccinate children under 12 in Western countries.
BioNTech has said it is expected to file its five- to 11-year regulatory filing in September. He also made plans to seek approval in children aged 6 months to 2 years later this year.
Tuereci also told Spiegel that final production steps are being adjusted to bottle a lower-dose pediatric version of its established Comirnaty vaccine. It is currently approved for adults and youth 12 and older.
Raw data from the trial was now being prepared for regulatory filing and “things are looking good, everything is going according to plan,” GM Ugur Sahin told Der Spiegel.
Runner-up Moderna said Thursday that a trial testing its injection in children six to 11 years old is now fully enrolled and is working on the best dosage in another study involving infants as young as six months old.
China has been ahead in lowering the age limit for its vaccination campaign. The country’s health authorities in June approved the emergency use of the Sinovac vaccine in children as young as three years old.
Chile, which has relied heavily on Sinovac’s vaccine, this month approved the vaccine for use in children over 6 years of age.
Israel’s health ministry said in July that children as young as five can be vaccinated with Pfizer-BioNTech if they suffer from conditions that make them particularly vulnerable to Covid-19.