BioNTech has announced they are expected to file for approval across the globe to use its COVID-19 in children as young as five over the next few weeks and preparations for a launch are on track, the biotech firm’s two top executives told Der Spiegel.
Ever since the Delta variant, and the announcement of in-person classes being started again in the US, reports of child COVID-19 infections have been increasing. Currently, there is no available vaccine that can be used in children as young as 12 years old.
“Already over the next few weeks we will file the results of our trial in five to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Chief Medical Officer Oezlem Tuereci told the German news weekly.
BioNTech has said it is expected to file its regulatory dossier on the five to 11-year-olds in September. It has also laid out plans to seek approval in children aged 6 months to 2 years later this year.
The statement, delivered with confidence, proves the lead of BioNTech in collaboration with Pfizer in the race to win broad approval to vaccinate children below the age of 12 in Western countries.
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Tuereci also added in his interview with Spiegel that final production steps were being adjusted to bottle a lower-dose pediatric version of its established Comirnaty vaccine. It is currently approved for adults and youngsters at least 12 years of age.
Chief Executive Ugur Sahin also said that the raw data is now being prepared for a regulatory filing and “things are looking good, everything is going according to plan”.
Additionally, Moderna said on Thursday that a trial testing its shot in children between six and 11 years was now fully enrolled and that it was working on the best dosage in another study involving infants as young as six months.
In other parts of the world, reports have surfaced that different countries are already trying to lower the age of their vaccination campaign. China’s health authorities in June approved emergency use of Sinovac’s vaccine in children as young as three years.
Chile, just this month, approved use of Sinovac in children over 6 years of age.
The health ministry in Israel also said in July that children as young as five can be vaccinated with a Pfizer-BioNTech shot if they suffer from conditions that make them vulnerable to Covid-19.
