Over the next few weeks, BioNTech will be seeking to request approval across the world to permit the use of its COVID-19 vaccine in children as young as five and preparations for a launch are in motion. This is according to the biotech firm’s two top executives.
According to the Chief Medical Officer, Oezlem Tuereci, over the next few weeks, the firm will file the results of its trial in five to 11 year olds with regulators across the world and will request approval of the vaccine in this age group.
Tuereci also mentioned that the final production steps to bottle a lower-dose pediatric version of its Comirnaty vaccine is underway which is currently approved for adults and youngsters at least 12 years of age.
The firm has said it intends to file its regulatory dossier on the 5- to 11-year-olds this September and also laid out plans to seek approval in children aged 6 months to 2 years later this year.
What you should know
- Moderna, however, has said that a trial testing its shot in children between six and 11 years has now been fully enrolled. The Pharmaceutical firm also assured that it was working on the best dosage in another study involving infants as young as six months.
- China’s health authorities in June approved the emergency use of Sinovac vaccine in children as young as three. The country has been ahead in lowering the age limit of its immunisation campaign.
- Chile, as well, which has relied heavily on Sinovac’s shot, this month approved use of the vaccine in children over 6 years of age.