Biotech firm to file regulatory dossier with officials around the world
In information obtained by Reuters, it was determined that BioNTech is planning to request approval with nations across the globe for use of its Comirnaty Covid-19 vaccine in children as young as 5 years old over the coming weeks, as preparations for a launch are in motion, several of the company’s executives told German magazine Der Spiegel.
"Already over the next few weeks, we will file the results of our trial in 5 to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe," BioNTech Chief Medical Officer Özlem Türeci, MD, says.
BioNTech has previously mentioned that it planned to file its regulatory dossier on the 5 to 11-year-old age group in September. It has even noted plans to seek approval in children aged 6 months to 2 years later this year.
Dr. Tuereci also told the publication that final production steps were being made to offer a lower-dose pediatric version of its vaccine, which was designed in collaboration with Pfizer. It is currently approved for adults and children who are 12 years of age and older.