The regulatory submission is based on data from the Phase 2/3 study of the Comirnaty 10μg dose in 2,268 children aged five to 12 years


Pfizer-BioNTech Covid-19 vaccine is also called Comirnaty. (Credit: Jan Felix Christiansen from Pixabay.)

Pfizer Canada and BioNTech have filed a Supplemental New Drug Submission (sNDS) with Health Canada for use of its Covid-19 vaccine Comirnaty in children aged five to 12 years.

Currently, the vaccine is approved in the country for people aged 12 and above.

The regulatory submission is based on data from the Phase 2/3 study of the Comirnaty, also called the Pfizer-BioNTech Covid-19 vaccine, in 2,268 children aged 5 to 12 years.

In the trial, participants were given a two-dose regimen of 10μg each.

The results showed were comparable to those observed in a previous study in people aged 16 to 25 years, who received 30μg doses.

Also, the 10μg dose was selected as the preferred dose for safety, tolerability and immunogenicity in children aged five to 12 years.

In a separate development, European Medicines Agency (EMA)’s human medicines committee (CHMP) has approved two new sites for the production of Comirnaty.

The two new facilities are located in Italy, one in Monza, operated by Patheon Italia, and the other in Anagni, operated by Catalent Anagni.

Designed to manufacture the finished product, the new sites are expected to produce up to 85 million additional doses to supply to the EU in 2021.

The CHMP recommendation is independent of European Commission (EC) decision and allows for immediate operations at the sites.

EMA said that it is working closely with all Covid-19 vaccine makers, as they plan to expand their production capacity to meet the vaccine supply demands.

Furthermore, CHMP has approved a ready-to-use formulation of Comirnaty, which does not require dilution before administration, and can be stored at 2-8°C for up to 10 weeks.

The new formulation is expected to be rolled out in a phased manner, starting from early 2022.