The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the use of Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, in children aged five to 11 years.
The CHMP’s decision is based on the scientific evidence submitted by the companies, including data from the controlled, randomised Phase II/III trial which was conducted in around 4,500 children in this age group.
In the trial, subjects were given two 10µg doses of Covid-19 vaccine at a gap of 21 days, while individuals aged 12 years and above received 30µg doses.
The findings demonstrated that the vaccine had a 90.7% efficacy rate in subjects seven days after the second dose. It was also found to have favourable safety profile and robust immune responses.
Additionally, the study’s Data Monitoring Committee has analysed the data and did not find any serious safety issues related to the vaccine shot.
Pfizer stated that the 10µg dose level was selected based on the tolerability, safety and immunogenicity results which were assessed as part of a dose-ranging study.
The CHMP’s recommendation will be reviewed by the European Commission (EC), which is anticipated to make a final decision on updating the conditional marketing authorisation for the Covid-19 vaccine soon.
If approved, the vaccine will become the first Covid-19 vaccine authorised in the European Union (EU) for this age group.
Furthermore, the decision will be applicable to all 27 EU member states.
The companies have also submitted applications to other regulators across the world for authorisation of Comirnaty in children.
Recently, the US Food and Drug Administration granted emergency use authorization for Pfizer-BioNTech’s Covid-19 vaccine in the same age group.