The European Union (EU) has expanded the conditional marketing authorization (CMA) for Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, to include adolescents aged 12 to 15 years.
The authorisation was granted after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion on the vaccine’s use in this age group.
Comirnaty is claimed to be the first Covid-19 vaccine to be authorised in the EU for this expanded indication.
The authorisation is based on data from a Phase III clinical trial in a total of 2,260 participants aged 12 to 15 years.
This trial showed 100% efficacy of the vaccine in participants with or without prior Covid-19 and strong antibody responses.
The participants were given two 30μg doses of the Covid-19 vaccine and will be tracked for long-term protection and safety for two additional years after receiving the second dose.
BioNTech CEO and co-founder Ugur Sahin said: “Today’s extension of our Covid-19 vaccine authorisation in the European Union is another critical milestone in our collective effort to broaden vaccination programmes to as many people as possible.
“Making vaccines available to adolescents will help re-open schools and support the return to a normal day-to-day life.”
Pfizer stated that the extended CMA allows all 27 EU member states to use Comirnaty.
Additionally, a paediatric trial to assess the efficacy and safety of the Covid-19 vaccine in children aged six months to 11 years is currently underway. Data from cohorts of subjects aged two to five years and five to 11 years is expected in September.
In a separate development, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Janssen’s single-dose Covid-19 vaccine.
The UK government has obtained 20 million doses of the vaccine with initial deliveries scheduled for later this year.