The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the usage of a booster dose of Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, in adolescents aged 12 to 17 years.
The 30ug booster vaccine is intended to be administered a minimum of six months following the second dose of Comirnaty.
Recommendation from the CHMP will be reviewed by the European Commission (EC), which is anticipated to provide a decision on modifying the vaccine’s Conditional Marketing Authorization (CMA) soon.
On EC granting approval, the booster vaccine will be made available for individuals aged above 12 years in all 27 EU member states.
The CHMP provided a positive opinion following the review of interim safety and efficacy results from a booster vaccine trial in people aged 16 years and above.
The committee also analysed the published and post-authorisation findings and real-world data from Israel on the usage of boosters in young people.
Furthermore, the CHMP concluded that the available data was adequate to decide that the immune response to a booster vaccine in adolescents would be on par with that observed in adults.
According to the available data, no new safety concerns linked to booster were reported.
Under an agreement with the EC, Pfizer and BioNTech are currently delivering the Covid-19 vaccine doses, including boosters.
In January, the US Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the booster vaccine for use in people aged 12 years and older.
Comirnaty is the only Covid-19 vaccine presently authorised in the US and Europe for use in individuals of this age group as the initial two-dose regimen and as a booster.
Pfizer and BioNTech also intend to submit the data to various other regulatory agencies in the near future.