Pfizer and BioNTech said they have asked the European Medicines Agency (EMA) to extend the conditional marketing authorization for their COVID-19 vaccine Comirnaty to adolescents 12 to 15 years of age. The companies recently made a similar request to the FDA for the vaccine, which is already authorized for people 16 and older in both the US and EU, and say they plan to seek additional amendments with other global regulatory bodies.
The EMA filing is based on data from a phase 3 trial of 2260 young people aged 12 to 15 years. Topline results reported in March demonstrated that Comirnaty, also known as BNT162b2, triggered “robust antibody responses” and was 100% effective at protecting against the disease, regardless of whether participants had previously contracted SARS-CoV-2 infection or not. Side effects were also generally consistent with those observed in people 16 to 25 years of age. Participants in the study will continue to be monitored for two more years after their second dose to assess long-term protection and safety.
Possible US approval in May
Rochelle Walensky, director of the US Centers for Disease Control and Prevention, recently indicated that she expects Pfizer and BioNTech’s vaccine to be authorized for 12- to 15-year-olds by mid-May. In March, the companies initiated another paediatric study of the vaccine in children under 12, with an data readout expected in the second half of this year.
Meanwhile, Johnson & Johnson and Moderna are also running trials evaluating their respective COVID-19 vaccines in paediatric populations, while a UK study testing AstraZeneca’s Vaxzevria in children was paused recently amid concerns that it may be linked to rare cases of blood clots seen in adult recipients.