Pfizer and BioNTech said they have asked the FDA to amend the emergency-use authorization (EUA) for their coronavirus vaccine BNT162b2 to include use in adolescents 12-to-15 years of age, adding they will be making similar requests to other global regulatory bodies in the coming days. The mRNA-based vaccine was authorized by the FDA in December for people 16 years and older, and has been cleared in several other markets as well, including the UK and EU.
According to the companies, the filing is supported by topline results reported recently from a Phase III study of adolescents aged 12 to 15, showing that BNT162b2 was safe and 100% effective at protecting against the disease. The analysis was calculated based on 18 cases of COVID-19, all of which were among placebo recipients. Side effects were also generally consistent with those observed in participants 16-to-25 years of age.
‘Critical step’ in ongoing vaccination drive
“These submissions represent a critical step in [our] ongoing efforts to support governments in broadening global vaccination efforts,” Pfizer and BioNTech stated. The companies recently initiated another paediatric study of BNT162b2 in children under 12, with an initial readout expected in the second half of the year.
Earlier this month, Johnson & Johnson said it started vaccinating adolescents aged 12 to 17 in an ongoing Phase IIa trial of its COVID-19 vaccine Ad26.COV2.S. A single-dose version of the inoculation was cleared for emergency use by the FDA in February for people 18 and older. Moderna, whose COVID-19 vaccine mRNA-1273 received an EUA in December, started testing it in children 12 years and older last year, and recently also began dosing those under 12 in a phase 2/3 trial.
Meanwhile, a UK study that has been testing AstraZeneca’s inoculation Vaxzevria since February in children between 6 and 17 years was paused a few days ago amid ongoing concerns that it may be linked to rare cases of blood clots seen in adult recipients. The University of Oxford, which co-developed the vaccine with AstraZeneca, is running the paediatric trial and it is unclear whether it will resume.