Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 for adolescents

The MHRA has updated its Conditions of Authorisation, Information for Healthcare Professionals and Information for UK Recipients documents in line with an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds.

SPS commentary:

Approval in this age group is based on two clinical studies that included 22,875 participants (of which 1,131 aged 12 to 15 years) that have received at least one dose of Pfizer/BioNTech vaccine.

Study BNT162-01 (Study 1) enrolled 60 participants, 18 through 55 years of age.

Study C4591001 (Study 2) enrolled approximately 44,000 participants, of which 2,260 were 12 to 15 years of age. Of these, 1,308 adolescents (660 Pfizer/BioNTech vaccine and 648 placebo) have been followed for at least 2 months after the second dose of COVID-19 mRNA Vaccine BNT162b2. Vaccine effiayc is reported to be 100% after two doses.

The most frequent adverse reactions in adolescents 12 to 15 years of age were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).


Medicines and Healthcare products Regulatory Agency