Safety Assessment of BNT162b2 Vaccine in Adolescents Aged 12-15 Years

Present evidence of the safety of BNT162b2 Vaccine in adolescents of 12 to 15 years relies only on 2260 subjects involved in phase 3 study. Therefore, clinical and post-clinical safety assessment of BNT162b2 Vaccine in Age Group of 12 to 15 Years is urgently needed to make an accurate judgment for mass vaccination. A rapid systemic review was conducted to determine safety profile of BNT162b2 Vaccine in Age Group of 12 to 15 Years following the PRISMA guidelines. Published literature before August 15, 2021 were searched in PubMed, Scopus, Web of Science, Embase, the Cochrane library and MedRxiv, using the defined search words. 135 records found from 6 databases, of which 4 studies (2 studies from NEJM and 2 MMWR), total subject who received at least one dose of vaccine: 64969, were included in this systemic review per the inclusion criteria. The major events reported in clinical phase and post-authorisation observational studies are pain at injection site (local), fatigue (systemic), headache (systemic), chill (systemic), diarrhoea (systemic) and joint pain (systemic). Post-authorisation observational study (n = 62,709) reported about 50% lower major systemic events, specifically, fatigue, headache, chill, diarrhoea and join pain and about 25% lower major local event, specifically, pain at injection site, than phase 3 clinical study (n = 1,131). Our study suggest that higher adherence rate (>97 percent received second dose) in clinical phase 3 and significantly lower incident of major local and systemic events in post-authorisation observational study indicating that BNT162b2 vaccine has highly favourable safety profile.