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

The current safety data for BNT162b2 Vaccine in 12-15 year olds comes from only 2260 subjects in a phase 3 study. So, a clinical and post-clinical safety assessment of BNT162b2 vaccine in the age group of 12 to 15 years is urgently required. Following PRISMA guidelines, a rapid systematic review was conducted to assess the vaccine’s safety in children aged 12 to 15. Using the defined search words, PubMed, Scopus, Web of Science, Embase, the Cochrane library, and MedRxiv were searched before August 15, 2021. This systematic review included 135 records from 6 databases, 4 studies (2 NEJM and 2 MMWR), and 64969 subjects who received at least one dose of vaccine. The most common adverse reactions reported in clinical trials and post-approval studies are injection site pain, fatigue, headache, chills, diarrhoea, and joint pain (systemic). This study (n = 62,709) reported half the major systemic events (fatigue, headache, chill, diarrhoea and joint pain) and half the major local events (injection site pain) as the phase 3 clinical study (n = 1,131). Our results show that the BNT162b2 vaccine has a very good safety profile, with high adherence (>97%) and low incidence of major local and systemic events (post-authorisation observational study).