Initial experience of the safety and tolerability of the BNT162b2 (Pfizer-Bio-N-Tech) vaccine in extremely vulnerable children aged 12–15 years

Healthy children generally have a mild illness with SARS-COV-2; however, some comorbidities may predispose to severe COVID-19 disease. Neurological conditions were the predominant comorbidity of hospitalised children in the UK with COVID-19 (11%)1 and a larger proportion (26%) of those with severe/fatal disease.2 Children perceived to be at highest risk of COVID-19 were shielded, reducing risks of infection and therefore underrepresented in the data.

Vaccination safety data for BNT162b2 (Pfizer-Bio-N-Tech) is now available from healthy adolescents age 12 to 15 years. Similar to adult studies, common side effects were mild-moderate pain at injection site (86%), fatigue (66%), headache (65%), and fever ≥38°C (20%).3

Although the side effects from adult studies were mild, they were inversely related to age, that is, younger participants (<55 years) had more side effects.4

The Joint Committee on Vaccination and Immunisation (JCVI) advised that children aged 12 and over with severe neurodisabilities who tend to get recurrent respiratory infections who may spend time in residential care be offered vaccination.5 Children identified by clinicians as meeting these ‘Green Book’ criteria were offered the vaccination with informed medical consent following discussion with the child’s clinician.

Given the unknown side effects of vaccination in this complex group, we asked parents to record side effects to inform the risk–benefit for subsequent COVID-19 vaccinations for each child. This was recorded in a diary followed up with a telephone call.

Author list

Hayley King, Sanjay Deshpande, Tamsin Woodbridge, Tom Hilliard, Jon Standing, Mary Lewis, Lesley Ward, Adam Finn, Marion Roderick

Novel Coronavirus SARS-CoV-2


BMJ - Archives of Disease in Childhood