Reported rates of all-cause serious adverse events following immunization with BNT-162b in 5–17-year-old children in the United States

Abstract

Vaccine development against COVID-19 has mitigated severe disease. However, reports of rare but serious adverse events following immunization (sAEFI) in the young populations are fuelling parental anxiety and vaccine hesitancy. With a very early season of viral illnesses including COVID-19, respiratory syncytial virus (RSV), influenza, metapneumovirus and several others, children are facing a winter with significant respiratory illness burdens. Yet, COVID-19 vaccine and booster uptake remain sluggish due to the mistaken beliefs that children have low rates of severe COVID-19 illness as well as rare but severe complications from COVID-19 vaccine are common. In this study we examined composite sAEFI reported in association with COVID-19 vaccines in the United States (US) amongst 5-17-year-old children, to ascertain the composite reported risk associated with vaccination. Between December 13, 2020, and April 13, 2022, a total of 467,890,599 COVID-19 vaccine doses were administered to individuals aged 5–65 years in the US, of which 180 million people received at least 2 doses. In association with these, a total of 177,679 AEFI were reported to the Vaccine Adverse Event reporting System (VAERS) of which 31,797 (17.9%) were serious. The rates of ED visits per 100,000 recipients were 2.56 (95% CI: 2.70–3.47) amongst 5-11-year-olds, 18.25 (17.57–18.95) amongst 12-17-year-olds and 33.74 (33.36–34.13) amongst 18-65-year olds; hospitalizations were 1.07 (95% CI 0.87–1.32) per 100,000 in 5-11-year-olds, 6.83 (6.42–7.26) in 12-17-year olds and 8.15 (7.96–8.35) in 18–65 years; life-threatening events were 0.14 (95% CI: 0.08–0.25) per 100,000 in 5-11-year olds, 1.22 (1.05–1.41) in 12-17-year-olds and 2.96 (2.85–3.08) in 18–65 year olds; and death 0.03 (95% CI 0.01–0.10) per 100,000 in 5–11 year olds, 0.08 (0.05–0.14) amongst 12-17-year olds and 0.76 (0.71–0.82) in 18–65 years age group. The results of our study from national population surveillance data demonstrate rates of reported serious AEFIs amongst 5–17-year-olds which appear to be significantly lower than in 18-65-year-olds. These low risks must be taken into account in overall recommendation of COVID-19 vaccination amongst children.