Teen COVE study finds Moderna COVID-19 vaccine safe in adolescents

Abstract

The Moderna COVID-19 vaccine [mRNA-1273; Spikevax] has an acceptable safety profile in adolescents, according to findings of the Moderna-funded Teen COVE study published in the New England Journal of Medicine. In this ongoing phase II/III study conducted at multiple centres in the USA, 3732 adolescents 12–17 years of age were randomised to receive two injections of Spikevax or two injections of placebo (with a 28-day interval between vaccinations) between December 2020 and February 2021. The most frequently reported adverse events (AEs) after the first Spikevax and placebo injection were injection-site pain (93.1% vs 34.8%), headache (44.6% vs 38.5%) and fatigue (47.9% vs 36.6%), and the most frequent AEs after the second injection were also injection-site pain (92.4% vs 30.3%), headache (70.2% vs 30.2%) and fatigue (67.8% vs 28.9%). Chills was also reported after Spikevax. The most common solicited local reaction after the first and second injection of Spikevax was injection-site pain (93.1% and 92.4%, respectively). Other local reactions after Spikevax included erythema (0.7%), swelling (0.4%) and lymphadenopathy (0.4%). No cases of myocarditis or pericarditis were reported. The safety and reactogenicity of mRNA-1273 in adolescents was similar to that observed in adults between the ages of 18 and 64 years in the phase 3 COVE trial, noted the authors. In this interim analysis of the ongoing trial, the overall benefit–risk profile of mRNA-1273 was favorable in adolescents, they concluded.