Key Findings: Novavax was authorized for use in Canada February 16, 2022 and has also been authorized for use in 35 other countries as a 2-dose primary series given as an intramuscular injection, 21 days apart; Phase 3 trials of Novavax in US/Mexico and UK showed an overall vaccine effectiveness of 89.7-90.4% against all severity COVID infection and 100% against moderate/severe infection and death; In the US/Mexico, vaccine effectiveness against the dominant Alpha variant was found to be 92.6%, while in the UK, it’s effectiveness dropped to 86.3%; The most frequently reported local and systemic adverse events in both trials were tenderness and pain at the injection site and headache, myalgia and fatigue, respectively. Adverse events were mild-to-moderate and transient in nature, and more frequently reported following the second dose; A Phase 2 trial assessing safety and efficacy of Novavax in South Africa in adults 18-64 years during Beta dominance found a vaccine efficacy of only 49.4%, however, in subgroup analysis of only HIV negative individuals, efficacy rose to 60.1% overall, and 51% against the Beta variant. (). While efficacy against disease severity was not measured, the majority of infections reported in both the vaccine and placebo group were mild to moderate

Cite As: Badea, A; Groot, G; Reeder, B; Miller, L. What is the safety/efficacy of the Novavax COVID-19 vaccine? 2022 Mar 10. Document no.: EOC220302 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2022. 7 p. (CEST rapid review report).

EOC220302 RR