Fri, 10/16/2020 – 15:30
In a randomized Phase I trial carried out in the United States, researchers evaluated the safety and immunogenicity of two lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates against COVID-19. The study population included 195 healthy volunteers aged 18–55 years and aged 65–85 years. Participants were split into 13 cohorts based on which vaccine candidate they received, vaccine dosage, and volunteer age. Each group consisted of 15 people, 12 of whom were given BNT162b1 or BNT162b2 and three of whom were given placebo. Both vaccine candidates elicited similar dose-dependent coronavirus-neutralizing geometric mean titers, on par with or better than those seen with samples of convalescent serum. With BNT162b2, however, investigators observed less frequent and less severe systemic reactions than with BNT162b1—especially among older adults. Based on results from the study, coupled with interim trial data on BNT162b1 in younger adults from earlier work in the United States and Germany, the investigators recommend that BNT162b2 progress to a pivotal Phase II/III safety and efficacy evaluation.