Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S.

ABSTRACT:

Background

The Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis.

Methods

We conducted the final analysis in the double-blind phase of our multinational, randomized, placebo-controlled trial, in which adults were assigned in a 1:1 ratio to receive single-dose Ad26.COV2.S (5×10¹⁰ viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration in the per-protocol population. Safety and key secondary and exploratory end points were also assessed.

Results

Median follow-up in this analysis was 4 month

SUBMITTER: Sadoff J 

PROVIDER: S-EPMC8849184 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature