Clinical efficacy and safety of two injections of a bivalent vaccine as a primary series during a period of Omicron circulation medrxivpreprint EmoryUniversity harvardmed fredhutch HopkinsMedicine vaccine vaccination COVID19 coronavirus covid
By Pooja Toshniwal PahariaDec 13 2022Reviewed by Danielle Ellis, B.Sc. In a recent study posted to the medRxiv* preprint server, researchers evaluated the bivalent [encoding spike proteins of severe acute respiratory syndrome coronavirus 2 D614 strain and the Beta variant of concern ] vaccine efficacy against the Omicron VOC.
The study comprised adults who were unvaccinated against SARS-CoV-2 before the commencement of the study. The participating individuals were allocated in a 1:1 ratio to either receive two bivalent vaccine infections intramuscularly three weeks apart of a bivalent SARS-CoV-2 recombinant protein vaccine or placebo injections. The first stage of the study involved the evaluation of recombinant vaccine efficacy.
Furthermore, genomic sequencing analysis was performed to identify the causative VOC. The prime study endpoint was symptomatic SARS-CoV-2 infection development prevention ≥2.0 weeks post-second vaccine dose . Secondary endpoints were symptomatic COVID-19 occurrence among infected and uninfected participants, moderate or severe COVID-19, and associated hospitalizations ≥2.0 weeks of PD2.
The average age of the study participants was 36.0 years, and most were men. In both groups, individuals were followed up after the first and second doses for 148.0 days and 234.0 days, respectively. Up to March 15, 2022, 121.0 symptomatic SARS-CoV-2 infection cases were documented, of which 32.0 cases and 89.0 cases occurred in the vaccine group and placebo group, respectively, ≥2.0 weeks of PD2 with 65.0% VE.
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