N. Engl J Med: “Omicron-specific” mRNA 1273 (Moderna) covid-19 booster trial (in human adults)–NO BENEFIT in preventing omicron infections

Chalkias S, Harper C, Vrbicky K, Walsh SR, Essink B, Brosz A, McGhee N, Tomassini JE, Chen X, Chang Y, Sutherland A, Montefiori DC, Girard B, Edwards DK, Feng J, Zhou H, Baden LR, Miller JM, Das R. “A Bivalent Omicron-Containing Booster Vaccine against Covid-19.” N Engl J Med. 2022 Sep 16. doi: 10.1056/NEJMoa2208343. Epub ahead of print. PMID: 36112399.

Link to full pdf of main study: Bivalent Null main__nejmoa2208343

Link to full pdf of study Supplement: Bivalent Null_nejmoa2208343_appendix

RESULTS

Incidence of SARS-CoV-2 Infection Among all participants, starting 14 days after the booster and regardless of prebooster SARSCoV-2 infection status, SARS-CoV-2 infection occurred in 11 participants (2.5%) in the mRNA1273.214 group and in 9 participants (2.4%) in the mRNA-1273 group. Asymptomatic infection occurred in 6 participants (1.4%) in the mRNA1273.214 group and in 7 participants (1.9%) in the mRNA-1273 group; Covid-19 according to the COVE trial definition occurred in 4 participants (0.9%) and in 2 participants (0.5%), respectively, and Covid-19 according to the Centers for Disease Control and Prevention (CDC) definition occurred in 5 participants (1.1%) and in 2 participants (0.5%), respectively. In participants with no previous SARS-CoV-2 infection, infections occurred in 11 of 339 participants (3.2%) in the mRNA-1273.214 group and in 5 of 266 participants (1.9%) in the mRNA1273 group after the booster (Table S12). Asymptomatic infection occurred in 6 participants (1.8%) in the mRNA-1273.214 group and in 4 participants (1.5%) in the mRNA-1273 group; Covid-19 according to the COVE trial definition occurred in 4 participants (1.2%) and in 1 participant (0.4%), respectively, and Covid-19 according to the CDC definition occurred in 5 participants (1.5%) and in 1 participant (0.4%), respectively. There were three SARS-CoV-2 reinfections in the mRNA-1273 group. No emergency department visits or hospitalizations due to Covid-19 were seen.

ABSTRACT & BASIC DESIGN FLOW

 

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