On Sept. 6, 2023, Moderna announced that clinical trial data from its research assay confirmed its updated COVID-19 vaccine, which is pending approval by the U.S. Food and Drug Administration for the fall 2023 vaccination season, generates an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola), a variant under monitoring.

Public health authorities were vigilantly monitoring the BA.2.86 variant, a highly-mutated strain of COVID-19 with over 30 mutations as compared to prior Omicron strains, with some governments accelerating COVID-19 vaccination campaigns due to its potential to break through protective immunity generated from previous COVID-19 vaccination or infection.

The emergence of BA.2.86, in addition to the growing prevalence of the EG.5 and FL1.5.1 variants, underscored the need for vaccination with an updated COVID-19 vaccine, which can help reduce severe disease and hospitalizations caused by current circulating strains.