Modern Clinical Trial Data Confirmed Updated COVID-19 Vaccine Generated Robust Immune Response Against Widely Circulating Variants

On August 17, 2023, Moderna, Inc. announced that preliminary clinical trial data have confirmed that its updated COVID-19 vaccine for the fall 2023 vaccination season demonstrated a significant boost in neutralizing antibodies against the EG.5 and FL.1.5.1 variants. These results suggest that Moderna’s updated COVID-19 vaccine may effectively target the expected circulating variants of COVID-19 during the upcoming vaccination season.

The World Health Organization (WHO) recently classified the EG.5, or “Eris,” strain as a variant of interest. EG.5 became the dominant variant in the U.S. according to the Centers for Disease Control and Prevention (CDC),1 while also accounting for a growing proportion of cases globally. The FL 1.5.1, or “Fornax,” variant is also starting to surge in parts of the U.S.

“These new results, which showed that our updated COVID-19 vaccine generated a robust immune response against the rapidly spreading EG.5 and FL 1.5.1 strains, reflect our updated vaccine’s ability to address emerging COVID-19 threats,” said Stephen Hoge, M.D., President of Moderna. “Moderna is committed to leveraging our mRNA technology to provide health security worldwide.”

In addition to demonstrating a human immune response against the EG.5 and FL 1.5.1 strains, Moderna had previously presented the only clinical trial data confirming that its updated COVID-19 vaccine showed robust human immune responses across the key circulating XBB strains at the June 2023 FDA VRBPAC. With this new trial data, Moderna had confirmed an antibody response against current strains of concern.

Moderna had submitted its updated COVID-19 vaccine to the U.S. Food and Drug Administration, the European Medicines Agency (EMA), and other regulators globally. Pending authorization, it was ready for fall vaccination with sufficient global supply.