Moderna, Inc. announced that clinical trial data from its research assay confirm its updated COVID-19 vaccine, which is pending approval by the FDA 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. The CDC indicates that the highly mutated BA.2.86 variant may be more capable of causing infection in individuals who previously had COVID-19 or were vaccinated with previous vaccines, noting that updated COVID-19 vaccines may be effective in reducing severe disease and hospitalization.

Stephen Hoge, MD, president of Moderna, stated, “These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. Taken together with our previously communicated results showing a correspondingly effective response against EG.5 and FL.1.5.1 variants, these data confirm that our updated COVID-19 vaccine will continue to be an important tool for protection as we head into the fall vaccination season. Moderna will continue rapidly assessing global public health threats and is committed to leveraging our mRNA platform against COVID-19.”

The press release noted that public health authorities are vigilantly monitoring the BA.2.86 variant—a highly mutated strain of COVID-19 with over 30 mutations as compared with prior Omicron strains—with some governments fast-tracking 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, underscores the need for vaccination with an updated COVID-19 vaccine, which can help reduce severe disease and hospitalizations caused by current circulating strains.

Moderna’s clinical trial data around its updated COVID-19 vaccine’s effectiveness against BA.2.86 have been shared with regulators and submitted for peer review publication.

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