Moderna Inc's (MRNA  ) clinical trial data from its research assay confirm that its updated COVID-19 vaccine generates an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola), a variant under monitoring.

The updated COVID-19 vaccine is pending approval by the FDA for the fall 2023 vaccination season.

Last month, Moderna said that preliminary clinical trial data confirmed its updated COVID-19 vaccine showed a significant boost in neutralizing antibodies against EG.5 and FL.1.5.1 variants.

The Centers for Disease Control (CDC) indicates that the highly mutated BA.2.86 variant may be more capable of causing infection in people 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.

The company says that the results demonstrate that the updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant.

Public health authorities are 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.

Price Action: MRNA shares are up 0.76% at $110.19 during the premarket session on the last check Wednesday.