Moderna Announces First Participant Dosed in Phase 2 Study of Omicron-Specific Booster Candidate and Publication of Data on Booster Durability Against Omicron Variant

Phase 2 study of Omicron-specific booster candidate (mRNA-1273.529) will include two cohorts: one including participants who received the two-dose primary series of mRNA-1273 and another including participants who received the two-dose primary series and a 50 µg booster dose of mRNA-1273

Omicron neutralization six months after the third 50 µg dose of mRNA-1273 declined, but remained detectable in all participants

CAMBRIDGE, MA / ACCESSWIRE / January 26, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in the Phase 2 study of the Company's Omicron-specific booster candidate (mRNA-1273.529). Additionally, Moderna announced the publication of neutralizing antibody data against the Omicron variant six months following a booster dose in The New England Journal of Medicine. While Omicron neutralization had declined 6.3-fold from peak titers at day 29 post-boost, levels remained detectable in all participants. Neutralizing titers against Omicron declined more rapidly than titers against the ancestral strain of the virus (D614G) which declined 2.3-fold over the same time period.

"We are reassured by the antibody persistence against Omicron at six months after the currently authorized 50 µg booster of mRNA-1273. Nonetheless, given the long-term threat demonstrated by Omicron's immune escape, we are advancing our Omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our Phase 2 study," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are also evaluating whether to include this Omicron-specific candidate in our multivalent booster program. We will continue to share data with public health authorities to help them make evidence-based decisions on the best booster strategies against SARS-CoV-2."

Phase 2 Study of mRNA-1273.529

This extension of an earlier study will evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.529 as a single booster dose in adults aged 18 years and older in two cohorts: individuals who previously received the two-dose primary series of mRNA-1273 with the second dose being at least six months ago (cohort 1), or who have received the two-dose primary series and a 50 µg booster dose of mRNA-1273 with the booster dose being at least three months ago (cohort 2). Participants in both cohorts will receive a single booster dose of mRNA-1273.529.

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