SpikeVax Booster Launches Omicron Specific Phase 2 Study

Massachusetts-based Moderna, Inc. today announced that the first participant had been dosed in the Phase 2 study of the Company's Omicron-specific mRNA vaccine booster candidate (mRNA-1273.529).

Moderna expects to enroll approximately 300 participants into each cohort of this study, conducted at up to 24 sites in the U.S.

Additionally, Moderna announced the publication of neutralizing antibody data from the SpikeVax vaccine against the SARS-CoV-2 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.

And 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," commented Stéphane Bancel, CEO of Moderna, in a press statement issued on January 26, 2022.

"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."

Moderna previously announced preliminary neutralizing antibody data against the Omicron variant following the Company's SpikeVax vaccine booster candidates at 50 µg and 100 µg dose levels.

The currently authorized 50 µg booster of SpikeVax increased neutralizing antibody levels against Omicron approximately 37-fold compared to pre-boost levels, and a 100 µg dose of mRNA-1273 increased neutralizing antibody levels approximately 83-fold compared to pre-boost levels.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing. It has empowered the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases.