Moderna (Nasdaq:MRNA) has announced that its omicron-containing bivalent COVID-19 booster candidate mRNA-1273.214 yielded 1.75 times more neutralizing antibodies than its FDA-approved mRNA-1273 vaccine.
The company also noted that a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against the omicron variant roughly eight times over baseline levels in the primary immunogenicity study.
The mRNA-1273.214 bivalent vaccine candidate, which is Moderna’s lead booster for the fall and winter, includes 32 omicron mutations.
Overall, solicited adverse events for recipients of the mRNA-1273.214 vaccine were lower than prior doses of the mRNA-1273 in the same population.
The study measured neutralizing antibody response 28 days after receipt of the new booster dose.
Participants in the study had received a two-dose 100-μg primary series of the mRNA-1273 vaccine and a 50-μg booster dose of the same vaccine before receiving a booster dose of the mRNA-1273.214 vaccine.
Moderna intends to file data to FDA in the coming weeks to potentially make the updated booster available by the late summer. “We want to be ready as early as August to be shipping,” said Moderna CEO Stéphane Bancel in a call with investors and analysts.
- [Image courtesy of Moderna]
Moderna is projecting that seasonal COVID-19 vaccines will be required as neutralizing antibody titers will wane as they do with endemic human coronaviruses, which cause mild to moderate respiratory infections.
Moderna aims to increase the durability of protective neutralizing antibodies against omicron to at least six months to provide robust support during fall and winter.
The company also expects that the continued emergence of new SARS-CoV-2 variants will continue to cause breakthrough infections, necessitating periodic boosting.
More data are needed to determine how various omicron subvariants influence the performance of the mRNA-1273.214 booster candidate.
“We’re going to be testing our samples across a range of subvariant assays,” said Stephen Hoge, Moderna president, in a call with investors and analysts. “But it’s important to note those are still research-grade assays, so there’s a high degree of variability in how they’re performing.” In addition, Hoge notes that such research will need further qualification and validation to enable “informed decisions about the relative performance of vaccines.”
MRNA shares were up almost 4% in mid-day trading to $150.74.
Filed Under: Drug Discovery, Infectious Disease