Moderna announces phase 2 study of omicron-specific booster
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Moderna on Wednesday announced the start of a phase 2 study of an omicron-specific COVID-19 booster shot.
Pfizer and BioNTech have initiated a similar trial.
Moderna’s study will assess the safety and efficacy of the omicron-specific booster in two cohorts of adults aged 18 years or older — people who are at least 6 months from receiving the two-dose primary series of the company’s COVID-19 vaccine, and people who are at least 3 months from receiving a third booster dose.
Participants in both groups will receive a single dose of the omicron-specific booster. Moderna is expected to enroll 300 participants into each cohort in up to 24 sites in the U.S.
Data published Wednesday in The New England Journal of Medicine showed that people who received a booster shot of the original Moderna vaccine experienced a 6.3-fold decrease in neutralization titers against the omicron variant 6 months after their third shot, although levels remained detectable in all participants.
“We are reassured by the antibody persistence against omicron at 6 months after the currently authorized 50 µg booster of mRNA-1273,” Moderna CEO Stéphane Bancel, MSc, MBA, said in a news release. “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.”
Data publicized by Moderna last month showed that a 50 µg booster dose of the company’s existing vaccine — which is the size authorized as a booster — increased antibody levels against omicron 37-fold compared to pre-boost levels, and a 100 µg booster dose increased levels 83-fold.
References:
Pajon R, et al. N Engl Med. 2022;doi:10.1056/NEJMc2119912.
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