The P-II/III trial evaluate mRNA-1273.214 (50µg) vs mRNA-1273 (50µg) booster dose in 437 patients against Omicron
The trial met all 1EPs including neutralizing Ab response over 50µg booster dose of mRNA-1273 in baseline seronegative patients, superiority is determined by neutralizing GMR with the lower bound of the confidence interval >1 using pre-specified criteria, mRNA-1273.214 exhibited an 8-fold increased in neutralizing GMT against omicron, MSD was higher against all other VOC, safety & tolerability was consistent with a prior booster dose of mRNA-1273
Additionally, non-inferiority was also met against SARS-CoV-2 with GMR. The company intends to submit an interim study & data to regulators for review in the coming wks.
Ref: Moderna | Image: Moderna
