The FDA is on the verge of authorizing updated COVID-19 boosters without the benefit of Phase 3 clinical trial data, according to media reports. The bivalent boosters, based on the omicron sublineages BA.4 and BA.5 and the original form of SARS-CoV-2, could be available soon after Labor Day. To authorize the omicron-specific COVID-COVID-19 boosters, FDA…
Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise
Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study. The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron. The company notes that the mRNA-1273.211 booster outperformed the first-generation…
Moderna shares R&D updates at third annual vaccines day
Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old.…