The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
The WHO has urged China to increase adoption of mRNA vaccines, given their high efficacy against variant strains.
Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
The vaccine is under FDA review
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