Clinical Trials | February 16, 2026
The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”
First Indian company to follow global recommendations in accordance with the World Health Organisation (WHO)
mRNA-1010 demonstrated superior relative vaccine efficacy
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
Phase 1 study of quadrivalent flu vaccine (mRNA-1010) successfully boosted titers against all four strains in older and younger adults, even at lowest dose; no significant safety concerns were observed
The first study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older
The pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine
Moderna will appeal to the Federal Circuit to assert that its government-contractor immunity limits liability under federal law
The decision marks a pivotal moment for the Massachusetts-based biotech giant
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