The US Food and Drug Administration (FDA) has refused to review Moderna’s seasonal influenza jab, mRNA-1010, as the shifting vaccine landscape within the country continues to prove volatile for pharma companies. Analysts note that the FDA’s refusal to review mRNA-1010 could impact Moderna’s capacity to break even in 2028.
The FDA sent a refusal-to-file (RTF) notice to Moderna, which was signed by the Center for Biologics Evaluation and Research (CBER) director, Vinay Prasad. The FDA’s call comes within a wider push from the US government to alter vaccine policy.
In the letter, the CBER cites the lack of an “adequate and well-controlled” study within Moderna’s biologics license application (BLA) for mRNA-1010 – leading the agency to deem the vaccine unsuitable for review. Moderna’s investigational vaccine uses the same underlying mRNA technology as its marketed Covid-19 jab Spikevax, which the FDA approved in 2022. The modality works by instructing cells to produce specific proteins that can recognise and fight pathogens.
The Core Dispute: The decision primarily revolves around the FDA’s belief that the control arm used in the study “does not reflect the best-available standard of care” (SoC) within the US at the time of the Phase III trial (NCT05415462). As per ClinicalTrials.gov, Moderna opted to use GSK’s marketed quadrivalent jab, Fluarix Tetra, as the comparator. Fluarix Tetra is an FDA-approved influenza vaccine.
The FDA shun sent Moderna’s stock sliding 10.5% from $41.99 at market close on 10 February to $37.60 at opening on 11 February. Moderna currently holds a market cap of approximately $14.7bn.
Moderna rebuts FDA stance on mRNA-1010
In a 10 February statement addressing the RTF, Moderna refuted the FDA’s claims regarding the regulatory requirements for the study design.
