Moderna may be publicly pivoting toward its cancer therapies, but it’s still notching up vaccine approvals, with the Food & Drug Administration last week approving its mFlusiva as a new flu vaccine option, reports Endpoints News.
The shot received standard approval for adults aged 50 to 64 and accelerated approval for over-65s. The company is planning to run a post-marketing study to further vet the efficacy in older adults.
CEO Stéphane Bancel said that the latest approval, Moderna’s fourth vaccine in the US, “demonstrates the continued strength and versatility of our mRNA platform”.
It’s also an indication of how much has changed at the FDA in six months.
In February, Moderna was issued a refuse-to-file letter by Vinay Prasad, the then-director of the Centre for Biologics Evaluation and Research (CBER), who over-ruled vaccine reviewers and division heads under him. Refuse-to-file letters typically indicate there’s a problem with a submission that precludes the agency from even reviewing the application.
The move triggered a two-week public fight between the company and the agency, with Moderna arguing that the FDA never indicated over the course of the vaccine’s development plan that the data wouldn’t be sufficient for review.
The FDA’s argument centred on Moderna’s decision to use a standard dose flu vaccine as the comparator in the Phase 3 study, despite the CDC’s recommendation that adults 65 and older receive a high-dose flu vaccine.
Reviewers never told Moderna that the plan would not be approvable, though they did flag that the trial design could be a problem for CDC advisors down the line, according to feedback voluntarily released by Moderna during the spat.
The Phase 3 results found Moderna’s flu vaccine was more effective at 27% relative vaccine efficacy than the standard dose. The FDA ultimately relented after Moderna agreed to submit the older age cohort for accelerated approval.
And in June, FDA vaccine advisors voted unanimously in favour of the benefit-risk profile of the vaccines for both age brackets. Though the infectious disease panellists noted higher levels of reactogenicity to the mRNA option, they were swayed by the better efficacy and the pandemic response potential of Moderna’s technology.
Moderna will now have to prove it can make inroads in a vaccine market it didn’t establish.
Its first attempt at this in the respiratory syncytial virus (RSV) market has been abysmal, with the company struggling to find older patients who haven’t already received GSK or Pfizer’s option.
See more from MedicalBrief archives:
FDA panel okays mRNA flu jab shot down by Kennedy
Moderna flu vaccine falls short – large trial
Vaccines against respiratory infections linked to fewer heart failure deaths