After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month.
Just two weeks ago, Moderna announced that its combination flu/COVID-19 vaccine outperformed current shots for both diseases. But on Wednesday, the famed biotech withdrew the FDA application for the shot after consultation with the agency.
Moderna had filed for a biological license application (BLA) for the vaccine, called mRNA-1083, in late 2024 with an eye toward a late 2025 approval. The company revealed Phase III results in adults 50 years and older in March, before pushing the expected approval date back to 2026 during its Q1 earnings call, citing an expectation for a request for additional data on flu shot efficacy from the FDA.
The withdrawal is a setback for Moderna, which had already expected delays for mRNA-1083. In its first quarter earnings report, the company announced that the shot would be deprioritized given “an extended review timeline.”
Following news of the withdrawal, Moderna’s shares dropped 4.5% when the markets opened Wednesday, to $26.79 apiece compared to $27.99 at Tuesday’s close.
Moderna plans to resubmit the BLA for its combo vaccine, mRNA-1083, later this year when Phase III data from its investigational seasonal flu vaccine, mRNA-1010, become available. Interim data from that trial is expected this summer. mRNA-1083 contains components of mRNA-1010 and components of its second-generation COVID-19 shot, mRNA-1283.
Phase III trial data announced earlier this month showed that mRNA-1083 generated as many or more antibodies against most flu strains and the Omicron XBB.1.5 COVID-19 variant in comparison to Moderna’s standalone COVID-19 shot and standard flu shots Fluarix (marketed by GSK for people aged 50 to 64) and Fluzone (from Sanofi for people aged 65 or older, a stronger dose than Fluarix).
BioSpace has reached out to Moderna for further comment.
The FDA’s regulation of vaccines is in flux. The agency earlier this year missed a deadline for a decision on Novavax’s protein-based COVID-19 vaccine. That vaccine ultimately won approval last week, but only for a subset of older patients and people with underlying conditions. This is largely reflective of new risk-based approval requirements for future COVID-19 candidates introduced Tuesday by FDA Commissioner Marty Makary and CBER Director Vinay Prasad in an editorial published in the New England Journal of Medicine and in an FDA Town Hall.
This follows a new requirement announced by the Department of Health and Human Services that all new vaccine trials have a full placebo arm going forward.
In a note to investors after the news of HHS’ new requirements, Leerink Partners wrote that “HHS’s judgment appears questionable and risky, in our view.” They added that “placebo-controlled trials are unnecessary and unethical for many populations,” and said “the world will look to other countries’ health authorities as the gold standards for vaccine testing.”
Moderna’s main competitor, Pfizer, has submitted applications for two COVID-19 mRNA vaccines for children aged six months to four years and five to 11 years. Pfizer is also conducting a Phase III trial of a shot for children six months to 11 years, as well as a Phase II trial for its own combo flu/COVID-19
