Moderna announced it has voluntarily withdrawn its pending biologics license application (BLA) for mRNA-1083, its investigational combination influenza/COVID-19 vaccine candidate designed for adults aged 50 years and older. The withdrawal follows a request from the FDA for additional phase 3 influenza efficacy data, prompting the company to reassess its regulatory timeline.
The FDA's request, issued earlier this month, specifically called for more comprehensive phase 3 influenza efficacy data to support the combination vaccine's approval. Based on the agency's feedback, Moderna anticipated an extended review timeline that would have significantly delayed potential approval.
Strategic Resubmission Plan
Moderna plans to resubmit the BLA later this year after obtaining vaccine efficacy data from its ongoing phase 3 trial of mRNA-1010, the company's investigational seasonal influenza vaccine. The company continues to expect interim data from the mRNA-1010 trial to become available this summer, which will inform the resubmission strategy.
The company has now shifted its target for FDA approval to 2026, representing a notable delay in bringing what would be the first combination respiratory vaccine to the U.S. market. This timeline adjustment reflects the regulatory complexity of demonstrating efficacy for combination vaccines that must prove effectiveness against multiple pathogens.
Regulatory Context and Market Impact
The withdrawal occurs amid broader changes in FDA policy regarding COVID-19 vaccines. In a recent New England Journal of Medicine article, FDA Commissioner Marty Makary and Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), outlined new approaches to COVID-19 vaccine approval that will raise the evidentiary bar for future applications.
The new policy framework divides populations into three distinct groups: adults 65 years and older, individuals between 6 months and 64 years, and high-risk populations, with differentiated approval approaches for each demographic. This shift suggests increased regulatory scrutiny for COVID-19 vaccine development moving forward.
Clinical Development Challenges
The mRNA-1083 combination vaccine represents a significant technical achievement in vaccine development, combining protection against two major respiratory pathogens in a single formulation. However, demonstrating efficacy against both influenza and COVID-19 in clinical trials presents unique challenges, particularly given the seasonal variability of influenza strains and the evolving nature of SARS-CoV-2 variants.
The FDA's request for additional phase 3 data underscores the agency's commitment to ensuring robust efficacy evidence before approving combination vaccines. This approach aligns with the agency's broader emphasis on comprehensive clinical evidence, particularly for vaccines targeting multiple pathogens simultaneously.
Market Implications
The delay in mRNA-1083's approval timeline may impact Moderna's competitive position in the combination vaccine market, where other companies are also developing multi-pathogen vaccines. The extended development timeline also affects healthcare providers and patients who could benefit from simplified vaccination schedules that combination vaccines offer.
Despite the setback, Moderna's decision to withdraw and resubmit demonstrates a strategic approach to regulatory engagement, prioritizing the submission of comprehensive efficacy data over expedited approval timelines. This approach may ultimately strengthen the vaccine's regulatory profile and market acceptance upon eventual approval.
