Moderna announced today that it has voluntarily withdrawn its pending Biologics License Application (BLA) for mRNA-1083, the company's combination vaccine candidate designed to protect against both influenza and COVID-19 in adults aged 50 years and older. The decision was made following consultation with the U.S. Food and Drug Administration (FDA).
The pharmaceutical company plans to resubmit the application later this year after gathering additional efficacy data from an ongoing Phase 3 clinical trial of its investigational seasonal influenza vaccine, mRNA-1010. Moderna expects interim data from this trial to become available this summer.
Strategic Withdrawal to Strengthen Future Application
The withdrawal appears to be a strategic move rather than a response to safety concerns. By incorporating forthcoming efficacy data from the mRNA-1010 trial, Moderna aims to strengthen its eventual resubmission for the combination vaccine.
This development represents a temporary setback in Moderna's efforts to expand its vaccine portfolio beyond its successful COVID-19 vaccine Spikevax and its recently developed RSV vaccine Mresvia. The company has been working to leverage its mRNA platform technology to address multiple respiratory viruses with combination vaccines.
Market Response
Following the announcement, Moderna's shares declined 1.7% to $27.52 in premarket trading, reflecting investor concern about the delay in bringing this potential product to market.
Significance of Combination Vaccines
Combination vaccines like mRNA-1083 represent an important advancement in vaccination strategy, potentially increasing compliance by reducing the number of separate injections patients need to receive. For older adults who are particularly vulnerable to both influenza and COVID-19, a single vaccine addressing both pathogens could significantly improve protection rates.
Moderna's mRNA Platform
The development of mRNA-1083 builds on Moderna's established mRNA technology platform, which gained worldwide recognition through its COVID-19 vaccine. This platform allows for relatively rapid vaccine development compared to traditional methods and has demonstrated effectiveness against multiple pathogens.
The company continues to expand its pipeline of mRNA-based medicines across infectious diseases, immuno-oncology, rare diseases, and autoimmune conditions.
Next Steps
Moderna will continue collecting data from its Phase 3 trial of mRNA-1010, with interim results expected in the summer of 2025. These findings will inform the company's approach to resubmitting the BLA for the combination vaccine.
The FDA consultation that led to this withdrawal suggests a collaborative approach between the regulator and Moderna to ensure that when the application is resubmitted, it will contain the comprehensive efficacy data needed for proper evaluation.
