Moderna discontinues the development of a combined Covid-19 and seasonal flu vaccine, as Robert F. Kennedy Jr., in his ongoing anti-vaccination crusade, continues to raise concerns.
In a strategic move to bolster the evidence base for its groundbreaking combined flu-COVID vaccine, Moderna has temporarily withdrawn its application for approval from the U.S. Food and Drug Administration (FDA). The decision, announced recently, comes as the pharmaceutical giant awaits additional efficacy data from a late-stage trial of its influenza vaccine, which is expected later this year.
The combination vaccine, referred to as a "Super-Vaccine" in a news report, was originally aimed at adults aged 50 and above. Initially, Moderna had hoped for approval in 2025, but the company now anticipates resubmitting the application and potentially receiving approval in 2026 after collecting and analysing more comprehensive data from its influenza vaccine, mRNA-1010. Early Phase 3 results have shown promising efficacy, with 26.6% higher efficacy than a standard flu shot in older adults.
The FDA's new requirement for clinical trials for COVID-19 booster shots and the recent leadership changes at the U.S. Department of Health and Human Services, notably with Robert F. Kennedy Jr., a known vaccine skeptic, taking the top health job earlier in 2025, are believed to have played a role in Moderna's decision.
The implications of this decision are far-reaching. The delay in the availability of a combined flu-COVID vaccine could impact simplified vaccination schedules for older adults, a key demographic at risk for both diseases. The increased regulatory caution, signalled by the FDA's demands for new clinical trials, suggests a potentially more stringent vaccine approval environment.
Investor concerns and pressure on Moderna's shares persist due to declining COVID vaccine revenues, delayed product approvals, and skepticism around mRNA technology, partly fueled by the current US health leadership and advisory committee members questioning mRNA vaccine safety.
The withdrawal also underscores the importance of robust vaccine efficacy data before regulatory approval, as Moderna pursues mRNA vaccines to offset falling revenues from earlier COVID vaccines and respiratory syncytial virus vaccines.
Multiple studies have found that young people are at a substantially higher risk of experiencing myocarditis from a COVID-19 infection compared to getting the vaccine. The development and approval of Moderna's combined vaccine are currently facing political challenges.
In summary, Moderna's temporary withdrawal is a strategic move to reinforce the evidence base for its combination vaccine amid a changing regulatory landscape, which could affect the timing of access to this potentially important seasonal respiratory vaccine.
- "The delay in the approval of Moderna's combined flu-COVID vaccine could potentially impact health-and-wellness for older adults, a demographic at risk for both diseases, as simplified vaccination schedules may be disrupted."
- "Gizmodo and other technology-focused media outlets might report on the implication of Moderna's decision, as the withdrawal serves as a reminder of the significance of science-based data in the technology of vaccine development."
- "In the future, the scrutiny on Moderna's mRNA vaccines could continue due to declining COVID vaccine revenues, political challenges, and ongoing skepticism around mRNA technology, especially within the US health leadership."
