A new vaccine developed by Moderna aims to protect against both flu and COVID-19 with just one shot. Early studies suggest the combination vaccine generates a stronger immune response compared to the separate flu and COVID-19 vaccines currently available.
Despite these promising results, the U.S. Food and Drug Administration (FDA) is requesting more evidence before granting approval.
The findings of the study were published in the Journal of the American Medical Association. Moderna’s research included 8,015 adults aged 50 and older. Participants who received the combined vaccine experienced common side effects like pain at the injection site, fatigue, and headaches.
While the study showed that the vaccine created antibodies—which are crucial for fighting off infections—the FDA still wants confirmation that it can actually prevent illness and hospitalizations, not just boost antibody levels.
Moderna initially hoped for faster approval but now expects the vaccine may not be available until 2026. Dr. Greg Poland, a vaccine expert at the Mayo Clinic, expressed his support for the FDA’s cautious approach, emphasizing the need to confirm that the shot truly prevents sickness, not just increases antibody levels.
The study’s results so far are based on measurements of antibodies in the blood just 29 days after vaccination. While the presence of antibodies is a good sign, it does not necessarily mean that people are fully protected from getting sick. More data is needed to see if the vaccine actually reduces infections and severe illness over time.
The flu component of the combined shot uses mRNA technology, the same method used in existing COVID-19 and RSV vaccines. This technology works by introducing a lab-created molecule that prompts the body to produce an immune response against the virus.
Although mRNA has been successfully used for COVID-19 vaccines, it has not yet been approved for flu shots. Moderna believes that using mRNA technology could make flu vaccine production faster and more efficient compared to traditional methods, which rely on growing the virus in chicken eggs or large containers of cells.
Moderna also hopes that combining the flu and COVID-19 shots will increase vaccination rates, making it easier for people to stay protected against both viruses with just one visit. However, some experts are unsure if the public will embrace the idea.
Dr. Poland pointed out that flu outbreaks are generally seasonal, while COVID-19 spreads throughout the year, making it tricky to determine the best timing for the combined shot.
Stephen Hoge, Moderna’s President, told investors that discussions with the FDA are progressing as usual, even though some public figures, like U.S. Health Secretary Robert F. Kennedy Jr., have raised concerns about mRNA vaccine safety.
Moderna remains confident that the combination shot is both safe and effective, though it acknowledges that more research is needed to meet the FDA’s standards.
In related news, Novavax recently announced that the FDA is requiring them to conduct a new trial for its protein-based COVID-19 vaccine after it receives full approval. This decision raises questions about the approval process and the future of vaccine development for COVID-19 and other illnesses.
Overall, the development of a combined flu and COVID-19 shot could be a major step forward in vaccine technology, potentially simplifying the way people protect themselves against these widespread infections.
However, the FDA’s call for more data highlights the need for solid proof that the vaccine not only boosts immune response but also genuinely reduces the risk of illness and hospital visits. As Moderna continues its studies, the world watches closely to see if this new approach will become a reality in the fight against seasonal flu and year-round COVID-19.
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The research findings can be found in JAMA.
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