Influenza vaccination rates among U.S. adults and children continue to decline, becoming a major public health concern. Despite numerous educational campaigns and anti-disinformation efforts, coverage for recommended vaccinations has not been effectively improved. Vaccine manufacturer Moderna believes change is brewing.

This month, Moderna released late-stage study data for its combined COVID-flu vaccine, showing it is more effective than separate vaccines for the two viruses. James Mansi, Vice President of Medical Affairs for North America at Moderna, stated that if the vaccine can be approved before the 2025 fall respiratory season, it could help increase vaccination rates by reducing the burden on patients.

The Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention (CDC) met this week to discuss vaccination recommendations for the 2024-25 respiratory season. Although Moderna's combination vaccine is not yet on the agenda, the company hopes to receive FDA approval by August 2025 to catch the fall vaccination window. Mansi noted that the combined COVID-flu vaccine could help alleviate persistent "vaccine fatigue" and, through more efficient adult vaccination methods, drive the adult vaccine market toward a combined vaccination model—a model already widely used in infant and toddler vaccines.

"We have optimized the opportunity to recommend both flu and COVID vaccines simultaneously at the start of the respiratory season, and operationally, I think we are in a better position than in previous years," Mansi said.

In this interview, Mansi discusses how the COVID-19 pandemic has changed public perception of vaccines, how combination vaccines can help improve vaccination rates, and how Moderna's technology platform maintains an advantage in responding to viral mutations.

This interview has been edited for length and style.

PHARMAVOICE: In what ways has the COVID-19 pandemic changed public views and attitudes toward vaccines?

JAMES MANSI:At the beginning of the pandemic, everyone was looking for solutions. Vaccines arrived with tremendous hope and excellent data—people expected vaccines to lead us out of the pandemic. Overall, that goal was achieved. But then there was a shift. After the public health emergency was lifted in May 2023, there was a widespread belief that COVID was over and no longer a concern. The reality is that hospitalization and mortality rates remain high, but they have been "normalized." We must stop treating COVID morbidity and mortality as the norm and instead treat health as the norm.

"The combined COVID and flu vaccine demonstrates high levels of immune response, even higher than the individual components, which is a major leap forward in public health."

—James Mansi, Vice President of Medical Affairs for North America, Moderna

How do you balance the messages of "the pandemic is over" and "we still need to remain vigilant"?

A Kaiser Family Foundation survey late last year found that 93% of the public trusts the health advice and recommendations from their healthcare providers. This is very reassuring because they are trusted voices. When they provide evidence-based recommendations based on individual needs, patients can understand the risks and available solutions. Recommending that patients receive both the COVID vaccine and the flu vaccine is part of the overall conversation between healthcare providers and patients.

How does Moderna directly combat disinformation without "fueling online trolls"? As a beneficiary of vaccine sales, how do you position yourself as a credible communicator?

Our responsibility is to ensure we provide safe and effective vaccines and therapies that meet public health needs. We must ensure that the evidence of vaccine safety and efficacy, research, and evaluations withstand the rigorous scrutiny of regulatory requirements. At the same time, we must help healthcare providers acquire the knowledge and evidence so they can communicate the risks of different diseases to patients.

Just last flu season, we partnered with multiple electronic health record platforms to evaluate the effectiveness of Moderna's updated mRNA vaccine in preventing hospitalizations. The results showed that vaccinated individuals had a 60% reduction in COVID hospitalizations compared to a matched unvaccinated cohort in the U.S. This strengthens healthcare providers' confidence in vaccine effectiveness.

What is the significance of the combined COVID-flu vaccine for the 2025 respiratory season?

In pediatrics, most immunizations use combination vaccines to provide the maximum number of antigens in a single visit, giving infants the greatest protection. Combination vaccines are more efficient, more convenient, and more acceptable. But in the adult space, combination vaccines are scarce. The combined COVID-flu vaccine we just released demonstrates high levels of immune response, even higher than the individual components, which is a major leap forward in public health and a significant advancement in improving vaccine acceptability and streamlining the vaccination process. When patients engage with healthcare providers, optimizing the opportunity to recommend recommended vaccines is crucial.

Please talk about Moderna's entry into the flu vaccine space and the logistical challenges involved in entering a new field.

From COVID to RSV, and now to flu, we are demonstrating the high efficiency, high speed, and high biological similarity to viruses that we have emphasized for years regarding mRNA vaccine manufacturing. This platform is highly flexible in both effectiveness and speed, especially for highly mutating viruses like COVID and flu—speed does not compromise the quality and rigor of evaluations from Phase 1 to Phase 3, nor does it affect the ability to produce vaccines for a market where recommendations change rapidly. This timeline is critical for public health benefits; we can quickly adjust when the FDA updates recommendations and deliver tens of millions of doses within weeks.

What are Moderna's next steps in coordinating the potential launch of the combination vaccine in fall 2025?

Looking ahead to the future of combination vaccines, we are completing Phase 3 studies. The data readouts are extremely encouraging in terms of immunogenicity and safety. We are working closely with the CDC to meet the evidence requirements needed for its vaccine recommendations. Therefore, we are optimistic and on track for the 2025 respiratory season launch.

The overarching theme throughout all of this is that we not only collaborate with experts but also maintain communication with health systems and community healthcare professionals to address patients' questions about perceived risk, safety, and effectiveness. This is crucial.