Declining flu vaccination rates for U.S. adults and children remain a major public health concern. Education campaigns and efforts to fight misinformation are failing to bring patients in for recommended jabs, but vaccine maker Moderna believes change is on the horizon.
Data from a late-stage study of Moderna’s combination COVID and influenza vaccine this month showed a promising efficacy profile compared to individual shots for each virus. What that means for the potential fall 2025 respiratory season rollout is better uptake thanks to the reduced burden for patients, said Moderna’s vice president of North American medical affairs, James Mansi.
As the CDC’s advisory committee on immunization practices convenes this week to decide the recommendations for the 2024-25 respiratory season, Moderna’s combo shot isn’t yet on the table, but the company is hoping for an FDA approval by August 2025 that would make it ready for fall. Mansi said the COVID-flu duo has the potential to address ongoing “vaccine fatigue” by allowing for more efficient administration in adults, and signifies a potential shift in the adult vaccine market towards a combo approach that’s long been leveraged in infants.
“We’ve optimized the opportunity to make recommendations to providers and immunize at the start of the season with both influenza and COVID, so operationally, I believe we’re in a much better situation than we were in previous years,” Mansi said.
Here, Mansi discusses how the public’s perception of vaccination has changed following the COVID-19 pandemic, how a combo shot could help improve immunization rates and how Moderna’s platform gives the company an edge in keeping up with mutating viruses.
This interview has been edited for brevity and style.
PHARMAVOICE: In what ways did the COVID-19 pandemic change the public’s perception and approach to vaccines?
JAMES MANSI: At the start of the pandemic, everybody was looking for a solution, something to help. And vaccines came onto the stage with great promise and wonderful data — there was the hope that these vaccines could bring us out of the pandemic. Across the board, it panned out. But then there was a shift. There was a perception in May 2023 when the Public Health Emergency was rescinded … that COVID [was] over and there was nothing to worry about. The truth is hospitalizations and mortality are still high, but they’ve been normalized. We need to stop normalizing COVID morbidity and mortality and start normalizing health.
"The COVID and influenza combination is demonstrating a high degree of immune response, even higher than the individual components, and that’s a great leap forward in terms of public health."
James Mansi
Vice president, North America medical affairs, Moderna
How do you strike that balance of saying, yes, the pandemic is over, but we also need to stay vigilant?
The Kaiser Family Foundation found in their survey at the tail end of last year that 93% of the population trusts their healthcare provider to give them advice and recommendations on healthcare. That’s incredibly assuring because they’re the trusted voice, and when they’re communicating a recommendation that is evidence-based based on an individual need, there is understanding of risk and the solutions that are out there. And the recommendation to have a patient updated with the COVID vaccine and influenza at the same time is part of the overall conversation healthcare providers are having with their patients.
Can Moderna fight misinformation head on without ‘feeding the trolls,’ so to speak? As a beneficiary of vaccine sales, how do you take that position as a trusted communicator?
Our role is to ensure that we bring safe and effective vaccines and therapeutics to address the public health need. We need to ensure that the evidence, the research, the evaluation from a safety and efficacy perspective of our vaccines are solid and meet the rigors of the regulatory requirements. But there’s also the point of helping to equip healthcare providers with the knowledge and evidence that allows them to communicate the risk of these different diseases for their patients.
Just this past season, we looked at the effectiveness of the Moderna mRNA updated vaccine in terms of preventing hospitalization, partnering with different [electronic health records] platforms, and what we found was that for individuals who received the vaccine there were 60% fewer hospitalizations from COVID than a cohort of the matched population in the U.S. who didn’t get vaccinated at all. That supports the confidence that healthcare providers know the vaccine works.
What is significant about a combination COVID-flu shot for the 2025 respiratory season?
When we look at pediatrics, the majority of immunizations are given as combinations to deliver the most antigens and give an infant the most protection when they’re in the office. Combining vaccines makes it more effective, more convenient and far more acceptable. But when you look at the adult space, I struggle to identify a combination — there are few and far between. But what we’ve just released, the COVID and influenza combination, is demonstrating a high degree of immune response, even higher than the individual components, and that’s a great leap forward in terms of public health, a great leap forward in the ability to make the vaccine more acceptable and easier to administer at the same time. It’s so important to optimize the opportunity to immunize an individual with the recommended vaccines at the point in time when they’re engaging with their healthcare provider.
Tell me about Moderna’s entrance into the influenza vaccine landscape and the logistics that surround a step into a new area?
From COVID to RSV and now influenza, we’re showing what we’ve been saying over the past several years around the efficiency, speed and ability to manufacture mRNA vaccines with a high degree of biologic similarity to the virus. This platform is incredibly versatile both in effectiveness and speed, especially against highly mutagenic viruses such as COVID and influenza — that speed doesn’t compromise the quality and rigor of evaluating from phase 1 to phase 3 and making that vaccine for a market where recommendations change quickly. That timeline is critical for a public health benefit, and we’re able to pivot when recommendations from the FDA are updated to deliver tens of millions of doses within weeks.
What’s next for Moderna in terms of coordinating the potential launch of the combo shot for fall 2025?
Looking down the line for the combination vaccine, we’re completing our phase 3 studies. The data from a readout was extraordinarily encouraging in terms of immunogenicity and safety. And we’re working hand-in-hand to meet the evidentiary needs and requests from the CDC to evaluate the vaccine for recommendations. So we’re optimistic and on track that this is moving forward for the 2025 season.
One of the themes that underpins all of this is we are constantly working with not just experts, but health systems and community healthcare professionals to be able to address questions that come from patients in terms of perceived risk, safety and efficacy. That’s paramount.
