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Declining influenza vaccination rates in the United States adult and The kids It remains a major public health concern, and awareness campaigns and efforts to combat misinformation have not been successful in increasing patient uptake of the recommended vaccine, but vaccine maker Moderna believes change is on the way.
From the data Late-Stage Research Moderna’s combined COVID-19 and influenza vaccine administered this month showed promising efficacy compared with individual vaccinations of each virus. James Mansi, Moderna’s vice president of North American medical affairs, said this means improved vaccination rates with less burden on patients as vaccinations begin for the fall 2025 respiratory season.
As the CDC Advisory Committee on Immunization Practices Held this week Moderna’s combo vaccine has not yet been considered in determining recommendations for the 2024-25 respiratory disease season, but the company hopes to have it ready by the fall, with FDA approval by August 2025. Mansi said the dual COVID-19/influenza vaccine could address ongoing “vaccine fatigue” by making it more efficient to administer to adults, signaling a possible shift in the adult vaccine market toward a combo vaccine approach that has long been utilized in infants.
“We took full advantage of the opportunity at the beginning of both the flu and COVID-19 seasons to encourage and vaccinate our providers, so operationally we believe we are in a much better position than we have been in years past,” Mansi said.
Here, Mansi discusses how public perception about vaccinations has changed in the wake of the COVID-19 pandemic, how combo shots can help improve vaccination rates, and how Moderna’s platform gives the company an advantage in responding to a mutating virus.
This interview has been edited for clarity and style.
PHARMAVOICE: How has the COVID-19 pandemic changed the public’s perception and approach to vaccines?
James Mansi: When the pandemic started, everyone was looking for a solution, something that would help. Then the vaccines came along with great expectations and great data, and there was hope that these vaccines would get us out of the pandemic. Overall it worked. But then there was a change. When the public health emergency was lifted in May 2023, there was a perception that COVID was over and there was nothing to worry about. In reality hospitalizations and mortality are still high, but they are normalizing. We need to stop normalizing COVID morbidity and mortality and start normalizing health.
“The combination of COVID and influenza shows an even higher level of immune response than each individual component, which is a major step forward in terms of public health.”
James Mansi
Vice President, North American Medical Affairs, Moderna
How do we strike that balance: Yes, the pandemic is over, but we still need to remain vigilant?
The Kaiser Family Foundation investigation A survey late last year showed that 93% of the public trust their healthcare providers for medical advice and recommendations. This is very encouraging because healthcare providers are a trusted voice who understand the risks and available solutions when it comes to communicating evidence-based recommendations based on individual needs. And encouraging patients to get COVID vaccine and flu updates at the same time is part of the overall conversation healthcare providers are having with their patients.
Can Moderna combat disinformation head-on without so-called “feeding the trolls”? How does it view its position as a trusted communicator as well as a beneficiary of vaccine sales?
Our role is to provide safe and effective vaccines and therapeutics that meet public health needs. We need to ensure that the evidence, research and evaluation of vaccines in terms of safety and efficacy is robust and meets the rigour of regulatory requirements. But we also want to provide knowledge and evidence to healthcare professionals so that they can communicate the risks of these different diseases to their patients.
Just this season, we partnered with various (electronic health record) platforms to look at the effectiveness of Moderna’s mRNA updated vaccine in terms of preventing hospitalizations. We found that individuals who received the vaccine had 60% fewer COVID hospitalizations than the same population in the U.S. who did not receive the vaccine at all. This supports the confidence that healthcare providers are aware of the efficacy of the vaccine.
What is the importance of getting the combined COVID and influenza vaccine for the 2025 respiratory season?
In pediatrics, most vaccinations are done in combinations to deliver the most antigens and give the most protection to the infants in the clinic. Combining vaccines makes them more effective, more convenient, and much more acceptable. But for adults, we struggle to identify combinations. There are very few combinations. But the COVID-influenza combination that we recently released has shown a higher level of immune response than the individual components, and this is a major step forward in terms of public health and our ability to make vaccines more acceptable and easier to administer together. At the point where an individual is engaging with their healthcare provider, it is really important to optimize the opportunity to confer immunity with the recommended vaccine.
How did Moderna enter the influenza vaccine field and what are the logistics of stepping into a new field?
From COVID to RSV and now influenza, we have demonstrated what we have been claiming over the past few years about the efficiency, speed, and manufacturing capabilities of mRNA vaccines that are biologically very similar to viruses. This platform is extremely versatile in both efficacy and speed, especially for highly mutagenic viruses like COVID and influenza, and that speed does not compromise the quality and rigor of evaluation from Phase 1 to Phase 3. It also allows us to manufacture vaccines for markets where recommendations are changing rapidly. This timeline is critical to the public health interest, allowing us to pivot to supply tens of millions of doses of vaccine within weeks as FDA recommendations are updated.
What are Moderna’s future plans for the launch of its combo shot in fall 2025?
We are completing Phase 3 trials for the combination vaccine. The data has been very encouraging in terms of immunogenicity and safety. And we are working together to meet the evidence needs and requests from the CDC to evaluate the vaccine for recommendation. So we are optimistic and on track to move forward for the 2025 season.
One of the underlying themes in all of this is that we are constantly collaborating not only with experts, but with health systems and local health professionals to ensure we are able to address questions from patients about risk, safety and efficacy, which is paramount.
