As the 2024–2025 respiratory season approaches, U.S. vaccine makers are encountering challenges on multiple fronts. COVID-19 vaccine sales are declining, there is anticipated weak demand for flu vaccines, and the expanding respiratory syncytial virus (RSV) market faces constraints from new recommendations. In this environment, Moderna is working to establish its presence.
Moderna’s Spikevax was a key component in the COVID-19 public health response, but sales have fallen as the pandemic has subsided, prompting the company to explore new growth opportunities. Moderna has received approval for an RSV vaccine, and the FDA recently authorized its updated mRNA COVID-19 vaccine—as well as Pfizer-BioNTech’s Comirnaty—to address current variants in the U.S. Moderna also reported positive Phase III results for a combined flu-COVID vaccine, while Pfizer/BioNTech experienced a setback in late-stage trials that could allow Moderna to advance its position, with the combo vaccine showing stronger immune responses against the coronavirus and three strains of influenza.
According to William Blair analyst Myles Minter, Moderna is “the clear lead for potential approval of a combo flu/COVID mRNA vaccine,” which could significantly impact the quality of its 2026 breakeven guidance, given the recent reduction in 2024 revenue forecasts.
Moderna revised its 2024 revenue estimate downwards from $4 billion to a range of $3 billion to $3.5 billion due to lower demand for its COVID vaccine, as reported in its second-quarter earnings.
Jefferies analyst Michael Yee noted that the updated guidance was “worse than expected” and questioned management’s credibility. “The disappointment is notable as this is the second consecutive year of significant guidance cuts despite consistent high management confidence,” Yee commented.
In the flu market, Moderna is entering a stagnant sector dominated by long-established players. Sanofi is predicting a slight decrease in flu vaccine sales this year due to anticipated “softer vaccination rates,” according to CFO François-Xavier Roger.
The distribution of flu vaccine doses in the U.S. peaked at 194.4 million during the pandemic era (2020–2021) but fell to 157.7 million by the 2023–2024 season. Despite an increase in 2023 over 2019 in those who believe vaccines are essential for preventing flu-related hospitalizations and deaths, the number of doses is still down compared to pre-pandemic levels. Last year’s survey revealed that 31% of people distrust vaccines.
Increasing the COVID Vaccination Rate
Although the flu vaccine market has contracted, flu vaccination rates still significantly surpass COVID-19 vaccine uptake. Minter noted that the U.S. COVID-19 vaccination rate was 11% last year, compared to approximately 44% for flu vaccines. This disparity presents an opportunity for Moderna.
“Can Moderna bridge the gap between the declining COVID-19 vaccine rate and the relatively stable flu rate? That’s the challenge with their potential combination product,” Minter stated. “The goal might not be to expand the flu market, but rather to increase the COVID-19 vaccination rate with a combination product.”
However, Moderna will not have a combination product ready for the upcoming respiratory season. Instead, the company is focusing on a “Back to Basics” awareness campaign to promote the importance of annual COVID-19 vaccinations and educate the public about long COVID. CEO Stéphane Bancel mentioned the campaign’s goal to highlight the risks of long COVID and how vaccines can mitigate them.
The company has initiated the campaign with ads on Facebook and Instagram emphasizing the risks of long COVID. Minter anticipates the ads will have a minimal effect.
“Long COVID isn’t a new issue,” Minter remarked. “The campaign might slightly improve vaccination rates, but it probably won’t make a significant difference for Moderna. The aim is to significantly close the gap between flu and COVID-19 vaccination rates.”
Gaining RSV Market Share
Bancel highlighted that Moderna is facing competitive pressures in both the COVID-19 and RSV markets. The company competes with Pfizer for COVID-19 and with Pfizer and GSK for RSV. The company is struggling as large competitors have bundled products and been more aggressive in areas like supply chain, pricing, and marketing.
Jefferies analyst Peter Welford reported that U.S. prescription volumes for GSK’s RSV vaccine Arexvy increased over 22% week over week, aligning with expectations. “GSK’s market share decreased 120 basis points to 69%, while Pfizer’s Abrysvo saw a slight increase at +29% week over week. Moderna’s mRESVIA remains negligible,” Welford wrote.
Approved by the FDA in late May, Moderna’s mRESVIA is the company’s second product and the third RSV vaccine to enter the market, following GSK and Pfizer’s offerings. However, all three companies face potential declines in vaccine sales due to recent CDC guidelines regarding RSV vaccines in seniors, which Minter believes do not favor any particular vaccine.
Moderna’s strategy to overcome challenges involves differentiating its mRESVIA vaccine with features such as being available in a prefilled syringe and avoiding cases of Guillain-Barré syndrome, a side effect associated with RSV vaccines according to the CDC.
Bancel expressed confidence in the delivery format of mRESVIA, which he believes will appeal to customers by improving efficiency and reducing potential medical errors during the busy vaccination season. However, Moderna CFO James Mock admitted that “this year is not turning out as we expected.” The product arrived too late to impact the 2024–2025 RSV season.
Minter noted that Moderna’s entry into the RSV market was delayed, resulting in missed opportunities as major retail pharmacies had already secured contracts with GSK and Pfizer.
Lee pointed out that Moderna has revised its expectations for RSV and anticipates a slower market entry due to competition and fewer contracts. Management now expects “modest” revenues this year.
Looking ahead to 2025, Moderna hopes for a more level playing field with GSK and Pfizer. Success will depend on factors such as safety, durability, and CDC recommendations, with convenience potentially playing a role. While Moderna may have some advantages, it will need to compete against well-established commercial operations.
“It will ultimately come down to contracting abilities,” Minter concluded. “GSK and Pfizer are formidable competitors in vaccine contracting and bundling.”