Moderna's combined flu, COVID shot successful in study

Moderna has announced promising results from a late-stage study of its combination flu and COVID-19 vaccine, mRNA-1083. This new shot, designed for adults aged 50 and older, showed stronger immune responses against both viruses compared to current vaccines. The mRNA-1083 vaccine incorporates Moderna's second-generation COVID vaccine and an experimental flu vaccine, both of which have previously been tested individually. The study compared mRNA-1083 to Moderna’s approved COVID vaccine, Spikevax, and flu shots from Sanofi and GSK.

In the study, mRNA-1083 was tested on two groups of 4,000 adults. One group included individuals aged 65 and older, who received either the mRNA-1083 shot or a combination of Spikevax and Sanofi’s high-dose Fluzone. The other group consisted of adults aged 50 to 64, who received either the mRNA-1083 vaccine or Spikevax alongside GSK’s Fluarix. The results indicated that mRNA-1083 was statistically non-inferior to the comparator vaccines, while eliciting higher antibody responses to influenza strains H1N1, H3N2, B/Victoria, and SARS-CoV-2.

The study also evaluated immune responses to the B/Yamagata strain of influenza. However, this strain is not commonly circulating anymore, prompting public health officials to recommend its removal from updated flu vaccines. The overall safety profile of mRNA-1083 was comparable to the licensed vaccines, with most adverse events being mild. Common side effects reported were injection site pain, headache, fatigue, and muscle pain.

Moderna believes that the combination vaccine could simplify vaccination efforts and improve coverage, especially among older adults who often need multiple vaccines each fall. If approved, mRNA-1083 could reduce the burden on healthcare workers and enhance public health outcomes. Combination vaccines like Tdap and MMR have already demonstrated benefits in terms of adherence and immunization coverage.

Moderna aims to present the full results of the study at an upcoming medical conference and engage with regulators about the next steps. The company is optimistic about bringing mRNA-1083 to the U.S. market as early as next year, which appears feasible given the positive trial outcomes.

In addition to this combination vaccine, Moderna’s immediate focus includes launching its newly approved RSV vaccine, Mresvia, and achieving its 2024 targets. The FDA recently approved Mresvia for older adults, making it the third RSV vaccine to receive approval, following GSK’s Arexvy and Pfizer’s Abrysvo.

Michael Yee, an analyst at Jefferies, noted that Moderna's pipeline is showing significant progress. However, he emphasized that the company should prioritize the launch of the RSV vaccine and adhere to its 2024 financial guidance.

In summary, Moderna's mRNA-1083 combination flu and COVID-19 vaccine has demonstrated strong immune responses and a favorable safety profile in late-stage trials. If approved, it could offer a more convenient vaccination option, particularly for older adults, while alleviating some of the seasonal burden on healthcare systems. The company's focus remains on introducing this innovative vaccine to the market and advancing its broader vaccine pipeline.