Stephen I. Feller , 2025-05-09 20:31:00
Key takeaways:
- Moderna has developed a messenger RNA vaccine that protects against SARS-CoV-2 and seasonal influenza.
- The ongoing phase 3 trial is expected to conclude later this year.
A combination messenger RNA vaccine against COVID-19 and seasonal influenza stacked up well against currently recommended vaccines in a phase 3 trial, according to findings published in JAMA.
The vaccine, mRNA-1083, “met all pre-specified primary immunogenicity objectives in adults 50 years and older,” Amanda K. Rudman Spergel, MD, director of clinical development at Moderna, which manufactures the vaccine, and colleagues wrote.
A phase 3 trial of a combination vaccine against influenza and SARS-CoV-2 generated a stronger immune response among participants compared to two separate vaccines, researchers reported. Image: Adobe Stock
Moderna began the first-ever study of an mRNA vaccine for influenza in 2021, after using the technology to create one of the world’s first COVID-19 vaccines. In 2023, the company announced results from a phase 1/2 trial that showed the combination mRNA vaccine against COVID-19 and influenza elicited neutralizing antibody levels that were as high or higher than existing individual vaccines.
Moderna announced last year that early data from the current phase 3 trial indicated the combination vaccine elicited “statistically significantly higher immune responses” to three influenza virus strains and to SARS-CoV-2. At the time, the company said it hoped to submit the shot for regulatory approval in 2025.
In the newly published study, Rudman Spergel and colleagues analyzed data from 8,015 study participants split into two age groups: 65 years or older (median age, 70 years; 54.2% women; 18.4% Black; 13.9% Hispanic/Latino) and 50 to 64 years (median age, 58 years; 58.8% women; 26.7% Black; 19.3% Hispanic/Latino. They randomly assigned the groups in a 1:1 ratio to receive either mRNA-1083 plus placebo or coadministered influenza and COVID-19 vaccines. (The younger age group received a standard-dose influenza vaccine, and the older age group a high-dose vaccine.)
All participants in the phase 3, randomized, observer-blinded trial were enrolled and vaccinated at one of 146 sites in the United States between Oct. 19, 2023, and Nov. 21, 2023, with data extraction completed on April 9, 2024.
The researchers reported that mRNA-1083 had an acceptable tolerability and safety profile, although adverse reactions were more common and with increased severity among participants who received the combo shot — 83.5% vs. 78.1% among participants aged 65 years and older, and 85.2% vs. 81.8% among those aged 50 to 64 years).
Most of the adverse health events after vaccination were injection site pain, fatigue, myalgia and headache. These adverse events were determined to be grade 1 or 2 in severity and continued for a median duration of 3 to 4 days. Among the two groups, events judged to be related to vaccination were similar (0.8% vs. 1%, respectively), as were medically attended events determined to be vaccination related (0.1% vs 0.2%). Additionally, no cases of myocarditis or pericarditis among participants were reported.
The researchers reported that the combination vaccine elicited noninferior immune responses in participants compared with the individual vaccines against all influenza and SARS-CoV-2 strains.
The researchers concluded that the comparative ease of developing mRNA vaccines as opposed to growing them in eggs “allows for timely and effective public health responses,” making it easier to target currently circulating strains of the viruses.
They also expressed hope that a combination vaccine could increase uptake of both the influenza and COVID-19 vaccines.
“A multicomponent vaccine against influenza and COVID-19 has potential to improve coverage and increase compliance with recommendations, therefor reducing COVID-19-related and influenza-related outcomes and health system burden in adults aged 50 years and older,” they wrote.
References:
Perspective
The immunogenicity results of the combination influenza/COVID-19 results are promising; however, it remains to be seen if the higher antibody concentrations achieved translate into higher protection from infection and severe disease than existing influenza vaccines. Studies with clinical endpoints will help to better evaluate this vaccine. Nonetheless, having more influenza vaccines that do not rely on antiquated and onerous egg-based manufacturing is important for seasonal and pandemic influenza preparedness.
Amesh A. Adalja, MD
Senior Scholar, Johns Hopkins Center for Health Security
Disclosures: Adalja reports no relevant financial disclosures.
Sources/Disclosures
Collapse
Disclosures:
Rudman Spergel reports being an employee of Moderna and possibly holding stock/stock options in Moderna. Please see the study for all other authors’ relevant financial disclosures.
