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Multicomponent COVID-19-Influenza Vaccine Induces Higher Immune Responses Than Standard Care Immunizations
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Key Takeaways
- mRNA-1083 showed higher immune responses than standard influenza and COVID-19 vaccines in a phase 3 trial, with an acceptable safety profile.
- The vaccine could alleviate vaccine hesitancy by combining influenza and COVID-19 protection, simplifying vaccination processes.
A new multicomponent vaccine, mRNA-1083, shows promise in enhancing immune responses against influenza and COVID-19, addressing vaccine hesitancy effectively.
mRNA-1083, a multicomponent vaccine designed to protect against seasonal influenza and SARS-CoV-2, was found to induce higher immune responses compared with recommended standard care influenza (standard and high dose) and COVID-19 vaccines against a variety of strains that can sicken patients with an acceptable safety and tolerability profile, according to results from a phase 3, randomized, observer-blinded trial (NCT06097273) published in the Journal of the American Medical Association.1,2
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Multicomponent Vaccine Could Alleviate Hesitancy Concerns
During the onset of the COVID-19 pandemic, as the public retreated to their homes and infection control measures were implemented, the prevalence of influenza was “almost nonexistent” in many areas of the United States, according to experts. Now that COVID-19 has become more endemic in the community, the spread of the seasonal flu has returned to pre-pandemic levels.3,4
As influenza has both disappeared and returned while the COVID-19 vaccine was front-of-mind for most of the public, vaccine hesitancy has steadily heightened in concurrence. Routine vaccine appointments are being missed, and patients are increasingly reluctant to receive yearly seasonal vaccinations. Results from a survey conducted by the National Foundation indicated that a large portion of US adults did not plan to or were unsure if they would get an annual influenza or COVID-19 vaccination.5
It is critical for novel strategies and methods of vaccination to be developed to possibly counter rising vaccine hesitancy and make it easier for patients to receive their respiratory vaccinations. Coadministration of both vaccines has been found to improve coverage and is recommended by clinical guidelines. Investigators have recently made progress on combination influenza-COVID-19 vaccines, with 2 recently being granted fast track designations by the FDA. In the current trial, the authors sought to determine the immunogenicity and safety of an investigational mRNA-based multicomponent vaccine targeting both viruses.1,6
mRNA-1083 Deemed More Effective, Safer Than Standard Vaccines
The vaccine combines aspects of a hemagglutinin-based influenza vaccine (mRNA-1010) and a second-generation SARS-CoV-2 vaccine encoding for spike (S) glycoprotein N-terminal domain and receptor-binding domain. Each vaccine has previously demonstrated efficacy and safety on its own and together in a previous phase 1/2. mRNA-1083 at a dose of 40 μg was compared with standard-dose Fluarix (SD-IIV4; GlaxoSmithKline; 50 to 64 years) or high-dose Fluzone (HD-IIV4; Sanofi; 65 years and older) influenza vaccines and a SARS-CoV-2 vaccine (Spikevax, mRNA-1273; Moderna) in adults 50 years and older.1
According to immunogenicity data gathered by the study authors, mRNA-1083 increased hemagglutination inhibition and antibody levels against each influenza and SARS-CoV-2 strain at day 29 versus baseline. In both sub-studies, the primary immunogenicity objective of noninferiority was met; noninferiority of mRNA-1083 vs SD-IIV4 plus mRNA-1273 and HD-IIV4 plus mRNA-1273 was observed against all influenza and SARS-CoV-2 strains. Importantly, immune responses in both sub-studies among participants with high-risk comorbid conditions were comparable to those without such conditions.1
The study authors observed some solicited adverse reactions (ARs) in each sub-study. Solicited ARs were reported by 83.5% and 78.1% of mRNA-1083 and HD-IIV4 plus mRNA-1273 recipients, respectively, 65 years and older, and in 85.2% and 81.8% of mRNA-1083 and SD-IIV4 plus mRNA-1273 recipients, respectively, aged 50 to 64 years, according to the authors. Notably, most of the solicited local and systemic ARs were grade 1 or 2 across the vaccine groups. Regarding unsolicited adverse events (AEs) within 28 days after vaccination, the rates of such were balanced between each vaccine group, and no AEs led to study discontinuation.1
Data Applications
Compared with other influenza-COVID-19 combinations being developed, mRNA-1083 has advantages due to the mRNA platform used to develop it. These include the avoidance of egg adaptation-related changes and improved breadth of immunity and T-cell responses for the influenza component, the investigators wrote. As a lesson from the experiences of the pandemic, the study authors said that this vaccine could adapt quickly to be coordinated with a public health response and be designed to target appropriate viral strains when necessary.1,5
“Altogether, the results of these interim analyses suggest that mRNA-1083 has the potential to provide protection against 2 respiratory pathogens in a single injection and, hence, positively impact public health,” the investigators concluded.1
