Moderna announces positive interim results for next-generation COVID-19 vaccine
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Key takeaways:
- The new vaccine outperformed Moderna’s bivalent vaccine from 2022 in a phase 3 trial.
- The findings pave the way for development of the company’s combination vaccine against COVID-19 and influenza.
Moderna announced positive interim results from a phase 3 trial of its next-generation COVID-19 vaccine, which the company said will help pave the way for its combination shot against COVID-19 and influenza.
The investigational COVID-19 vaccine, mRNA-1283, induced a more robust immune response compared with the company’s bivalent vaccine, mRNA-1273.222, according to a press release.
The updated vaccine design offers a longer shelf life and can be distributed in prefilled syringes, replacing the multidose bottles that have been used for previous COVID-19 vaccines. Moderna said the success “paves the way” for its combination COVID-19 and influenza vaccine — one of several vaccine candidates the company is developing.
The investigational COVID-19 vaccine “is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much-needed vaccine to market,” Moderna CEO Stéphane Bancel, MSc, MBA, said in the release.
Moderna enrolled 11,400 people aged 12 years or older in the United States, United Kingdom and Canada in the ongoing randomized, observer-blind, active-controlled phase 3 NextCOVE trial to compare mRNA-1283 with the older bivalent mRNA-1273.222 vaccine.
The new mRNA-1283 vaccine elicited a higher immune response against the SARS-CoV-2 omicron BA.4 and BA.5 variants and subvariants, as well as the original wild virus, than the previous vaccine, according to the company. Moderna said the benefit was “most acutely seen” in study participants aged older than age 65.
Moderna also announced positive clinical data for three other vaccines against Epstein-Barr virus, varicella-zoster virus and norovirus and said it expects data from phase 3 trials on its combination COVID-19/influenza vaccine and its cytomegalovirus vaccine later this year. Additionally, it is seeking FDA approval and CDC support of its mRNA-based RSV vaccine this year.
“Our mRNA platform continues to have a remarkable track record across our broad vaccine portfolio,” Bancel said. “With five vaccines in phase 3, and three more moving toward phase 3, we have built a very large and diverse portfolio addressing significant unmet needs.”
References:
- Moderna achieves positive interim results from phase 3 trial of next-generation COVID-19 vaccine. https://investors.modernatx.com/news/news-details/2024/Moderna-Achieves-Positive-Interim-Results-from-Phase-3-Trial-of-Next-Generation-COVID-19-Vaccine/default.aspx. Published March 26, 2024. Accessed March 27, 2024.
- Moderna advances multiple vaccine programs to late-stage clinical trials. https://investors.modernatx.com/news/news-details/2024/Moderna-Advances-Multiple-Vaccine-Programs-to-Late-Stage-Clinical-Trials/default.aspx. Published March 27, 2024. Accessed March 27, 2024.
- A study of mRNA-1283.222 compared with mRNA-1273.222 injection in participants age 12 years or older to prevent COVID-19 (NextCOVE). https://classic.clinicaltrials.gov/ct2/show/NCT05815498. Last updated Sept. 7, 2023. Accessed March 27, 2024.
Perspective
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As COVID-19 transitions to endemicity, there will always be need for innovation in the countermeasures used to combat it. In the current era, developing vaccines that have enhanced immunogenicity and provide more protect against infection — protection against mostly severe disease — will be valued.
Also, vaccines that are easier to give in terms of enhanced shelf life and less owner storage requirements will make vaccination programs easier to implement.
Lastly, combination vaccines may make vaccination more convenient for those in certain risk groups that require more frequent vaccination, although not all will merit that frequent dosing.
Perspective
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Influenza and SARS-CoV-2 are two viruses that evolve to overcome pre-existing immunity. Because the body’s immune response is made against parts of the viruses that can change, vaccines must be periodically updated to take account of the actual viruses that will circulate in the forthcoming season.
Because it is likely that both vaccines will be recommended at the same time each year, progress in developing a combination COVID-19/influenza vaccine should help in implementation and, hence, enhancing uptake. Moderna’s announcement of progress in developing a combination vaccine is promising. Results of a phase 3 trial are expected this year.
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