October 04, 2023
2 min read
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Key takeaways:
- Moderna’s messenger RNA combination vaccine generated immune responses similar to existing flu and COVID-19 vaccines.
- The company said a phase 3 trial of the vaccine will start later this year.
Moderna said Wednesday that its messenger RNA-based combination vaccine against influenza and COVID-19 elicited neutralizing antibody levels that were as high — or higher — than existing vaccines in a phase 1/2 trial.
Based on data from the ongoing trial, which is set to conclude in December, Moderna said it will begin a phase 3 trial of the combination vaccine in adults aged 50 years or older this year and is targeting regulatory approval applications for 2025.
Moderna announced positive results from its phase 1/2 trial of a combination vaccine against influenza and COVID-19. Image: Adobe Stock
“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, health care systems and economies,” Moderna CEO Stéphane Bancel, MSc, MBA, said in a press release. “Combination vaccines offer an important opportunity to improve consumer and provers experience, increase compliance with public health recommendations and deliver value for health care systems.”
Moderna recruited roughly 600 participants for the randomized, observer blind trial to test its combination mRNA-1083 vaccine against a standard influenza vaccine in adults aged 50 to 64 years, an enhanced influenza vaccine in adults aged 65 to 79 years, and the company’s bivalent COVID-19 booster in both groups of adults.
According to Moderna, the vaccine achieved antibody titer levels similar to or greater than both quadrivalent influenza vaccines and a SARS-CoV-2 neutralizing antibody titer response similar to the bivalent booster, with geometric mean titer (GMT) ratios of 1 or greater for all comparisons except relative to the bivalent COVID-19 booster in adults aged 50 to 64 years, for which the ratio was 0.9 or greater.
Reported rates of adverse reactions to the combination vaccine were also similar to those from standalone COVID-19 vaccines, with grade 3 local or systemic reactions reported in less than 4% of participants aged 50 years and older.
In 2021, Moderna began testing an investigational mRNA influenza vaccine and said it was expanding its mRNA program to develop vaccines against HIV and Nipah virus. Last month, it announced positive results of the influenza mRNA vaccine, saying it met its primary endpoint in a phase 3 trial and outperformed a high-dose influenza vaccine in the phase 1/2 trial.
In July, the company initiated a rolling submission with the FDA for its mRNA-based vaccine against respiratory syncytial virus vaccine after phase 3 trial data showed it was effective.
References:
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