Moderna sees positive results in its COVID flu vaccine trial

Moderna's late-stage trial for its COVID-flu combination vaccine produced positive results, the pharmaceutical and biotechnology company said announced on Monday.

The combination vaccine, which Moderna calls mRNA-1083, produced a higher immune response than standalone vaccines for COVID-19 or flu. The results were also seen among participants aged 65 and older, who often do not respond as strongly to vaccines as younger individuals.

The announcement makes Moderna the first to report positive Phase 3 data for its combination vaccine, putting the company slightly ahead of Pfizer and BioNTech, which initiated a Phase 3 trial for its combination flu and COVID-19 vaccine last year . Vaccine developer Noravax is also testing a combined injection for the same viruses.

“Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine. Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health,” said Chief Executive Officer of Moderna. Stéphane Bancel said in a statement.

Bancel told MSNBC Moderna plans to apply for regulatory approval for the combination, which was listed in the US this summer, and aims to bring it to market in 2025.

She said Monday that the combination shot will hopefully reduce the “burden” of respiratory viruses on health care systems and pharmacies while offering patients a more convenient vaccination option.

The mRNA-1083 vaccine consists of Moderna's seasonal flu vaccine candidate and mRNA-1283, its “next generation” COVID-19 vaccine candidate. Each of the experimental vaccines showed positive Phase 3 clinical trial results.

The Phrase 3 study for the combined vaccine involved 8,000 patients. In a cohort of about 4,000 adults aged 65 and older, researchers compared the combination shot with Fluzone HD, an improved flu vaccine, and Spikevax, Moderna's currently approved COVID-19 shot.

In a second cohort of adults aged between 50 and 64, the study compared the combination vaccine with Fluarix, a standard flu shot, and Spikevax.

Moderna's combination vaccine produced “statistically significantly higher immune responses” against three flu strains and COVID-19 in both groups.

The safety and tolerability of the injection were “acceptable”, the company said, with the most serious reactions being pain, fatigue, myalgia and headache.

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