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Moderna Inc. announced positive interim results from a Phase 1/2 trial of its combination vaccine against COVID-19 and flu on Wednesday, and said it would start a Phase 3 trial for adults aged 50 and above this year.
The trial sought to evaluate the safety and immunogenicity of the vaccine called mRNA-1083 compared to a standard dose influenza vaccine, Fluarix, in adults 50-64 years of age, and against an enhanced influenza vaccine, Fluzone HD, in adults 65-79 years of age. For both age groups, mRNA-1083 was compared against the company’s Spikevax COVID booster.
The trial found mRNA-108 achieved antibody titers similar to or greater than both licensed flu vaccines and achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax booster.
The trial found no new safety concerns compared to the standalone vaccines and adverse reactions were similar to the standalone COVID vaccine and mostly grade 1 or 2 in severity.
The company expects to launch the Phase 3 trial in 2023 and is aiming for approval in 2025.
“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies,” Moderna Chief Executive Stéphane Bancel said in a statement.
Flu epidemics occur seasonally and vary in severity from year to year, putting a burden on healthcare systems. The flu causes 3 to 5 million severe disease cases a year and 290,000 to 6750,000 deaths, despite the availability of vaccines. Older people are more vulnerable to flu and its complications.
Moderna has previously said it expects respiratory product sales of $8 billion to $15 billion in 2027, producing operating profit of $4 billion to $9 billion.
The news comes a day after the Food and Drug Administration approved the updated COVID vaccine developed by Novavax Inc. for people aged 12 and older. Unlike the mRNA vaccines developed by Moderna and Pfizer
PFE,
and BioNTech
BNTX,
the Novavax
NVAX,
one triggers an immune response with a more traditional protein-based approach.
The new vaccine was developed to target the omicron subvariant XBB.1.5 but also appears to be effective against newer variants, according to the vaccine makers. Novavax said in August that its new shot appeared effective against the EG.5.1 “Eris” and XBB.1.16.6 variants.
Last month, the FDA approved new COVID vaccines developed by Pfizer and Moderna.
The stock
MRNA,
was up 0.6% premarket but has fallen 43% in the year to date, while the S&P 500
SPX
has gained 10%.
