08:43 AM EDT, 06/10/2024 (MT Newswires) -- Moderna ( MRNA ) released positive data from a phase 3 clinical study of its combined vaccine for influenza and COVID-19 on Monday, saying the product was more effective versus existing standalone shots for the viruses.

The candidate, called mRNA-1083, met the primary endpoints of the trial and elicited a "higher immune response" to licensed comparator vaccines, according to the drugmaker. The product is made up of Moderna's ( MRNA ) mRNA-1010 vaccine candidate for seasonal influenza and its "next generation" COVID-19 vaccine candidate mRNA-1283.

"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," Chief Executive Stephane Bancel said in a statement.

The trial evaluated mRNA-1083 in two age group cohorts of 4,000 adults. In people aged 65 years and older, the product was compared to Sanofi's (SNY) Fluzone enhanced influenza vaccine and Moderna's ( MRNA ) COVID-19 Spikevax vaccine. The candidate was compared in the other group of adults aged 50 to 64 years to GlaxoSmithKline's (GSK) Fluarix vaccine and Spikevax.

The immune responses from mRNA-1083 weren't inferior to the other licensed vaccines, Moderna ( MRNA ) said. The combined vaccine showed "statistically significantly higher" immune responses against three influenza virus strains and the omicron variant of COVID-19 in both age groups, the company said.

The product showed an "acceptable" tolerability and safety profile, the company said. The majority of the adverse reactions were consistent with the existing vaccines used in the trial, such as injection site pain, fatigue, myalgia and headache. Moderna ( MRNA ) said it will work with regulators on the next steps for the vaccine.

The drugmaker announced at the end of May that the US Food and Drug Administration approved its mRESVIA respiratory syncytial virus vaccine, or RSV, for people aged 60 years and above. Earlier in the same month, the company reported that its first-quarter revenue plunged to $167 million from $1.86 billion the year before.

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