February 26, 2024

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What are the clinical results of Moderna mRNA influenza vaccine?

What are the clinical results of Moderna mRNA influenza vaccine?

What are the clinical results of Moderna mRNA influenza vaccine?

On December 10, 2021, Moderna announced that its Phase 1 clinical trial of the influenza vaccine mRNA-1010 has obtained positive interim data.

mRNA-1010 is a quadrivalent seasonal influenza mRNA candidate vaccine, targeting four seasonal influenza virus strains recommended by the World Health Organization (WHO), including influenza A virus strains H1N1 and H3N2, and influenza B virus strain Yamagata And Victoria.

The test results showed that in young adults and elderly people, 29 days after vaccination with mRNA-1010 candidate vaccine, the level of antibodies against all virus strains was increased.

Moderna also announced that the phase 2 clinical trial of mRNA-1010 has completed the enrollment of all 500 subjects, and preparations for the phase 3 clinical trial are in progress.

The epidemic of seasonal flu causes respiratory diseases and places a huge burden on the healthcare system.

According to WHO estimates, there are approximately 3 million to 5 million severe cases of influenza worldwide each year, and approximately 290,000 to 650,000 influenza-related respiratory disease deaths occur.

However, the current influenza vaccines are only about 40-60% effective, and their formulations were decided 6-9 months before the planned use of the vaccine.

In addition, most of the licensed flu vaccines use egg-based culture technology, which may allow the vaccine virus to produce unexpected antigenic changes.

This phase 1 clinical trial evaluated the effects of 3 doses of mRNA-1010 (50 µg, 100 µg, and 200 µg) in a cohort of young adults (18-49 years) and elderly (over 50 years).

In young adults, compared with baseline, the geometric mean titer (GMT) of antibodies against H1N1 increased by about 10 times, the GMT of antibodies against H3N2 increased by about 8 times, and the GMT of antibodies against Yamagata and Victoria increased by 3 times and 2 times, respectively.

No significant dose dependence was observed, which means that lower dose vaccines may be explored.

What are the clinical results of Moderna mRNA influenza vaccine?

▲The immunogenicity data of mRNA-1010 in young adults (picture source: Moderna official website)

In the elderly group, compared with baseline, the increase in antibody GMT was 6 times (H1N1), 6 times (H3N2), 3 times (Yamagata), and 2 times (Victoria).

In terms of safety, no serious safety signals were observed. At higher doses, more adverse reactions (AR) were reported in the young group.

The most common local AR in the two age groups included pain and axillary swelling/tenderness, and the most common systemic AR included fatigue, arthralgia, myalgia, and headache.

Mr. Stéphane Bancel, CEO of Moderna, said: “About 3 million people die from respiratory infections every year, and many more people are hospitalized or sick.

At Moderna, our goal is to develop a new coronavirus + influenza virus + respiratory tract A single-dose booster vaccine for syncytial virus (RSV).

The positive interim results of the phase 1 clinical trial of our quadrivalent influenza vaccine candidate mRNA-1010 are an important milestone in achieving this goal.”


[1] Moderna Announces Positive Interim Phase 1 Data for mRNA Flu Vaccine and Provides Program Update. Retrieved December 10, 2021

What are the clinical results of Moderna mRNA influenza vaccine?

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