17.02.2023 13:52:38

Moderna Reports Mixed Results Of Flu Vaccine MRNA-1010 In Phase 3 Trial; Stock Down

(RTTNews) - Moderna (MRNA) reported mixed results from its pivotal Phase 3 safety and immunogenicity trial of mRNA-1010, an mRNA-based seasonal influenza (flu) vaccine candidate, in adults.

In Friday pre-market trade, MRNA was trading at $163.09 down $9.22 or 5.35%.

The trial enrolled 6,102 adults across Argentina, Australia, Colombia, Panama, and the Philippines during the Southern Hemisphere influenza season. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a single dose of a licensed seasonal influenza vaccine as a comparator.

mRNA-1010 encodes for hemagglutinin (HA) glycoproteins of the four influenza strains recommended by the World Health Organization (WHO) to prevent influenza, including influenza A/H1N1, A/H3N2, and influenza B/Yamagata- and B/Victoria-lineages.

According to the company, the interim results showed that mRNA-1010 achieved superiority on seroconversion rates for A/H3N2 and A/H1N1, as well as superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1. Non-inferiority was not met for either endpoints for the influenza B/Victoria- and B/Yamagata-lineage strains.

The company said it now looks forward to the efficacy results from the ongoing pivotal Phase 3 efficacy study being conducted in parallel. The ongoing mRNA-1010 Phase 3 efficacy study (P302) conducted in Northern Hemisphere countries has accrued more than 200 PCR-confirmed cases.

The first per protocol interim analysis of efficacy is now expected to be reviewed by an independent Data and Safety Monitoring Board (DSMB) before the end of the first quarter.

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