Moderna stock falls on mixed results of flu vaccine mRNA-1010 in phase 3 trial
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Moderna (NASDAQ:MRNA) reported interim data from a phase 3 trial of its mRNA-based seasonal influenza (flu) vaccine candidate mRNA-1010 in adults 18 years and older in the Southern Hemisphere.
People received either a single dose of mRNA-1010 or a single dose of a licensed seasonal influenza vaccine as a comparator in the study, dubbed P301.
Data showed that mRNA-1010 achieved superiority on seroconversion rates for influenza A/H3N2 and A/H1N1 lineages, and superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1.
However, non-inferiority was not met for either goals of seroconversion rates and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains, the company added.
Moderna noted that 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.
HA is considered an important target to generate protection against influenza and is the main target of currently available influenza vaccines, according to the company.
The mRNA-1010 vaccine was found to be generally well-tolerated and 70% of mRNA-1010 recipients reported solicited adverse reactions (SARs) compared to 48% of people in the active comparator group, Moderna noted.
The majority of SARs were grade 1. Pain and axillary swelling were the most common local SARs.
The trial enrolled 6,102 adults across Argentina, Australia, Colombia, Panama, and the Philippines during the Southern Hemisphere influenza season.
In addition, Moderna said an ongoing mRNA-1010 phase 3 trial called P302 being conducted in Northern Hemisphere countries has accrued more than 200 PCR-confirmed cases. More than 99% of confirmed cases in the trial are caused by influenza A viruses.
An interim analysis of efficacy is expected to be reviewed by an independent Data and Safety Monitoring Board (DSMB) before the end of Q1.
Moderna noted that based on these results the DSMB will inform the company if the main efficacy goal has been met or if the trial should continue accruing further cases towards the final analysis.
MRNA -5% to $163.70 premarket Feb. 17