Moderna’s Flu Shot Struggles to Clear Phase 3 Trial

Moderna has stated that the company’s first-ever seasonal flu vaccine has not met expectations for effectiveness in phase 3 of the ongoing study. The company believes that due to a lack of sufficient cases during the interim analysis of a late-stage study in the northern hemisphere, the vaccine, known as mRNA-1010, did not exceed the statistical threshold necessary to claim early success.

 The independent Data and Safety Monitoring Board did not raise any safety issues but proposed that the experiment move toward the next analysis stage with efficient follow-up.

According to a preliminary examination of immunogenicity from a subgroup of trial participants, mRNA-1010 displayed geometric mean titer ratios, suggesting it was more effective against both influenza A strains than an authorized flu vaccine. When it came to both influenza B strains, the vaccine could only demonstrate non-inferiority to the competition.

This research corroborated findings from a different phase 3 experiment conducted in the southern hemisphere, which revealed that while the vaccination was effective against two influenza A strains, it was less effective against influenza B strains. This is problematic for a prospective vaccination that Moderna praised for improving protection against all strains back in 2021.

Moderna has upgraded mRNA-1010 to boost immunogenicity against influenza B strains to address this vulnerability. A confirmatory phase 3 study is scheduled to begin shortly. According to statements made by Moderna’s senior management, the business was confident that mRNA-1010’s effectiveness would not be shown during the interim analysis. Moderna President Stephen Hoge stated on the company’s fourth-quarter earnings call in that month, “If we do not yet achieve that barrier, then we’ll be looking forward to following interim assessments in that research.”

Hoge further stated that several of the currently licensed influenza vaccines have, in the past, failed on noninferiority for an influenza B strain objective here or there and nevertheless have gained full approval or expedited approvals. Given that Moderna’s shares dropped 6.46% to $149.80 in the morning from a closing price of $160.15, it is uncertain if investors would be willing to invest based on Hoge’s performance.

An early investigation, according to Moderna, did support the intensity of the immunological responses that mRNA-1010 induced in the recent experiment. According to SVB Securities analyst Mani Foroohar, reasoning the results of the trial’s more than 22,000 participants was challenging because comparing immune responses was not a pre-specified research aim. A special investor presentation on vaccinations featured updates on experimental injections for HIV, norovirus, and Lyme disease, as well as a refrigerator-stable version of its COVID-19 vaccine. The flu findings were also presented as part of this presentation.

While Wall Street analysts expect Moderna to continue making billions of dollars a year from its COVID-19 vaccine, they are becoming more interested in other potential avenues of development. One opportunity that investors are eagerly monitoring is the flu vaccine. Tailored cancer therapy and vaccination for the respiratory syncytial virus are among the other avenues. 

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