Moderna's Influenza Vaccine Succeeds in Phase III Clinical Trial

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Moderna’s Influenza Vaccine Succeeds in Phase III Clinical Trial

Moderna’s Influenza Vaccine Succeeds in Phase III Clinical Trial, Clearing Path for Approval

On Sep 13, Moderna announced that its mRNA-1010 influenza vaccine produced a stronger immune response against four influenza viruses in Phase III clinical trials compared to traditional flu vaccines, paving the way for its approval in the United States.

The news initially propelled Moderna’s stock price up by 8%, though it has since narrowed to 3%.

Moderna stated that the efficacy of its influenza vaccine, mRNA-1010, was validated across different patient populations and was found to be safe and well-tolerated.

In a separate study, the company even found that its vaccine outperformed Sanofi’s high-dose influenza vaccine.

Moderna's Influenza Vaccine Succeeds in Phase III Clinical Trial

Furthermore, muscle pain, headaches, fatigue, pain, and swelling were the most common side effects of mRNA-1010, consistent with previous trial results.

Phase III clinical trials are the confirmation stage of therapeutic effects, a critical phase for providing the basis for new drug registration applications, and the final stage before drug approval following Phase I and Phase II clinical trials.

Jefferies analyst Michael Yee noted in a report that Moderna may use this data to seek accelerated approval for its influenza vaccine by the end of the year and potentially launch the vaccine within a little over a year.

This news comes as Moderna is working to bolster its product lineup. Moderna anticipates that by 2027, annual sales of its new products, including the influenza vaccine and RSV vaccine, will reach $15 billion.

Moderna also announced that it is scaling down production of its COVID-19 vaccine to accommodate lower demand in the post-pandemic era. Just this week, the U.S. FDA approved Moderna’s and Pfizer’s newly introduced COVID-19 booster shots for emergency use, designed to provide enhanced protection against currently prevalent variants. Moderna has publicly stated that the updated vaccine will be ready this fall, with the FDA expecting its swift release.

Moderna’s President, Stephen Hoge, stated in an interview that negotiations are underway with partners to downsize production due to the evolving phases of the pandemic, leading to reduced demand for COVID-19 vaccines.

In August, Moderna predicted that the United States would require 50 million to 100 million doses of COVID-19 vaccine in the fall. According to data from the Centers for Disease Control and Prevention (CDC), approximately 153.8 million COVID-19 vaccine doses were administered in the United States in 2022.

Hoge added, “For the past few years, we have been in pandemic mode, producing a billion doses of vaccine every year. We’ve been waiting for that moment when the pandemic formally ends, and we need to restructure our production business.”