In a recent late-stage trial, Moderna announced that its experimental mRNA-based flu vaccine demonstrated a stronger immune response against four strains of the virus compared to the currently available flu vaccine. This positive result clears the path for potential approval in the United States.
Following this announcement, shares of Moderna increased by 4% during premarket trading on Wednesday.
These results mark an important milestone for Moderna as the company aims to expand its pipeline beyond its successful mRNA Covid vaccine, which recently received additional approvals from U.S. regulators. Moderna forecasts that its Covid shot, along with its flu vaccine and other respiratory vaccines, could generate up to $15 billion in sales by 2027.
Wednesday’s positive results are a relief for Moderna after the company faced setbacks earlier this year when it had to delay its experimental flu shot program. The initial vaccine formula did not yield enough data to determine its efficacy, resulting in the company reformulating the shot.
In the latest phase three trial, Moderna compared its flu vaccine, known as mRNA-1010, to an approved seasonal flu vaccine called Fluarix by GlaxoSmithKline. An interim analysis of the trial revealed that mRNA-1010 generated higher antibody levels for all four strains of influenza recommended by the World Health Organization, outperforming Fluarix. The Moderna vaccine also exhibited higher seroconversion rates, indicating the development of specific antibodies against the virus.
Moderna reported that the safety findings in the trial align with previous trials, with muscle pain, headache, fatigue, and pain and swelling at the injection site being the most common side effects of mRNA-1010.
Additionally, Moderna announced that it is discontinuing a separate phase three trial of the initial version of its flu vaccine due to insufficient cases to provide efficacy data.
Meanwhile, Moderna anticipates receiving a decision from the Food and Drug Administration (FDA) regarding its mRNA vaccine for respiratory syncytial virus in adults aged 60 and older by April. In May, the FDA approved RSV vaccines for older adults from Pfizer and GSK.
Moderna CEO Stephane Bancel expressed confidence in the company’s mRNA platform, stating, “With today’s positive phase 3 flu results, along with previous results in Covid and RSV, we are now three for three on advancing respiratory disease programs to positive phase 3 data.”
A virtual event will be held at 1 p.m. ET on Wednesday for Moderna to discuss research and development updates with investors.
