(CTN News) – In a significant development, Moderna announced on Wednesday that its experimental mRNA-based flu vaccine has demonstrated a robust immune response against four strains of the flu virus in a late-stage trial.
This promising outcome paves the way for potential approval in the United States. As a result of this news, Moderna’s stock surged by 4% in premarket trading on Wednesday morning.
This achievement holds particular importance for Moderna as the company strives to expand its product portfolio beyond its groundbreaking mRNA COVID-19 vaccine, which recently received additional approvals from U.S. regulatory authorities.
Moderna anticipates that its COVID-19 vaccine, flu vaccine (mRNA-1010) and other experimental respiratory vaccines, could contribute up to $15 billion in sales by 2027.
These positive results mark a turnaround for Moderna, which faced setbacks earlier in the year when it had to delay its experimental flu shot program due to insufficient data regarding its efficacy. However, the company’s reformulation efforts seem to have paid off in the latest phase three trial.
During the trial, Moderna compared mRNA-1010 to Fluarix, a currently approved seasonal flu vaccine from GlaxoSmithKline.
An interim analysis revealed that mRNA-1010 generated higher levels of antibodies for all four influenza strains recommended by the World Health Organization, including two strains each of influenza A and B, compared to Fluarix.
Moderna’s flu shot also exhibited higher seroconversion rates, indicating the development of specific antibodies against the flu virus.
In terms of safety, the trial results were consistent with previous findings. Common side effects of mRNA-1010 included muscle pain, headache, fatigue, and pain and swelling at the injection site.
In a related announcement, Moderna disclosed its decision to conclude a separate phase three trial involving the initial version of its flu vaccine, as it did not yield sufficient data to determine its efficacy.
Moreover, Moderna expects to receive a decision from the Food and Drug Administration (FDA) on its mRNA vaccine targeting respiratory syncytial virus (RSV) in adults aged 60 and older by April. Notably, in May, Pfizer and GlaxoSmithKline had already received FDA approval for RSV vaccines for older adults.
Modern CEO Stephane Bancel expressed his satisfaction with the progress, stating, “Our mRNA platform is working. 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.”
To gain further insights into Moderna’s research and development updates, the company will host a virtual event at 1 p.m. ET on Wednesday, providing investors with more comprehensive details.