Moderna’s Phase 3 Flu Vaccine Trial Shows Promising Results for Licensure


Moderna has announced that its experimental mRNA-based flu vaccine demonstrated a stronger immune response against four strains of the flu virus than an existing flu vaccine in a late-stage trial. These results pave the way for a potential path to approval in the United States.

The late-stage trial compared Moderna’s flu vaccine, mRNA-1010, to the currently approved seasonal flu vaccine Fluarix by GlaxoSmithKline (GSK). The interim analysis found that mRNA-1010 produced higher antibody levels for all four influenza strains recommended by the World Health Organization (two strains of influenza A and two of influenza B) compared to Fluarix. Additionally, Moderna’s flu shot generated higher seroconversion rates, indicating the development of specific antibodies against the virus.

Moderna aims to diversify its product portfolio beyond its highly successful mRNA COVID-19 vaccine. The company expects that its COVID-19 vaccine, flu vaccine, and other experimental respiratory vaccines will collectively generate up to $15 billion in sales by 2027.

This announcement is significant for Moderna, as it had previously delayed its experimental flu shot program in April due to insufficient data on its initial vaccine formula. After reformulating the shot, the latest phase three trial has demonstrated promising results, providing an alternative to existing flu vaccines.

Moderna also revealed plans to conclude a separate phase three trial for the first version of its flu vaccine, which did not generate enough cases to provide efficacy data.

In addition to the flu vaccine development, Moderna is awaiting a decision from the Food and Drug Administration (FDA) on its mRNA vaccine for respiratory syncytial virus (RSV) in adults aged 60 and older by April. The FDA previously approved RSV vaccines for older adults from Pfizer and GSK in May.

Moderna’s CEO, Stephane Bancel, expressed confidence in their mRNA platform’s success, noting that the company has achieved positive phase 3 data for respiratory disease programs in COVID-19, flu, and RSV.

Moderna plans to provide further updates on its research and development during a virtual event with investors.