A nurse prepares a flu shot at Huntington Village Pediatrics, in Huntington, New York on December 8, 2021.
Steve Pfost | Newsday | Getty Images
Moderna announced today that its pioneering mRNA-based flu vaccine outperformed an existing flu vaccine in a late-stage trial, demonstrating a more potent immune response against four strains of the virus.This breakthrough development clears the path for approval in the United States.
Following the announcement, Moderna’s stock rose 4% in premarket trading today.
These results are significant for Moderna as it seeks to expand its pipeline beyond its highly successful mRNA Covid vaccine, which has recently gained additional approvals from U.S. regulators. Moderna anticipates that its Covid vaccine, along with its flu shot and other respiratory vaccines in the experimental stage, will generate up to $15 billion in sales by 2027.
This achievement comes as a relief to Moderna, as the company had to postpone its experimental flu shot program earlier this year. The initial vaccine formulation did not yield sufficient data to assess its effectiveness, prompting the company to reformulate the shot.
The latest phase three trial showed promising results for Moderna’s flu vaccine, named mRNA-1010. The vaccine was compared to Fluarix, a currently approved flu vaccine from GlaxoSmithKline.
An interim analysis of the trial revealed that mRNA-1010 elicited higher levels of antibodies for all four influenza strains recommended by the World Health Organization, surpassing the performance of Fluarix. Moderna’s flu shot also resulted in higher seroconversion rates, indicating the development of specific antibodies against the virus.
In terms of safety, the trial produced consistent findings with previous studies, identifying muscle pain, headache, fatigue, pain, and swelling as the most common side effects of mRNA-1010.
In other news, Moderna announced the discontinuation of a separate phase three trial for the initial version of its flu vaccine due to insufficient data for assessing efficacy.
Additionally, Moderna expects a decision from the Food and Drug Administration on its mRNA vaccine for respiratory syncytial virus (RSV) in adults aged 60 and older by April. The FDA approved RSV vaccines for older adults from Pfizer and GSK in May.
Moderna CEO Stephane Bancel expressed satisfaction with 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.”
The company will be hosting a virtual event at 1 p.m. ET today to discuss research and development updates with investors.
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