The US Food and Drug Administration has approved the country’s first mRNA-based influenza vaccine, giving older adults a new option for protection against seasonal flu.
The vaccine, developed by Moderna and called mFlusiva, was approved on August 5 for people aged 50 and above. The decision marks a significant development in influenza vaccination, as mRNA technology could allow manufacturers to produce updated vaccines more quickly when circulating strains change.
A study submitted by Moderna to the FDA and published in the New England Journal of Medicine in May found that mFlusiva was up to 27% more effective than four existing flu vaccines. The trial involved more than 40,000 adults aged over 50 who received either the Moderna vaccine or one of the established vaccines.
Dr Jeanne Marrazzo, chief executive of the Infectious Diseases Society of America, described the approval as an important scientific and public health development.
Influenza can cause serious complications, including pneumonia and respiratory problems, particularly among older adults, young children and people with weakened immune systems.
Traditional flu vaccines can take several months to manufacture because they often rely on growing influenza viruses in eggs. Moderna’s mRNA technology uses genetic instructions to produce the vaccine and could shorten the manufacturing process to about six weeks.
The faster process could allow manufacturers to respond more quickly to changes in influenza strains. Each year, health experts assess viruses circulating around the world and recommend strains for upcoming vaccines. When the selected strains do not closely match those spreading during flu season, vaccine effectiveness can fall.
Moderna plans to make mFlusiva available during the autumn vaccination campaign. Its initial approval is limited to adults aged 50 and older.
The approval comes amid uncertainty over US government recommendations for flu vaccination. Federal guidance has recently changed, with routine vaccination decisions placed more heavily on families and doctors. Several major medical organisations continue to recommend annual flu vaccination for most people.
The vaccine also faced an uncertain path to approval. The FDA initially declined to review Moderna’s application in February, citing concerns about the study design and the choice of comparison vaccines. Moderna subsequently provided additional data and held discussions with regulators before resubmitting its application.
The agency then agreed to consider the vaccine, leading to its approval several months later.
The decision comes as public confidence in vaccines remains a major concern in the United States. Health experts say the new vaccine could offer scientific advantages, but they also acknowledge that convincing people to use it may prove challenging.
Marrazzo said the approval demonstrated the potential of mRNA technology, while warning that mixed messages from government agencies could make it harder for the public to understand the benefits of vaccination.
You must be logged in to post a comment Login