Moderna’s mRNA-based combination flu and COVID-19 vaccine has been given the green light in Europe but remains shelved in the United States, where it was developed.
This week, the European Commission authorized Moderna to market the vaccine, mRNA-1083 or mCOMBRIAX, making it the world’s first authorized combination shot for the two respiratory viruses. The decision remains a positive review in February from a key committee of the European Medicines Agency, which paved the way for approval.
Moderna CEO Stéphane Bancel welcomed the news. “By combining protection against two important respiratory viruses in a single dose, our vaccine aims to simplify the immunization of adults, particularly those at high risk,” Bancel said. in a press release. “mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe.”
mCOMBRIAX combines Moderna’s COVID-19 vaccine with an investigational flu vaccine called mRNA-1010, which is still under review in Europe. The combination injection was authorized based on findings from a Phase III clinical trial involving around 4,000 adults. The trial consisted of two groups, one with participants ages 50 to 64 that included a comparison of a standard flu vaccine, and another ages 65 and older that included a comparison of a high-dose flu vaccine. In both groups, mCOMBRIAX stimulated statistically significantly higher immune responses against common influenza strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 than the comparator vaccines. There were no concerns about safety or adverse events.
