Moderna’s mRNA-based combination vaccine against both flu and COVID-19 has got the green light in Europe – but it is still in limbo in the US, 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 two respiratory viruses. The decision followed a positive review by a key European Medicines Agency committee in February, paving 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 make vaccination easier for adults, especially 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 health care systems across Europe.”
mCOMBRIAX combines Moderna’s COVID-19 vaccine with an investigational influenza vaccine called mRNA-1010, which is still under review in Europe. The combination shot was authorized based on findings from a Phase 3 clinical trial of nearly 4,000 adults. The trial involved two groups, one with participants aged 50 to 64 that included a comparison of a standard flu vaccine, and the other with participants aged 65 and older that included a comparison of a high-dose flu vaccine. In both groups, mCOMBRIAX induced a statistically significant higher immune response against SARS-CoV-2 compared to the common flu strains (A/H1N1, A/H3N2, and B/Victoria) and comparator vaccines. There were no concerns about safety or adverse events.
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