Moderna’s mRNA-based combination vaccine against both flu and COVID-19 has received the green light in Europe, but remains on the shelf in the US, where it was developed.
This week, the European Commission gave Moderna permission to market its mRNA-1083, or mCOMBRIAX, vaccine, the world’s first authorized combination shot for the two respiratory viruses. The decision is as follows positive feedback from a key European Medicines Agency committee, paving the way for approval in February.
Moderna CEO Stefan Bansel welcomed the news. “By combining protection against two important respiratory viruses in one dose, our vaccine aims to simplify immunization 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 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 approved based on the results of Phase III clinical trials in nearly 4,000 adults. The trial consisted of two groups, one involving participants aged 50 to 64, which included a comparison of the standard flu vaccine, and another group aged 65 and older, which included a comparison of the high-dose flu vaccine. In both groups, mCOMBRIAX induced statistically significant higher immune responses compared to comparator vaccines against common influenza strains (A/H1N1, A/H3N2 and B/Victoria) and SARS-CoV-2. There were no concerns about safety or adverse events.
