Europe-not US-first to authorize Moderna's combo mRNA flu-COVID vaccine
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Europe-not US-first to authorize Moderna's combo mRNA flu-COVID vaccine
"By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk. mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe."
"The combination shot was authorized based on findings from a Phase III clinical trial of around 4,000 adults. The trial contained two groups, one with participants aged 50 to 64 that included a comparison of a standard flu vaccine, and another aged 65 and up that included a comparison of a high-dose flu vaccine."
"In both groups, mCOMBRIAX spurred statistically-significant higher immune responses against common flu strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 than the comparator vaccines. There were no concerns over safety or adverse events."
Moderna's mRNA-1083, or mCOMBRIAX, has received authorization from the European Commission as the first combination vaccine for flu and COVID-19. This follows a positive review from the European Medicines Agency. The vaccine aims to simplify immunization for adults, especially high-risk individuals. It combines Moderna's COVID-19 vaccine with an investigational flu vaccine, mRNA-1010. A Phase III clinical trial with 4,000 adults showed mCOMBRIAX elicited higher immune responses against flu strains and SARS-CoV-2 compared to standard vaccines, with no safety concerns reported.
Read at Ars Technica
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