First combined COVID-19 and flu vaccine set for EU market

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European drug regulators have recommended granting a marketing authorization for Moderna’s combination flu and COVID-19 vaccine. The shot, dubbed mCombriax, is an mRNA-based vaccine intended to protect people aged 50 years and older from both COVID-19 and seasonal influenza.

The positive recommendation is based on data from a study of around 8,000 participants. It showed that mCombriax triggered the production of adequate levels of antibodies against both influenza and SARS-CoV-2, which were noninferior to those who received the co-administered usual-care vaccines (Moderna’s COVID-19 shot Spikevax and standard flu shots).

The shot contains messenger RNA (mRNA) with instructions for making proteins found on the SARS-CoV-2 virus and on seasonal influenza viruses types A(H1N1), A(H3N2), and the B/Victoria lineage. As with existing COVID-19 and flu vaccines, the composition of mCombriax will be regularly updated to match circulating strains.

While most cases of COVID-19 and influenza are mild to moderate, severe cases can occur, especially among older people and those with compromised immune systems. Co-infection with influenza virus and SARS-CoV-2 can lead to more severe disease than infection with either virus alone.