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European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion mCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX® (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. "The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine.

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review Moderna has received a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026 CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.

Moderna Receives European Commission Marketing Authorization for COVID-19 Vaccine mNEXSPIKE

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe CAMBRIDGE, MA / ACCESS Newswire / February 17, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mNEXSPIKE® (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. This marketing authorization follows the positive opinion adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and marks Moderna's third product authorized in the European Union, alongside Spikevax® and mRESVIA®, further strengthening the Company's respiratory vaccine portfolio in Europe.