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Moderna’s mNEXSPIKE mRNA COVID-19 Shot Approved by European Commission

Moderna’s mNEXSPIKE mRNA COVID-19 Shot Approved by European Commission

The European Commission (EC) has granted marketing authorization for Moderna’s mNEXSPIKE mRNA COVID-19 shot, allowing it to be marketed across the European Union (U.N.). The authorization follows a regulatory review and permits all 27 E.U. Member States, as well as Iceland, Liechtenstein and Norway, to consider the shot for use within their vaccination programs. It […]

Combination mRNA COVID-Influenza Shot Recommended by European Medicines Agency

Combination mRNA COVID-Influenza Shot Recommended by European Medicines Agency

The European Medicine Agency (EDA) has recommended marketing authorization for Moderna’s mCombriax mRNA (messenger ribonucleic acid) shot. The product, also known as mRNA-1083, is a genetically engineered biologic targeting both influenza and COVID-19. It builds on work Moderna has done on its next-generation mRNA COVID shot known as mNexSpike and mRNA-1010.1 2 3 The recommendation […]

European Commission Probes Sanofi for Possible Antitrust Violations Related to Flu Shots

European Commission Probes Sanofi for Possible Antitrust Violations Related to Flu Shots

French pharmaceutical company Sanofi said that European Commission (EC) officials carried out unannounced inspections at its premises in France and Germany as part of an investigation into its conduct in the seasonal influenza vaccine market.1 It is not clear whether the investigation has any impact beyond Europe, but Sanofi produces influenza vaccines for the U.S. […]

Oxford Begins COVID-19 Vaccine Trials to Meet September Deadline

Oxford Begins COVID-19 Vaccine Trials to Meet September Deadline

On Mar. 17, 2020, European Commission (EC) president Ursula von der Leyen said she was hopeful a vaccine for COVID-19 could be available this September. Her view was based on conversations she had had with managers of German biotechnology firm CureVac AG which has developed an experimental messenger RNA (mRNA) vaccine that it plans to […]

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