Europe On 11 December 2025, EMA’s CHMP recommended granting marketing authorisation in the EU for mNexspike, an mRNA COVID-19 vaccine targeting the LP.8.1 variant for the 2025–26 season, adding another option to the adapted boosters already on the market. Source: https://www.ema.europa.eu/en/medicines/human/EPAR/mnexspikeema.europa The European Commission granted marketing authorisation for Moderna’s updated Spikevax formulation targeting SARS-CoV-2 variant LP.8.1 for individuals ≥6 months, with supply planned across all 27 EU member states plus Iceland, Liechtenstein and Norway ahead of the 2025–26 season. Source: https://pharmatimes.com/news/moderna-wins-eu-approval-for-updated-covid-19-vaccine/pharmatimes United States FDA approved Pfizer–BioNTech’s LP.8.1 adapted monovalent COMIRNATY 2025–26 formulation for adults ≥65 years and people 5–64 years with at least one high-risk condition, with shipments starting immediately to US vaccination sites. Source: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approvalpfizer VRBPAC recommendations for 2025–26 COVID-19 vaccine strain selection: FDA’s VRBPAC met on 22 May 2025 to recommend the 2025–26 COVID-19 vaccine formula for use in the US from autumn 2025, aligning strain composition with currently circulating variants. Source: https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025fda China China’s NMPA implemented new biological...
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