EU recommendations for 2024/2025 seasonal flu vaccine composition

26 March 2024 - EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for ...

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European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...

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GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA for the prevention of RSV disease in adults aged 50-59 at increased risk

29 January 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability ...

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EU medicines agencies reflect on lessons learned from COVID-19

1 December 2023 - The European Medicines Regulatory Network has been at the forefront of the fight against COVID-19 with ...

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EMA accepts Valneva’s Chikungunya vaccine marketing authorisation application for accelerated assessment

27 November 2023 - Valneva today announced that the EMA has performed a technical validation of the marketing authorisation application ...

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EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5

31 October 2023 - The EMA’s CHMP has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of ...

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Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment

25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...

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EU delays approval of Novavax's revised COVID vaccine

16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...

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Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5

14 September 2023 - EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 ...

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European Commission expands Merck’s Ervebo [Ebola Zaire vaccine, live] indication to include children 1 year of age and older

7 September 2023 - Milestone signifies on-going effort to help prepare for outbreaks of Zaire ebolavirus. ...

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Arcturus Therapeutics and CSL announce European Medicines Agency validates marketing authorisation application for ARCT-154 vaccine to prevent COVID-19

5 September 2023 - EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met. ...

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EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5

30 August 2023 - The EMA’s CHMP has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. ...

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European Commission approves Pfizer’s Abrysvo to help protect infants through maternal immunisation and older adults from RSV

24 August 2023 - Abrysvo is the first and only RSV vaccine approved in the European Union for both older ...

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First RSV vaccine to protect infants up to 6 months of age and older adults

21 July 2023 - EMA has recommended granting a marketing authorisation in the European Union for Abrysvo, a vaccine to protect ...

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Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345

5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...

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