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RSS FeedPosted by Michael Wonder on 15 Feb 2025
European Commission approves CSL and Arcturus Therapeutics’ Kostaive, the first self-amplifying mRNA COVID-19 vaccine
14 February 2025 - Kostaive represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to ...
Posted by Michael Wonder on 11 Oct 2024
Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine receives authorisation in the EU
9 October 2024 - Novavax today announced that the European Commission granted marketing authorisation for Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine ...
Posted by Michael Wonder on 06 Sep 2024
EMA Committee for Medicinal Products for Human Use adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-COV-2 variant JN.1
5 September 2024 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European ...
Posted by Michael Wonder on 28 Jun 2024
Pfizer and BioNTech receive positive CHMP opinion for omicron JN.1 adapted COVID-19 Vaccine in the European Union
27 June 2024 - The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for ...
Posted by Michael Wonder on 25 Jun 2024
Novavax submits application to EMA for updated protein-based 2024-2025 formula COVID-19 vaccine
24 June 2024 - Novavax's JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 ...
Posted by Michael Wonder on 18 Apr 2024
COVID-19 vaccine strain updates: global regulators agree on timing and data requirements
17 April 2024 - International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 05 Dec 2023
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 ...
Posted by Michael Wonder on 31 Oct 2023
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 ...
Posted by Michael Wonder on 16 Oct 2023
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 ...
Posted by Michael Wonder on 14 Sep 2023
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 ...
Posted by Michael Wonder on 06 Sep 2023
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. ...
Posted by Michael Wonder on 05 Sep 2023
SK Bioscience withdraws conditional marketing authorisation for COVID-19 vaccine in EU
4 September 2023 - SK Bioscience said it has voluntarily withdrawn its application for a conditional marketing authorisation license to ...
Posted by Michael Wonder on 31 Aug 2023
InflaRx’s marketing authorisation application for vilobelimab for treatment of critically ill COVID-19 patients under review by European Medicines Agency
30 August 2023 - Regulatory submission based on pivotal data from PANAMO Phase III trial. ...
Posted by Michael Wonder on 30 Aug 2023
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. ...
Posted by Michael Wonder on 07 Jul 2023
Phasing out of extraordinary COVID-19 regulatory flexibilities
6 July 2023 - EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the ...