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RSS FeedPosted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
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 29 Aug 2024
European Commission approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk
29 August 2024 - This follows approval in US, with other countries anticipated, including Japan later this year. ...
Posted by Michael Wonder on 25 Aug 2024
Moderna receives European Commission approval for RSV vaccine mRESVIA
23 August 2024 - Moderna today announced that the European Commission has granted marketing authorisation for mResvia (mRNA-1345), an mRNA respiratory ...
Posted by Michael Wonder on 19 Aug 2024
Bavarian Nordic submits data to EMA to extend Mpox/smallpox vaccine approval to adolescents
16 August 2024 - Interim results from clinical study show non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and ...
Posted by Michael Wonder on 01 Aug 2024
BioNet’s recombinant pertussis vaccine submitted to EMA
31 July 2024 - BioNet Europe has announced the submission of a centralised marketing authorisation application to the EMA for its ...
Posted by Michael Wonder on 19 Jul 2024
Bavarian Nordic receives EMA filing acceptance and validation of the MAA for its chikungunya vaccine
18 July 2024 - EMA will now initiate its centralised review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine. ...
Posted by Michael Wonder on 02 Jul 2024
Valneva receives marketing authorisation in Europe for the world’s first chikungunya vaccine Ixchiq
1 July 2024 - 2024 – Valneva today announced that the European Commission has granted marketing authorisation in Europe for Valneva’s ...
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 27 Jun 2024
Bavarian Nordic submits marketing authorisation application for its chikungunya vaccine candidate to EMA
26 June 2024 - Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by ...
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 01 Jun 2024
First vaccine to protect adults from Chikungunya
31 May 2024 - EMA has recommended granting a marketing authorisation in the European Union for Ixchiq, the first vaccine ...
Posted by Michael Wonder on 31 May 2024
Highlights from the 27-30 May 2024 CHMP meeting
31 May 2024 - The EMA’s CHMP recommended 14 medicines for approval at its May 2024 meeting. ...
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 27 Mar 2024
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 ...