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RSS FeedPosted by Michael Wonder on 09 Jan 2026
GSK’s Shingrix (recombinant zoster vaccine) pre-filled syringe presentation approved by the European Commission
7 January 2026 - New presentation will begin rolling out across EU countries in 2026. ...
Posted by Michael Wonder on 06 Jan 2026
Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine
5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...
Posted by Michael Wonder on 13 Dec 2025
GSK’s RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older
12 December 2025 - GSK today announced that the EMA's CHMP has recommended expanding the indication of its adjuvanted recombinant respiratory ...
Posted by Michael Wonder on 31 Jul 2025
EMA CHMP adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant LP.8.1
25 July 2025 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European ...
Posted by Michael Wonder on 26 Jul 2025
Pfizer and BioNTech receive positive CHMP opinion for LP.8.1 adapted COVID-19 vaccine in the European Union
25 July 2025 - Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sub-lineages ...
Posted by Michael Wonder on 14 Jun 2025
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA to expand use in adults 18 years and older
13 June 2025 - Regulatory decision anticipated H1, 2026. ...
Posted by Michael Wonder on 12 Jun 2025
Oxford vaccine against deadly Nipah virus granted EMA PRIME designation
11 June 2025 - The University of Oxford’s vaccine to protect people from deadly Nipah virus has been granted support from ...
Posted by Michael Wonder on 29 May 2025
Pfizer and BioNTech submit EMA application for COVID-19 vaccine targeting LP.8.1 for 2025-2026 season
28 May 2025 - 2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...
Posted by Michael Wonder on 14 May 2025
EMA starts review of Ixchiq (live attenuated chikungunya vaccine)
7 May 2025 - The vaccine must not be used in people 65 years and above while review is underway. ...
Posted by Michael Wonder on 02 Apr 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above
1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...
Posted by Michael Wonder on 01 Apr 2025
European Commission approves Pfizer’s RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease
1 April 2025 - Abrysvo is the first and only RSV vaccine approved in the European Union for non-pregnant adults ...
Posted by Michael Wonder on 27 Mar 2025
European Commission approves Merck’s Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
26 March 2025 - EC decision marks the fourth approval for Capvaxive for pneumococcal vaccination in adults ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...
Posted 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 31 Jan 2025
Highlights from the 27-30 January 2025 CHMP meeting
31 January 2025 - Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the ...