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RSS FeedPosted 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 ...
Posted by Michael Wonder on 06 Jul 2023
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, ...
Posted by Michael Wonder on 05 Jul 2023
Global regulators confirm good safety profile of COVID-19 vaccines
5 July 2023 - EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the ...
Posted by Michael Wonder on 04 Jul 2023
Moderna submits regulatory application to the EMA for its updated COVID-19 vaccine
3 July 2023 - The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 ...
Posted by Michael Wonder on 06 Jun 2023
EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
6 June 2023 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...
Posted by Michael Wonder on 30 May 2023
Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...
Posted by Michael Wonder on 30 May 2023
Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU
26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as ...
Posted by Michael Wonder on 11 May 2023
EMA and European medicines regulatory network lift COVID-19 business continuity status
10 May 2023 - EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully ...
Posted by Michael Wonder on 09 May 2023
Statement from Emer Cooke on the end of the COVID-19 public health emergency
9 May 2023 - On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern ...
Posted by Michael Wonder on 30 Mar 2023
EMA recommends approval of Bimervax as a COVID-19 booster vaccine
30 March 2023 - The EMA’s CHMP has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a ...
Posted by Michael Wonder on 24 Feb 2023
Merck and Ridgeback provide update on EU marketing authorisation application for Lagevrio (molnupiravir)
24 February 2023 - Merck and Ridgeback Biotherapeutics today announced that the CHMP of the EMA has recommended the refusal ...
Posted by Michael Wonder on 07 Dec 2022
ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
6 December 2022 - EMA’s Emergency Task Force considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron ...
Posted by Michael Wonder on 11 Nov 2022
Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
10 November 2022 - Pfizer and BioNTech today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Comirnaty Original/Omicron ...
Posted by Michael Wonder on 11 Nov 2022
Sanofi and GSK’s next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission
10 November 2022 - First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe. ...
Posted by Michael Wonder on 01 Nov 2022
Vaxzevria receives full marketing authorisation in the EU for the prevention of COVID-19
1 November 2022 - AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full marketing authorisation in the European Union. ...