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RSS FeedPosted by Michael Wonder on 19 May 2022
EMA accepts filing of marketing authorisation application for Valneva’s inactivated COVID-19 vaccine candidate
19 May 2022 - 2022 – Valneva today confirmed that the EMA has accepted the filing of a marketing authorisation ...
Posted by Michael Wonder on 17 May 2022
International regulators and WHO: support health care professionals to enhance public confidence in COVID-19 vaccines
17 May 2022 - the EMA has endorsed a statement for health care professionals jointly developed by the International Coalition ...
Posted by Michael Wonder on 17 May 2022
Valneva receives notice of European Commission’s intent to terminate COVID-19 vaccine purchase agreement
16 May 2022 - Valneva today announced that it has received a notice from the European Commission of intent to ...
Posted by Michael Wonder on 16 May 2022
Pfizer and BioNTech provide update on COVID-19 vaccine supply agreement with European Commission
13 May 2022 - May 13, 2022 — Pfizer and BioNTech today announced they have reached an agreement with the European ...
Posted by Michael Wonder on 01 May 2022
Moderna files to expand conditional marketing authorisation for its COVID-19 vaccine to include children six months to under six years in the European Union
29 April 2022 - The filing follows the European Medicines Agency's Committee for Medicinal Products for Human Use recent decision ...
Posted by Michael Wonder on 06 Apr 2022
ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
6 April 2022 - The European Centre for Disease Prevention and Control and EMA’s COVID-19 task force have concluded that ...
Posted by Michael Wonder on 31 Mar 2022
Novavax submits request to expand conditional marketing authorisation of COVID-19 vaccine in the European Union to adolescents (ages 12-17)
31 March 2022 - If granted, Nuvaxovid COVID-19 vaccine (recombinant, adjuvanted) would be the first protein-based option for adolescents aged ...
Posted by Michael Wonder on 31 Mar 2022
EMA starts review of Sanofi-GSK COVID vaccine application
30 March 2022 - The European Union's drug regulator has started reviewing Sanofi and its British partner GlaxoSmithKline's application seeking ...
Posted by Michael Wonder on 30 Mar 2022
EMA starts rolling review of COVID-19 vaccine HIPRA (PHH-1V)
29 March 2022 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine HIPRA (also known as PHH-1V). ...
Posted by Michael Wonder on 28 Mar 2022
Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis of COVID-19 in a broad population
28 March 2022 - Evusheld retains neutralising activity against the Omicron BA.2 subvariant, now the dominant strain in Europe ...
Posted by Michael Wonder on 24 Mar 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis of COVID-19
24 March 2022 - Recommendation based on Phase 3 PROVENT trial showing a significant reduction in the risk of developing ...
Posted by Michael Wonder on 16 Mar 2022
Europe begins reviewing application for AstraZeneca COVID drug
15 March 2022 - Europe's drug regulator said on Tuesday it had begun reviewing AstraZeneca's application for antibody based COVID-19 therapy, ...
Posted by Michael Wonder on 08 Mar 2022
Vaccine approval before Phase 3 trial results: a consequence of vaccine access inequity
2 March 2022 - The final Phase 3 clinical data for CanSino Biologics' adenovirus type 5 vector vaccine show that Ad5-nCoV ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
24 February 2022 - EMA’s CHMP has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends approval of Spikevax for children aged 6 to 11
24 February 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use ...