Blog
RSS FeedPosted by Michael Wonder on 04 Jun 2021
Advancing international collaboration on COVID-19 real world evidence and observational studies
4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...
Posted by Michael Wonder on 01 Jun 2021
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
1 June 2021 - EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in ...
Posted by Michael Wonder on 28 May 2021
First COVID-19 vaccine approved for children aged 12 to 15 in EU
28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 26 May 2021
EU seeks large AstraZeneca fine
26 May 2021 - A lawyer for the European Union has accused AstraZeneca of failing to respect its contract with ...
Posted by Michael Wonder on 23 May 2021
Pfizer and BioNTech to supply the European Union with up to 1.8 billion additional doses of Comirnaty
20 May 2021 - New agreement to supply 900 million doses to the European Commission, with option to request up to ...
Posted by Michael Wonder on 21 May 2021
Vaxzevria: further advice on blood clots and low blood platelets
21 May 2021 - EMA has provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria ...
Posted by Michael Wonder on 17 May 2021
More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine
17 May 2021 - EMA’s CHMP has recommended a change to the approved storage conditions of Comirnaty, the COVID-19 vaccine ...
Posted by Michael Wonder on 11 May 2021
Additional measures to allow experts to focus on COVID-19 activities
11 May 2021 - EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network ...
Posted by Michael Wonder on 04 May 2021
EMA starts rolling review of COVID-19 vaccine (Vero Cell) inactivated
4 May 2021 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine (Vero Cell) inactivated, developed by Sinovac ...
Posted by Michael Wonder on 03 May 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
3 May 2021 - EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 27 Apr 2021
The European Union sues AstraZeneca over missing vaccine doses
26 April 2021 - The European Union has sued AstraZeneca over what the bloc has described as delays in shipping ...
Posted by Michael Wonder on 26 Apr 2021
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26 April 2021 - The EMA and the European Centre for Disease Prevention and Control today kicked off a new ...
Posted by Michael Wonder on 24 Apr 2021
AstraZeneca’s COVID-19 vaccine: benefits and risks in context
23 April 2021 - Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause ...
Posted by Michael Wonder on 23 Apr 2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderns
23 April 2021 - EMA’s human medicines committee (CHMP) has adopted two important recommendations that will increase manufacturing capacity and supply ...
Posted by Michael Wonder on 22 Apr 2021
WHO and EMA to inspect Sputnik V manufacturing in May
22 April 2021 - Technical experts from the World Health Organization are due to start the next round of their ...