Blog
RSS FeedPosted by Michael Wonder on 20 Jul 2021
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...
Posted by Michael Wonder on 19 Jul 2021
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
19 July 2021 - EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 13 Jul 2021
European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps
13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...
Posted by Michael Wonder on 11 Jul 2021
EMA advises against use of COVID-19 vaccine Janssen in people with history of capillary leak syndrome
9 July 2021 - EMA’s safety committee has recommended that people who have previously had capillary leak syndrome must not be ...
Posted by Michael Wonder on 09 Jul 2021
Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
9 July 2021 - EMA’s safety committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases ...
Posted by Michael Wonder on 22 Jun 2021
Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine
22 June 2021 - EMA’s CHMP has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed ...
Posted by Michael Wonder on 20 Jun 2021
AstraZeneca welcomes court ruling on supply of its COVID-19 vaccine to Europe
18 June 2021 - AstraZeneca today welcomed the ruling by the Court of First Instance in Brussels. The European Commission had ...
Posted by Michael Wonder on 19 Jun 2021
European regulator EMA says it won't set 50% efficacy threshold for COVID shots
18 June 2021 - The EMA said on Thursday it would not impose a 50% efficacy threshold for COVID-19 vaccines, ...
Posted by Michael Wonder on 14 Jun 2021
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...
Posted by Michael Wonder on 11 Jun 2021
International regulators and WHO address need to boost COVID-19 vaccine confidence
11 June 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have jointly developed a statement ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 07 Jun 2021
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
7 June 2021 - EMA’s COVID-19 taskforce (COVID-ETF) is advising health care professionals in the EU to consider recommendations by learned ...
Posted 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 ...