Blog
RSS FeedPosted by Michael Wonder on 05 Nov 2020
EMA will assess potential COVID-19 vaccine on ‘case by case’ basis
5 November 2020 - Agency will not specify a minimum level of efficacy. ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 28 Oct 2020
Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein based COVID-19 vaccine
28 October 2020 - COVAX Facility is led by Gavi and aims to secure successful and equitable access to COVID-19 vaccines ...
Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted by Michael Wonder on 15 Oct 2020
EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine
15 October 2020 - The EMA has confirmed that Moderna’s COVID-19 vaccine candidate mRNA-1273 is eligible for submission under the ...
Posted by Michael Wonder on 09 Oct 2020
Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen’s COVID-19 vaccine candidate
8 October 2020 - Agreement provides option for European Union Member States to secure up to 200 million additional doses for ...
Posted by Michael Wonder on 06 Oct 2020
EMA starts second rolling review of a COVID-19 vaccine
6 October 2020 - EMA’s CHMP has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, ...
Posted by Michael Wonder on 05 Oct 2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
5 October 2020 - The EMA has re-affirmed today that it will uphold its long-standing commitment to independence and transparency ...
Posted by Michael Wonder on 01 Oct 2020
EMA starts first rolling review of a COVID-19 vaccine in the EU
1 October 2020 - EMA’s CHMP has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed ...
Posted by Michael Wonder on 22 Sep 2020
CHMP recommends approval of MenQuadfi for active immunisation of individuals from the age of 12 months and older against invasive meningococcal ACWY disease
22 September 2020 - Positive opinion based on a large, international clinical program demonstrating a good safety profile and a high ...
Posted by Michael Wonder on 22 Sep 2020
CHMP recommends approval of Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
22 September 2020 - Positive opinion based on clinical data demonstrating safety and efficacy of Supemtek for adults aged 18 and ...
Posted by Michael Wonder on 20 Sep 2020
Sanofi and GSK will provide up to 300 million doses of COVID-19 vaccine to the European Union
18 September 2020 - Agreement signed today supports scale-up of manufacturing capabilities in several European countries. ...
Posted by Michael Wonder on 17 Aug 2020
AstraZeneca seals deal with EC for coronavirus vaccine supply
17 August 2020 - AstraZeneca has finalised an agreement with the European Commission to supply up to 400 million doses ...
Posted by Michael Wonder on 13 Aug 2020
Once we have it, will we use it? A European survey on willingness to be vaccinated against COVID-19
13 August 2020 - While the focus of attention currently is on developing a vaccine against the Coronavirus SARS-CoV-2 to protect ...