Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2022
EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 20 Jun 2022
EFPIA and Vaccines Europe are deeply disappointed about the decision taken by World Trade Organization at the Ministerial Conference to endorse a TRIPS waiver for COVID-19 vaccines
17 June 2022 - Speaking about the waiver, EFPIA Director General, Nathalie Moll said. “The decision is a serious retrograde step ...
Posted by Michael Wonder on 19 Jun 2022
Start of rolling review for adapted Spikevax COVID-19 vaccine
17 June 2022 - EMA has started a rolling review for a version of Spikevax adapted to provide better protection ...
Posted by Michael Wonder on 15 Jun 2022
Start of rolling review for adapted Comirnaty COVID-19 vaccine
15 June 2022 - EMA has started a rolling review for a version of Comirnaty adapted to provide better protection ...
Posted by Michael Wonder on 23 May 2022
Vaxzevria approved in the EU as third dose booster against COVID-19
23 May 2022 - Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU approved ...
Posted 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 03 May 2022
VBI Vaccines announces European Commission marketing authorisation for PreHevbri, a 3 antigen adult hepatitis B vaccine
2 May 2022 - Regulatory review in the United Kingdom is on-going as part of the European Commission Decision Reliance ...
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 ...