Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
European Medicines Agency
News & Press Releases
News: EMA recommends Nuvaxovid for authorisation in the EU (new)
CHMP, Last updated: 20/12/2021
EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age.
News: New treatment for sickle cell disease (new)
CHMP, Last updated: 17/12/2021
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021 (new)
CHMP, Last updated: 17/12/2021
…The monoclonal antibody Xevudy (sotrovimab) received a positive opinion from the Committee for the treatment of COVID-19. More details are available in a separate news announcement…
…The CHMP gave a positive opinion for Apexxnar (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)) as prophylaxis against pneumococcal pneumonia and associated invasive disease…
European Centre for Disease Prevention and Control
ECDC updates its guidance regarding quarantine and isolation considering the rapid spread of Omicron in the EU/EEA
News story – 7 Jan 2022
Considering the rapid spread of the Omicron variant of concern (VOC), ECDC is proposing options regarding quarantine and isolation, and recommendations that can be adapted and implemented by EU/EEA Member States when resources are limited and when there is high pressure on healthcare systems and other functions in society (e.g. staff shortage and reduced resources). Due to limited scientific evidence on the epidemiological characteristics of Omicron, the proposed options are not evidence based and may imply an additional risk for transmission.
Weekly epidemiological update: Omicron variant of concern (VOC) – week 1 (data as of 7 January 2022) EU/EEA
Epidemiological update – 7 Jan 2022
Over the past two weeks, a steep increase in COVID-19 notification rates has been observed in several EU/EEA countries.
Statement 6 January 2022
Statement by President von der Leyen on vaccine sharing in 2021 and targets for 2022
The European Union is the biggest donor of safe and effective COVID-19 vaccines so far.
As Team Europe we have exceeded our vaccine-sharing target in 2021.
We promised to share 250 million doses with low and middle income countries by the end of 2021. And in fact we shared 380 million doses, mostly through COVAX.
More than 255 million of these doses were already delivered to recipient countries. And we will do more.
The Team Europe has promised to share 700 million doses by mid-2022. We are on track to fulfill this promise.
In particular, we will step up our efforts to support Africa where vaccination rates are lower than in other parts of the world.
Because we will only control this global pandemic if we fight it in every corner of the world.
Press release 23 December 2021
EU and US officials discuss efforts to donate and deliver 1.7 billion vaccine doses around the world by mid-2022
Press release 22 December 2021
Rule of Law: Commission launches infringement procedure against Poland for violations of EU law by its Constitutional Tribunal
Today, the European Commission has decided to launch an infringement procedure against Poland because of serious concerns with respect to the Polish Constitutional Tribunal and its recent case law.