Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
European Medicines Agency
News & Press Releases
News: ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic (new)
Last updated: 03/12/2021
[See Milestones above for detail]
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021 (new)
PRAC, Last updated: 03/12/2021
PRAC update on risk of myocarditis and pericarditis with mRNA vaccines
News: EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001) (new)
CHMP, Last updated: 02/12/2021
News: Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca (new)
CHMP, Last updated: 01/12/2021
European Centre for Disease Prevention and Control
Publication & Data
Epidemiological update: Omicron variant of concern (VOC) – data as of 4 December 2021 (12.00)
4 Dec 2021
As of 4 December and since 3 December 2021, 58 additional SARS-CoV-2 Omicron variant of concern (VOC) cases have been confirmed in the European Union and European Economic Area (EU/EEA), contributing to an overall total of 167 confirmed cases so far.
Cases have been reported by 17 countries: Austria (10), Belgium (6), Czechia (1), Denmark (18), Finland (1), France (12, including 2 in Reunion), Germany (15), Greece (1), Iceland (7), Ireland (1), Italy (9), Luxembourg (1), the Netherlands (18), Norway (19), Portugal (34), Spain (7) and Sweden (7) according to information from public sources. One new EU/EEA country (Luxembourg) has reported the Omicron variant and a number of probable cases are currently under investigation in several countries.
The majority of confirmed cases have a history of travel to countries in Africa, with some having taken connecting flights at other locations between Africa and Europe. Several EU/EEA countries (Belgium, Germany, Spain) detected cases without an epidemiological link to areas where community transmission of the Omicron variant is documented or presumed. This indicates that undetected community transmission could be ongoing in these countries. Finland reported cases with travel history within the EU/EEA (Sweden, Denmark).
All cases for which there is available information on severity were either asymptomatic or mild. No deaths have been reported among these cases so far. These figures should be assessed with caution as the number of confirmed cases is too low to understand if the disease clinical spectrum of Omicron differs from that of previously detected variants.
Statement 1 December 2021
Statement by President von der Leyen on facing current and new COVID-19 challenges
Press release 1 December 2021
Commission reiterates calls to step up vaccination, rapid deployment of boosters, vigilance and rapid reaction to Omicron variant
The Commission is today putting forward a common and coordinated EU approach to address effectively the challenges from the resurgence of COVID-19 in many Member States this autumn.
There are rapidly rising case numbers and a renewed pressure on hospitals, which calls for urgent and determined action. The new potential threat from the Omicron variant is adding to these concerns, and underlines the importance of tackling the pandemic to progress towards long-term health security, both in the EU and globally…
Press release 30 November 2021
European Health Union: Commission welcomes agreement on a stronger European Centre for Disease Prevention and Control
Last night, the European Parliament and the Council reached an agreement on a reinforced role for the European Centre for Disease Prevention and Control (ECDC). The revised ECDC mandate will allow the agency to take a stronger role in supporting the EU and its Member States in the prevention and control of communicable disease threats and improve European preparedness for future health challenges…
Statement 26 November 2021
Press statement by President von der Leyen on the new COVID variant
Commission President von der Leyen has given a press statement on the new COVID variant.