Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment


European Medicines Agency
News & Press Releases
News: COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality (new)
Last updated: 11/06/2021

News: Additional manufacturing capacity for Moderna’s COVID-19 vaccine (new)
CHMP, Last updated: 11/06/2021


News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021 (new)
PRAC, Last updated: 11/06/2021
PRAC concludes review of signal of capillary leak syndrome with COVID-19 vaccine Vaxzevria
EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk…


News: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis (new)
PRAC, Last updated: 11/06/2021


European Centre for Disease Prevention and Control
Latest Updates
Rapid risk assessment: Assessing SARS-CoV-2 circulation, variants of concern, non-pharmaceutical interventions and vaccine rollout in the EU/EEA, 15th update
Risk assessment – 10 Jun 2021
Although SARS-CoV-2 transmission remains widespread in large parts of the EU/EEA, most countries report declining trends in 14-day COVID-19 notification rates, hospital and intensive care unit (ICU) occupancy, and mortality. Many countries have initiated partial lifting of different non-pharmaceutical interventions (NPIs) that aim to reduce the degree of citizens physical contact and mobility. Since January 2021, EU/EEA countries have reported an increase in the number and proportion of SARS-CoV-2 cases of variants of concern (VOC) associated with increasing transmissibility and/or severity, with Alpha (B.1.1.7) the current dominant variant across the EU/EEA. Estimates across the region show that a large proportion of the population across Europe still remains susceptible to SARS-CoV-2 and that population immunity is far from being reached. As of 3 June, the median cumulative vaccine uptake in the EU/EEA adult population (aged 18 years and older) had reached 46.2% for at least one vaccine dose and 22.3% for the full vaccination course. The highest level of vaccine uptake was observed among the elderly aged over 80, in which the uptake reached 80.5% for at least one dose and 66.3% for full vaccination coverage. For healthcare workers, the median level of at least one dose uptake was 87% and the median uptake for the full vaccination course was 65.2%. Increased vaccine supply has allowed countries to expand eligibility for vaccination to younger age groups.


European Commission
No new relevant announcements identified.