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

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



European Medicines Agency
News & Press Releases 
News: Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 (new)
CHMP, Last updated: 25/11/2021



News: A vision for use of real-world evidence in EU medicines regulation (new)
Last updated: 24/11/2021



News: EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19 (new)
CHMP, Last updated: 23/11/2021



News: EMA evaluating data on booster dose of COVID-19 Vaccine Janssen (new)
CHMP, Last updated: 22/11/2021





European Centre for Disease Prevention and Control
Latest Updates
ECDC publishes Threat assessment brief – Emergence of SARS-CoV-2 variant B.1.1.529
News – 26 Nov 2021
The B.1.1.529 variant, first detected in southern Africa, is the most divergent variant that has been detected in significant numbers during the pandemic to date, raising serious concerns that it may significantly reduce the effectiveness of vaccines and increase the risk of reinfections.
ECDC Director Dr Andrea Ammon said: “Today we are releasing a threat assessment on the emergence of a new Sars-COV-2 variant of concern. There is still considerable uncertainty related to the transmissibility, vaccine effectiveness, risk for reinfections and other properties of this variant. At this stage, based on our experience with previous variants we must be proactive and implement measures as a precaution to buy time until we gain more knowledge. Therefore, I would like to reiterate the three key recommendations from our rapid risk assessment from the 24th of November. Firstly, it is imperative we close the immunisation gap. Secondly, booster doses should be considered for all adult individuals, prioritising persons above 40 years of age. Finally, due to the uncertainties involved with this situation, the timely reinforced implementation of non-pharmaceutical interventions is now more important than ever”…

Threat Assessment Brief: Implications of the emergence and spread of the SARS-CoV-2 B.1.1. 529 variant of concern (Omicron) for the EU/EEA
Risk assessment – 26 Nov 2021

WHO/ECDC: Nearly half a million lives saved by COVID-19 vaccination in less than a year
Press release – 25 Nov 2021




Accessed 27 Nov 2021





European Commission
Statement 26 November 2021
Press statement by President von der Leyen on the new COVID variant

Press release 26 November 2021
EU replaces COVID-19 vaccines export authorisation mechanism with new monitoring tool
The EU will not extend the COVID-19 vaccines export transparency and authorisation mechanism, which expires on 31 December 2021.

Statement 25 November 2021
Statement by President von der Leyen on stepping up vaccination
Vaccination against COVID-19 saves thousands of lives in the European Union. But a new wave is hitting us and we need to step up vaccination further.
The good news is that we have enough vaccine doses. By the end of this week, Europe will have delivered 1 billion doses to our Member States.
And another important news is that you should take your booster shot six months after the original vaccination. We must keep up the immunity of people who are vaccinated. The EU agencies recommend now booster doses for all adults. Boosters give us an even higher level of protection than the original vaccination. They will prevent many hospitalisations and deaths.
Finally, we need to convince more people to get vaccinated. A quarter of EU adults are still not fully vaccinated. If you are unvaccinated, you are more at risk of having severe COVID-19 symptoms.
Vaccination protects you, and the others.

Press release 25 November 2021
Coronavirus: Commission proposes to strengthen coordination of safe travel in the EU
Today, the European Commission has proposed to update the rules on coordination of safe and free movement in the EU, which were put in place in response to the COVID-19 pandemic.

Press release 25 November 2021
Coronavirus: Commission proposes an updated framework for travel from outside the EU, prioritising vaccinated travellers, with strong safeguards
The Commission is proposing today to update the Council recommendation on non-essential travel from outside the EU to simplify the framework and reflect recent developments. Priority will be given to vaccinated travellers.