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: International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines (new)
Last updated: 16/07/2021
Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 vaccines to address emerging coronavirus variants. The important role of regulatory alignment is described in the summary of the second workshop on COVID-19 vaccine development and virus variants, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), which has been published today.

COVID-19 variants have been emerging since March 2020, steadily spreading already before the start of the vaccination campaigns in Europe and abroad. In light of continued mutations and new variants emerging globally, medicines regulators from around the globe have stressed the urgent public health priority to streamline regulatory processes and requirements for the development of new and adaptations of already-approved vaccines to protect against current or future strains.

Workshop participants discussed key regulatory considerations related to the development of second-generation COVID-19 vaccines and booster doses. In particular, they exchanged views on the use of immunobridging (i.e. an approach to infer the likelihood of a vaccine’s protective effect) in the assessment of second-generation COVID-19 vaccines, the design and use of controlled clinical trials (placebo or other controls), and correlates of immunity (i.e. levels of a specific immune marker that indicates optimal protection has been achieved) for vaccines against COVID-19. They also highlighted challenges and issues, such as authorisation of second-generation vaccines and alternative approaches to demonstrate vaccine efficacy, where alignment between regulators is needed to respond to the emerging COVID-19 virus variants. The virtual workshop took place on 24 June 2021

 

News: EMA and ECDC update on COVID-19 (new)
Last updated: 14/07/2021

 

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European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en
Latest Updates
SARS-CoV-2 resurgence in EU and EEA related to relaxation of non-pharmaceutical interventions and increasing spread of Delta variant
News story
16 Jul 2021
There has been a 64.3% increase of weekly COVID-19 cases compared to last week, according to ECDC’s epidemic intelligence and TESSy data reported by EU and EEA countries, as of 15 July 2021.

EMA and ECDC update on COVID-19
News story
14 Jul 2021
Complete vaccination courses vital for maximum protection.

 

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https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

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European Commission
https://ec.europa.eu/commission/presscorner/home/en
Press release 16 July 2021
European Green Deal: Commission proposes new strategy to protect and restore EU forests
Today, the European Commission adopted the New EU Forest Strategy for 2030, a flagship initiative of the European Green Deal that builds on the EU Biodiversity Strategy for 2030.

Press release 15 July 2021
EU founding values: Commission starts legal action against Hungary and Poland for violations of fundamental rights of LGBTIQ people
Equality and the respect for dignity and human rights are core values of the EU, enshrined in Article 2 of the Treaty of the European Union. The Commission will use all the instruments at its disposal to defend these values.

Press release 15 July 2021
Coronavirus: Over 3 million vaccines doses shared via the EU Civil Protection Mechanism
Following new offers of assistance from EU Member States to countries in need, the Commission has so far supported the sharing of over 3 million COVID-19 vaccines with countries outside of the EU through the European Civil Protection Mechanism…
Currently the EU is supporting the delivery of the following offers via the European Civil Protection Mechanism:
Albania: 250 000 doses from Denmark and 30 000 from Latvia;
Bhutan: 129 000 vaccine doses from Denmark and 10 000 doses from Croatia;
Bosnia and Herzegovina: 250 000 doses from Denmark;
Kosovo: 250 000 doses from Denmark;
North Macedonia: 250 000 doses from Denmark;
Taiwan: 10 000 doses from Slovakia;
Tunisia: 50 400 doses from Latvia;
Ukraine: 500 000 doses from Denmark and 100 800 doses from Romania;

The following offers have already been delivered via the European Civil Protection Mechanism:
Albania: 100 000 doses shared by Greece;
Bhutan: 121 900 vaccine doses delivered from Denmark;
Bosnia and Herzegovina: 120 000 doses delivered from Greece;
Cabo Verde: 150 150 doses shared by the Netherlands;
Kosovo: 182 900 vaccines doses delivered from Norway;
Moldova: 405 600 vaccine doses shared by Romania;
North Macedonia: 100 000 doses delivered from Greece;
Serbia: 50 400 doses shared by Romania;
Suriname: 156 000 doses shared by the Netherlands;

Press release 15 July 2021
Commission refers HUNGARY to the Court of Justice of the European Union for unlawfully restricting access to the asylum procedure
Today the Commission has decided to refer Hungary to the Court of Justice of the European Union for unlawfully restricting access to the asylum procedure in breach of Article 6 of the Asylum Procedures Directive (Directive 2013/32/EU).

Press release 12 July 2021
Humanitarian aid: EU mobilises €22 million to support most vulnerable in Iran and Pakistan
Today the Commission has announced renewed support for those most in need in Iran and Pakistan with €22 million in humanitarian aid.

Press release 10 July 2021
Taxation: Historic global agreement to ensure fairer taxation of multinational enterprises
The European Commission welcomes the historic global agreement endorsed by G20 Finance Ministers and Central Bank Governors today, which will bring fairness and stability to the international corporate tax framework.