European responses to the corona crisis – Part 14

During the Coronavirus crises, the European Science-Media Hub is collecting and publishing a regular update of the most relevant releases provided by EU institutions and other European and global actors. 🆕 Last Update : 18 June 2021

June, 2021 update

On 15 June 2021: The European Commission publishes early lessons from the COVID-19 pandemic. The 10 lessons take stock of the past 18 months and focus on what can be improved and done better in the future. For example, a new and improved European pandemic information gathering system will be launched in 2021 for faster detection. The EU should also appoint a European Chief Epidemiologist and a corresponding governance structure by the end of 2021.

On 14 June 2021: The Presidents of the EU institutions attend the ceremony for signing the Regulation on the EU Digital COVID Certificate.

On 10 June 2021: To accelerate global vaccine rollout, MEPs voted to temporarily lift the intellectual property rights protection for COVID-19 vaccines. The European Parliament also called on the US and UK to abolish their export ban on vaccines and raw materials, and asked for more support for the global vaccine distribution mechanism COVAX.

On 9 June 2021: the European Parliament gives its final green light to the EU Digital COVID Certificate. This completes the legislative work on this package to facilitate travel within the EU and contribute to economic recovery.

The certificate, accepted and issued free of charge by the member states, proves vaccination, a negative test result or recovery from a COVID infection. A common EU framework will make the certificates interoperable and verifiable across the EU, as well as prevent fraud and forgery. The system will apply from 1 July 2021 and be in place for 12 months.

On top of this, affordable and accessible testing is encouraged: at the request of the EP, €100 million in EU funds is made available for countries to purchase tests.

On 1 June 2021, the technical system behind the EU Digital COVID Certificate goes live with seven countries joining. This system, the so called EU Gateway, will allow the verification of certificates in a secure and privacy-friendly way. Currently, seven Member States are connected and have started to issue and/or verify at least one of the certificates: Bulgaria, Czech Republic, Denmark, Germany, Greece, Croatia and Poland.

May, 2021 update

On 28 May 2021: EMA approves the use of the COVID-19 vaccine Comirnaty (Pfizer/BioNTech) for children aged 12 to 15. The use in these children will be the same as it is in people aged 16 and above: two injections in the muscles of the upper arm, given three weeks apart. The effects of Comirnaty in children were investigated in 2,260 children aged 12 to 15 years.

On 21 May 2021, global leaders (the G20) adopt an agenda to overcome the COVID-19 crisis and avoid future pandemics. Some of the topics on the agenda: equitable access to vaccines, support to low and middle-income countries, and early warning information, surveillance and trigger systems, which will be interoperable

On 20 May 2021, the European Parliament and the Council reach an agreement on the Regulation governing the EU Digital COVID Certificate. This means that the certificate (previously called the Digital Green Certificate) is well on track to be ready end of June, as planned.

On 20 May 2021: The European Commission signs a third contract with BioNTech-Pfizer for an additional 1.8 billion doses on behalf of all EU Member States, between the end of 2021 to 2023. This will allow for the purchase 900 million doses of the current vaccine and an option to purchase an additional 900 million doses.

On 17 May 2021: EMA has approved more flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine. An unopened thawed vial can now be stored for one month instead of five days at 2-8°C (i.e. in a normal fridge). Increased flexibility in the vaccine storage and handling is expected to have a significant impact on planning and logistics of the vaccination roll-out in EU Member States.

On 6 May 2021: Next to having an EU Vaccines Strategy, the European Commission launches a strategy on COVID-19 therapeutics. This will support the development and availability of medicines, including for the treatment of ‘long COVID’.

On 5 May 2021: The World Health Organization (WHO) and the Federal Republic of Germany will establish a new global hub for pandemic and epidemic intelligence, data, surveillance and analytics innovation. The Hub, based in Berlin and working with partners around the world, will lead innovations in data analytics across the largest network of global data to predict, prevent, detect, prepare for and respond to pandemic and epidemic risks worldwide.

On 4 May 2021:
EMA starts evaluating the use of the COVID-19 vaccine Comirnaty (Pfizer/BioNTech) in young people aged 12 to 15. Currently it’s only authorised for use in people aged 16 and older. EMA expects the outcome of its evaluation in June.

On 3 May 2021: The Commission proposes that entry to the EU should be allowed for all persons who are vaccinated and who are coming from countries with good epidemiological situations.

At the same time, the Commission proposes a new ‘emergency brake’ mechanism to be coordinated at EU level which would limit the risk of COVID variants entering the EU. It allows Member States to act quickly and limit all travel from affected countries to a strict minimum for the time needed to put in place appropriate sanitary measures.”

April 23-29, 2021 update

On 29 April 2021:

The European Parliament has adopted its negotiating position on the creation of COVID-19 digital certificates aimed at facilitating safe travel amidst the pandemic. MEPs agreed that the new ‘EU COVID-19 certificate’ (instead of Digital Green Certificate, as proposed by the Commission) should be in place for 12 months and not longer. The Parliament also stressed that certificate holders should not be subject to additional travel restrictions, such as quarantine or testing. And to avoid discrimination against those who couldn’t yet be vaccinated, EU countries should ensure free of charge testing.

On 27 April 2021:
A new European project called IMMUNION has been launched to improve vaccine uptake in the EU. It will strengthen collaboration between healthcare professionals, public health authorities, the media and local communities. The project will also deliver education to health professionals and better information to the general public.

On 27 April 2021:
The EU will ship urgently needed oxygen, medicine and equipment to India, following the country’s request for support.

On 23 April 2021:
A new European forecast hub will support European policy makers in their pandemic planning by providing them with evidence-based near-term forecasts of COVID-19 cases and deaths. This initiative of the European Centre for Disease Prevention and Control (ECDC) comes at a time that many EU countries are relaxing restrictions, “some against a backdrop of increasing numbers of cases and with new variants emerging, while still rolling out their vaccination programmes”.

April 22, 2021 update

On 22 April 2021: Member States, as part of the eHealth Network, agree on the technical specifications of a Digital Green Certificate. This technical implementation, in parallel to the ongoing legislative process, is crucial in order to ensure a roll-out of Digital Green Certificates across the EU by June 2021.

April 20, 2021 update

On 20 April 2021: the European Medicines Agency finds a possible link to cases of unusual blood clots with low blood platelets after use of the COVID-19 vaccine Janssen, but the agency confirms that the overall benefit-risk remains positive. A warning about unusual blood clots with low blood platelets should be added to the product information for the COVID-19 Vaccine Janssen, and these events should be listed as very rare side effects of the vaccine, EMA concludes.

April 7-14, 2021 update

On 14 April 2021: the EU reaches 100 million vaccinations against COVID-19. According to President von der Leyen, vaccination is picking up speed; Member States have received over 126 million doses of vaccines as of 13 April.

On 14 April 2021: the European Commission has taken steps to ensure that borrowing under the temporary recovery instrument ‘NextGenerationEU’ will be on the most advantageous terms for EU countries. The Commission will use a diversified funding strategy to raise up to around €800 billion until 2026 used for the recovery of EU countries from the current crisis.

On 9 April 2021: EMA has started assessing very rare cases of unusual blood clots with low platelets following the use of Janssen’s COVID-19 vaccine. Six of these very rare cases of unusual blood clots occurred in the United States where the agencies FDA and CDC recommended that the use of the vaccine should be paused while they review the reported cases. While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.

On 8 April 2021: last year, ‘Team Europe’ supported 130 partner countries with more than €26 billion. This amount was spent on humanitarian needs, strengthening health, water and sanitation systems and on mitigating the socio-economic consequences of the pandemic. Team Europe is also working to ensure global, equitable access to COVID-19 vaccines and supporting the rollout of vaccination campaigns, while exploring possibilities for boosting local manufacturing capacity. The EU played a leading role in setting up the COVAX Facility, where Team Europe is one of its leading donors, with over €2.2 billion.

On 7 April 2021: the European Commission announced that it is mobilising €123 million from Horizon Europe for urgent research into coronavirus variants. This first emergency funding under Horizon Europe adds to a range of EU-funded research and innovation actions to fight COVID-19 and is in line with the new European bio-defence preparedness plan HERA Incubator.

On 07 April 2021:
the European Medicines Agency (EMA)’s safety committee has concluded its review of very rare cases of unusual blood clots with the AstraZeneca vaccine. EMA finds a possible link to very rare cases of unusual blood clots with low blood platelets. EMA confirms that the overall benefit-risk remains positive.

March 23-25, 2021 update

On 25 March 2021: European Commission President Ursula Von der Leyen revealed that the EU has exported 77 million doses of vaccines to 33 countries since 1 December 2020. As a lead donor to COVAX, it has also contributed to exports to low and middle-income countries. She called on pharmaceutical companies to honour their contracts and match Europe’s ‘openness’ when it comes to the distribution of COVID-19 vaccines.

On 24 March 2021: the European Parliament held a Plenary debate on the Digital Green Certificate. MEPs were largely supportive of the Commission proposal although there were calls for it not to lead to a de facto need for vaccination. On the vaccine issue, practically all speakers called for the Commission to take steps to ensure that companies respect their supply commitments. Press release

March 15-18, 2021 update

On 18 March 2021: after concluding a preliminary review of a signal of blood clots in people vaccinated with AstraZeneca, EMA continues to support the AstraZeneca vaccine. EMA confirmed that the benefits of the vaccine outweigh the risk of side effects.

Out of 20 million people who had been vaccinated with AstraZeneca, EMA found only 7 cases of blood clots in multiple blood vessels and 18 cases of CVST (clots in the vessels draining blood from the brain). According to EMA, a causal link with the vaccine is not proven, but is possible and deserves further analysis. The product information of the vaccine will be updated.

On 17 March 2021: the European Commission proposes a Digital Green Certificate to facilitate safe free movement inside the EU during the COVID-19 pandemic. The Digital Green Certificate will be a proof that a person has been vaccinated against COVID-19, received a negative test result or recovered from COVID-19. It will be available, free of charge, in digital or paper format. It will include a QR code to ensure security and authenticity of the certificate.

On 16 March 2021: the eHealth Network (consisting of all EU member states and Norway) published guidelines for EU countries to be used in order to create interoperable proofs of vaccination that are reliable and verifiable and can be presented by its holder upon request.

These guidelines are the result of the discussions and reflections stemming from the eHealth Network and its subgroups on Semantics and Technical interoperability so far, as well as first consultations with Health Security Committee, EMA, ECDC and WHO.

On 15 March 2021: while EMA is investigating a number of events of blood clots in people who had received the AstraZeneca vaccine, several EU countries have temporarily paused vaccination with the vaccine. This is a precaution taken in the light of their national situation.

At this time, EMA remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.

On 15 March 2021: the European Parliament published ‘Covid-19 variants: state of play and impact on vaccination in the EU‘.

As part of Parliament’s continued close monitoring of the EU’s vaccination strategy, members of the environment and public health committee heard from representatives from the European Centre for Disease Prevention and Control, the European Medicines Agency and the World Health Organization on the efficacy of vaccines against mutations of the Covid-19 virus.

March 1-4, 2021 update

On 4 March 2021: the European Medicines Agency (EMA) announced that its human medicines committee (CHMP) had started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH.

On 3 March 2021: the European Space Agency and the European Commission announced the launch of a new series of monthly challenges asking for innovative solutions on how satellite data can be used to help better understand the effects of COVID-19 on society, economy and the environment. Each challenge, published at the beginning of each month, will be based on a specific interdisciplinary theme focusing on how different components of the environment interact with pandemic-driven changes around the world.

EC – Team Europe support to access to COVID-19 vaccines: Global roll-out of COVAX doses begins

On 2 March 2021: the European Commission announced that Ghana and Côte d’Ivoire were the first countries to receive and start administering COVID-19 vaccines provided by the Gavi COVAX Advanced Market Commitment (AMC).

On 2 March 2021: the European Medicines Agency (EMA) and Health Canada announced the publication of clinical data used to support their authorisations of the Moderna COVID-19 vaccine.

On March 1 2021: EU Ministers of Health held an informal video conference chaired by Marta Temido, Minister for Health of Portugal, which focused on the appearance of new variants of COVID-19 and the importance of new approaches to testing and vaccination processes in the EU countries. The majority of the Member States highlighted the importance of a coordinated approach to the pandemic as one of the aspects essential to the success of the response.

Consult older ESMH articles on the European responses to the corona crisis

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