EUROPEAN AGENDA: PUBLIC HEALTH

The EU is supporting local governments to achieve common objectives, pool resources and overcome shared challenges. In addition, measures are being taken to fight the COVID-19 pandemic.

INSTITUTIONS	MEETINGS
	DATE
European Council	25-26.02.2021 Video conference of the members of the European Council

We highlight below what the European institutions have been working on to date:

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17 February, European Commission: Commission approves second contract with Moderna to ensure up to additional 300 million doses

The European Commission approved a second contract with the pharmaceutical company Moderna, which provides for an additional purchase of 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in 2022) on behalf of all EU Member States. The new contract also provides for the possibility to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.

The contract with Moderna builds upon the broad portfolio of vaccines to be produced in Europe, including the already signed contracts with BioNTech/Pfizer, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, Curevac and Moderna. This diversified vaccines portfolio will ensure Europe has access to 2.6 billion doses, once the vaccines have been proven to be safe and effective.

The Commission has granted conditional marketing authorisation for the vaccine developed by BioNTech and Pfizer on 21 December 2020, Moderna on 6 January 2021 and AstraZeneca on 29 January 2021.

President of the European Commission, Ursula von der Leyen, said: “We are securing 300 million additional doses of the COVID-19 vaccine produced by Moderna, which is already used for vaccination in the European Union. This brings us closer to our major objective: ensure that all Europeans have access to safe and effective vaccines as quickly as possible. With a portfolio of up to 2.6 billion doses, we will be able to provide vaccines not just to our citizens, but to our neighbours and partners as well.”

More information

Press Release – European Commission

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17 February, European Commission: Europe prepares for new variant threats

The European Commission is preparing within the European framework a biodefense material called “HERA Incubator” to deal with new variants of COVID-19.

It will work with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.

The keys to this project are:

1. Detect, analyse and assess variants
2. Speed up regulatory approval of adapted vaccines
3. Ramp up production of COVID-19 vaccines.

The actions announced will go hand-in-hand with global cooperation via the World Health Organisation and global initiatives on vaccines. They will also prepare the ground for the European Health Emergency Preparedness and Response Authority (HERA). HERA will build on the actions launched on February 17 and provide a permanent structure for risk modelling, global surveillance, technology transfers, manufacturing capacity, supply chain risk mapping, flexible manufacturing capacity and vaccine and medicine research and development.

The actions announced on February 17 will go hand-in-hand with global cooperation via the World Health Organisation and global initiatives on vaccines. They will also prepare the ground for the European Health Emergency Preparedness and Response Authority (HERA). HERA will build on the actions launched that day and provide a permanent structure for risk modelling, global surveillance, technology transfers, manufacturing capacity, supply chain risk mapping, flexible manufacturing capacity and vaccine and medicine research and development.

Members of the College said

President of the European Commission, Ursula von der Leyen, said: “Our priority is to ensure that all Europeans have access to safe and effective COVID-19 vaccines as soon as possible. At the same time, new variants of the virus are emerging fast and we must adapt our response even faster. To stay ahead of the curve, we are launching the HERA Incubator. It brings together science, industry and public authorities, and pulls all available resources to enable us to respond to this challenge.”

More information

Press Release – European Commission

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16 February, European Medicines Agency: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V.

EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.

Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review. During this phase, EMA assessed quality data and data from laboratory studies which looked at how well the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2 (the virus that causes COVID-19). The Agency also looked at clinical safety data on the viral vector used in the vaccine.

EMA is now assessing additional data on the efficacy and safety of the vaccine as well as its quality. If EMA concludes that the benefits of the vaccine outweigh its risks, it will recommend granting a CMA. The European Commission will then issue a decision on whether to grant a CMA valid in all EU and EEA Member States within days.

How is the vaccine expected to work?

COVID-19 Vaccine Janssen works by preparing the body to defend itself against COVID-19. It is made up of another virus (an adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.

Once it has been given, the vaccine delivers the SARS-CoV-2 spike protein gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise the spike proteins on the virus and be ready to defend the body against it. The adenovirus in the vaccine cannot reproduce and does not cause disease.

More information

Press Realeas – European Medicines Agency

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15 February, European Centre for Disease Prevention and Control: Outbreak of Ebola virus disease in Africa

As of 14 February 2021, four cases of Ebola virus disease (EVD), including two deaths, have been reported in the North Kivu province in the eastern part of the Democratic Republic of the Congo (DRC) as well as seven cases in Guinea, including three deaths.

On 7 February 2021, the Minister of Health of the Democratic Republic of the Congo (DRC) declared an outbreak of Ebola virus disease after a laboratory-confirmed case was detected. Since then, and as of 14 February, four cases and two deaths have been reported in the North Kivu province in the eastern part of the DRC, where the 10th outbreak in the DRC of Ebola virus disease, which resulted in 3 470 cases including 2 287 deaths, was declared over in June 2020. This current outbreak constitutes the 12th outbreak of Ebola virus disease in the DRC.

On the other hand, according to the World Health Organization’s Regional Office for Africa and the Ministry of Health of Guinea, on 28 January 2021, a healthcare worker from Goueké Health Center died. Six people who attended his funeral on 1 February 2021 later began to show Ebola-like symptoms (diarrhoea, vomiting and bleeding). Two of these cases have since died and the other four have been hospitalised.

More information

Press release – European Centre for Disease Prevention and Control (Democratic Republic of the Congo)

Press release – European Centre for Disease Prevention and Control (Guinea)