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Explainer: COVID-19 vaccination in the EU

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The Pfizer-BioNTech COVID-19 vaccine is the first vaccine to be made readily available in some parts of the world. BioNTech

With which companies have you concluded COVID-19 vaccine agreements?

The Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at fair prices. Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 300 million doses, CureVac (405 million doses) and Moderna (160 million doses). The Commission has concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses.

This means that the Commission has secured a portfolio of more than 2 billion doses. For the Commission it was important from the beginning to build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA. Should all vaccines candidates turn out to be safe and effective, Member States have the possibility to donate part of their doses to lower and middle income countries.

Which vaccine is now authorised?

The Commission has given on 21 December the conditional marketing authorisation for the vaccine developed by BioNTech and Pfizer, following EMA positive assessment of its safety and efficacy. It is now waiting for EMA’s opinion on the possible conditional marketing authorisation for the vaccine by Moderna, which should be provided by 6 January at the latest.

No other vaccine producer has formally applied for a marketing authorisation to EMA. In order to accelerate the process, EMA has started rolling reviews on the vaccines produced by Johnson and Johnson and AstraZeneca.

How will vaccines be monitored post authorisation under the Conditional Marketing Authorisation (CMA)?

The monitoring of the safety and effectiveness of vaccines after authorisation is a requirement under EU law and a cornerstone of the EU’s pharmacovigilance system relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The system is exactly the same than for a normal market authorisation.

The safety and effectiveness of vaccines which have received conditional marketing authorisations are rigorously monitored, as for all medicines, through the EU’s established medicines monitoring system.

In addition, special measures are in place to quickly collect and evaluate new information. For example, manufacturers must usually send a safety report to the European Medicines Agency every six months. For COVID-19 vaccines, safety reports must be sent every month.

The European Medicines Agency will set up additional large-scale safety monitoring given the exceptionally high numbers of people expected to receive the vaccines.

Once authorised, when will vaccines be available in the EU?

In line with the EU vaccine strategy agreed with Member States, once authorised and produced, each vaccine will be available to Member States at the same time and at the same conditions. 

The distribution will start progressively. This means that in the first few months, there will not be enough doses available to vaccinate all adults. The first doses will go to the priority groups identified by Member States (e.g. healthcare professionals, persons over 60 years of age). Supplies will increase over time, and all adults should be able to get vaccinated during the course of 2021.

For most contracts concluded, the majority of delivery is foreseen to be completed in 2021. Under some contracts, first deliveries are expected to already start in the first quarter of 2021.

First deliveries of the BioNTech and Pfizer vaccine are expected within days of authorisation and first vaccinations would take place in the context of the EU vaccination days of 27-29 December.

The Commission has been asking national authorities to prepare as early as possible for organising the fast and accessible deployment of vaccines, according to national vaccination plans and has issued guidance on the large-scale vaccination deployment.

The Commission is following the developments of national vaccination plans very closely and provides support notably by organising joint procurement for vaccination supplies, such as syringes and needles, and running a stress test of the national vaccination plans ahead of deployment together with the ECDC.

Will the EU have enough capacity to manufacture the COVID vaccines?

There is already substantial vaccine production capacity in the EU – and the Commission is working intensively to increase it. In addition, and in order to ensure that vaccine developers have the necessary capacity to scale up the production of COVID-19 vaccines as soon as they have been approved by the EMA, the Commission supports the necessary investment in the development of such production capacities.

How will logistics work? How will vaccines be distributed?

Logistics and transportation is a key aspect on which all Member States have to work, as emphasised in the Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment of 15 October.

Delivery to national distribution hub(s) will be ensured by the manufacturers.

Further distribution to vaccination centres will be ensured by Member States, who will also be responsible for the vaccination of their population.

Who should be vaccinated first?

All Member States will have access to COVID-19 vaccines at the same time on the basis of the size of their population. The overall number of vaccine doses will however be limited during the initial stages of deployment and before production can be ramped up. The Commission has therefore provided examples of unranked priority groups to be considered by countries once COVID-19 vaccines become available.

Most countries have defined priority groups and are further refining who should get priority in these priority groups e.g. older person over 80 years of age. The ECDC published an overview of where EU/EEA countries and the UK are with the development of their vaccination plans/strategies. ECDC is also working on a modelling exercise on prioritisation to support Member States. This report should be published before Christmas.

Will citizens know which vaccine they will be getting?

Yes.

When vaccines receive conditional marketing authorisation, the package leaflet with details on the specific vaccine will be translated into all languages and published in electronic form by the Commission.

All health care professionals and all patients would therefore have access to a leaflet in electronic form in their own languages.

The vaccine companies are responsible for putting in place the necessary mechanisms to ensure that each patient receives the package leaflet in print form in his/her language upon request without burdening healthcare professionals administering the vaccine.

What labelling and packaging information will citizens and health care professionals get with the COVID-19 vaccines?

In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has developed, with Member States and the European Medicines Agency, labelling and packaging flexibilities for a temporary period. Flexibility in the labelling and packaging requirements is expected to reduce transport costs and storage space, improving the distribution of the doses between Member States and limit possible impact on the production of other routine vaccines. Despite these flexibilities, anyone vaccinated and health care professionals will have access to all the information on the vaccine used.

An example of such flexibilities is the fact that the outer and immediate packaging may only be printed in English. Also, the package leaflet does not have to be included inside the package of the medicinal product, but will be provided separately by the vaccine company, who will be responsible for the distribution of the printed package leaflet locally in the national language(s).

Some Member States do not require the package leaflet to be printed in their national language(s). The leaflet may be printed in English only, but the information contained in the leaflet should still be available in the national language(s), for instance via a QR code printed in the package leaflet and also available in the EMA website in all languages.

How will the Commission support Member States in the rolling-out of vaccines?

The Commission stands ready to support Member States to ensure the smooth deployment of COVID-19 vaccines. A number of EU instruments in the programming period 2021-2027 can offer financial support in this regard.

For instance, investments to support health reforms and resilient, effective and accessible health systems are eligible under the Recovery and Resilience Facility (RRF), and can be included in the national Recovery and Resilience Plans. Furthermore, the Cohesion Policy funds (European Regional Development Fund – ERDF and European Social Fund Plus – ESF+) as well as the REACT-EU programme can provide financing to Member States and their regions to strengthen their health systems, both in terms of managing and recovering from the current health crisis and as well as ensuring their resilience in the longer term.

Collectively, these programmes can support a range of investment needs, for example, in health infrastructure, training of health professionals, health promotion, disease prevention, integrated care models, digital transformation of healthcare, and equipment, including critical medical products and supplies to strengthen the resilience of health systems.

In this context, investments to prepare health systems for the roll out COVID-19 vaccines are eligible under these programme, especially given the direct link to the resilience of health systems, the availability of critical medical products and disease prevention. However, it will be up to each Member State to decide on the priorities and content of their Recovery and Resilience Plan and also their Programmes for the Cohesion Policy funds.

How will vaccination certificates work?

A common approach to pharmacovigilance, and to trusted, reliable and verifiable vaccination certificates across the EU could reinforce the success of vaccination programmes in Member States and the trust of citizens.

Registering data on vaccination is important both at individual and population levels. For an individual, it is a means to know and demonstrate their vaccination status. Proof of vaccination should be available from the moment vaccination starts. Vaccination certificates could for example be useful in the context of travel, showing that a person has been vaccinated and therefore may not need testing and quarantine upon arrival in another country.

The Commission and Member States, together with WHO, are working on vaccination certificates. This work includes a minimum dataset, including a unique identifier, for each individual vaccination which will ease the issuance of certificates and vaccination monitoring on a Europe-wide basis from the moment that the COVID-19 vaccines are authorised.

The development of the common specifications framework will take account of and contribute to the work of WHO. EU funds, such as RRF, ERDF, InvestEU can support the setting up of the Immunisation Information Systems (IIS), Electronic Health Records and secondary use of health data on immunisation.

How much does the vaccine cost? What is the price of the vaccine?

The Commission negotiated advantageous deals with vaccine manufacturers to secure access to almost 2 billion doses so far.

At this stage the specific pricing per dose is covered by confidentiality obligations. However, a significant part of the overall costs are funded by a contribution from the overall EU funding for vaccines.

Will the vaccine be free in all EU Member States?

While this is a Member State responsibility, the large majority of the Member States intend to offer vaccination free of charge.

Are the contracts with the companies publicly available?

The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious.

Contracts are protected for confidentiality reasons, which is warranted by the highly competitive nature of this global market. This is in order to protect sensitive negotiations as well as business related information, such as financial information and development and production plans.

Disclosing sensitive business information would also undermine the tendering process and have potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set out in the legal instruments that form the basis of the negotiations. All companies require that such sensitive business information remains confidential between the signatories of the contract. The Commission therefore has to respect the contracts it concludes with the companies.

When will the vaccine allow the control of the pandemic?

For some known communicable diseases, it is understood that herd immunity allowing to control a pandemic and eventually eradicate a disease requires around 70% of the population to have protection either from vaccination or previous infection.

Depending on the pace of vaccination and natural infections, the pandemic might be controlled by the end 2021 in Europe.

Can we still spread the disease once vaccinated?

We do not yet know. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine’s use post-authorization.

Therefore, and for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and respect social distance, so on. Other factors, including how many people get vaccinated and how the virus is spreading in communities may also prompt revision of this guidance.

If I have already had COVID-19 and recovered, do I still need to get the vaccine?

There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this.

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70% of the EU adult population fully vaccinated

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Today, the EU has reached a crucial milestone with 70% of the adult population now fully vaccinated. In total, over 256 million adults in the EU have now received a full vaccine course. Seven weeks ago already, the Commission’s delivery target was met, ahead of time: to provide Member States, by the end of July, with enough vaccine doses to fully vaccinate 70% of the adult EU population.

The President of the European Commission, Ursula von der Leyen, said:  “The full vaccination of 70% of adults in the EU already in August is a great achievement. The EU’s strategy of moving forward together is paying off and putting Europe at the vanguard of the global fight against COVID-19.  But the pandemic is not over. We need more. I call on everyone who can to get vaccinated. And we need to help the rest of the world vaccinate, too. Europe will continue to support its partners in this effort, in particular the low and middle income countries.”

Stella Kyriakides, Commissioner for Health and Food Safety, said:  “I am very pleased that as of today we have reached our goal to vaccinate 70% of EU adults before the end of the summer. This is a collective achievement of the EU and its Member States that shows what is possible when we work together with solidarity and in coordination. Our efforts to further increase vaccinations across the EU will continue unabated. We will continue to support in particular those Member States that are continuing to face challenges. We need to close the immunity gap and the door for new variants and to do so, vaccinations must win the race over variants.”

Global cooperation and solidarity

The rapid, full vaccination of all targeted populations – in Europe and globally – is key to controlling the impact of the pandemic. The EU has been leading the multilateral response. The EU has exported about half of the vaccines produced in Europe to other countries in the world, as much as it has delivered for its citizens.  Team Europe has contributed close to €3 billion for the COVAX Facility to help secure at least 1.8 billion doses for 92 low and lower middle-income countries. Currently, over 200 million doses have been delivered by COVAX to 138 countries.

In addition, Team Europe aims to share at least 200 million more doses of vaccines secured under the EU’s advance purchase agreements to low and middle-income countries until the end of 2021, in particular through COVAX, as part of the EU sharing efforts

Preparing for new variants

Given the threat of new variants, it is important to continue ensuring the availability of sufficient vaccines, including adapted vaccines, also in the coming years. That is why the Commission signed a new contract with BioNTech-Pfizer on 20 May, which foresees the delivery of 1.8 billion doses of vaccines between the end of the year and 2023. For the same purpose, the Commission has also exercised the option of 150 million doses of the second Moderna contract. Member States have the possibility to resell or donate doses to countries in need outside the EU or through the COVAX Facility, contributing to a global and fair access to vaccines across the world. Other contracts may follow. This is the EU’s common insurance policy against any future waves of COVID-19.

Background

A safe and effective vaccine is our best chance to beat coronavirus and return to our normal lives. The European Commission has been working tirelessly to secure doses of potential vaccines that can be shared with all.

The European Commission has secured up to 4.6 billion doses of COVID-19 vaccines so far and negotiations are underway for additional doses. The Commission is also working with industry to step up vaccine manufacturing capacity.

At the same time, the Commission has started work to tackle new variants, aiming to rapidly develop and produce effective vaccines against these variants on a large scale. The HERA Incubator helps in responding to this threat.

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EU’s defence measures against unfair trade practices remained effective in 2020

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The system for protecting EU businesses from dumped and subsidised imports continued to function well in 2020 thanks to the EU’s robust and innovative ways of using trade defence instruments (TDI), despite the practical challenges presented by the COVID-19 pandemic. This is part of the European Commission’s new trade strategy, whereby the EU takes a more assertive stance in defending its interests against unfair trade practices.

Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “The EU needs effective tools to defend ourselves when we face unfair trade practices. This is a key pillar of our new strategy for an open, sustainable and assertive trade policy. We have continued to use our trade defence instruments effectively during the COVID-19 pandemic, improved their monitoring and enforcement, and tackled new ways of giving subsidies by third countries.  We will not tolerate the misuse of trade defence instruments by our trading partners and we will continue to support our exporters caught up in such cases. It is crucial that our companies and their workers can continue to rely on robust trade defence instruments that protect them against unfair trade practices.”

At the end of 2020, the EU had 150 trade defence measures in force, in line with previous years’ activity levels with an increase in the number of cases lodged towards the end of 2020. In addition, for the first time, the Commission addressed a new type of subsidy given by third countries in the form of cross-border financial support that was a serious challenge for EU companies.

The following are the main trade-defence highlights of 2020:

Continued high level of EU trade defence activity

Due to the COVID-19 pandemic, the Commission had to swiftly introduce temporary changes to its work practices, especially concerning on-the-spot verification visits. This allowed the Commission to continue applying the instruments at the highest standards without a drop in the levels of activity. At the end of 2020, the 150 trade defence measures that the EU had in place – 10 more than at the end of 2019 – included 128 anti-dumping, 19 anti-subsidy and 3 safeguard measures.

In 2020, the Commission launched:

  • 15 investigations, compared to 16 in 2019, and imposed 17 provisional and definitive measures, compared to 15 in 2019;
  • 28 reviews, compared to 23 the previous year.

The highest number of EU trade defence measures concerns imports from:

  • China (99 measures);
  • Russia (9 measures);
  • India (7 measures);
  • The United States (6 measures).

Tackling new types of subsidies

In 2020, the Commission strengthened its action against subsidies granted by third countries. In particular, the Commission imposed countervailing duties on cross-border financial support given by China to Chinese-owned companies manufacturing glass fibre fabrics and continuous filament glass fibre products based in Egypt for export to the EU.

This means that, for the first time, the Commission addressed cross-border subsidies given by a country to enterprises located in another country for exports to the EU.

Support to, and defence of, EU exporters facing trade defence investigations in export markets

The importance of monitoring trade defence action taken by third countries was again evident in 2020. The number of trade defence measures in force by third countries affecting EU exporters reached its highest level since the Commission started this monitoring activity, with 178 measures in place. In addition, the number of cases initiated also increased in 2020, with 43 compared to 37 the previous year.

The report outlines the Commission’s activities to ensure that WTO rules are correctly applied and procedural errors and legal inconsistencies are addressed in order to avoid any misuse of trade defence instruments by third countries. The Commission’s interventions yielded success in some cases where measures were not ultimately imposed, affecting important EU export products such as ceramic tiles and fertilisers.  

Strong focus on monitoring and enforcement

There was a renewed focus on the monitoring of measures in place in 2020, including changes to surveillance practices to ensure the ongoing effectiveness of the trade defence instruments. This also involved customs authorities, EU industry, and in certain instances, the European Anti-Fraud Office (OLAF). Continuing its efforts to address instances where exporters tried to avoid measures, the Commission initiated three anti-circumvention investigations in 2020 and completed five such investigations during the year, where measures were extended in four cases to also address imports from third countries where transhipment was found to have taken place.

The report also recalls the findings of the European Court of Auditors from July 2020, which confirmed the successful enforcement of the EU’s trade defence instruments by the Commission. The report made a number of recommendations to further strengthen the Commission’s response to the challenges posed by unfairly traded imports that the Commission has started to implement in 2020, such as improving monitoring to ensure the effectiveness of measures. 

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Fishing opportunities in the Baltic Sea for 2022: improving long-term sustainability of stocks

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The Commission today adopted its proposal for fishing opportunities for 2022 for the Baltic Sea. Based on this proposal, EU countries will determine how much fish can be caught in the sea basin, for what concerns the most important commercial species.

The Commission proposes to increase fishing opportunities for herring in the Gulf of Riga, whilst maintaining the current levels for sprat, plaice and by-catches of eastern cod. The Commission proposes to decrease fishing opportunities for the remaining stocks covered by the proposal, in order to improve the sustainability of those stocks and to help other stocks such as cod and herring recovering.

Virginijus Sinkevičius, Commissioner for Environment, Oceans and Fisheries, said: “The poor environmental status of the Baltic Sea is heavily affecting our local fishermen and women, who rely on healthy fish stocks for their livelihoods. This is why the Commission is doing its utmost to restore those stocks, and today’s proposal is a reflection of that ambition. However, the state of the Baltic Sea is not only related to fishing, so everyone must do their part to build the long-term sustainability of this precious sea basin.”

Over the past decade, EU’s fishermen and women, industry and public authorities have made major efforts to rebuild fish stocks in the Baltic Sea. Where complete scientific advice was available, fishing opportunities had already been set in line with the principle of maximum sustainable yield (MSY) for seven out of eight stocks, covering 95% of fish landings in volume. However, in 2019 scientists discovered that the situation was worse than previously estimated. Decisive action is still necessary to restore all stocks and ensure that they grow to or remain at sustainable levels.

The proposed total allowable catches (TACs) are based on the best available peer-reviewed scientific advice from the International Council on the Exploration of the Seas (ICES) and follow the Baltic multiannual management plan adopted in 2016 by the European Parliament and the Council. As regards western Baltic cod, western Baltic herring and salmon, the Commission will update its proposal once the relevant scientific advice will be available (expected by mid-September).

Cod

For eastern Baltic cod, the Commission proposes to maintain the TAC level and all the accompanying measures from the 2021 fishing opportunities. Despite the measures taken since 2019, when scientists first alarmed about the very poor status of the stock, the situation has not yet improved.

For western Baltic cod the scientific advice from the International Council on the Exploration of the Seas (ICES) is postponed to mid-September, and the Commission will update its proposal accordingly. However, since it seems unlikely that the stock has developed favourably, the Commission proposes already now to maintain the spawning closure. It also proposes to maintain all accompanying measures in the eastern part of the catch area, given the predominance of eastern Baltic cod in that area.

Herring

The stock size of western Baltic herring remains below safe biological limits and scientists advise for the fourth year in a row to stop catching western herring. The Commission, therefore, proposes to close the directed fishery and set a TAC limited to unavoidable by-catches, whose level the Commission will propose at a later stage, as ICES is currently not in a position to provide sufficient scientific data.

For central Baltic herring, the Commission proposes a reduction of 54% in line with the ICES advice, because the stock size has dropped very close to the limit below which the stock is not sustainable. In line with the ICES advice, the Commission proposes to decrease the TAC level for herring in the Gulf of Bothnia by 5%, while the situation for Riga herring allows for an increase of the TAC by 21%.

Plaice

While the ICES advice would allow for an increase, the Commission remains cautious, mainly to protect cod – which is an unavoidable by-catch in plaice fisheries as currently conducted. It therefore proposes to maintain the TAC level unchanged.

Sprat

Similarly to plaice, the ICES advice for sprat would allow for an increase. The Commission however advises prudence and proposes to maintain the TAC level unchanged. This is because sprat and herring are caught in mixed fisheries and the TAC for central Baltic herring has to be reduced again significantly. Moreover, sprat is a prey species for cod, which is not in a good condition.

Salmon

ICES has postponed its scientific advice for salmon to mid-September. The Commission will update its proposal accordingly. A special advice from ICES of April 2020 already provides information about the issues affecting these stocks, pointing to the fact  that the MSY objective cannot be achieved for all salmon river stocks if the commercial and recreational mixed-stock sea fisheries are continued at current levels.

Next steps

The Council will examine the Commission’s proposal in view of adopting it during a Ministerial meeting on 11-12 October.

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