Questions and answers on COVID-19 vaccination in the EU

Following positive assessment of the European Medicines Agency (EMA) of their safety, quality and efficacy, the Commission has so far given the conditional marketing authorisation for 4 vaccines developed by:

• BioNTech and Pfizer, on 21 December
• Moderna, on 6 January
• AstraZeneca, on 29 January
• Janssen Pharmaceutica NV, on 11 March

The EMA has started rolling reviews of a COVID-19 vaccine from Novavax on 3 February 2021, from CureVac AG on 12 February 2021 and of Sputnik V vaccine on 4 March 2021. These rolling reviews will continue until enough evidence is available for formal marketing authorisation application.

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 (600 million doses), CureVac (405 million doses) and Moderna (460 million doses). The Commission has concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses and with Valneva with a view to purchase up to 60 million doses.

This means that the Commission has secured a portfolio of more than 2.6 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.

In line with the EU vaccine strategy agreed with Member States, once authorised and produced, each vaccine becomes available to Member States at the same time and at the same conditions. This has been the case for the first two authorised vaccines: BioNTech-Pfizer, and Moderna. First deliveries of the AstraZeneca vaccine started on 5 February.

The distribution is progressive. 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. First deliveries of the BioNTech and Pfizer vaccine occurred within days of authorisation and most of the first vaccinations took place in the context of the EU vaccination days of 27-29 December. Deliveries and vaccinations of the Moderna vaccine are also ongoing. 

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.

By March 2021, at least 80% of people over the age of 80, and 80% of health and social care professionals in every Member State, should be vaccinated.

By summer 2021, Member States should have vaccinated 70% of the entire adult population.

The Commission, Member States and the EMA will work with companies to use the EU's potential for increased vaccine manufacturing capacity to the fullest.

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.

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 Member States.

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.

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

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.

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.

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 after authorisation.

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.

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.

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.

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 as 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.

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.

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.

The Commission jointly with a Joint Negotiation Team carries out the negotiations with vaccine suppliers. The members of the Joint Negotiation Team – representing seven Member States - are appointed by a Steering Committee. The Steering Committee discusses and reviews all aspects of the Advanced Purchase Agreement (APA) contracts before signature. All EU Member States are represented in this Committee, which meets on a weekly basis.

All Member States have endorsed this approach, which is at the heart of the EU Vaccines Strategy. At the European Council in June 2020, the Member States of the European Union mandated the Commission to organise the joint procurement of vaccines. As a result, the European Commission has started talks with the most promising vaccine manufacturers.

The Negotiation Team first holds exploratory talks with the company to find out if there is sufficient common ground to proceed with detailed contractual negotiations. If that is the case, a tender invitation is sent to the company, which then has to propose an offer.

An APA is concluded when both sides have finalised the contractual work. This is discussed and agreed with the Steering Committee. The conclusion of an APA requires the approval of the Commission.

If the APA provides for an obligation for the Member States to purchase vaccine doses Member States have five working days to notify if they wish to opt out. The contract is only signed if at least four Member States are ready to be bound by it.

In the negotiation process, Member States tell the Commission how much of a certain vaccine they want to order. 

But they are then responsible for purchasing the vaccines when they become available, once they prove to be safe and effective. The Commission does not sign contracts for deliveries to individual countries. Advance Purchasing Agreements allow the Commission to secure a certain number of doses. It is then for Member States to purchase these doses, activate potential options included in the APA to order additional doses, and conclude specific contracts with the companies.

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.

The Commission has published redacted contracts of the advance purchase agreement with CureVac and with AstraZeneca.

The production capacity and the ability to deliver on time are the main considerations. Other criteria include liability issues with respect to all contracts and prices. To decide whether an Advance Purchase Agreement should be concluded, the following non-exhaustive criteria were taken into account:

• Soundness of scientific approach and technology used
• Speed of delivery at scale, capacity, timelines for supply
• Logistical challenges, cooling chains etc.
• Costs
• Liability
• Coverage of different technologies in order to maximise the chances of having a successful candidate
• Global solidarity, i.e. a commitment to making future doses of vaccines available for lower and middle income countries

Vaccines have to be affordable. This is also part of the rationale for doing this together as a team: this reduces costs for everyone and gives us a stronger negotiating position.

When it comes to prices, all companies require that such sensitive business information remains confidential between the signatories of the contract.

The details of the contracts concluded are known to the Commission and all 27 Member States, who make the decisions for the vaccine of their choice and pay the purchase price.

Even after a contract has been concluded with the EU, the manufacturers still have an interest in marketing their vaccines on the world market in the best possible way. Therefore, there is a legitimate interest of the companies, which have made very large investments in research and in production capacity, that the terms of the contracts with the EU are not publicly available during this phase of intense global competition. Due to contractual obligation, the Commission cannot indicate at this stage the specific pricing per dose.

The Commission has mobilised funds to increase the production capacity of the suppliers that it signed APAs with. It has provided more than €2 billion from the Emergency Support Instrument. Member States have agreed to contribute an additional €750 million.

An important point and principle is that the price of the vaccine is the same for all EU Member States.

Member States indicate early on in the negotiation phase with a company if they are interested in a particular vaccine and what quantity they would want to buy.

Once the contract is concluded, the vaccines are allocated according to a distribution key, based on the size of the population. So Member States receive vaccines under the same conditions – on a pro-rata basis, at the same price.

Adjustments of quantities of vaccines between Member States are possible, according to their needs. For instance, a Member State may decide not to buy additional vaccines from the options negotiated, in which case other Member States can take over those options and buy more of that particular vaccine.

Member States place orders with vaccine suppliers directly, indicating the timing and place of deliveries of vaccines, for instance, and specifying logistic aspects.

Delivery to national distribution hubs is ensured by the manufacturers. Further distribution to vaccination centres is ensured by Member States, who are also responsible for the vaccination of their population.

There is already substantial vaccine production capacity in the EU. The Commission has supported the increase in production capacity – and continues doing so.

It has frontloaded money to support the production capacities of all the vaccine suppliers it signed contracts with, allowing larger volumes of vaccines to be produced. The European Investment Bank is providing additional financial support, backed by the EU budget. This has been the case for CureVac and BioNTech, for example. 

The capacity to supply within the EU is also one of the main criteria taken into account when engaging on negotiations with companies.

There is already substantial vaccine production capacity in the EU. The Commission has supported the increase in production capacity – and continues doing so.

It has frontloaded money to support the production capacities of all the vaccine suppliers it signed contracts with, allowing larger volumes of vaccines to be produced. The European Investment Bank is providing additional financial support, backed by the EU budget. This has been the case for CureVac and BioNTech, for example. 

The capacity to supply within the EU is also one of the main criteria taken into account when engaging on negotiations with companies.

Independent scientific safety, efficacy and quality assessment by the European Medicines Agency

Any vaccine developer that wishes to put a vaccine on the market in the EU, should first request a marketing authorisation for the vaccine. The request is submitted to the European Medicines Agency (EMA), which assesses the safety, efficacy and quality of the vaccine. If the EMA gives a positive recommendation, the Commission can proceed with the authorisation of the vaccine on the EU market.

In response to public health threats such as the current pandemic, the EU has a specific regulatory tool in place to allow early availability of medicines for use in emergency situations. In such emergency situations, the Conditional Marketing Authorisation (CMA) procedure is specifically designed to enable marketing authorisations as quickly as possible, as soon as sufficient data becomes available. It provides the EU with a robust framework for accelerated approval and post-authorisation safety and safeguards and controls.

For its assessment, the EMA will undertake an independent, thorough and robust review of all the evidence submitted by the vaccine developer.  The process contains several checks and balances and is based on a system of peer reviews with many experts involved: two rapporteurs responsible for the assessment, a peer reviewer, specialised Committees and working parties (e.g. the Pharmacovigilance Risk Assessment Committee (PRAC) for safety, the Biologics Working Party for quality) and finally EMA's Committee on Human Medicines (with members from all Member States) which issues the recommendation.

The Committee on Human Medicines will only issue a positive recommendation when the evidence shows convincingly that the benefits of vaccination are greater than any risks from the vaccine.

Marketing authorisation by the European Commission

The European Commission is legally responsible for the marketing authorisation. Following a positive recommendation from the EMA's Committee for Medicinal Products for Human Use (CHMP), the Commission will verify the soundness of all elements supporting the marketing authorisation. These include scientific justifications, product information, educational material to health care professionals, labelling, obligations for the vaccine developer, conditions for use, and possible obligations for Member States.

The Commission is also responsible for ensuring that all necessary information is available to patients and health care professionals across the EU in their national language.

Before taking its decision, the Commission consults the Member States who are responsible for the marketing and use of the product in their countries (through the Comitology process – examination procedure). In case of a qualified majority of Member States in favour of the authorisation, the Commission can proceed with the adoption of its decision to authorise the marketing of the vaccine.

As a result, the vaccine may be marketed everywhere in the EU. Vaccine developers do not need to request any further authorisations in the different EU Member States.

The European Medicines Agency (EMA) and the Commission are making full use of the provisions under EU legislation for emergency situations to speed up the procedure for approval, whilst fully ensuring that all requirements in terms of efficacy, quality and safety of the vaccine are fully assessed.

In view of the urgency due to the COVID-19 pandemic, EMA has put in place rapid review procedures to assess applications in the shortest possible timeframes while ensuring robust scientific opinions. Key to speeding up the process are ‘rolling reviews', allowing EMA in public health emergencies to assess data for promising medicines or vaccines as they become available instead of waiting until all trials have concluded to start its work.

Through these rolling reviews, EMA can start evaluating data while the development is still ongoing, and before the vaccine developer has submitted a request for marketing authorisation. The rolling review assesses data on the vaccine's quality as well as results from laboratory studies. EMA also looks at results on the vaccine's efficacy and initial safety data emerging from large-scale clinical trial as they become available. This significantly shortens the normal assessment times while maintaining the principles of quality, safety and efficacy.

In the context of the rolling reviews, a dedicated group of experts, the COVID-19 EMA pandemic Task Force, has been established on the development, authorisation and safety monitoring of COVID-19 vaccines and is responsible for thoroughly assessing the scientific data. Hence, when a marketing authorisation is requested, the formal assessment can proceed much more quickly, as the data have already been scrutinised during the rolling review.

Moreover, EMA assesses the data with a view to issue a Conditional Marketing Authorisation (CMA). Such an authorisation ensures that the safety, efficacy and quality of the vaccine is demonstrated and that the benefits of the vaccine outweigh its risks, whilst at the same time allowing the vaccine developers to submit additional data also after the marketing authorisation (contrary to a normal marketing authorisation where all data are submitted before the authorisation is granted).

The European Commission is also ensuring that the process leading to the marketing authorisation can take place as quickly as possible by shortening administrative steps, such as the period for consulting Member States and by allowing for the translation of the product information in all official languages to take place in the first instance in electronic form to save time.

Whilst the average standard process for the authorisation of medicinal products takes 67 days, including 22 for the consultation of Member States, by making use of the provisions specifically provided for under EU legislation for emergency situations, the Commission will be able to proceed with a marketing authorisation within 3 days following a positive recommendation from EMA.

A Conditional Marketing Authorisation (CMA) follows a controlled and robust framework providing safeguards that emergency use authorisations might not. In reality, an emergency use authorisation is not an authorisation of the vaccine but an authorisation of the temporary use of the unauthorised vaccine. The CMA ensures that all pharmacovigilance, manufacturing controls including batch controls for vaccines and other post-approval obligations apply in a legally binding manner and are evaluated by EMA's scientific committees on a continuous basis and a regulatory action can be taken, if necessary. Notably:

• It ensures a rigorous monitoring, through the EU pharmacovigilance system, of the safety of the medicine across the EU. Additionally, there may be special measures to collect and evaluate all new information rapidly emerging in order to meet the specific demands of the pandemic and mass vaccination.
• It ensures post-authorisation safety monitoring and allows the collection of additional data in a structured manner. A risk management plan (RMP) is implemented by the company as agreed before authorisation, forming an enforceable feature of the authorisation.
• Rigorous manufacturing including batch release for vaccines and distribution, are subject to the same ongoing controls as for all authorised medicines. The monitoring of the manufacturing processes ensures that the medicine is manufactured and controlled according to high pharmaceutical standards in the context of large scale commercialisation.
• That the medicine's conditions for use are presented in all EU languages in electronic form in the immediate instance.
• The provision of an investigation plan for future use of the medicine in children.

These are essential elements to ensure a high level of protection for citizens during the course of a mass vaccination campaign and is a key component of EU Vaccine Strategy. All 27 EU Member States have formally signed up to the EU Vaccine Strategy proposed by the Commission in June, agreeing jointly to follow the conditional marketing authorisation procedure through the European Medicines Agency for COVID-19 vaccines. By following this route the safety, efficacy and quality of the vaccines will be thoroughly assessed and the trust of citizens will be safeguarded.

An Emergency Use Authorisation (EUA) allows for the temporary use of a medicine under specific conditions as long as emergency circumstances apply. The medicine however remains unlicensed and cannot be put on the market, contrary to a (conditional) marketing authorisation.

Whilst Emergency Use Authorisations are allowed under the EU pharmaceutical legislation, the use of a vaccine for which a Member State has issued such an authorisation is restricted to the authorising Member State only under its responsibility. Some third countries are also using similar procedures to allow the temporary emergency use of COVID-19 vaccines prior to authorisation.

Under an EU Conditional Marketing Authorisation (CMA), liability is with the holder of the marketing authorisation. The marketing authorisation holder will be responsible for the product and its safe use.

The CMA is valid for a one-year period, on a renewable basis and contains the same rights and liability for its holder as per that of a standard marketing authorisation. In addition, the holder of a CMA has specific obligations such as to complete or conduct new studies within a defined time period in order to confirm that the benefit/risk balance remains positive.

In the case of an Emergency Use Authorisation to temporarily authorise the distribution as an unauthorised product (Art. 5(2) of Directive 2001/83), EU legislation requires Member States to remove administrative and civil liability from the manufacturer and marketing authorisation holder, when this emergency use is recommended or required by the Member State. 

In case of a Conditional Marketing Authorisation (CMA) EMA thoroughly assesses all required information to confirm that the benefits outweigh the risks of the medicine.

For instance, in addition to the data demonstrating safety and efficacy, the data submitted in a marketing authorisation application for a COVID-19 vaccine must include information on:

• the group of people to be given the vaccine;
• the vaccine's pharmaceutical quality and purity;
• manufacturing and controls of batches;
• compliance with international requirements for laboratory testing and conduct of clinical trials;
• types of immune responses;
• side effects e.g. with regard to older people, or pregnant women;
• labelling and package leaflet;
• the way risks will be managed and monitored once the vaccine is authorised.

The Conditional Marketing Authorisation procedure provides the necessary assurance to citizens that the full range of requirements are being applied as mass vaccination programmes are rolled out including independent controls performed on vaccine batches by the network of Official Medicines Control Laboratories (OMCLs) before the vaccine reaches the patient.

If a Member State grants an Emergency Use Authorisation, it decides itself which data is required for such authorisation, and which requirements it will impose for the vaccine's use and supervision.  It is therefore possible that less detailed data is required and that less strict obligations are imposed than under the Conditional Marketing Authorisation process, relating to for example:

• the manufacturing process of the vaccine;
• the good manufacturing practice (GMP) status certification of the facilities in which the vaccine is to be manufactured;
• The extent of the clinical data, including size of the safety database and efficacy clinical data analyses available.

Whilst the full use of the provisions specifically provided for under EU legislation for emergency situations speeds up the procedure for approval, the robustness of the assessment framework of a CMA and the extent of the data assessed by the EMA may result in a process that requires more time than an emergency use authorisation procedure.

The package leaflet for centrally authorised COVID-19 vaccines will be translated into all languages and published in electronic form by the Commission. This is one of the requirements of the Conditional Marketing Authorisation, which is a centralised procedure for the authorisation of medicinal products.

Moreover, and 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, other labelling and packaging flexibilities. Flexibility in the labelling and packaging requirements can facilitate the rapid deployment of the vaccine by increasing production capacity, reducing 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. For instance, the outer and immediate packaging may only be printed in English.

Also, the package leaflet does not have to be included inside the medicinal product carton but it may be provided separately by the vaccine company.

In addition, 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 leaflet info should still be available in the national language(s), for instance via a QR code printed in the package leaflet.

All health care professionals and all patients would therefore have access to a leaflet in their own languages. The vaccine companies have to put in place the necessary mechanisms to ensure that each patient receives the package leaflet in his/her language upon request without burdening healthcare professionals administering the vaccine.

The monitoring of the safety and effectiveness of vaccines after authorisation is a requirement under EU law and a cornerstone of pharmacovigilance. EU law requires vaccine companies (i.e. marketing authorisation holders), national competent authorities and the EMA to follow a number of monitoring (pharmacovigilance) processes after a product has been authorised.

In addition, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), in close collaboration with the Commission, Member States, European and international partners are establishing enhanced vaccine effectiveness, coverage, safety and impact monitoring activities including studies specifically for COVID-19 vaccines. These additional, independent monitoring studies are being proposed to collect and analyse vaccination data from public authorities across Member States on the effectiveness and safety of the vaccines.

These studies will help characterise the safety and efficacy of the vaccine along its life cycle. This additional data can also be used to complement regulatory actions as necessary, e.g. changes in the conditions of use, warnings and related changes to product information for health care professionals and patients.

Under the CMA process, vaccine companies are notably responsible for:

• the continued monitoring of safety of vaccines;
• reporting of serious adverse events;
• keeping the product information up to date, conducting safety and effectiveness studies;
• looking at performance of their products in the larger populations on the market and
• submitting regular safety and benefit risk reports to the EMA.

Member States are responsible for:

• supervising the collection of information on suspected side effects, in the assessment of signals, periodic safety update reports, post-authorisation safety studies and risk management plans;

EMA is responsible for:

• monitoring all reported suspected adverse reactions, new or changing safety issues. if detected, will be rapidly assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) and any necessary risk minimisation action will be taken;
• providing supplemental guidance and requirements to vaccine manufacturers for drafting risk management plans of COVID-19 vaccines;
• monthly summary safety post approval reports from manufacturers (in addition to 6 monthly Periodic Safety Update Reports);
• developing and maintaining EudraVigilance, a system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area (EEA). EudraVigilance is a single repository for reports of suspected adverse reactions seen in healthcare practice and clinical trials. It is used by Member states, the Agency and industry;
• analysing information and establishing studies in the general population to follow both the safety and the effectiveness of the vaccines.

Transparency and communication on this process will be key and is essential for sustaining and supporting public confidence in vaccines and vaccination.

The objective of a transparency and authorisation mechanism for exports of COVID-19 vaccines is to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU.

The European Union has supported the rapid development and production of several vaccines against COVID-19 with a total of €2.7 billion and it is important to protect the integrity of this substantial investment from the EU budget.

The Commission is concerned by the lack of transparency around the ways some companies are operating and wants to have complete information in order to ensure they fulfil their contractual commitments.

It is not our intention to restrict exports any more than absolutely necessary, and the Union remains fully committed to international solidarity and its international obligations.

To address this very serious and immediate public health issue, the Commission has adopted a temporary export transparency and export authorisation mechanism on the basis of Regulation 2015/479 on common rules for exports.

This is not an export ban. This measure would specifically target exports of COVID-19 vaccines covered by an Advance Purchase Agreement (APA) with the EU. These exports will be subject to an early notification and authorisation before they are effectively shipped outside the EU.

This measure was originally envisaged to last until 31 March. Following persistent delays in some of the deliveries of vaccines to the EU, the Commission extended the measure until the end of June 2021.

A large number of exports will be exempted from the mechanism.

An export authorisation foreseen in the Regulation is required for exports outside the Union market (whether or not originating in the Union).

Such authorisation shall be granted by the competent authorities of the Member State where the vaccines are manufactured and shall be issued in writing or by electronic means.

• Exports to Republic of Albania, Andorra, Bosnia and Herzegovina, the Faeroe Islands, the Republic of Iceland, Kosovo*, the Principality of Liechtenstein, Montenegro, the Kingdom of Norway, the Republic of North Macedonia, the Republic of San Marino, Serbia, the Swiss Confederation, Vatican City State, the overseas countries,  territories listed in Annex II of the Treaty of the Functioning of the European Union, and exports to Büsingen, Heligoland, Livigno, Ceuta and Melilla, Algeria, Egypt, Jordan, Lebanon, Libya, Morocco, Palestine*, Syria, Tunisia, Armenia, Azerbaijan, Belarus, Georgia, Israel, Moldova and Ukraine.
• Exports to any of the 92 low and middle-income countries in the COVAX Advance Market Commitment list.
• Exports of COVID vaccines purchased and/or delivered through COVAX, UNICEF and PAHO with destination to any other COVAX participating country.
• Exports of purchases by EU Member States under the EU Advance Purchase Agreements and redirected to a third country as a donation or resale.
• Exports in the context of a humanitarian emergency response.
• Exports to facilities located on the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to the United Nations Convention on the Law of the Sea.

The Commission is mindful of APAs contracted by third countries, and will endeavour to ensure that the expectations of these countries to obtain their deliveries will be met.

We call on companies with APAs to meet their obligations to deliver on their commitments.

Member States are part of the Steering Committee which discusses all decisions in the context of the negotiations with vaccine producers and their follow-up, including the possibility to include a transparency and authorisation mechanism in relation to the exports of vaccines.

Member States are required to set up export authorisation regimes.

Companies request an export authorisation in the Member State where the vaccine is manufactured.

Member States will process applications for export authorisations as soon as possible and no later than two working days after receiving all the required information.

This period may be extended by a further two working days but only under exceptional circumstances and for duly justified reasons.

In deciding whether to grant an export authorisation under this Regulation, Member States, together with the Commission, shall assess whether the volume of exports is not such that it poses a threat to the execution of the Advance Purchase Agreements the EU has concluded with vaccine manufacturers.

Upon receiving the request, Member States must immediately notify the Commission of any application and, after analysis, submit their draft decision to the Commission. If the Commission would disagree with this draft decision, it shall issue an opinion and the Member State shall decide on the request for authorisation in accordance with the Commission's opinion.

In order to allow the relevant authorities to assess the request for export authorisation, vaccine producers subject to this Regulation are requested to provide relevant data on their exports since 29 October 2020 together with their first request for export. They should also provide the number of vaccine doses they distributed in the Union since 1 December 2020 broken down by Member States.

Even after authorising an export, the competent Member State authorities can verify the information submitted by the exporter.

The absence of such information may lead to export authorisations being refused.

The Commission will regularly report on the authorisations granted and refused.

It's an implementing act.

It is in line with all of the EU's international obligations and commitments.

The EU strongly supports the principle that any measures deemed necessary to prevent or relieve critical shortages are implemented in a manner that is targeted, transparent, proportionate, temporary and consistent with WTO obligations.

The measure is also fully in line with what the EU has proposed in the context of the WTO trade and health initiative as it gives particular consideration to the interest of the least developed and developing countries with scarce manufacturing capacities and which are highly dependent on imports. The scheme also ensures that the operation of the COVAX facility is not impeded.

The EU will ensure transparency about this measure towards its trading partners at the WTO.

*This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

A number of variants of coronavirus are already causing great concern as they are more transmissible and spreading rapidly across Europe. According to the European Centre for Disease Prevention and Control (ECDC), the B.1.1.7 variant first reported in Britain appears to be on course to become dominant over the previous strains in the EU. Other strains and mutations may emerge in the future.

The EU is setting up a European bio-defence preparedness plan “HERA Incubator” against COVID-19 variants to bring together researchers, biotech companies, manufacturers, regulators and public authorities to monitor variants, exchange data and cooperate on adapting vaccines. The plan will focus on:

• Detecting, analysing and adapting to virus variants;
• Speeding up regulatory approval of vaccines, providing guidance on data requirements and facilitating the certification of new or repurposed manufacturing infrastructures; and
• Supporting the speedy mass production of adapted or novel COVID-19 vaccines.

New variants are already present in Europe and the ECDC assesses the risk of further spread from variants as high to very high. Some variants appear to be more transmissible and could become the dominant strain, or even reduce the efficacy of vaccination campaigns. Likewise, future variants may not be receptive to current vaccines and Europe has to anticipate this risk.

Sequencing capacity varies greatly across the EU but is below 10% in all but one EU country. As efforts and capacity around sequencing increase, additional variants may be detected that will require surveillance and evaluation.

The Commission will support EU countries to carry out more testing and genome sequencing by developing specialised tests for new variants, with at least €75 million in EU funding and prepare for adapting vaccine and vaccine production capacity.

Advance Purchase Agreements help de-risk private investments in the early development of production capacity for vaccine candidates still in early clinical trial stages.

Companies that successfully developed COVID-19 vaccines are already closely monitoring the efficacy of their vaccines against emerging variants and looking into the possibilities of adapting their vaccines.

The Commission will use existing Advance Purchase Agreements to ensure rapid access to and delivery of the next generation of vaccines, if necessary. Existing agreements may have to be updated to cover protection against variants. Based on the lessons learned, a detailed and credible plan showing capability to produce vaccines in the EU on a reliable timescale will be a prerequisite to any new or updated agreement. This should not prevent the EU from considering sources from outside the EU if needed, provided they meet the EU safety requirements

In addition to Advance Purchase Agreements, capacity support will be considered, notably for smaller firms, to facilitate the production of vaccines and ensure the availability of intermediary inputs and infrastructures, such as laboratories.

We have already considerably accelerated the procedure for approving new vaccines and medicines over the last year. The European Medicines Agency undertakes rolling reviews of new vaccines or therapeutics, allowing it to recommend a conditional marketing authorisation much quicker than in the past.

We are proposing to speed up the procedures for approving adapted versions of existing vaccines, in case new variants becoming less receptive to current vaccines. We will base the framework on that used for the annual flu vaccine, which has worked successfully for many years. This means speedy approval based on a rolling review of data and clear guidance on data requirements from the European Medicines Agency, and a clear path to certification of new or repurposed manufacturing sites.

Private-public cooperation will be key to improving vaccine production capacity and overcoming bottlenecks in the supply chain. The bio-defence preparedness plan “HERA Incubator” will facilitate contacts and cooperation between regulators, other public authorities and industry and between industry players involved in the supply chain. The Task Force for Industrial Scale Up will act as a one-stop-shop helpdesk for any queries and operational support to address bottlenecks in production and supply of raw materials.

The Commission will foster the creation, if need be, of a voluntary, dedicated licensing mechanism to enable sharing of technical know-how through pre-production industrial partnerships in order to increase production.

The Commission will support the cooperation between undertakings necessary to achieve the specific objective in terms of research and development, production or supply, which the companies acting alone would not be in a position to do. The Commission stands ready to provide competition law guidance in relation to the production of vaccines or treatments, including in light of the criteria set out in the Antitrust Temporary Framework Communication.

The Commission will set up the EU-FAB flexible manufacturing capacity reserve.

The Commission will build on the ongoing mapping of industrial capacities.

“EU FAB” project will set up a network of single or multi-user, single or multi-technology emergency response production capacity for vaccine and medicine manufacturing at European level. The project is being set up with the long-term perspective of becoming over time an asset for the future European Health Emergency Preparedness and Response Authority (HERA).

16 Member States and five associated countries including Israel and Switzerland will participate in VACCELERATE, the clinical trials network launched on 17 February. The network will make cooperation and data exchange during clinical trials on COVID-19 therapeutics and vaccines much smoother. It will also focus on setting up paediatric trials to look into the effectiveness of vaccines in children and young people.

The Commission will invest in various aspects of the platform, including:

• €75 million to support genomic sequencing in Member States and to develop new standardised tests for variants;
• €150 million for existing and new research projects on variants under Horizon Europe;
• Topping up the Emergency Support Instrument and using the Horizon 2020 InnovFin Infectious Diseases Finance Facility and under InvestEU to finance new or extended advance purchase agreements.

The bio-defence preparedness plan “HERA Incubator” will start off immediately, it will lay the foundations for a future fully-fledged bio-preparedness authority, the European Health Emergency Preparedness and Response Authority (HERA). The EU bio-preparedness authority was part of the Commission's legislative package on building resilience to health threats of 11 November 2020.

An EU authority for bio-preparedness would remediate structural gaps in the EU's health preparedness and response capacities with regard to biomedical development, production and surge capacity development. It will also provide a horizon scanning function, focusing on emerging biomedical technologies that can be scaled-up for real-world application during times of crisis. The authority will engage with industry, science, academia and clinical research organisation networks, with the aim of implementing successful public-private cooperation.

A consultation on the inception impact assessment for a European Health Preparedness and Response Authority is ongoing. The preparatory actions on new variants announced on 17 February will also contribute to shaping the new agency. The Commission will make a legislative proposal towards the end of the year.

The EU investment into creating state-of-the-art vaccine and drug research, development and manufacturing capacities will be one of the core blocks for future pandemic response, but will also contribute to EU strategic autonomy in the area of health and the strategic positioning of the European healthcare industry.