Covid19 elleni védőoltások az EU-ban – kérdések és válaszok

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 eight vaccines developed by:

• BioNTech and Pfizer, on 21 December 2020
• Moderna, on 6 January 2021
• AstraZeneca, on 29 January 2021
• Janssen Pharmaceutica NV, on 11 March 2021
• Novavax, on 20 December 2021
• Valneva, on 24 June 2022
• Sanofi and GSK, on 11 November 2022
• HIPRA, on 30 March 2023

The EMA has started rolling reviews of a COVID-19 vaccine from

• Gamaleya Institute, Sputnik V vaccine on 4 March 2021
• (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd, on 4 May 2021

These rolling reviews will continue until enough evidence is available for formal marketing authorisation application.

The Commission has negotiated 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 (2.4 billion doses), CureVac (405 million doses), Moderna (460 million doses), Novavax (200 million), Valneva (1.2 million) and HIPRA (up to 250 million doses).

EMA has ended the rolling review of CureVac COVID-19 vaccine, after the company informed the Agency that it was withdrawing from the process. This means that the Commission has secured a portfolio of more than 4.2 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.

Safety is a fundamental requirement for any vaccine to reach the EU market. Before being made available for purchase and use, any COVID-19 vaccine candidate needs to meet the rigorous requirements and evidence thresholds of the European Medicines Agency’s scientific assessment to receive market authorisation. These requirements are no different from those for any other vaccine produced and used in the EU. The European Medicines Agency (EMA) constantly monitors reports of any side effects after a vaccine is used and publishes regular safety updates.

• Our decisions on which vaccines to use are based on science, and a rigorous scientific evaluation of risks and benefits. Safety and protection of public health come first.
• The European Medicines Agency has been very clear – the AstraZeneca and Johnson and Johnson vaccines are effective and the overall benefits in preventing COVID-19 outweigh the risks of very rare and unusual side effects.
• Moreover, this shows that our pharmacovigilance system works: suspected side effects are reported rapidly, information is shared and our experts come together swiftly to assess the way forward.

Effective and broad vaccination is the best strategy to overcome the pandemic.

Based on current evidence, all vaccines authorised in the EU are highly protective against hospitalisation, severe disease and death, with an effectiveness in the general population of over 80%.

Unvaccinated individuals are at a much greater risk of being hospitalised or dying compared to vaccinated individuals. The unvaccinated make up the big majority of people in the most precarious situations in hospitals.

There is a clear link between the level of vaccination and the hospitalisation and death rates: the higher the vaccination rate, the lower the risk of being hospitalised or dying.

In past pandemic waves, an increase in infections also meant a proportional increase of hospitalisations and death rates. In the current pandemic, however, this is no longer the case: increasing infections are no longer leading to a similar increase in hospitalisations and higher death rates. This is another clear sign that the vaccines do their job.

By June 2022, more than 1.7 billion doses have been delivered to EU Member States. 86% of adult Europeans have been fully vaccinated.

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, Member States and the EMA are working 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 have access to COVID-19 vaccines at the same time on the basis of the size of their population.

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 overviewof 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.

As President von der Leyen stressed, the decision to vaccinate children is not a political decision, but an evidence-based scientific decision.

This is why it is so important to closely follow the science, and in particular the views of specialists such as EMA on safety and ECDC on the epidemiological aspects.

EMA has given its green light for the use of the BioNtech Pfizer vaccine for children over the age of 5 years. According to the agency, the use of the vaccine for children is effective and safe. Furthermore, scientific evidence demonstrates that children may also get infected and transmit the virus, and vaccination is a good way to protect children.

Ultimately, the establishment and implementation of vaccination strategies is a Member State competence, and a decision to be made by parents with their children.

On the basis of scientific evidence, and trusting the robustness of the data and assessments made by EMA and ECDC, we encourage parents to discuss the vaccination of their children with a medical specialist.

The contracts we concluded with the different vaccine developers allow us to ensure the delivery of a sufficiently high number of doses, as well as of paediatric vaccines in future agreements that take into account the need to also vaccinate children. Moreover, they also allow us to continue to fulfil our responsibilities in terms of vaccine supply to the rest of the world.

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

Yes.

When a vaccine receives conditional marketing authorisation, the package leaflet with details on the specific vaccine is 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.

EU law does not require compulsory vaccination. Vaccination, mandatory or otherwise, is a Member State competence.

However, the Commission continues to call on all eligible citizens to ensure they get their full vaccination against COVID-19. Full vaccination offers the best protection against the virus and its variants, including the Delta variant, and its transmissibility.

This is especially important for the most vulnerable, and those who are at high risk of catching and transmitting the virus.

If we want to beat the variants it is absolutely crucial to proceed with vaccinations and ensure that as many as possible are fully vaccinated. Scientific studies show that full vaccination offers good protection against the variants.

According to the ECDC, the proportion of the population that should be vaccinated against COVID-19 to achieve herd immunity, and whether this can be achieved, is not yet known and will depend largely on how well the vaccines work in reducing transmission.

The rapid, full vaccination of all targeted populations - in Europe and globally - is key to controlling the impact of the pandemic.

We therefore need to continue our vaccination campaigns, especially in view of the spread of variants. Given the threat of these 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 2021, which foresees the delivery of 1.8 billion doses of vaccines between the end of the year and 2023. The Commission has also exercised the option of 150 million doses of the second Moderna contract.

HERA (European Health Emergency Preparedness and Response Authority) will also work on tackling new variants, aiming to rapidly develop and produce effective vaccines against variants on a large scale.

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, depending on the epidemiological situation at any given point, even vaccinated people may need to wear masks, avoid indoor crowds, and respect physical distance, and 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.

To prepare for the future, we drew the lessons from the first phase of our response to the pandemic. It is clear that to defeat the virus decisively, we have to be prepared to ensure the quick availability in sufficient quantities of booster doses as soon as boosters are recommended by the scientific community.

Based on this, we signed a new contract with BioNTech-Pfizer, which foresees the delivery of 1.8 billion doses of vaccines between the end of the year and 2023. This is the world's largest contract for COVID-19 vaccines.

For the same purpose, we have also exercised our option of 150 million doses of the second Moderna contract.

The EU has therefore secured a sufficient number of vaccine doses to launch the booster phase of the response.

Taking into account the Commission’s proposals on the validity period of certificates and the need for boosters, Member States must place their orders in time to ensure that they can administer the doses in a sequential manner, and in line with the Commission’s proposed approach.

To ensure more flexibility, the Commission amended the regulatory procedure to accelerate approvals, building on what already exists for influenza vaccines. For instance, data requirements are reduced and data can be complemented later. But adapted vaccines still need to meet the EMA’s data requirements as laid out in its new guidance and EMA carries out a rolling review.

• Currently, the vaccines authorised within the EU appear to provide protection against the variants that are prevalent across the EU. Continued health safety measures will also continue to be key for a foreseeable future, so is testing and contact tracing to block transmission chains.
• We also hope that newer technologies such as mRNA vaccines could make the adaptation of existing vaccines even easier.
• We believe that it should be possible to have amended vaccines developed and approved rapidly. Depending on the platform technology used, the time needed to make such changes may vary from 3-4 months up to 6-9 months.

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: France, Germany, Italy, Poland, Spain, Sweden, The Netherlands - 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, available on the Commission website.

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.

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), theCommission 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 languagesin 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 languagesand 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.

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

This measure was originally envisaged to last until 31 March 2021, and has been extended until 31 December 2021.

The EU will not extend it beyond that date. This means that, as of 1 January 2022, vaccine producers will no longer have to request an authorisation for the export of vaccines outside the EU.

Transparency of exports will continue to be ensured through a new monitoring mechanism that will provide the European Commission with timely, company-specific vaccine export data. The Commission will continue to monitor the ongoing epidemiological situation in order to take appropriate measures if necessary.

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.