European Commission - Questions and answers

Questions and Answers: COVID-19 vaccination in the EU*

Brussels, 8 January 2021
With which companies have you concluded COVID-19 vaccine agreements?
The Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at
fair prices. Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300
million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 600 million doses,
CureVac (405 million doses) and Moderna (160 million doses). The Commission has concluded
exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200
million doses 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 2.3 billion doses. For the
Commission it was important from the beginning to build a diversified portfolio of vaccines based on
different technologies, to increase the chances that one or more of the vaccine candidates are
approved by EMA. Should all vaccines candidates turn out to be safe and effective, Member States
have the possibility to donate part of their doses to lower and middle income countries.
Which vaccine is now authorised?
The Commission has given the conditional marketing authorisation for the vaccines developed by
BioNTech and Pfizer on 21 December, and Moderna on 6 January following EMA positive assessment
of their safety, quality and efficacy.
The EMA received an application for a marketing authorisation by AstraZeneca and Oxford University
on 12 January. An opinion by EMA could be given by 29 January. No other vaccine producer has
formally applied for a marketing authorisation to EMA. In order to accelerate the process, EMA has
started a rolling review on the vaccine produced by Johnson and Johnson.
How will vaccines be monitored post authorisation under the Conditional Marketing
Authorisation (CMA)?
The monitoring of the safety and effectiveness of vaccines after authorisation is a requirement under
EU law and a cornerstone of the EU's pharmacovigilance system relating to the detection,
assessment, understanding and prevention of adverse effects or any other medicine-related problem.
The system is exactly the same than for a normal market authorisation.
The safety and effectiveness of vaccines which have received conditional marketing authorisations
are rigorously monitored, as for all medicines, through the EU's established medicines monitoring
system.
In addition, special measures are in place to quickly collect and evaluate new information. For
example, manufacturers must usually send a safety report to the European Medicines Agency every
six months. For COVID-19 vaccines, safety reports must be sent every month.
The European Medicines Agency will set up additional large-scale safety monitoring given the
exceptionally high numbers of people expected to receive the vaccines.
Once authorised, when will vaccines be available in the EU?
In line with the EU vaccine strategy agreed with Member States, once authorised and produced, each
vaccine will be available to Member States at the same time and at the same conditions, which has
been the case for the two vaccines already authorised: BioNTech-Pfizer, and Moderna
The distribution will start progressively. This means that in the first few months, there will not be
enough doses available to vaccinate all adults. The first doses will go to the priority groups identified
by Member States (e.g. healthcare professionals, persons over 60 years of age). Supplies will
increase over time, and all adults should be able to get vaccinated during the course of 2021.
For most contracts concluded, the majority of delivery is foreseen to be completed in 2021.
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. First
deliveries and vaccinations of the Moderna vaccine are also now 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.
Will the EU have enough capacity to manufacture the COVID-19 vaccines?
There is already substantial vaccine production capacity in the EU – and the Commission is working
intensively to increase it. In addition, and in order to ensure that vaccine developers have the
necessary capacity to scale up the production of COVID-19 vaccines as soon as they have been
approved by the EMA, the Commission supports the necessary investment in the development of
such production capacities.
How will logistics work? How will vaccines be distributed?
Logistics and transportation is a key aspect on which all Member States have to work, as emphasised
in the Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment
of 15 October.
Delivery to national distribution hub(s) will be ensured by the manufacturers.
Further distribution to vaccination centres will be ensured by Member States, who will also be
responsible for the vaccination of their population.
Who should be vaccinated first?
All Member States will have access to COVID-19 vaccines at the same time on the basis of the size of
their population. The overall number of vaccine doses will however be limited during the initial
stages of deployment and before production can be ramped up. The Commission has therefore
provided examples of unranked priority groups to be considered by countries once COVID-19
vaccines become available.
Most countries have defined priority groups and are further refining who should get priority in these
priority groups e.g. older person over 80 years of age. The ECDC published an overview of where
EU/EEA countries and the UK are with the development of their vaccination plans/strategies. ECDC is
also working on a modelling exercise on prioritisation to support Member States. This report should
be published before Christmas.
Will citizens know which vaccine they will be getting?
Yes.
When vaccines receive conditional marketing authorisation, the package leaflet with details on the
specific vaccine will be translated into all languages and published in electronic form by the
Commission.
All health care professionals and all patients would therefore have access to a leaflet in electronic
form in their own languages.
The vaccine companies are responsible for putting in place the necessary mechanisms to ensure that
each patient receives the package leaflet in print form in his/her language upon request without
burdening healthcare professionals administering the vaccine.
What labelling and packaging information will citizens and health care professionals get
with the COVID-19 vaccines?
In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has
developed, with Member States and the European Medicines Agency, labelling and packaging
flexibilities for a temporary period. Flexibility in the labelling and packaging requirements is expected
to reduce transport costs and storage space, improving the distribution of the doses between
Member States and limit possible impact on the production of other routine vaccines. Despite these
flexibilities, anyone vaccinated and health care professionals will have access to all the information
on the vaccine used.
An example of such flexibilities is the fact that the outer and immediate packaging may only be
printed in English. Also, the package leaflet does not have to be included inside the package of the
medicinal product, but will be provided separately by the vaccine company, who will be responsible
for the distribution of the printed package leaflet locally in the national language(s).
Some Member States do not require the package leaflet to be printed in their national language(s).
The leaflet may be printed in English only, but the information contained in the leaflet should still be
available in the national language(s), for instance via a QR code printed in the package leaflet and
also available in the EMA website in all languages.
How will the Commission support Member States in the rolling-out of vaccines?
The Commission stands ready to support Member States to ensure the smooth deployment of
COVID-19 vaccines. A number of EU instruments in the programming period 2021-2027 can offer
financial support in this regard.
For instance, investments to support health reforms and resilient, effective and accessible health
systems are eligible under the Recovery and Resilience Facility (RRF), and can be included in the
national Recovery and Resilience Plans. Furthermore, the Cohesion Policy funds (European Regional
Development Fund - ERDF and European Social Fund Plus - ESF+) as well as the REACT-EU
programme can provide financing to Member States and their regions to strengthen their health
systems, both in terms of managing and recovering from the current health crisis and as well as
ensuring their resilience in the longer term.
Collectively, these programmes can support a range of investment needs, for example, in health
infrastructure, training of health professionals, health promotion, disease prevention, integrated care
models, digital transformation of healthcare, and equipment, including critical medical products and
supplies to strengthen the resilience of health systems.
In this context, investments to prepare health systems for the roll out COVID-19 vaccines are
eligible under these programme, especially given the direct link to the resilience of health systems,
the availability of critical medical products and disease prevention. However, it will be up to each
Member State to decide on the priorities and content of their Recovery and Resilience Plan and also
their Programmes for the Cohesion Policy funds.
How will vaccination certificates work?
A common approach to pharmacovigilance, and to trusted, reliable and verifiable vaccination
certificates across the EU could reinforce the success of vaccination programmes in Member States
and the trust of citizens.
Registering data on vaccination is important both at individual and population levels. For an
individual, it is a means to know and demonstrate their vaccination status. Proof of vaccination
should be available from the moment vaccination starts. Vaccination certificates could for example be
useful in the context of travel, showing that a person has been vaccinated and therefore may not
need testing and quarantine upon arrival in another country.
The Commission and Member States, together with WHO, are working on vaccination certificates.
This work includes a minimum dataset, including a unique identifier, for each individual vaccination
which will ease the issuance of certificates and vaccination monitoring on a Europe-wide basis from
the moment that the COVID-19 vaccines are authorised.
The development of the common specifications framework will take account of and contribute to the
work of WHO. EU funds, such as RRF, ERDF, InvestEU can support the setting up of the
Immunisation Information Systems (IIS), Electronic Health Records and secondary use of health
data on immunisation.
How much does the vaccine cost? What is the price of the vaccine?
The Commission negotiated advantageous deals with vaccine manufacturers to secure access to 2.3
billion doses so far.
At this stage the specific pricing per dose is covered by confidentiality obligations. However, a
significant part of the overall costs are funded by a contribution from the overall EU funding for
vaccines.
Will the vaccine be free in all EU Member States?
While this is a Member State responsibility, the large majority of the Member States intend to offer
vaccination free of charge.
Are the contracts with the companies publicly available?
The focus for the Commission is the protection of public health and securing the best possible
agreements with companies so that vaccines are affordable, safe and efficacious.
Contracts are protected for confidentiality reasons, which is warranted by the highly competitive
nature of this global market. This is in order to protect sensitive negotiations as well as business
related information, such as financial information and development and production plans.
Disclosing sensitive business information would also undermine the tendering process and have
potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set
out in the legal instruments that form the basis of the negotiations. All companies require that such
sensitive business information remains confidential between the signatories of the contract. The
Commission therefore has to respect the contracts it concludes with the companies.
The Commission has published the redacted contract of the advance purchase agreement with
CureVac and hopes to be able to publish other contracts .
When will the vaccine allow the control of the pandemic?
For some known communicable diseases, it is understood that herd immunity allowing to control a
pandemic and eventually eradicate a disease requires around 70% of the population to have
protection either from vaccination or previous infection.
Depending on the pace of vaccination and natural infections, the pandemic might be controlled by
the end 2021 in Europe.
Can we still spread the disease once vaccinated?
We do not yet know. Additional evaluations will be needed to assess the effect of the vaccine in
preventing asymptomatic infection, including data from clinical trials and from the vaccine's use
post-authorization.
Therefore, and for the time being, even vaccinated people will need to wear masks, avoid indoor
crowds, and respect social distance, so on. Other factors, including how many people get vaccinated
and how the virus is spreading in communities may also prompt revision of this guidance.
If I have already had COVID-19 and recovered, do I still need to get the vaccine?
There is not enough information currently available to say if or for how long after infection someone
is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests
natural immunity from COVID-19 may not last very long, but more studies are needed to better
understand this.
*Updated 26 January 2021 at 16:13.
QANDA/20/2467

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