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Resolution 2361 (2021)
Covid-19 vaccines: ethical, legal and practical considerations
1. The pandemic of Covid-19, an infectious
disease caused by the novel coronavirus SARS-CoV-2, brought about
much suffering in 2020. By December 2020, more than 65 million cases
had been recorded worldwide and more than 1.5 million lives had
been lost. The disease burden of the pandemic itself, as well as the
public health measures required to combat it, have devastated the
global economy, laying bare pre-existing fault- lines and inequalities
(including in access to healthcare), and causing unemployment, economic
decline and poverty.
2. Rapid deployment worldwide of safe and efficient vaccines
against Covid-19 will be essential in order to contain the pandemic,
protect healthcare systems, save lives and help restore global economies.
Although non-pharmaceutical interventions such as physical distancing,
the use of face masks, frequent hand washing, as well as shutdowns
and lockdowns, have helped slow down the spread of the virus, infection
rates are now rising again across most of the globe. Many Council
of Europe member States are experiencing a second wave that is worse
than the first, while their populations are increasingly experiencing
“pandemic fatigue” and are feeling demotivated about following recommended
behaviour to protect themselves and others from the virus.
3. Even rapidly deployed, safe and effective vaccines, however,
are not an immediate panacea. Following the festive season at the
end of 2020 and the beginning of 2021, with its traditional indoor
gatherings, infection rates will likely be very high in most member
States. In addition, a correlation has just been scientifically established
by French doctors between outdoor temperatures and the disease incidence
rate on hospitalisations and deaths. The vaccines are unlikely to
be sufficient to bring down infection rates significantly this winter
– in particular when taking into account that demand far outstrips
supply at this point. It will thus not be possible to resume a semblance
of “normal life”, even in the best of circumstances, until mid to
late 2021 at the earliest.
4. For the vaccines to be effective, their successful deployment
and sufficient uptake will be crucial. However, the speed at which
the vaccines are being developed may cause a feeling of mistrust
that is difficult to combat. An equitable deployment of Covid-19
vaccines is also needed to ensure their efficacy. If not widely enough
distributed in a severely hit area of a country, vaccines become
ineffective at stemming the tide of the pandemic. Furthermore, the
virus knows no borders and it is therefore in every country’s interest
to co-operate in ensuring global equity in access to Covid-19 vaccines.
Vaccine hesitancy and vaccine nationalism have the capacity to derail
the so-far surprisingly fast and successful Covid-19 vaccine effort,
by allowing the SARS-CoV-2 virus to mutate and thus blunt the world’s
most effective instrument against the pandemic so far.
5. International co-operation is thus needed now more than ever
in order to speed up the development, manufacturing and fair and
equitable distribution of Covid-19 vaccines. The COVAX Facility
is the leading initiative for global vaccine allocation and access.
Co-led by the World Health Organization (WHO), the Vaccine Alliance
(Gavi) and the Coalition for Epidemic Preparedness Innovations (CEPI),
COVAX uses funding from subscribing countries to support the research,
development and manufacture of a wide range of Covid-19 vaccines
and negotiate their pricing. Adequate vaccine management and supply
chain logistics, which require international co-operation and preparation
by member States, will also be needed in order to deliver the vaccines
in a safe and equitable way. In this regard, the Parliamentary Assembly
draws attention to guidance for countries, developed by WHO, on
programme preparedness, implementation and country-level decision making.
6. Member States must already now prepare their immunisation
strategies to allocate doses in an ethical and equitable way, including
deciding on which population groups to prioritise in the initial
stages when supply is short, and how to expand vaccination as availability
of one or more Covid-19 vaccines improves. Bioethicists and economists
largely agree that persons over 65 years old, those under 65 with
underlying health conditions that put them at a higher risk of severe
illness and death, healthcare workers (especially those who work
closely with persons who are in high-risk groups) and people who
work in essential infrastructure should be given priority for vaccination.
Children, pregnant women and nursing mothers, for whom no vaccine
has so far been authorised, should not be forgotten.
7. Scientists have done a remarkable job in record time. It is
now for governments to act. The Assembly supports the vision of
the Secretary-General of the United Nations that a Covid-19 vaccine
must be a global public good. Immunisation must be available to
everyone, everywhere. The Assembly thus urges member States and
the European Union to:
7.1. with
respect to the development of Covid-19 vaccines:
7.1.1. ensure
high-quality trials that are sound and conducted in an ethical manner
in accordance with the relevant provisions of the Convention for
the Protection of Human Rights and Dignity of the Human Being with
regard to the Application of Biology and Medicine: Convention on
Human Rights and Biomedicine (ETS No. 164, Oviedo Convention) and
its Additional Protocol concerning Biomedical Research (CETS No. 195),
and which progressively include children, pregnant women and nursing
mothers;
7.1.2. ensure that regulatory bodies in charge of assessing and
authorising vaccines against Covid-19 are independent and protected
from political pressure;
7.1.3. ensure that relevant minimum standards of safety, efficacy
and quality of vaccines are upheld;
7.1.4. implement effective systems for monitoring the vaccines
and their safety following their roll-out to the general population,
also with a view to monitoring their long-term effects;
7.1.5. put in place independent vaccine compensation programmes
to ensure compensation for undue damage and harm resulting from
vaccination;
7.1.6. pay special attention to possible insider trading by pharmaceutical
executives or pharmaceutical companies unduly enriching themselves
at public expense, by implementing the recommendations contained
in Resolution 2071 (2015) “Public
health and the interests of the pharmaceutical industry: how to
guarantee the primacy of public health interests?”;
7.1.7. overcome the barriers and restrictions arising from patents
and intellectual property rights in order to ensure the widespread
production and distribution of vaccines in all countries and to
all citizens;
7.2. with respect to the allocation of Covid-19 vaccines:
7.2.1. ensure respect for the principle of equitable access to
healthcare, as laid down in Article 3 of the Oviedo Convention,
in national vaccine allocation plans, guaranteeing that Covid-19 vaccines
are available to the population regardless of gender, race, religion,
legal or socio-economic status, ability to pay, location and other
factors that often contribute to inequities within the population;
7.2.2. develop strategies for the equitable distribution of Covid-19
vaccines within member States, taking into account that the supply
will initially be low, and plan how to expand vaccination programmes
as the supply increases; follow the advice of independent national,
European and international bioethics committees and institutions,
as well as of WHO, in the development of these strategies;
7.2.3. ensure that persons within the same priority groups are
treated equally, paying special attention to the most vulnerable
such as older persons, those with underlying conditions and healthcare
workers, especially those who work closely with persons who are
in high-risk groups, as well as people who work in essential infrastructure
and public services, in particular in social services, public transport,
law enforcement and schools, as well as those who work in the retail sector;
7.2.4. promote equity in access to Covid-19 vaccines between
countries by supporting international efforts such as the Access
to Covid-19 Tools (ACT) Accelerator (ACT-Accelerator) and its COVAX
Facility;
7.2.5. refrain from stockpiling Covid-19 vaccines, as this undermines
the ability of other countries to procure vaccines for their populations,
and ensure that stockpiling does not result in escalating vaccine
prices for those who cannot stockpile; conduct auditing and due
diligence to ensure rapid deployment of vaccines at minimum cost
based on need and not on market power;
7.2.6. ensure that every country is able to vaccinate their healthcare
workers and vulnerable groups before vaccination is rolled out to
non-risk groups, and thus consider donating vaccine doses or accepting
that priority be given to countries which have not yet been able
to do so, bearing in mind that a fair and equitable global allocation
of vaccine doses is the most efficient way of beating the pandemic
and reducing the associated socio-economic burdens;
7.2.7. ensure that Covid-19 vaccines whose safety and effectiveness
have been established are accessible to all who require them in
the future, by having recourse, where necessary, to mandatory licences
in return for the payment of royalties;
7.3. with respect to ensuring a high vaccine uptake:
7.3.1. ensure that citizens are informed that the vaccination
is not mandatory and that no one is under political, social or other
pressure to be vaccinated if they do not wish to do so;
7.3.2. ensure that no one is discriminated against for not having
been vaccinated, due to possible health risks or not wanting to
be vaccinated;
7.3.3. take early effective measures to counter misinformation,
disinformation and hesitancy regarding Covid-19 vaccines;
7.3.4. distribute transparent information on the safety and possible
side effects of vaccines, working with and regulating social media
platforms to prevent the spread of misinformation;
7.3.5. communicate transparently the contents of contracts with
vaccine producers and make them publicly available for parliamentary
and public scrutiny;
7.3.6. collaborate with non-governmental organisations and/or
other local initiatives to reach out to marginalised groups;
7.3.7. engage with local communities in developing and implementing
tailored strategies to support vaccine uptake;
7.4. with respect to Covid-19 vaccination for children:
7.4.1. ensure a balance between the rapid development of vaccination
for children and duly addressing safety and efficacy concerns and
ensuring the complete safety and efficacy of all vaccines made available
to children, with a focus on the best interests of the child, in
accordance with the United Nations Convention on the Rights of the
Child;
7.4.2. ensure high-quality trials, with due care for relevant
safeguards, in accordance with international legal standards and
guidance, including a fair distribution of the benefits and risks for
the children who are studied;
7.4.3. ensure that the wishes of children are duly taken into
account, in accordance with their age and maturity; where a child’s
consent cannot be given, ensure that agreement is provided in other
forms and that it is based on reliable and age-appropriate information;
7.4.4. support the United Nations Children’s Fund (UNICEF) in
its efforts to deliver vaccines from manufacturers that have agreements
with the COVAX Facility to those who need them most;
7.5. with respect to ensuring the monitoring of the long-term
effects of Covid-19 vaccines and their safety:
7.5.1. ensure
international co-operation for timely detection and elucidation
of any safety signals by means of real-time global data exchange
on adverse events following immunisation (AEFIs);
7.5.2. use vaccination certificates only for their designated
purpose of monitoring vaccine efficacy, potential side effects and
adverse events;
7.5.3. eliminate any gaps in communication between local, regional
and international public health authorities handling AEFI data and
overcome weaknesses in existing health data networks;
7.5.4. bring pharmacovigilance closer to healthcare systems;
7.5.5. support the emerging field of “adversomics” research,
which studies inter-individual variations in vaccine responses based
on differences in innate immunity, microbiomes and immunogenetics.
8. With reference to Resolution
2337 (2020) on democracies facing the Covid-19 pandemic,
the Assembly reaffirms that parliaments, as cornerstone institutions
of democracy, must continue to play their triple role of representation,
legislation and oversight in pandemic circumstances. The Assembly
thus calls on parliaments to exercise these powers, as appropriate,
also in respect of the development, allocation and distribution
of Covid-19 vaccines.