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Assembly's special page
Covid-19 vaccines: ethical, legal and practical
considerations
Resolution 2361 (2021) | Provisional version
Author(s): Parliamentary Assembly
Origin
Assembly debate
on 27 January 2021 (5th Sitting) (see
Doc. 15212,
report of the Committee on Social
Affairs, Health and Sustainable Development, rapporteur: Ms Jennifer De Temmerman).
Text adopted by
the Assembly
on 27 January 2021 (5th Sitting).
1 The pandemic of Covid-19, an infectious disease caused by the novel coronavirus SARS-CoV-2, has caused
much suffering in 2020. By December, 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 health care), 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 health-care systems, save lives and help restore global economies. Although non-
pharmaceutical interventions such as physical distancing, the use of facemasks, 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 which is
worse than the first, while their populations are increasingly experiencing “pandemic fatigue” and are feeling
demotivated about following recommended behaviours 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 the year 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 will no doubt not be sufficient to bring down infection rates
significantly this winter – in particular when taking into account that demand far outstrips supply at this point. A
semblance of “normal life” will thus not be able to resume 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 pose a difficult to combat challenge to building up trust in
them. An equitable deployment of Covid-19 vaccines is also needed to ensure the efficacy of the vaccine. 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 on 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 Covid-19 Vaccine Allocation Plan,
also known as COVAX, is the leading initiative for global vaccine allocation. Co-led by the World Health
Organization (WHO), the Vaccine Alliance (Gavi) and the Coalition for Epidemic Preparedness Innovations
(CEPI), the initiative pulls funding from subscribing countries to support the research, development and
manufacturing 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 preparations by member States, will also
be needed in order to deliver the vaccines against the virus in a safe and equitable way. In this regard, the
Parliamentary Assembly draws attention to guidance for countries on programme preparedness, implementation
and country-level decision-making developed by WHO.
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 and persons under 65 with underlying health
conditions putting them at a higher risk of severe illness and death, health-care workers (especially those who
work closely with persons who are in high-risk groups), and people who work in essential critical infrastructure
should be given priority vaccination access. 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 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)
on 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 health care 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 prepare for how to expand vaccination programmes when the
supply expands; 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, with special attention to the most
vulnerable people such as older persons, those with underlying conditions and health care workers, especially
those who work closely with persons who are in high-risk groups, as well as people who work in essential
infrastructure and in public services, in particular in social services, public transport, law enforcement, and
schools, as well as those who work in retail;
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 Accelerator (ACT Accelerator) and its COVAX Facility;
7.2.5 refrain from stockpiling Covid-19 vaccines which undermines the ability of other countries to procure
vaccines for their populations, ensure stockpiling does not translate to escalating prices for vaccines from those
who stockpile to those who cannot, conduct auditing and due diligence to ensure rapid deployment of vaccines at
minimum cost based on need not market power;
7.2.6 ensure that every country is able to vaccinate their health-care workers and vulnerable groups before
vaccination is rolled out to non-risk groups, and thus consider donating vaccine doses or accept 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 has 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 high vaccine uptake:
7.3.1 ensure that citizens are informed that the vaccination is NOT mandatory and that no one is politically,
socially, or otherwise pressured to get themselves vaccinated, if they do not wish to do so themselves;
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 efforts 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 balance between the rapid development of vaccination for children and duly addressing safety and
efficacy concerns and ensuring complete safety and efficacy of all vaccines made available to children, with a
focus on the best interest 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 in 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 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 the 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 health-care 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, as cornerstone institutions of democracy, parliaments 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.
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