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A TRACK AND CHECK OF HUMAN RIGHTS ON THE DEVELOPMENT AND CLINICAL TRIALS OF THE RTS, S/AS01 (RTS, S) MALARIA VACCINE BY: MARBANSHNGAIN DKHAR
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Article Details
A TRACK AND
CHECK OF HUMAN RIGHTS ON THE DEVELOPMENT AND CLINICAL TRIALS OF THE RTS, S/AS01
(RTS, S) MALARIA VACCINE
AUTHORED
BY: MARBANSHNGAIN DKHAR
LLM (Human
Rights) Amity University Uttar Pradesh (2022-2023)
Abstract
The increase
in numerous types of diseases has led man to think and find ways how to curb
this challenge. Malaria is a disease which has created a global alarm for a
long time. The Continent of Africa has been the main victim of this disease in
which its fatalities ranges to about 0.8 million each year. Recently the
RTS,S/AS01 (RTS,S) Malaria Vaccine that was developed has received a good
response from the participant in its clinical trial conducted over the years
and this has led to the decrease in the fatality rate to 0.4 million each year,
moreover this vaccine has received a nod from the World Health Organisation.
However with the recent achievement and development in the medical field, this
paper/ article seeks to examine and observe the process initiated in the
research, development and clinical trials of the vaccine whether it is in
accordance with the human rights or is it guilty of violation of human rights.
Technology along with globalisation has shaped and impacted greatly in our
world even within the health sector. This article is based on the various
reports of the CDC, WHO and social/personal understanding approach.
Key Words: Africa, health, human rights,
infringement, Malaria, vaccine,
violation
Introduction
The
uncertainty of life that it brings with it the unannounced arrival of death and
the increase in numerous diseases and health deteriorating factors has made us
conscious of our own health, after all the life given to each one of us is
precious and there is beauty in each of it. August Comte also known as the
Father of Sociology, in his theory of the Law of Three Stages has explained
that human life evolved in three stages and the first being the Theological
stage, the second being the Positive stage and the third being the Scientific
stage. In all of the development leading from the first to the third stage we
see that logic, discovery and inventions were the main catalysts that led to
the advancement and progression in all aspects. Our world had gone through
numerous epidemics and pandemics and these have taken with it the lives of so
many precious souls. The birth of new and complicated diseases and illnesses
has made researchers, scientists and medical experts to find ways and methods
how to control and to eradicate these hindrances which were the main culprits
for the deaths of so many lives. Thus, for centuries medical research began,
firstly in Europe and slowly it spread to all the different continents. These
research involved and still involves clinical trials of the techniques, drugs,
medicines and vaccines discovered by the researchers and scientist which act as
salvation grace and to put an end or to control the diseases.
Law who
existed initially as the law of nature as explained by thinkers such as Jean
Jaques Rousseau, John Locke and Thomas Hobbes later developed and grew and were
codified and became legislations and Acts in which in it contains the rights,
duties, remedies and punishments prescribed for the individuals and citizens.
Law touches every aspect and area of our world be it health, agriculture,
society, economy, politics, etc. Every human is entitled to the human rights
and human rights over the years have acted as a tool to track all the conducts
taking place in different fields, to check if these conducts have been found
guilty of violating or depriving humans from these human rights. Similarly the
medical and health sector in its involvement with their medical research and
their clinical trials despite of being a blessing for our health but without a
doubt and as per the facts and records some of these researches were found
guilty for infringement of human rights. Thus Human rights act as a tool to
administer and uphold justice in all sectors amidst the world’s advancement and
progression that is witnessed but human rights seeks that all these are taking
place within the ambit to ensure a safe, a fair and a peaceful world.
The Development phase of the RTS,S/AS01 (RTS,S)
Malaria Vaccine:
The World
Health Organisation (WHO) in 2019 has estimated that there were 229 million
cases of malaria infections and of these approximately 0.4 million of the
infected individuals succumbed from this disease. Malaria is a serious concern
and fatal disease and over the years it has alarmed the world particularly the
African continent. This disease is often associated and accompanied by fever,
chills, etc, and it is caused by the female mosquito Anopheles carrying and transmitting a parasite called Plasmodium falciparum, Plasmodium vivax,
Plasmodium ovale and Plasmodium malariae, thus, a female Anopheles mosquito when infected by
either of the mentioned parasite may cause it to transmit the parasite to
humans through mosquito bites and leading to malaria. Malaria can also be
transmitted through blood transfusion from a person carrying the malaria
parasite to another person or even from a mother to her unborn child in her womb.
Of all the mentioned parasites, the most dangerous and fatal of all the malaria
parasites is the Plasmodium falciparum and
this has been the leading cause of so many deaths if the infected individual
does not receive treatment at the earliest. Drugs such as quinine and its
derivative chloroquine were used in the treatment for malaria but were not
completely successful up to a higher mark or degree.
“Malaria vaccine development entered a
new era in 2015 when the pre-erythrocytic Plasmodium falciparum candidate
RTS,S was favourably reviewed by the European Medicines Agency and subsequently
introduced into national pilot implementation programs, marking the first human
anti-parasite vaccine to pass regulatory scrutiny. Since the first trials
published in 1997, RTS,S has been evaluated in a series of clinical trials
culminating in Phase 3 testing, while testing of other pre-erythrocytic
candidates (that target sporozoite- or liver-stage parasites), particularly
whole sporozoite vaccines, has also increased.” [1]
The RTS,S vaccine was the biggest achievement in the history of the development
of a malaria vaccine because in 2015 it received its favoured opinion from the
European Medicine Agency (EMS) and for the first time it also passed through
the WHO’s highest regulatory scrutiny.
“RTS,S, the most advanced PEV, incorporates a P.
falciparum CSP fragment comprising central repeat (hence “R”) and
C-terminal regions (containing T cell epitopes, hence “T”) fused to hepatitis B
surface antigen (“S”), or altogether “RTS”. RTS is expressed in yeast that also
carry hepatitis B “S” expression cassettes, and thus synthesize S and RTS
polypeptides that spontaneously co-assemble into mixed lipoprotein particles
(or “RTS,S”) with the CSP fragment on their surface.”[2]
The clinical trial of the malaria vaccine was conducted
in Africa, a region with highest concentration of malaria. The trial was
conducted on infants, young children, adults and also on pregnant mothers
largely in the Sub-Saharan region of Africa and the statistics showed a
promising effect and high efficacy rate largely in young children compared to
the infants. Thus this vaccine was further improved. On the 6th of
October 2021, after many years of observation and further research the World
Health Organisation has recommended for the widespread use of the RTS,S vaccine
after its successful and positive impactful results of the malaria vaccines
inoculated in Ghana, Kenya and Malawi. This became one of the historic record
and achievement of mankind for their fight against a dreadful disease such as
malaria which has caused so much of bitterness, despair and deaths in the lives
of many.
Did the Development
and clinical trials of the Malaria vaccine Passed the Human Rights test?
The Second World War period witnessed the highest
atrocities and health crimes especially in Germany in the concentration camps. We
now live in the age of globalisation and since the end of the cold war in the
90s, our world wanted and opted for the integration of all nations together to
achieve the global agendas or goals and thus the United Nations through its
various bodies were given utmost importance. Globalisation has not only brought
about the integration of economies, but over the years it has also brought
about an increase in the international clinical trials of vaccines and
medicines and most of the countries in which these trials were conducted were
and are the weaker nations found in Asia, Africa and South America, thus the
real question arises is that if such can be accepted or is it a violation of
the human rights?
In an era where the Sustainable Development Goals are the
global agendas and objectives for the world to achieve, thus in order to reach
such an aspiration, it is essential and it also involves the improvement of the
health sector and related aspects, thus clinical trials are important too but
should be done and carried upon within the ambit of human rights. Article 3 of
the Universal Declaration of Human Rights has stated that everyone has got the
right to life, liberty and security of person. Vaccines, medicines, etc, are
ways and measures to sustain life and to improve our health condition in this
world, no doubt that over the years with the inset of various vaccines and
medicines we have been able to decrease death rates from diseases which were
once upon a time fatal, eg tuberculosis, chickenpox, polio, etc. For research
and development purposes of such vaccines and medicines clinical trials is
mandatory in order to observe and analyse the efficacy rate of medicines or
vaccines.
It is learnt that the Malaria Vaccine Implementation
Programme (MVIP) is being rolled out only in the continent Africa and the
reason is that African continent accounts for the majorities of the malaria
fatalities and infections in the world and especially the young children are
the most vulnerable section of the society to contract the disease, this has
suffered a lot of criticisms that Africa being a vulnerable continent with
respect to the economy, military, polity, etc, and thus was chosen as a hotspot
to conduct various medical research and trials, but in relation and on the
basis of Article 3 of the Universal Declaration of Human Rights that all humans
are entitled to the right to health, the World Health Organisation has made a
clear statement that they have opted for countries such as Kenya, Ghana and
Malawi which have witnessed high and increasing number of malaria cases and
also in those countries where there is a good response with the past and recent
vaccination programmes, in which thousands of people could be saved through
this vaccine. However, there are some medical researches and clinical trials
that have always been guilty of violation of human rights in which trials and
research were conducted without prior consent of the victim or the patient. Conducting
of clinical trials without the consent would amount to infringement of Article
3 and in the case of “Herczegfalvy v. Austria”[3] a man by the name Herczegfalvy was given a sedative
without his consent in a psychiatric hospital and the Court did agree that this
could breach Article 3 in theory. However, the court held that in order to show
that article 3 has been breached because of the absence of consent, a minimum
level of harm or severity met must be shown and that such medical treatment was
not essential or needed. In the case of the Malaria (RTS,S) vaccine awareness
programs and information on the vaccines were given from time to time including
the risk, the benefits that this vaccine could offer and the eligibility
criteria of who can receive the vaccine were given. Further-more they
encouraged people to continue using and adopting malaria control measures such
as mosquito nets, insecticides even after receiving the vaccine.
“Information is provided one on one by health
workers, through health talks led by health officials and health providers –
using flip charts, informational leaflets and posters – as well as meetings with
community leaders, community health volunteers, public service announcements,
and through the local health media, among other methods. Parents who bring
their children to clinics for vaccination do so with the option to vaccinate
their children or not, as with other vaccines. The vaccine is being delivered
through EPI programmes as part of routine delivery, and similar to how other
childhood vaccines are offered to families. Because it is not an experimental
vaccine, but approved by the regulatory authorities, written consent is not
sought for individuals who are vaccinated.”[4]
The states have an
obligation to take steps nationally and also through international assistance
and cooperation towards the full realization and administration of various
rights, including the right to health. Thus, developed countries have a human
rights responsibility to help the developing and weaker nations to deliver the
right to health. In India in “Rahul Dutta v. Union of India”[5] and “Swasthya Adhikar Manch v. Union of India”[6] Courts
in both these cases have criticised the government for its failure to deal and
curb the illegal trials and stated that
the untimely death of trial participants in such trials is a gross violation of
the fundamental right to life guaranteed under Article 21 of the Indian
Constitution. The Apex Court went on to observe that the unrestrained clinical
trials are causing disaster to human life. The Court by way of the writ of
mandamus would direct the government to amend the laws as per international
accepted standards. Article 5 of the
Universal Declaration of Human Rights says that no human shall be subjected or
inflicted by any means of torture, or cruelty, or inhuman or degrading
treatment or punishment. It is a fact that clinical trials is a risky process
and in such a process no humans should fall victim or face any fatalities else
only if prior consent is given with proper explanation such as risks, benefits
and side effects involving in the process is given and explained by the
experts. “From the human rights perspective, all malaria initiatives must be
subject to effective, accessible and transparent monitoring and accountability,
to ensure not just financial propriety but also that the initiatives are
conforming to human rights standards and delivering to all without
discrimination.”[7]
The
Success Story of the Malaria Vaccine - An achievement of Human Rights:
Article 25 of the Universal
Declaration of Human Rights speaks about the right of every human to an
adequate standard of living for health and well-being which includes food,
clothing, housing and medical care etc. The RTS,S Malaria vaccine received a
good response and efficacy rate in which in 2015 the European Medicines Agency
concluded that the benefits of the vaccine are more compared to the risks.
However during the phase 3 of the trial cases of meningitis were found in those
children who have received the malaria vaccine already, but studies show that
it is not the effect of the vaccine. A positive impact was witnessed in the decrease
in malaria cases in children who received the vaccine by 29%. “Among children aged 5–17 months who received 4 doses of RTS,S, the
vaccine prevented approximately 4 in 10 (39%) cases of malaria over 4 years of
follow-up and about 3 in 10 (29%) cases of severe malaria, ** with significant
reductions also seen in overall hospital admissions as well as in admissions
due to malaria or severe anaemia. The vaccine also reduced the need for blood
transfusions, which are required to treat life-threatening malaria anaemia by
29%.”[8] The
University of Oxford has also made a comment that the Malaria vaccine could be
a major breakthrough against the disease that has taken away too many precious
lives and that it efficacy rate stands at 77%. The fatality figures have
dropped by half from approximately 0.8 million in 2015 to about 0.4 million in
2019, but this disease is still a concern in many regions of Africa and the
world because of the large number of population.
Conclusion:
The dawn of technology in our world
has helped and assisted us to achieve many of our pending goals and objectives
especially those related to the health sector. The concept of global
citizenship has made us realised and transcended our thoughts beyond our
nationalist or regionalist spirit and for this reason, a collective global
responsibility has emerged in our fight against the challenges. The research,
development and clinical trials involved with the RTS,S Malaria vaccine was not
a one country’s achievement but a global achievement. Since health is our first
and foremost priority, it is important that the health sector must go hand in
hand with Human Rights. When an achievement has been attained in the clean way
without any manipulation or coercion this truly reflect that our world has
firmly set its track towards reaching its global objectives.
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23, 2021) http://
https://www.bbc.com/news/health-56858158
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Ruth, Medical Consent: What do Human Rights have to do with it?, (Sept 19,
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[1] Patrick E Duffy & J. Patrick
Gorres, Malaria Vaccines since 2000: Progress, priorities, products, NPJ
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Article Information
A TRACK AND CHECK OF HUMAN RIGHTS ON THE DEVELOPMENT AND CLINICAL TRIALS OF THE RTS, S/AS01 (RTS, S) MALARIA VACCINE BY: MARBANSHNGAIN DKHAR
Authors: MARBANSHNGAIN DKHAR
- Journal IJLRA
- ISSN 2582-6433
- Published 2024/06/17
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International Journal for Legal Research and Analysis
- Abbreviation IJLRA
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