Raquel Serrano Madrid
Madrid
Updated Friday, February 2, 2024-00:30
Data from a clinical trial with nearly
5,000 boys and girls
between
5 and 36 months
of age indicate that a new malaria vaccine - the so-called
R21/MatrixM -
has reduced symptomatic cases between 68 and 75%.
during the following year
.
In the aforementioned
phase III trial, whose data are published in
The Lancet
, it is indicated that "the vaccine
will be low cost
and could contribute to substantially reducing suffering and deaths from malaria in sub-Saharan Africa," according to the coordinator of the work. ,
Mehreen Datoo
, from the
Center for Clinical Vaccination and Tropical Medicine, Jenner Institute, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford, UK
.
The vaccine for which the data has now been released has been developed by researchers at the
University of Oxford
and will be manufactured by the
Serum Institute of India
. Its objective is to expand access to
prevention
through malaria vaccination, a pathology from which 600,000 people die each year in the world. The development of immunizations for this disease has been, by the way, considered one of the
scientific milestones of last year 2023
, as EL MUNDO reported.
To know more
Health.
Ozempic, anti-Alzheimer's drugs and anti-malaria vaccines, the scientific milestones of 2023
Editor: P. PÉREZ Madrid
Ozempic, anti-Alzheimer's drugs and anti-malaria vaccines, the scientific milestones of 2023
Health.
WHO approves the use of malaria vaccine in children
Editorial: REUTERS
WHO approves the use of malaria vaccine in children
The breakthrough began with the large-scale evaluation of the first malaria vaccine,
RTSMosquirix (RTS, S) (RTS,S/AS01)
, which achieved prequalification status in July 2022. Data revealed that it significantly reduced deaths in children, the group most affected by the disease. However, its
production capacity is limited
, with only 18 million doses available until 2025.
For this reason, the
WHO
added a second one,
R21/Matrix-M
, to its list of prequalified vaccines and for which its positive phase III results have now been released. It is expected, if everything follows a normal course, that this new vaccine will be available for
widespread use in mid-2024.
We must not lose sight of the fact that malaria is a mosquito-borne disease that places a particularly high burden on children in the
African Region
, where almost
half a million children die
from this disease each year. Globally, in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths in 85 countries.
Phase 3 data with R21/Matrix-M, the
second malaria vaccine recommended for children
in malaria-endemic areas, which recently received prequalification from the World Health Organization, were expected around this time.
BIG STEP IN WORLD HEALTH
Preliminary data already indicated that its efficacy was, at least, similar to the first available vaccine, although
greater efficacy was suggested
than that achieved with the other recommended vaccine, the
first antimalarial
RTS,S/AS01. In any case, both immunizations will facilitate greater access to a key tool to prevent malaria in children.
In fact,
Kate O'Brien
,
director of the Department of Immunization, Vaccines and Biological Products at the WHO
, stated that with the prequalification of the second malaria vaccine "a
great step has been marked in global health
by welcoming the prequalification of R21/Matrix-M, the second vaccine against malaria".
When antimalarial vaccines are widely implemented, along with other recommended
malaria control
interventions , they are expected to have a high impact on public health, the global health entity indicates.
The implementation of antimalarials, along with other recommended measures, would have a high impact on public health
Regarding the clinical trial now presented in
The Lancet
, carried out in four African countries with a sample size of almost 5,500 children,
Jaime Jesús Pérez Martín
,
specialist in Preventive Medicine and Public Health, deputy director general of Public Health of the Region of Murcia
and president of The
Spanish Association of Vaccinology (AEV)
considers it to be "excellent", declares to SMC Spain.
On the one hand, "this vaccine had published results from phase II clinical trials and the
results were concordant
. Furthermore, as the authors say, the vaccine is already authorized by the WHO and its use has begun in several African countries."
The data, in his opinion, are also consistent with those of another vaccine already in use against malaria, specifically Mosquirix, which was the first authorized vaccine against malaria, "so with this new vaccine we already have two." . "The most important novelty is that
the efficacy data increases compared to those obtained by Mosquirix
, which has figures of between 45 and 55% protection. Here we increase up to between 70 and 80%, that is, it offers a notable improvement regarding protection."
GREATER PROTECTION AND DISTRIBUTION
Thus, the news is
greater protection
, and at the same time, "it will allow more extensive vaccination programs against malaria than we had until now, since a second vaccine will be available that has a
large number of doses prepared
for use. Also as an added advantage we could have an increase in the duration of protection."
Pérez Martín also highlights the fact that the vaccine uses a
new adjuvant, Matrix-M
, which until now has not been in use "but which can be configured as a very promising adjuvant for use in numerous vaccines.
As for the
limitations
, there are those given by the authors themselves, such as the fact of not measuring efficacy against mortality, but "that is very difficult in a clinical trial because logically they are ideal situations in which the treatment of early form. However, by measuring the effectiveness against the disease later in real life we will achieve
important reductions in mortality
, so I do not think it will be an important limitation."
For
Consuelo Giménez Pardo
,
professor in the Parasitology Area at the University of Alcalá (UAH)
, the current study by the Datoo team continues with the work published in
The Lancet
already published in
2021
and
2022
.
In this case, phase III of the trial "shows an efficacy of 75% against clinical malaria in places with seasonal malaria and 67%, in places with regular malaria, in children from 5 to 36 months. Although There seems to be a decrease in effectiveness in periods of 3 months, during the
first 12 months the effectiveness remains
above 60%," he tells SMC Spain.
In the double-blind trial carried out over a year in different areas of Burkina Faso, a
control group was used to receive the rabies vaccine
, which, according to other studies, seems to protect against meningitis.
"In this case, despite the limitations of the study, the authors propose that R21/Matrix-M is capable of being produced in terms of 100-200 million doses annually at a
cost of less than $4 per dose
and that it may help to prevent malaria," explains the also director of the Master's Degree in Humanitarian Health Action (UAH-Médicos del Mundo).
R21/Matrix-M could be produced in 100-200 million doses annually at a cost of less than $4 per dose
"The truth, he emphasizes, is that the demand for antimalarial vaccines has never been greater and, however, stocks of the already marketed vaccine, RTS,S, are limited. Now, with the R21/Matrix-M vaccine on the list of malaria vaccines recommended by WHO, the supply is expected to be sufficient to
immunize all children living in areas
where this disease is a public health risk.
In this sense, it is proposed as "cost-effective and safe, so that
the choice of one vaccine or another
will be made in each country according to the characteristics of the programs, the supply of vaccines and their affordability. As is done with other vaccines new ones, their possible toxicity will continue to be monitored," concludes the specialist.