The World Health
Organisation (WHO), on Wednesday, endorsed the widespread use of the
RTS,S/AS01 (RTS,S) malaria vaccine.
The development comes amid research efforts to address
malaria, which remains one of the leading causes of child mortality in
sub-Saharan Africa, with over 250,000 deaths reported yearly.
The recommendation followed a two-year vaccination
programme, which involved more than 800,000 children in Ghana, Kenya and
Malawi.
Here are 10 things to know about the groundbreaking vaccine.
Who can take the vaccine?
The vaccine is recommended for
children from five months of age to around 18 months, close to their second
birthday.
In the vaccination programme, Malawi first offered the
vaccine to children aged five months, while in Ghana and Kenya, the vaccine was
first offered to persons at six months of age.
What is the dosage?
The vaccine is recommended to be taken in four doses. The
first three doses are given one month apart at five, six and seven months old,
and then a final dose is given at around 18 months.
How effective is the vaccine?
According to the phase three trial conducted between 2009
and 2014, “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 was also found to offer a 29 percent reduction
on the need for blood transfusions, which are required to treat
life-threatening malarial anaemia.
The phase three trial involved
15,000 children in seven sub-Saharan African countries — Burkina Faso,
Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania.
Is it safe?
According to WHO, the vaccine has a favourable safety profile —
after more than 2.3 million doses of the vaccine have been administered in
three African countries.
Also, the European
Medicines Agency had issued a scientific opinion on
the vaccine in July 2015, concluding that the benefits outweigh the risks.
Are there side effects?
The WHO says the side effects of the vaccine include pain and swelling at the injection
site, and fever. But these side effects are similar to reactions observed with
other vaccines administered to children.
The vaccine is also associated with an increased risk of
febrile seizures — a seizure caused by fever — within seven days of the
administration, but according to the phase three trial, children who developed
these seizures recovered fully.
How does the vaccine work?
RTS,S aims to trigger the immune system to defend against the
first stages when the plasmodium falciparum malaria parasite enters the human
host’s bloodstream through a mosquito bite and infects liver cells.
The vaccine is designed to prevent the parasite from
infecting the liver, where it can mature, multiply, re-enter the bloodstream,
and infect red blood cells, which can lead to disease symptoms.
How long did it take to make the vaccine?
The vaccine is the result of over 30 years of research led
by GlaxoSmithKline (GSK), with PATH, a non-governmental health agency and other
partners.
Does the vaccine work against all types of malaria
parasites?
There are different malaria parasites in existence. The
RTS,S specifically targets plasmodium falciparum parasite, which is the one
that is most common in Africa.
What makes the RTS,S vaccine different from other
vaccines under development?
According to WHO, the RTS,S malaria vaccine is the first
vaccine that has demonstrated it can significantly reduce malaria in children
across Africa, and also cut back on fatality counts.
Speaking on the vaccine, Tedros Ghebreyesus, WHO DG, said
“it significantly reduces life-threatening severe malaria, and we estimate it
to be highly cost-effective”.
How was the making of the vaccine funded?
The Bill & Melinda Gates Foundation provided funding for
late-stage development of RTS,S between 2001 and 2015. Two notable donations
within this period include $107.6 million to the PATH malaria vaccine
initiative (MVI) to work with GlaxoSmithKline Biologicals and African
investigators to complete testing and apply for licensure of the most advanced
malaria vaccine candidate in 2005, and $168.7 million to PATH for its
malaria vaccine initiative in 2008.
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