Ghana first to approve Oxford's malaria vaccine
Send a link to a friend
[April 13, 2023]
By Natalie Grover and Jennifer Rigby
LONDON (Reuters) -Ghana has become the first country in the world to
approve a new malaria vaccine from Oxford University, with children
under the age of three-years-old in line to benefit.
The mosquito-borne disease kills more than 600,000 people each year,
most of them children in Africa, and scientists have been trying for
years to develop vaccines.
It is unclear when the Oxford vaccine will be rolled out in Ghana.
Childhood vaccines in Africa are typically paid for by international
organisations such as Gavi and UNICEF after they have been backed by the
World Health Organization (WHO), which is still assessing the vaccine's
safety and effectiveness.
However, Oxford scientist Adrian Hill said Ghana's drug regulator has
approved it for the age group at highest risk of death from malaria -
children aged 5 months to 36 months. It has a deal with Serum Institute
of India to produce up to 200 million doses annually.
This is the first time a major vaccine has been approved first in an
African country ahead of rich nations, Hill said.
It was unusual that a regulatory authority in Africa had reviewed the
data quicker than the WHO, he added.
"Particularly since COVID, African regulators have been taking a much
more proactive stance, they've been saying...we don't want to be last in
the queue," Hill said.
The first malaria vaccine, Mosquirix from British drugmaker GSK, was
endorsed by the WHO last year after decades of work. But a lack of
funding and commercial potential thwarted the company's capacity to
produce as many dose as needed.
GSK has committed to produce up to 15 million doses of Mosquirix every
year through 2028, well under the roughly 100 million doses a year of
the four-dose vaccine the WHO says is needed long-term to cover around
25 million children.
[to top of second column]
|
A nurse fills a syringe with malaria
vaccine before administering it to an infant at the Lumumba
Sub-County hospital in Kisumu, Kenya, July 1, 2022. REUTERS/Baz
Ratner
Ghana, Kenya and Malawi were all
involved in the pilot programme for the roll-out of Mosquirix, and
have begun rolling it out more widely in recent months.
Since it began in 2019, 1.2 million children across the three
countries have received at least one dose of the vaccine, and the
WHO said last month that in the areas where the vaccine has been
given, all-cause child mortality has dropped by 10%, a sign of its
impact.
Mid-stage data from the Oxford vaccine trial involving more than 400
young children was published in a medical journal in September.
Vaccine effectiveness was 80% in the group that received a higher
dose of the immune-boosting adjuvant component of the vaccine, and
70% in the lower-dose adjuvant group, at 12 months following the
fourth dose.
The doses were administered ahead of peak malaria season in Burkina
Faso.
Data from an ongoing phase III clinical trial in Burkina Faso,
Kenya, Mali and Tanzania that has enrolled 4,800 children is
expected to be published in a medical journal in the coming months.
However, late-stage data - which suggests a similar vaccine
performance as in the phase II trial - has been shared with
regulatory authorities over the last six months, Hill said.
(Reporting by Natalie Grover in London; Editing by Angus MacSwan)
[© 2023 Thomson Reuters. All rights
reserved.]This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
|