Hopes are high that the R21/Matrix-M malaria vaccine – recently approved by Ghana and Nigeria – will be manufactured on the continent in the not-too-distant future, bringing the potential for an affordable elimination of the dreaded disease a step closer.
Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for children aged from five months to three years, the age group at the highest risk of death from malaria, reports Health Policy Watch.
It was the first country in the world to do so – followed shortly afterwards by Nigeria – and this was despite the vaccine not yet being given World Health Organisation (WHO) pre-qualification approval.
SII, the manufacturing and commercialisation licence holder for the vaccine, said Ghana’s approval was the “first crucial step enabling the vaccine to help Ghanaian and African children to combat malaria”.
“This is a significant milestone in our efforts to combat malaria worldwide,” said Adar Poonawalla, SII CEO.
Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII.
The agency said the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the data were robust and met the criteria for efficacy, safety, and quality.
Local production?
Ghana’s regulator said the application for approval had been submitted by SII’s local agent, DEK, which expects to eventually manufacture the vaccine locally.
“The status of the (Ghana) FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the vaccine in the future,” the agency said.
A few days after the regulatory approval, a ground-breaking ceremony was held at DEK Vaccines’ vaccine fill-and-finish plant. The company is a private sector-led consortium of Ghanaian pharmaceutical companies.
Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorisation Holder (MAH), allowing the Nigerian firm to distribute, sell and commercialise the jab.
In September 2022, the country also signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Ltd (a joint venture between the government of Nigeria and May & Baker Nigeria Plc), and SII.
“The government has approved 15% of the vaccines Unicef normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. SII will now join Biovaccines Nigeria in building its manufacturing plant here in Nigeria,” said Health Minister Osagie Ehanire.
From Oxford to West Africa via India
Designed and developed at the University of Oxford, the vaccine has been tested in the UK, Thailand and several African countries.
A current phase three trial in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4 800 children, the results of which are expected later this year.
While the Nigerian regulator has also recommended an in-country phase four clinical trial or pharmacovigilance study, it noted that the efficacy results from the clinical trials contributed to its decision to approve it.
Professor Adrian Hill, chief investigator for R21/Matrix-M programme, and director of the Jenner Institute at Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford.
“I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said.
The vaccine contains Novavax’s Matrix-M, a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable.
Matrix-M stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s Covid-19 vaccine and is a key component of other development-stage vaccines.
Approval without WHO prequalification
Unlike the developments surrounding the approval of the Covid-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators green-lighted the vaccine without WHO approval.
In addition to affirming their regulators’ competence and authorisation to undertake such approvals, Dr Franklin Asiedu–Bekoe, director of Public Health in Ghana, told Health Policy Watch the vaccine – the second malaria jab being rolled out by the country – will be closely reviewed by scientists.
“In Ghana, we have 93 districts now using the TRS,S. So if we have a vaccine which is good, nothing stops us from using it,” he argued.
Local manufacturing elements of both approvals
In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5m doses of the vaccine have been administered through routine immunisation programmes.
“Community demand for the vaccine is high and it is well accepted in communities, even when additional visits to clinics are required for the four-dose schedule,” WHO said.
But RTS,S roll-out has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply.
In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200m doses annually.
But there are also considerations for local manufacturing.
WHO and Gavi falling in line
Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support, acknowledging that a second malaria vaccine may be coming forward.
Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, said Ghana and Nigeria “have not jumped the gun because it is expected that, at national level, regulatory authorities can also review data once they have received information from different vaccine developers”.
Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, told Health Policy Watch the alliance is prepared to provide funding for the R21 malaria vaccine.
She said the restricted supply of the RTS,S made it “really important” to have several tools, apart from affordability.
“It’s not just about the volumes, it’s also about affordability. SII has made an important public commitment to keep the vaccine’s cost to $3 or less. So we look forward to them honouring that commitment because ultimately, it means more people are protected.”
Health Policy Watch article – Africa to Manufacture New Malaria Vaccine? (Open access)
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