What to know about life-changing R21

Like her West-African counterpart- Ghana, Nigeria on Monday made history with the approval granted a new malaria vaccine- R21/Matrix-M, which has been developed by the University of Oxford and manufactured by the Serum Institute of India.

With malaria accounting for 60 per cent of outpatient visits to the nation’s health facilities; 30 per cent of childhood deaths; 11 per cent of maternal death, and 25 per cent of deaths in infants, Nigeria is said to contribute a huge 27 per cent to the global malaria burden.

Confronted by this staggering statistics, Nigeria’s decision to endorse any measure aimed at curtailing the rampaging disease would be applauded by the people. And this was the basis the country’s National Agency for Food and Drug Administration and Control (NAFDAC) announced the approval granted the vaccine use after it conducted its in-house checks.

NAFDAC said Nigeria expects to get at least 100,000 doses of the vaccine in donations soon.

This development has been described by many as a step forward in the fight against the life-threatening disease.

About new vaccine

The R21, otherwise referred to as Matrix-M malaria vaccine, is the second vaccine ever developed for a disease that claims more than 600,000 lives each year, most of which are children.

The first-ever malaria vaccine, RTS, S or mosquirix, from British drugmaker- GlaxoSmithKline (GSK), was approved by the WHO in 2021 after decades of work, but various research shows that the effectiveness of the vaccine is approximately 60 per cent, and that it significantly wanes over time, even with a booster dose.

But the latest intervention, according to the University of Oxford, a booster dose of the R21/Matrix-M vaccine at one year following a primary three-dose regime, maintained high efficacy against malaria and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75 per cent efficacy.

It is also reported that the 2021 results from the Phase-IIb trial reported that R21/Matrix-M demonstrated high-level efficacy of 77 per cent.

The researchers also confirmed that R21/Matrix-M vaccine has undergone clinical trials in the UK, Thailand, and several African countries, including an ongoing phase III trial in Burkina Faso, Kenya, Mali and Tanzania, which the said has enrolled 4,800 children.

However, while the World Health Organisation (WHO) is yet to give go-ahead for its roll-out, both Nigeria and Ghana’s drug regulators have approved it domestically for children between the ages of five months and three years old.

Vaccine’s targets

The R21/Matrix-M vaccine is said to target the plasmodium ‘sporozoite’, which is the first form of the malaria parasite entering the human body.

According to the Director General of NAFDAC, Mojisola Adeyeye, “the R21 Malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution. A dose which is 0.5ml is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an adjuvant filled in a vial as a ready-to-use liquid formulation for intramuscular injection.”

Mrs Adeyeye said the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was bench-marked, adding that its torage temperature is 2-8 °C.”

Vaccine supply

Gavi, a public–private global vaccine alliance with the goal of increasing access to immunisation in poor countries, has said the supply of the R21/Matrix-M vaccine should be able to meet its demand.

PREMIUM TIMES has reported that the Oxford team in collaboration with the Serum Institute of India will produce up to 200 million doses annually with a vaccine factory being constructed in Accra, Ghana.

According to Gavi, mass production of the vaccine will mean that it won’t face the same bottlenecks in manufacturing hurdles encountered by other vaccines, including the COVID-19 vaccines.

“This is critical because vaccinating those at high risk of malaria simultaneously will be important in stemming the spread of disease, as well as protecting the vaccinated,” it noted.

Possible roll-out schedule

Gavi has also confirmed that WHO is currently assessing whether to prequalify the vaccine for wider use or not.

It said if WHO eventually recommends it, “Gavi and UNICEF could begin funding and procuring doses immediately to protect children across Africa as soon as possible.”

“However, the idea is not to replace RTS, S but to be complementary – Gavi has already approved funding for a malaria vaccine programme and is ready to support the roll-out of R21 alongside RTS, S,” it added

Africa’s malaria burden

According to the latest WHO World Malaria Report, the African region continues to carry a disproportionately high share of the global malaria burden.

The report published in December 2022 shows that there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020. The estimated number of malaria deaths stood at 619,000 in 2021 compared to 625,000 in 2020.

In 2021, Africa accounted for about 95 per cent of all malaria cases and 96 per cent of deaths, with children under 5 years of age accounting for about 80 per cent of all malaria deaths in the region.

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Four African countries accounted for just over half of all malaria deaths worldwide: Nigeria (31.3 per cent), the Democratic Republic of the Congo (12.6 per cent), the United Republic of Tanzania (4.1 per cent) and Niger (3.9 per cent).

Nigeria’s Health Minister, Osagie Ehanire, said in the country, about 10 persons die every hour due to malaria or malaria-related issues.