NAFDAC-Approved Nigeria Has Approved Oxford University’s Malaria Vaccine for Use

The R21/Matrix-MTM malaria vaccine developed by Oxford University and the Serum Institute of India PvT Ltd vaccine has been licensed by the National Agency for Food and Drug Administration and Control.

Nigeria has approved the new malaria vaccine developed by Oxford University and the Serum Institute of India PvT Ltd. The R21/Matrix-MTM malaria vaccine has been licensed by the National Agency for Food and Drug Administration and Control (NAFDAC).

On Monday, Mojisola Adeyeye, NAFDAC’s director general, announced that the vaccine has been approved for use in children from five to 36 months with Fidson Healthcare PLC as its Marketing Authorisation Holder.

According to Adeyeye:

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 ready-to-use liquid formulation for intramuscular injection. The vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age. The storage temperature of the vaccine is 2-8 °C. 

Nigeria is one of the four African countries that account for over half of all malaria deaths worldwide. Other countries include the Democratic Republic of the Congo, Tanzania and Niger. Nigeria accounts for about 31.9 per cent of the global malaria deaths; with approximately 200,000 deaths in 2021. Over 60 million people are infected yearly.

According to the 2022 world malaria report, the World Health Organization’s ‘African Region’—with an estimated 234 million cases recorded in 2021—accounted for about 95 per cent of global cases. Children younger than five accounted for about 80 per cent of all malaria deaths in Africa.

Ghana was the first country in the world to approve the new malaria vaccine before the publication of final-stage trial data. On 13 April, Ghana’s Food and Drug Administration announced the approval, clarifying its position and mandate as a regulator and defended the vaccine’s approval.

‘The WHO can provide support, but it is not an approving institution. The FDA has the mandate as a regulator, and that is what we have done,’ Delese Darko, CEO of Ghana’s Food and Drugs Authority (FDA) told Reuters.

R21 has demonstrated high levels of efficacy and safety in Phase II trials, including children who received a booster dose of the vaccine a year after following a three-dose vaccination system.

The vaccine was designed and developed at the University of Oxford and has undergone clinical trials in the United Kingdom and Thailand. Across African countries including Burkina Faso, Kenya, Mali and Tanzania, an ongoing phase III trial has seen the enrolment of 4,800 children. The results from these trials are expected to be reported later this year.

In 2021, WHO approved RTS, S/AS01 vaccine or Mosquirix from British pharmaceutical company, GlaxoSmithKline—the first malaria vaccine. Ghana, Kenya and Malawi were all involved in the pilot programme for the roll-out of Mosquirix and have recently begun introducing it within their countries.

As of September 2022, Mosquirix’s efficacy against the first and only episode of clinical malaria over twelve months after the third dose was 31.1 per cent in infants and 55.8 per cent in children. The R21 vaccine, however, demonstrated high-level efficacy of 77 per cent following 2021 results from the Phase-IIb trial.

Adeyeye noted that NAFDAC has recommended a provisional approval of the vaccine to be done in line with WHO’s Malaria Vaccine Implementation Guideline. She also noted the need for expansion of the clinical trial. The expanded trial will include a Phase IV clinical trial/Pharmacovigilance study carried out in Nigeria.

The director general said a brief on approval of the R21 Malaria vaccine has been communicated to the Minister of Health and National Primary Health Care Development Agency (NPHCDA) for action toward immunisation in respective population

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