NIGERIA – The National Agency for Food and Drug Administration and Control (NAFDAC) has granted registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).

Director General of NAFDAC, Prof Mojisola Christianah Adeyeye made this announcement at a press briefing to hint to Nigerians on the regulatory approval of R21 malaria vaccine by NAFDAC in Abuja.

“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHO’s Malaria Vaccine Implementation Guideline,” Adeyeye said,

“While granting the approval, the Agency has also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria.

“The brief on the approval of the R21 Malaria vaccine has been communicated to the Honourable Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunization in the respective population.”

She said that the Marketing Authorization Holder’s (MAHs) is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.

With the Malaria Vaccine and Regulatory Approval Process, NAFDAC is fulfilling one of its mandates as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004.

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 ready-to-use liquid formulation for intramuscular injection.

The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.

The National Agency for Food and Drug Administration and Control (NAFDAC) has several pathways for registration of vaccines.

These pathways are in line with the Agency’s guideline for registration of Imported Drugs, Vaccines and IVDs under Collaborative Registration Procedure, or the Agency’s guideline for registration of imported Drug and Vaccines.

The R21 Malaria Vaccine was reviewed using the latter which involves full review of product dossiers.

This approval comes a week after Ghana became the first country in the world to approve a new malaria vaccine from Oxford University, R21//Matrix-M, with children under the age of three in line to benefit.

Ghana’s drug regulators have assessed the final trial data on the vaccine’s safety and effectiveness, which is not yet public, and have decided to use it, although it is unclear when the rollout will begin.

The World Health Organization is also considering approving the vaccine.

Malaria is one of the most important public health concerns in the world.

According to the latest WHO World Malaria Report, 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.

Over the two peak years of the pandemic (2020–2021), COVID-19-related disruptions led to about 13 million more malaria cases and 63 000 more malaria deaths.

The WHO African Region continues to carry a disproportionately high share of the global malaria burden. In 2021 the Region was home to about 95% of all malaria cases and 96% of deaths. Children under 5 years of age accounted for about 80% of all malaria deaths in the Region.

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

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