Nigeria has become the second country in the world (after Ghana) to approve the use of the R21 malaria vaccine, the country’s drug and food regulatory agency, revealed earlier today.
The National Agency for Food and Drugs Administration and Control or NAFDAC said the decision was reached after rigorous testing and trials that were conducted by the Joint Review Committee.
Announcing the decision in Abuja, Nigeria’s capital, the head of the agency, Prof. Mojisola Adedyeye, said the vaccine complies with international standards and that it is of quality and safe for use.
Adeyeye held that the vaccine has shown 75% effectiveness against malaria and that the benefits outweigh its known and potential risks, which is why the country is granting the vaccine approval.
Her words; “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.
“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.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the World Health Organization’s Malaria Vaccine Implementation Guideline,” she said.
Adedeye said the country is expecting to get at least 100,000 doses of the vaccine as donations before the arrangement will be made to get more.
The R21 Malaria Vaccine (Recombinant, Adjuvanted) is manufactured by Serum Institute of India Pvt. Ltd. or SIIPL.
Nigeria has become the second country after Ghana to approve the R21 malaria vaccine, as announced by the National Agency for Food and Drugs Administration and Control (NAFDAC). The decision followed rigorous testing and trials by the Joint Review Committee.
Prof. Mojisola Adeyeye, head of NAFDAC, confirmed the vaccine’s compliance with international standards and its 75% effectiveness against malaria. It is deemed safe for use with benefits outweighing potential risks.
The vaccine, designed for children aged 5 to 36 months, is presented as a ready-to-use liquid for intramuscular injection and must be stored at 2-8°C. Provisional approval aligns with WHO's Malaria Vaccine Implementation Guideline, with Nigeria expecting an initial donation of at least 100,000 doses.
The R21 Malaria Vaccine is manufactured by the Serum Institute of India Pvt. Ltd. (SIIPL).
