The National Food and Drug Administration regulatory agency, NAFDAC, has granted registration approval to the R21 malaria vaccine (recombinant, adjuvanted) manufactured by Serum Institute of India Ltd.
The agency said it was part of its mandate under the enabling act, NAFDAC Act CapN1, LFN 2004.
The Director-General of NAFDAC, Professor Mojisola Adeyeye, who announced the approval at a news conference in Abuja on Monday, noted that malaria is one of the most important public health threats in the world.
She explained that the R21 malaria vaccine is an additional protein vaccine supplied as a pure solution, adding that a dose of 0.5ml contains R21 malaria antigen 5µg and Matrix-M1 50µg as a ready-to-use in-vitro adjuvant for intramuscular injection.
He added that the vaccine is useful in preventing clinical malaria in children aged 5 months to 36 months.
Adeyeye said, “The National Agency for Food and Drug Administration and Control (NAFDAC) in fulfilling its mandate under the Act, NAFDAC Act CapN1, LFN 2004 is authorizing the registration of serum-derived R21 malaria vaccine (Recombinant, Adjuvanted) Indian Institute Pvt. Ltd. (SIIPL)
The marketing authorization holder (MAHs) under the Agency’s Medicines and Related Products Registration Regulations 2021 is Fidson Healthcare Ltd.
“The R21 Malaria Vaccine is an adjuvant protein vaccine supplied as a pure solution. A 0.5ml dose consists of R21 Malaria Antigen 5µg and Matrix-M1 50µg adjuvant in a vial as a ready-to-use liquid formulation for intramuscular injection. The vaccine lasts from 5 months to It is indicated for the prevention of clinical malaria in children aged 36 months.The storage temperature of the vaccine is 2-8 °C.
Prof. Adeye said that NAFDAC has several ways to register vaccines, “These ways are based on the agency’s guidelines for registering imported drugs, vaccines and IVDs through the cooperative registration system or the agency’s guidelines for registering imported drugs.” and vaccines. “
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