The National Agency for Food and Drug Administration Control (NAFDAC), has granted registration approval for the R21 Malaria Vaccine (Recombinant, Adjuvanted), manufactured by Serum Institute of India Limited.
Prof Mojisola Adeyeye, Director General of the Agency, made the disclosure during a press briefing in Abuja on Monday.
The development comes a few days after Ghana approved the vaccine, thereby making Nigeria the second country in the world to approve the vaccine.
The malaria vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
“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 storage temperature of the vaccine is 2-8 °C”, Prof. Adeyeye said.
“NEVAC members reviewed all sections independently using best review practices and met physically in plenary to assess and debate the reviews by sections, raised queries, and made recommendations accordingly.
“Overall, the assessment was scored as adequate -fully compliant with standards”.
It was also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
Prof. Adeyeye said the country expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency.
