The National Agency for Food and Drug Administration and Control, NAFDAC, has approved the R21 malaria vaccine manufactured by the Serum Institute of India.
This makes Nigeria the second country to approve the new malaria vaccine developed at the University of Oxford, after Ghana.
The Director General of NAFDAC, Prof Mojisola Adeyeye, disclosed this on Monday, April 17, at a press briefing in Abuja.
Prof Adeyeye said the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
She 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.
Adeyeye said “NAFDAC in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. Overall, the assessment was scored as adequate -fully compliant with standards, and the report was submitted to the Director General.
“The review of NAFDAC’s Committee has always been guided by the same international standards and best practices with the same modality of an independent review by members followed by long hours of plenary where a rigorous assessment of each review took place. The Committee also independently scored the assessment as satisfactory and forwarded it to the Director General.”
According to her, the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked.
She said the Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met the criteria for efficacy, safety, and quality.
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.
“The Joint Review Committee recognised the importance of an effective malaria vaccine (with 75 per cent protection) as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.
“The Joint Review Committee also recommended additional phase four clinical trial, pharmacovigilance study in-country in the implementation given the peculiarity and heterogeneous nature of malaria in Nigeria.
“The Joint Review Committee was also interested in reviewing data of the human-malaria parasite dynamics of the 25 per cent not covered to understand issues bothering on non-protection that could inform further research.
“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,” she noted.
Source: Linda Ikeji Blog
