Provisional Approval For R21 Malaria Vaccine Manufactured: NAFDAC
NAFDAC, The National Agency for Food and Drug Administration and Control, on Monday gave a provisional approval for R21 malaria vaccine for use in Nigeria.
With the approval of the vaccine manufactured by the Serum Institute of India, Nigeria becomes second country to approve the product after Ghana.
Disclosing this during a media briefing, the Director General of the Agency, Prof Christianah Adeleye also explained that while the review committee recognised that the vaccine is 75 percent effective in protecting against malaria, added that the vaccine’s potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
Adeleye further explained that the provisional approval of the R21 makes Nigeria the second country in the world to approve its use after Ghana added that Nigeria 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 (NPHCDA), NAFDAC.
She said the vaccine is indicated for prevention of clinical malaria in children from 5 months to 36 months of age. Nigeria becomes 2nd country to give approval.
The storage temperature of the vaccine is 2-8 °C.
“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. (SIIPL).
“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the the World Health Organization’s (WHO’s) Malaria Vaccine Implementation Guideline.”
Stating that Malaria is one of the most important public health concerns in the world., she noted that the latestWHO World Malaria Report showed that 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.
Continuing, she explained that the brief on the approval of the R21 Malaria vaccine has been communicated to the Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunization in the respective population.
She further pledged NAFDAC committed in ensuring that only products that are safe, high quality and efficacy are made available for Nigerians.
provisional approval for R21 malaria vaccine manufactured: NAFDAC.