Nigeria Becomes Second Nation After Ghana To Approve Oxford’s R21 Malaria Vaccine

Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) has granted provisional approval to Oxford University's R21 malaria vaccine.

Addressing a press conference in Abuja on Monday, Director General of NAFDAC, Professor Mojisola Adeyeye, said Nigeria became the second country in the world to approve the R21 malaria vaccine after Ghana.

R21 is an "Adjuvanted protein vaccine" that will help in preventing malaria in children aged between 5 to 36 months, according to Adeyeye. Ahead of market authorization, Nigeria will receive 100,000 doses of the vaccine as a donation from Oxford University.

"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," Adeyeye said, as reported by ChannelsTV.

"The Marketing Authorization Holder's (MAHs) is Fidson Healthcare Ltd in line with the Agency's Drug and Related Products Registration Regulation 2021," she added.

She further explained that a dose of the vaccine, which is 0.5ml, is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an adjuvant filled in a vial in a ready-to-use liquid formulation for intramuscular injection. The vaccine is supposed to be stored at a temperature between 2-8 °C.

Adeyeye also disclosed that the vaccine's approval came after it was independently reviewed by NAFDAC's Vaccine Advisory Committee (NEVAC) using standards of the World Health Organisation (WHO).

Moreover, they also used the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines and European Medicines Agency guidelines to review the vaccination.

"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," she said. "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."

"Overall, the assessment was scored as adequate - fully compliant with standards," the professor noted.

The Joint Review Committee noted that the R21 Malaria vaccine data was robust and met all the quality, safety and efficacy criteria, affirming the vaccine provides 75% of protection.

Nigeria has reported nearly 27% of global malaria cases, with 241 million malaria cases and 6,27, 000 malaria deaths worldwide in 2020. These cases increased by 14 million compared to 2019, according to WHO. Nigeria's 97% of the population is at risk of malaria, as per Punch.