NAFDAC to embark on nationwide clinical trials of malaria vaccine

The Director-General of NAFDAC, Professor Mojisola Adeyeye, made this known on Sunday in Lagos.

She said the agency has mandated the pharmaceutical industry to raise Pharmacovigilance surveillance departments in their individual outfits, noting that PV would revolutionise things.

In a statement made available by NAFDAC Resident Media Consultant, Sayo Akintola, the DG said the industry must put structures in place to ensure monitoring of products across the supply chain.

Prof. Adeyeye stressed that strategies, goals, and clear-cut objectives to achieving the mission must be conceptualised, adding that Marketing Authorisation Holders must, as a matter of importance, train and engage relevant stakeholders on the need for pharmacovigilance and use of relevant platforms for reportage of Adverse Drug Reactions/Adverse Events Following Immunisation (ADR/AEFI) to NAFDAC.

The NAFDAC DG submitted that the sustainable safety of medical products in Nigeria lies on stakeholders and called for compliance with the PV initiative, and other existing laws to promote the sector.

She gave an assurance that the six pharmacovigilance centres established across the geopolitical zones would be strengthened to deliver creditably and that Nigerians would personally supervise the exercise.

Prof. Adeyeye highlighted the importance of community pharmacists, noting that they are strategic in the project, as they penetrate the populace based on available statistics.

She said since community pharmacists are also involved in immunisation, it has become imperative that their PV systems be accessed to ensure compliance with regulations and guidelines.

The NAFDAC DG noted that since inception, the agency embraced a number of activities to ensure the safe use of medical products in the country, adding that the PV was brought to the fore during the COVID-19 pandemic and is aimed at achieving the African Union Smart Safety Surveillance on the continent.

Recall that in April, NAFDAC approved the R21 malaria vaccine manufactured by the Serum Institute of India, making Nigeria the second country, after Ghana, to approve the new malaria vaccine developed at the University of Oxford.

Prof. Adeyeye said the vaccine was indicated for the prevention of clinical malaria in children from five to 36 months of age.

She said the country is expected to get at least 100,000 doses of the vaccine in donations soon before the market authorisation when arrangements would be made 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.

“The Marketing Authorisation Holder is Fidson Healthcare Ltd in line with the agency’s Drug and Related Products Registration Regulation 2021.

“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 a ready-to-use liquid formulation for intramuscular injection.

“The vaccine is indicated for the prevention of clinical malaria in children from five months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.”

Not long after, the Federal Government revealed that the RTS,S/AS01 malaria vaccine is expected to be in the country by April 2024.

The announcement came just after The PUNCH exclusively reported that Nigeria failed to apply for the vaccine before the second application window closed on January 17, 2023.

The World Health Organisation, in 2021, recommended the widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and other regions with moderate to high Plasmodium falciparum malaria transmission.

Meanwhile, Prof, Adeyeye said the dossier of the malaria vaccine approved by NAFDAC was subjected to independent review at two levels.

She said the dossier was reviewed by NAFDAC’s Vaccine Advisory Committee independently, using standards of the World Health Organisation across relevant domains.

She 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, 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.

Four African countries accounted for just over half of all malaria deaths worldwide – Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), the United Republic of Tanzania (4.1%) and Niger (3.9%).

In Nigeria, 97 per cent of the population is at risk of malaria.

Malaria accounts for 30 per cent of infant mortality and 11 per cent of mortality cases, recorded in the country.

As of 2020, Nigeria shouldered 31.9% of global malaria deaths and ranked as the most malaria-burdened country in Africa.

in 2021, the Federal Government launched the Malaria Eradication Fund to strengthen the country’s public health system, so as to respond to the challenge posed by the disease.