‘100,000 doses expected soon’
Children under three can now be immunised for malaria.
The National Agency for Food and Drug Administration and Control (NAFDAC) yesterday okayed the provisional use of an anti-malaria vaccine.
It said the R21 vaccine by the Serum Institute in India met safety and efficacy criteria after an evaluation by a Joint Review Committee.
The review committee noted that the vaccine is 75 per cent effective in protecting against malaria.
It added that the vaccine’s potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
NAFDAC said the provisional approval of the R21 malaria vaccine makes Nigeria the second country to approve its use after Ghana.
North African country, Algeria, also yesterday gave its approval for use of the vaccine on its children.
Malaria is far more deadly than COVID-19 in Africa. It killed 386,000 Africans in 2019, according to a WHO estimate.
NAFDAC Director-General, Prof. Mojisola Adeyeye, said the country expects to get at least 100,000 doses of the vaccine in donations soon, to be coordinated by the National Primary Health Care Development Agency (NPHCDA).
Prof. Adeyeye said: “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 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.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the World Health Organisation’s (WHO’s) Malaria Vaccine Implementation Guideline.”
Prof. Adeyeye said she got the dossier for the vaccine in the last quarter and confirmed its availability.
“The Serum Institute of India contact said Nigeria would get a donation first as quickly as possible.
“Our expectation is that the vaccine will come in very soon. At least maybe 100,000 doses in donations first before the market authorisation will start.
“We are the second to approve the use of the vaccine. Nigeria’s approval sends a lot of signals to the world because we have the highest prevalence (of malaria) in the world.”
Prof Adeyeye cited the 2021 World Malaria Report, which says Nigeria had the highest number of global malaria cases (27 per cent of global malaria cases) and the highest number of deaths (32 per cent of global malaria deaths) in 2020.
The country, according to the report, accounted for an estimated 55.2 per cent of malaria cases in West Africa in 2020.
“Four African countries accounted for just over half of all malaria deaths worldwide: Nigeria (31.3 per cent), the Democratic Republic of the Congo (12.6 per cent), United Republic of Tanzania (4.1 per cent) and Niger (3.9 per cent),” she said.
On the vaccine approval process, the DG said: “NAFDAC received the dossier of the R21 Malaria manufactured by the Serum Institute of India Pvt Ltd (SSPL) and it was subjected to independent review at two levels.
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“Essentially, the dossier was reviewed by NAFDAC’s Vaccine Advisory Committee (NEVAC) independently, using standards of the WHO across relevant domains, in addition to the ICH guidelines, European Medicines Agency guidelines (where appropriate), scientific rigour on the vaccine and the context of malaria generally and specifically to Nigeria and best research and manufacturing governance.”
“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 committee also independently scored the assessment as satisfactory.”
Last Thursday, Ghana became the first country to approve a new malaria vaccine for young children.
Final results from late-stage trials have not yet been published, and the vaccine is under review by the WHO.
Preliminary results from early testing of the new vaccine, developed at the University of Oxford, have suggested the vaccine is far more effective than the only malaria vaccine now authorised for use by the WHO.
Late-stage testing of the vaccine is still underway in Burkina Faso, Kenya, Mali and Tanzania, with results expected later this year.
Results from an earlier trial released last year showed that in children vaccinated in Burkina Faso, the vaccine was up to 80 per cent effective, depending on how much of an immune-boosting ingredient was included in the shots.
WHO, in October 2021, said the only approved vaccine against malaria then should be widely given to African children.
The WHO recommendation is for “Mosquirix”, a vaccine developed by British drugmaker GlaxoSmithKline.
That programme followed a decade of clinical trials in seven African countries.
“This long-awaited malaria vaccine is a breakthrough for science. This is a vaccine developed in Africa by African scientists and we’re very proud,” said WHO Director-General Tedros Adhanom Ghebreyesus.