The federal government has granted provisional approval for
the R21/Matrix developed by scientists at Oxford University.
Mojisola Adeyeye, director-general of the National Agency
for Food and Drug Administration And Control (NAFDAC), made the announcement at
a press briefing on Monday.
The development comes days after Ghana became the first
country to approve the vaccine — which is said to be 80 percent effective.
The malaria vaccine is manufactured by the Serum Institute
of India Pvt Ltd.
“The National Agency
for Food and Drug Administration and Control (NAFDAC) in exercising its mandate
as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 is granting registration approval for
R21 malaria vaccine,” Adeyeye said at the press briefing.
“The vaccine is indicated for prevention of clinical malaria
in children from 5 months to 36 months of age. The storage temperature of the
vaccine is 2-8 °C.”
‘VACCINE SCORED AS
SATISFACTORY AFTER REVIEW’
Adeyeye said NAFDAC received the dossier of the R21 and
subjected it to independent review by experts from Nigeria’s tertiary
institutions and the agency’s in-house vaccine review committee.
The director-general said a joint review was then called
after the team assessed the vaccine as “adequate” and the in-house committee
also assessed it as “satisfactory”.
“Overall, the R21 malaria vaccine dossier complied
substantially with best international standards with which the dossier was
benched-marked as mentioned above. The joint review committee concluded that
the data on the R21 malaria vaccine were robust and met criteria for efficacy,
safety, and quality,” she said.
“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.
“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.
“While granting the
approval, the agency has also communicated the need for expansion of the
clinical trial conducted to include a phase 4 clinical trial/pharmacovigilance
study to be carried out in Nigeria.
“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 immunisation in the
respective population.”
The only vaccine currently endorsed for malaria by the World
Health Organisation (WHO) is the RTS, S/AS01 (RTS,S) vaccine which is 29
percent effective in preventing severe malaria.
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