FG approves use of groundbreaking Oxford malaria vaccine

The malaria vaccine created by researchers at Oxford University, R21/Matrix, has received provisional authorisation from the federal government.

The declaration was made on Monday at a press briefing by Mojisola Adeyeye, director-general of the National Agency for Food and Drug Administration and Control (NAFDAC).

The news comes a few days after Ghana became the first nation to formally approve the vaccine, which is reportedly 80% effective.

The Serum Institute of India Pvt Ltd produces the malaria vaccine.

As required by its enabling law, the NAFDAC Act CapN1, LFN 2004, the National Agency for Food and Drug Administration and Control (NAFDAC) is approving the registration of the R21 malaria vaccine, according to Adeyeye.

“The vaccination is recommended for the prevention of clinical malaria in children between the ages of five and 36 months. The vaccination should be stored between 2 and 8 °C.

After assessment, the vaccine received a good rating.
Adeyeye claimed that after receiving the R21 dossier, NAFDAC had an internal vaccine review committee and tertiary institution specialists in Nigeria independently evaluate it.After the team rated the vaccination as “adequate” and the internal committee gave it a “satisfactory” rating, the director-general stated that a joint evaluation was then ordered.

Overall, the R21 malaria vaccine dossier mostly conformed with the highest international criteria, with which the dossier was bench-marked as previously noted. The results on the R21 malaria vaccine were strong and met standards for efficacy, safety, and quality, according to the joint review committee’s findings, she added.

Additionally, it was determined that the vaccine’s known and potential advantages outweigh its known and possible drawbacks, justifying the manufacturer’s advised use.

The WHO’s malaria vaccine implementation guideline was followed when recommending a provisional approval of the R21 malaria vaccine.

“While approving the application, the FDA also expressed the necessity for the clinical trial’s scope to be expanded to include a phase 4 clinical trial and pharmacovigilance research to be undertaken in Nigeria.

“The minister of health and the national primary health care development agency have received the brief on the approval of the R21 Malaria vaccine for appropriate actions toward immunisation in the respective population.”

The only malaria vaccine that the World Health Organization (WHO) now recommends is the RTS, S/AS01 (RTS,S) vaccination, which has a 29 percent success rate in avoiding severe malaria.