- The National Agency for Food and Drug Administration and Control (NAFDAC) is preparing for nationwide clinical trials of a malaria vaccine called R21.
- The vaccine has a 75% success rate and is part of NAFDAC’s efforts to eliminate malaria in Nigeria.
- NAFDAC is urging pharmaceutical industry players to enhance their pharmacovigilance surveillance departments.
- The vaccine was approved for use in Ghana after successful clinical trials involving 5,000 children, and it is manufactured by the Serum Institute of India.
The National Agency for Food and Drug Administration and Control (NAFDAC) has finalised plans for nationwide clinical trials of a malaria vaccine.
The Director-General, Prof. Mojisola Adeyeye of the agency made this known through a statement by the Resident Media Consultant during the pharmacovigilance inspection interactive session with key industry players in Lagos.
According to her, the agency has mandated players in the pharmaceutical industry to increase the level of pharmacovigilance (PV) surveillance departments in their offices.
The vaccine known as R21 has a 75% success rate which is effective and this trial forms part of the agency’s drive to exterminate malaria in the country the DG said.
She also emphasized the safety of medical products and the importance of stakeholders in ensuring the process of monitoring and pharmacovigilance.
She went on further that the six pharmacovigilance centers in the country would be strengthened to serve as convergence centers from community to state to center.
Prevalence of Malaria in Nigeria
- In an earlier interview, Prof. Adeyeye stated the agency’s resolve to reduce the prevalence of malaria. She said, “Even if it is only 30% of the children that will not die or the death would be prevented, that will be good enough.”
Every year in Nigeria, around 250,000 children die of the disease and about 177 million people are at risk of contracting malaria in the country. Nigeria also accounts for 23% of incidents of the disease worldwide and it’s responsible for a third of all malaria-related deaths globally.
About the Malaria Vaccine
In April this year, Ghana’s Food and Drug Authority approved the use of the vaccine for children between five months and three years old. It became the first country to approve the vaccine after clinical trials involving around 5000 children.
The vaccine was developed by Jenner Institute at the University of Oxford and manufactured by the Serum Institute of India which plans to produce around 100 to 200 million doses yearly.
