Lagos, Nigeria – The National Agency for Food and Drug Administration and Control (NAFDAC) has announced its plans to initiate a nationwide clinical trial of a malaria vaccine. In light of this development, the agency has mandated the pharmaceutical industry to establish Pharmacovigilance (PV) surveillance departments within their organizations.
Speaking at a press conference in Lagos over the weekend, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, emphasized the significance of PV in revolutionizing the healthcare sector. In a statement released by Resident Media Consultant, Sayo Akintola, Prof. Adeyeye emphasized the need for the industry to establish robust structures for monitoring products throughout the supply chain.
Prof. Adeyeye stressed the importance of developing strategies, goals, and clear objectives to ensure the successful implementation of the PV mission. As a matter of priority, Marketing Authorization Holders (MAHs) were urged to train and engage relevant stakeholders in understanding the importance of pharmacovigilance and utilizing appropriate platforms for reporting Adverse Drug Reactions/Adverse Events Following Immunization (ADR/AEFI) to NAFDAC.
Highlighting the shared responsibility for the safety of medical products in Nigeria, Prof. Adeyeye called for compliance with the PV initiative and existing laws to bolster the growth of the sector. She also pledged to strengthen the six pharmacovigilance centers established across the geopolitical zones, ensuring their ability to deliver credible results.
Emphasizing the crucial role of community pharmacists in this endeavor, Prof. Adeyeye noted that they have extensive reach within the population based on available statistics. Given their involvement in immunization programs, it becomes imperative to access and evaluate their PV systems to ensure compliance with regulations and guidelines.
Reflecting on NAFDAC’s commitment to ensuring the safe use of medical products in the country, Prof. Adeyeye highlighted the agency’s past and ongoing activities. She noted that PV gained prominence during the COVID-19 pandemic and was further accentuated to achieve the African Union Smart Safety Surveillance (AU 3S) goals across the continent.
Assuring the Nigerian public, Prof. Adeyeye expressed her personal commitment to overseeing the clinical trial of the malaria vaccine. With the collective efforts of stakeholders and compliance with PV practices, she expressed optimism about the sustainable safety of medical products in Nigeria.
The commencement of the nationwide clinical trial of the malaria vaccine marks a significant step forward in the fight against malaria, a disease that has had a devastating impact on the country. The collaboration between NAFDAC, pharmaceutical companies, and healthcare professionals underscores the collective determination to improve public health outcomes and ensure the safety of medical interventions.
As the clinical trial progresses, it is anticipated that the data gathered will provide valuable insights and contribute to the development of effective malaria prevention strategies. The success of this initiative has the potential to bring us closer to a future where malaria is no longer a major public health concern in Nigeria.
NAFDAC continues to play a pivotal role in safeguarding the health and well-being of Nigerians, and their commitment to pharmacovigilance initiatives demonstrates their dedication to ensuring the availability of safe and efficacious medical products.