NAFDAC Preparing Nigeria for Vaccine Production – Adeyeye

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Prof. Moji Adeyeye

– Says COVID-19 has created exciting opportunities, strategies to tackle future challenges

The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Professor Mojisola Adeyeye, has said that the outbreak of the COVID-19 pandemic has strengthened its operations, saying NAFDAC has now moved to a higher level of efficiency, such that it is now preparing the country for vaccine manufacturing.

The NAFDAC DG, who was the keynote speaker at the 94th Annual National Conference of the Pharmaceutical Society of Nigeria (PSN), held in Port Harcourt, Rivers State, spoke on “COVID-19 Lessons: Broadening and Strengthening the Nigerian Pharmaceutical/Health Sector”.

In her address, Adeyeye said although the pandemic wreaked a lot of havoc across the globe, it also heralded exciting opportunities that spurred creation of strategies and viable tools necessary to respond effectively to current challenges and also provide sustainable solution to future challenges.

According to the NAFDAC boss, COVID-19, which was first reported in China, in December 2019, and spread throughout the globe in less than three months, exacted enormous pressure and created challenges in many areas of the health sector, noting that it also caused disruptions of the socioeconomic wellbeing of the general public.

While analysing the effects of the deadly virus on the world, Adeyeye said COVID-19 created unprecedented pressure on healthcare systems and exposed the inability of the existing capacities to provide full and affordable access to quality healthcare. She added that the pandemic affected even the most resourceful and advanced healthcare systems in the world.

Adeyeye also said that uncertainties over how the pandemic would progress added further complexities to the uncertain healthcare environment, since there was no vaccine or effective treatment at the beginning. This, she said, affected health programmes planning and budgeting, adding that the disruption of the pharmaceutical supply chain, travel restrictions and lockdowns led to the disruption of medicine supplies.

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Adeyeye said NAFDAC, in particular, was confronted with many challenges when the pandemic broke out in Nigeria. According to her, ensuring business continuity amid the restriction of movement, to guarantee continued availability and access to safe, quality and efficacious medical products, was one of the challenges the pandemic posed to it.

She said: “Disruption of the global pharmaceutical supply chain, due to travel restrictions/lockdowns and attendant shortages in medical product supplies; limited supply of COVID-19 related health products, due to disruption in the global supply chain and increase in demand for these products by the public; and the need to proactively fight the proliferation of substandard and falsified medical products due to surge in demand for COVID-related products are some of the challenges imposed on the agency by COVID-19.”

Other challenges imposed on NAFDAC by the pandemic, according to Adeyeye, include increase in regulatory workload due to large volume of applications for COVID-19 related products/consumables, health risks to NAFDAC’s frontline workforce that are ensuring NAFDAC’s business continuity in the ports and other formations, the need for the regulatory agency to proactively provide up-to-date guidance and regulations in response to the evolving crisis and to support the development and expedited approval of safe and efficacious treatments for COVID-19 and COVID-related infections.

She however noted that some of the moves and programmes that the agency was already embarking on before the pandemic broke out helped a lot to confront the global disease in Nigeria.

According to her, “In line with the agency’s mandate, policies, programmes and projects, measures had been in place to ensure ready access and quick availability of safe, efficacious and quality assured medical products.”

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As part of the agency’s preparedness for emergency before the pandemic broke, Adeyeye noted that the agency had migrated from physical and manual processing to electronic processing of product registration and issuance of permit, adding that NAFDAC was already undergoing World Health Organisation benchmarking audit, while also having increased investment in regulatory infrastructure, and was set to be a reference listed regulatory authority (ML3).

According to Adeyeye, “NAFDAC leveraged its antecedents and existing infrastructure. We ensured that the nation’s pharmaceutical supply chain was not adversely affected. We ensured the availability of safe, effective and quality assured COVID-19 related products, vaccines and technologies.

“The agency also embraced business-continuity strategies, developed and implemented protocol for workplace preparedness and prevention of COVID-19 infection, ramped up the complete migration of all application submissions and processing to electronic platforms, deployed digital tools and expanded use of alternative regulatory approval pathways”.

The NAFDAC boss disclosed that before COVID-19, Nigeria had only 21 approved alcohol-based hand sanitizers. During the pandemic, however, 231 more were approved. She also said that before the pandemic, there was no approved locally made nose mask and other personal protective Equipment (PPE) in the country, noting that during the outbreak, 10 nose masks were approved and accordingly, the first NAFDAC-approved medical mask has been exported to the United States of America from Nigeria.

Adeyeye pointed out that NAFDAC now aims to have full visibility over all products moving within the pharmaceutical supply chain in Nigeria, having earlier instituted the Pharmaceutical Traceability Desk in 2019.

“The Nigeria National Pharmaceutical Traceability Strategy guided the development of a five-year implementation plan and it is the first step in positioning Nigeria to be a leader in driving the monitoring of regulated products supply chain or traceability of pharmaceuticals in Africa”, Adeyeye said.

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To achieve the set goals, the NAFDAC DG also said the agency is currently collaborating with other agencies and institutions within and outside the country, including the National Primary Health Care Development Agency (NPHCDA), the Nigeria Centre for Disease Control (NCDC), the United Nations Children’s Fund (UNICEF), the United States Agency for International Development (USAID), African Union 3S (Smart, Safety, Surveillance), the Medicines and Healthcare products Regulatory Agency (MHRA), the Bill and Melinda Gates Foundation, the University of Maryland and the United States Centres for Disease Control and Prevention (US CDC).

Adeyeye averred, “The COVID-19 pandemic has disrupted pharmaceutical healthcare systems of all countries, irrespective of resourcefulness and advancement. For the pharmaceutical sector, there was disruption of the medical products supply chain and a sharp increase in the demand for COVID-19 related consumables.

“NAFDAC responded to these challenges, using its antecedents and infrastructure, by ensuring that the nation’s pharmaceutical supply chain was not adversely affected. Notwithstanding the numerous challenges, the pandemic has heralded exciting opportunities that spur the creation of strategies and the development of viable tools necessary to respond effectively and rapidly to current challenges and provide sustainable solutions to future challenges.”

She added, “NAFDAC’s regulatory preparedness guidance made the agency to be at high alert for the advent of COVID-19 vaccines. COVID-19 vaccine has been successfully used as a pilot for supply chain monitoring, using GS1-driven traceability, with Nigeria leading globally. Adverse events following Immunisation reporting has improved significantly, using Med Safety App.

“Reliance and collaboration have contributed to the relative success of the COVID-19 vaccine launch in Nigeria. Despite the pandemic, NAFDAC has moved from Machine Learning one (ML1) in 2018 to ML3, ready for assessment, thus preparing Nigeria for vaccine manufacturing.”

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