Interview: Moji Adeyeye
In what ways did NAFDAC contribute to the country’s Covid-19 vaccine rollout?
MOJI ADEYEYE: NAFDAC developed its own quality management and auditing systems in cooperation with the World Health Organisation (WHO) that met international benchmarks, and the agency has been working with the WHO to expand our capacity to handle future pandemics. At the start of the Covid-19 pandemic we knew that vaccines against the disease would eventually be developed, so we made a plan to obtain vaccines early and grant emergency authorisation for their use. We met early on in the process with vaccine manufacturers to coordinate distribution, and met with legislators to discuss concerns about safety, quality and NAFDAC’s strategy for the rollout.
After negotiating directly with manufacturers and overcoming import and logistical challenges, we received our first batch of vaccines in February 2021. We had met with various international medicine regulatory authorities, studied their data prior to receiving the vaccines and highlighted the data relevant to our region that required further research. The agency approved Nigeria’s first Covid-19 vaccine after just five days of exhaustive, rigorous testing. In addition, NAFDAC created a database and released a customised version of the Med Safety app to track the health developments of vaccinated individuals. We trained professionals in pharmacovigilance and disease surveillance across all 36 states, and are using the data collected to steer our response to ensure the health and safety of all Nigerians.
What role can the regulatory body play in creating a framework that is attractive for both foreign and local private investment?
ADEYEYE: Attracting investment is tied to quality, both in terms of the regulatory system and domestic manufacturing capacity. NAFDAC is actively encouraging local manufacturers to meet international standards, in part through inspections. We inspected 165 manufacturers and categorised them as low, medium or high risk. Once manufacturers were assigned to a risk category, we provided them with a corrective and preventive action programme to lower their risk. This has resulted in a noticeable increase in interest from major multinationals to invest and create partnerships here. It is a win-win situation, as multinationals receive competitively priced pharmaceuticals produced in Nigeria, while our manufacturing capacity is enhanced. As capacity grows, it is expected that there will be greater access to and affordability of medications, especially when compared to medicines that are produced overseas.
To what extent does counterfeit medicine continue to be a challenge in Nigeria?
ADEYEYE: Counterfeits are one of the most challenging issues faced by regulators. NAFDAC offices were removed from ports between 2011 and 2018, and during that period Nigeria became a haven for counterfeit and substandard medicines. The situation has improved after we resumed operations at the ports as we were able to monitor goods moving in and out of the country, but we are continuing to tackle counterfeits being manufactured at home.
To do so, we have strengthened our capacity, implemented a quality management system, and trained our staff to tackle counterfeit and substandard medicines. If the regulatory agency is weak, there will be counterfeit drugs even if our borders are strong. Moreover, to strengthen the supply chain we have implemented a track-and-trace barcode system, as recommended by the WHO and UNICEF. Nigeria is leading efforts to use track-and-trace technologies in vaccine distribution. It is not enough to have access to high-quality medicines that are both imported from abroad and manufactured at home; through track and trace we can ensure that these medicines get to patients.
Read More from OBG
