• NAFDAC tasks low-income nations on strong regulatory systems for quality vaccines

Latest figures from United Nations Children Fund (UNICEF), yesterday, indicated that Nigeria, India, Pakistan, Democratic Republic of Congo (DR Congo), Ethiopia and Bangladesh accounted for almost half of over 5,000 babies that were stillborn at 28 weeks or more of gestation in 2021.

The report indicated a staggering 1.9 million babies stillborn in just one year. Two in five of the infants died during labour, also known as intrapartum stillbirth. The estimates in the publication, the second report to address stillbirth by the United Nations Inter-agency Group for Child Mortality Estimation (UN IGME), were derived from the most recent data from 195 countries and provided a picture of late gestation stillbirth or deaths that occurred at 28 weeks or more of gestation.

They highlight the immense and continuous burden of stillbirths and predisposition of women to the phenomenon globally, even as it was established that if pregnant women have access to quality care, most stillbirths could be prevented.

The burden of stillbirths is highest in sub-Saharan Africa and Southern Asia, with the two regions accounting for three quarters of all stillbirths. In sub-Saharan Africa, the stillbirth rate of 21.0 per 1,000 total births was seven times higher than the lowest regional rate of 2.9 found in the Europe, North America, Australia and New Zealand regions. More worrisome, Sub-Saharan Africa’s portion of the global number of stillbirths has increased from 26 per cent in 2000 to 45 per cent in 2021, as population growth has outpaced decreases in stillbirth rates.

Over the past two decades, substantial progress has been made in reducing the stillbirth rate globally, which declined from 21.3 stillbirth per 1,000 total births in 2000 to 13.9 in 2021 – a 35 per cent reduction. Similarly, the total number of stillbirths also decreased by 35 per cent, from 2.9 million to 1.9 million. However, these reductions have not kept pace with other indicators such as under-five mortality.

Meanwhile, Uganda has declared an end to Ebola disease outbreak caused by Sudan ebolavirus, less than four months after the first case was confirmed in the country’s central Mubende district on September 20, 2022.

“Uganda put a swift end to the Ebola outbreak by ramping up key control measures such as surveillance, contact tracing and infection, prevention and control. While we expanded our efforts to put a strong response in place across the nine affected districts, the magic bullet has been our communities, which understood the importance of doing what was needed to end the outbreak and took action,” the Minister of Health, Dr. Jane Ruth Aceng Ocero, said.

It was the East African nation’s first Sudan ebolavirus outbreak in a decade and overall fifth for this kind of disease. In total, there were 164 cases (142 confirmed and 22 probable), 55 confirmed deaths and 87 recovered patients. More than 4000 people who came in contact with confirmed cases were followed up and their health monitored for 21 days. Overall, the case-fatality ratio was 47 per cent. The last patient was released from care on November 30 when the 42-day countdown to end of the outbreak began.

Authorities exhibited strong political commitment and implemented accelerated public health actions. People in the hotspot communities of Mubende and Kasanda experienced restricted movements.

“I congratulate Uganda for its robust and comprehensive response, which has resulted in today’s (yesterday) victory against Ebola. Uganda has shown that Ebola can be defeated when the whole system works together, from having an alert system in place, to finding and caring for people affected and their contacts, to gaining the full participation of affected communities in the response,” Director-General of World Health Organisation (WHO), Dr. Tedros Adhanom Ghebreyesus, observed.

The causative Sudan ebolavirus is one of six species of the disease against which no therapeutics and vaccines have been approved yet. However, Uganda’s long experience in responding to epidemics allowed the country to rapidly strengthen critical areas of the response and overcome the lack of these key tools.

WHO Regional Director for Africa, Dr. Matshidiso Moeti, noted: “With no vaccines and therapeutics, this was one of the most challenging Ebola outbreaks in the past five years, but Uganda stayed the course and continuously fine-tuned its response. Two months ago, it looked as if Ebola would cast a dark shadow over the country well into 2023, as the outbreak reached major cities such as Kampala and Jinja, but this win starts off the year on a note of great hope for Africa.”

Soon after Uganda declared the Sudan ebolavirus outbreak, WHO worked with a wide range of partners, including vaccine developers, researchers, donors and relevant health authorities to identify candidate therapeutics and vaccines for inclusion in trials. Three candidate vaccines were identified and over 5000 doses of them arrived in the country, with the first batch on December 8 and the last two on December 17. These vaccines were, however, not deployed.

The global health agency provided nearly $ 6.5 million to Uganda’s response and an additional $ 3 million to support readiness in six neighbouring countries.

Besides, Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has stressed that only a regulatory system that could guarantee and accelerate development, approval of and access to safe and effective quality therapeutic medicines and vaccines in low, medium income countries of the world.

Speaking at a hybrid University of California San Francisco UCSF)-Stanford Centre of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) summit in the United States, the NAFDAC boss harped on the need for nations to strengthen their regulatory systems in compliance with the World Health Assembly Resolution 67.20 of 2014 to build capacity of member-states to ensure access to quality medicines by low, medium income nations.

She noted that WHO supports member-states in sustaining effective regulatory oversight of medical products through the regulatory systems strengthening (RSS) programme.

Adeyeye, who is the only panelist s from Africa at the event with the theme ‘Building a Global Vision for Product and Drug Development: Challenges and Opportunities’, explained to the global audience how NAFDAC, under her leadership, deployed the WHO Global Benchmarking Tools to achieve Maturity Level 3 WHO Certification Status in March 2022 and its significance to Nigeria.

The DG, according to a statement by Resident Media Consultant, Sayo Akintola, said NAFDAC was benchmarked on seven functions plus licensing establishment, which is under the Pharmacy Council of Nigeria (PCN) jurisdiction, stressing that both agencies were benchmarked together. She hinted that the agency satisfied 268 indicators and 860 recommendations, adding that the 268 indicators were distributed under Maturity Levels 1, 2, 3 and 4.

According to Adeyeye, there is what is called World Listed Authority (WLA), where it is almost like a specialised grouping, stating that part of Maturity Level 4 indicators also applies to WLA.

In the low and middle-income countries, she said testing is sacrosanct unlike FDA, where products are not tested because the system works. The NAFDAC boss pointed out that commitment from top management of the regulatory agencies is required to get Maturity Level 3, which is the minimum required in terms of A well-functioning and stable regulatory system. (The Guardian)

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