Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry.

The rapid development and worldwide distribution of COVID-19 vaccines is a remarkable achievement of biomedical research and logistical implementation. However, these developments are associated with the risk of a surge of substandard and falsified (SF) vaccines, as illustrated by the 184 incidents with SF and diverted COVID-19 vaccines which have been reported during the pandemic in 48 countries, with a paucity of methods for their detection in supply chains. In this context, matrix-assisted laser desorption ionisation-time of flight (MALDI-ToF) mass spectrometry (MS) is globally available for fast and accurate analysis of bacteria in patient samples, offering a potentially accessible solution to identify SF vaccines.

Can public education campaigns equitably counter the use of substandard and falsified (SF) medical products in African countries?

Substandard and falsified (SF) medical products are a serious health and economic concern that disproportionately impact low- and middle-income countries and marginalized groups. Public education campaigns are demand-side interventions that may reduce risk of SF exposure, but the effectiveness of such campaigns, and their likelihood of benefitting everybody, is unclear. Nationwide pilot risk communication campaigns, involving multiple media, were deployed in Ghana, Nigeria, Sierra Leone, Uganda in 2020-2021.

Closing the gaps in the access to quality-assured medicines for global health: The case for oxytocin for postpartum haemorrhage.

Introduction: Access to quality-assured medicines remains unequal between high-income and low-income countries. To bridge this gap, product development and supply in low- and middle-income countries (LMICs) should follow World Health Organization (WHO)'s policies and recommendations whilst aligning with international standards.

Areas Covered: We reviewed two cases on oxytocin access for postpartum hemorrhage (PPH), a condition that disproportionately affects mothers in low-income countries.

Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products.

Having a robust, integrated regulatory system is important for ensuring the availability of safe and efficacious medical products of good quality and for protecting public health. However, less than 30% of countries globally have reached the required regulatory maturity level three, with low- and middle-income countries facing challenges in attracting and retaining qualified staff. World Health Organization (WHO) advocates for systematic workforce development, including competency-based education, to address these gaps.

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation.

Background: Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrumental for the newly incepted African Medicine Agency.

Aims: This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally.

Innovative method for rapid detection of falsified COVID-19 vaccines through unopened vials using handheld Spatially Offset Raman Spectroscopy (SORS).

Preventing, detecting, and responding to substandard and falsified vaccines is of critical importance for ensuring the safety, efficacy, and public trust in vaccines. This is of heightened importance in context of public health crisis, such as the COVID-19 pandemic, in which extreme world-wide shortages of vaccines provided a fertile ground for exploitation by falsifiers. Here, a proof-of-concept study explored the feasibility of using a handheld Spatially Offset Raman Spectroscopy (SORS) device to authenticate COVID-19 vaccines through rapid analysis of unopened vaccine vials.

Collaborative reliance in medicine safety and quality regulation: Investigation of experiences in handling N-nitrosamine impurities among ZaZiBoNa participating countries.

Introduction: The presence of N-nitrosamine impurities in medicines raised concerns globally as they are genotoxic and probable human carcinogens. A review of N-nitrosamine impurities in medicines provides an opportunity for National Regulatory Authorities (NRAs) to ensure that corrective and preventive actions are applied so that safe and good quality medicines are made available to the public. This study aimed to investigate the experiences on reviews conducted by NRAs from various Southern African Development Community countries which participate in the regional work-sharing forum, ZaZiBoNa, on the quality and safety data due to the presence of N-nitrosamine impurities in medicines.

Oxytocin quality: evidence to support updated global recommendations on oxytocin for postpartum hemorrhage.

Background: The use of quality injectable oxytocin effectively prevents and treats postpartum hemorrhage, the leading cause of maternal death worldwide. In low- and middle-income countries (LMICs), characteristics of oxytocin-specifically its heat sensitivity-challenge efforts to ensure its quality throughout the health supply chain. In 2019, WHO, UNFPA and UNICEF released a joint-statement to clarify and recommend that oxytocin should be kept in the cold chain (between 2 and 8 °C) during transportation and storage; however, confusion among stakeholders in LMICs persists.