Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)

Background The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. Methods There were 3148 finalised products in 2011–2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confirmed by a sample size calculation with a 95% confidence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratified-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the deficiencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P). Results A total of 3253 deficiencies were collected from 325 non-sterile applications while 2742 deficiencies were collected from 244 sterile applications. The most common deficiencies in the FPP section for non-sterile products were on the following sections: Specifications (15%), Description and Composition (14%), Description of the Manufacturing Process (13%), Stability Data (7.6%) and the Container Closure System (7.3%). The deficiencies applicable to the sterile products were quantified and the subsection, Validation and/or Evaluation (18%) has the most deficiencies. Comparison of the deficiencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions The overall top five most common deficiencies observed by SAHPRA were extensively discussed for the generic products. The findings provide an overview on the submissions and regulatory considerations for generic applications in South Africa, which is useful for FPP manufacturers in the compilation of their dossiers and will assist in accelerating the registration process.

Vaccine effectiveness against hospital admission in South African health care workers who received a homologous booster of Ad26.COV2 during an Omicron COVID19 wave: Preliminary Results of the Sisonke 2 Study.

Following the results of the ENSEMBLE 2 study, which demonstrated improved vaccine efficacy of a two-dose regimen of Ad26.COV.2 vaccine given 2 months apart, we expanded the Sisonke study which had provided single dose Ad26.COV.2 vaccine to almost 500 000 health care workers (HCW) in South Africa to include a booster dose of the Ad26.COV.2. Sisonke 2 enrolled 227 310 HCW from the 8 November to the 17 December 2021. Enrolment commenced before the onset of the Omicron driven fourth wave in South Africa affording us an opportunity to evaluate early VE in preventing hospital admissions of a homologous boost of the Ad26.COV.2 vaccine given 6-9 months after the initial vaccination in HCW. We estimated vaccine effectiveness (VE) of the Ad26.COV2.S vaccine booster in 69 092 HCW as compared to unvaccinated individuals enrolled in the same managed care organization using a test negative design. We compared VE against COVID19 admission for omicron during the period 15 November to 20 December 2021. After adjusting for confounders, we observed that VE for hospitalisation increased over time since booster dose, from 63% (95%CI 31-81%); to 84% (95% CI 67-92%) and then 85% (95% CI: 54-95%), 0-13 days, 14-27 days, and 1-2 months post-boost. We provide the first evidence of the effectiveness of a homologous Ad26.COV.2 vaccine boost given 6-9 months after the initial single vaccination series during a period of omicron variant circulation. This data is important given the increased reliance on the Ad26.COV.2 vaccine in Africa.

High Rate of Asymptomatic Carriage Associated with Variant Strain Omicron

The early widespread dissemination of Omicron indicates the urgent need to better understand the transmission dynamics of this variant, including asymptomatic spread among immunocompetent and immunosuppressed populations. In early December 2021, the Ubuntu clinical trial, designed to evaluate efficacy of the mRNA-1273 vaccine (Moderna) among persons living with HIV (PLWH), began enrolling participants. Nasal swabs are routinely obtained at the initial vaccination visit, which requires participants to be clinically well to receive their initial jab. Of the initial 230 participants enrolled between December 2 and December 17, 2021, 71 (31%) were PCR positive for SARS-CoV-2: all of whom were subsequently confirmed by S gene dropout to be Omicron; 48% of the tested samples had cycle threshold (CT) values <25 and 18% less than 20, indicative of high titers of asymptomatic shedding. Asymptomatic carriage rates were similar in SARS-CoV-2 seropositive and seronegative persons (27% respectively). These data are in stark contrast to COVID-19 vaccine studies conducted pre-Omicron, where the SARS-CoV-2 PCR positivity rate at the first vaccination visit ranged from <1%-2.4%, including a cohort of over 1,200 PLWH largely enrolled in South Africa during the Beta outbreak. We also evaluated asymptomatic carriage in a sub study of the Sisonke vaccine trial conducted in South African health care workers, which indicated 2.6% asymptomatic carriage during the Beta and Delta outbreaks and subsequently rose to 16% in both PLWH and PHLWH during the Omicron period. These findings strongly suggest that Omicron has a much higher rate of asymptomatic carriage than other VOC and this high prevalence of asymptomatic infection is likely a major factor in the widespread, rapid dissemination of the variant globally, even among populations with high prior rates of SARS-COV-2 infection.

Knowledge sharing practices among African health sciences librarians

Objective: The objective of this study was to investigate knowledge sharing practices among health sciences librarians in African countries.Methods: A cross-sectional survey design was employed. The study population consisted of African health sciences librarians that attended the 16th Biennial Conference of the Association for Health Information and Libraries in Africa on October 14–18, 2019, at the University of Ibadan in Nigeria. Data were collected using a questionnaire and analyzed using descriptive statistics.Results: The types of knowledge most commonly shared by respondents were information on conferences, workshops, and seminars as well as information on new trends and technologies in librarianship. The main avenue of knowledge sharing was face-to-face interaction. Unwillingness to share knowledge and a lack of awareness about current trends and issues were the top identified challenges to knowledge sharing.Conclusion: These survey results establish the existence of a low level of knowledge sharing among health science librarians in Africa and suggest that concerted efforts should be made to overcome barriers to knowledge sharing within and across African countries.

The Economics of Health in South Africa

The remnants of the colonial and apartheid era are evident in the South African health system’s persistently higher levels of injury, mental health problems, disease and mortality amongst the poor and marginalized—mediated through a wide range of social determinants including environmental health factors such as hygiene, access to clean water, clean air and adequate sanitation, violent crime and trauma, occupational risk, alcohol abuse and tobacco dependence. Due to such structural factors, children of poor parents have lower levels of cognitive development, are more likely to be stunted and a greater share die young. The legacy also persists via severe inequalities in the resourcing of health providers across districts and provinces and also between the public and private sector. Additionally, there is evidence of inefficient resource allocation and inefficient use of resources in both sectors, which further diminishes the health sector’s ability to meet the needs of its population.

Obituary for Dr Harriet Nabudere (1973– 2021), Former Managing Editor of the East African Health Research Journal

It is with great sadness we learned about the sudden demise of our colleague, and former Managing Editor of the East African Health Research Journal (EAHRJ) Dr Harriet Nabudere who passed away on 07th August 2021. Dr Nabudere is remembered as one of the founders of the EAHRJ. Dr Nabudere was instrumental for establishing the infrastructure of the EAHRJ notable the journal Editorial Manager (EM) system. Her range of contributions on publishing EAHRJ issues regularly was extraordinary. Dr Nabudere initially was an associate editor of the EAHRJ before she was promoted to the position of Managing Editor (ME).

Advancing African Medicines Agency through Global Health Diplomacy for an Equitable Pan-African Universal Health Coverage: A Scoping Review

The African continent is home to 15% of the world’s population and suffers from a disease burden of more than 25% globally. In this COVID-19 era, the high burden and mortality are further worsened due to inequities, inequalities such as inadequate health systems, scarce financial and human resources, as well as unavailability of inexpensive medicines of good quality, safety, and efficacy. The Universal Health Coverage ensures that people have access to high-quality essential health services, secure, reliable, and affordable essential medicines and vaccines, as well as financial security. This paper aimed at addressing the critical need for a continental African Medicines Agency (AMA) in addressing the inequities and the role of global health diplomacy in building consensus to support the ratification of the Treaty of AMA. A literature review was done in Scopus, Web of Science, MEDLINE/PubMed, and Google Scholar search engine to identify the critical literature in the context of study objectives. All the articles published after 2015 till 2021 in the context of AMA were included. African Health Strategy 2016–2030 highlighted the importance of an African regulatory mechanism for medicines and medical products. Through global health diplomacy (GHD), the African Union and its partners can negotiate and cooperate in providing infrastructural, administrative, and regulatory support for establishing the AMA. The paper emphasizes the South–South cooperation and highlights the contributions of India and China in the supply of medicines and vaccines to Africa. A strong AMA created through GHD can be a vital instrument in utilizing Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities extension and an ideal partner for European and other regional regulatory authorities seeking to stem the tide of counterfeit, sub-standard, or fake products.

Measles outbreak amidst COVID-19 pandemic in Africa: grappling with looming crises

Coronavirus disease 2019 (COVID-19) and measles are major threats to the health and wellbeing of Africans. Measles is an endemic disease in Africa with a high mortality rate especially in children despite available vaccines. This letter aims to discuss the impact of the COVID-19 pandemic on prevention and management of measles in Africa. The emergence of COVID-19 has exacerbated the morbidities of measles due to multi-factors like the disruption of mass measles routine vaccination, a monopolistic focus on COVID-19 eradication, malnutrition, and poor surveillance. Currently, the COVID-19 pandemic and looming measles epidemic pose a double burden on the African health sector. We recommend urgent interventions from government and other stakeholders including community leaders to strengthen measles research and vaccination programs in Africa amidst the pandemic.