SAFETY OF HETEROLOGOUS mRNA-1273 BOOST AFTER Ad26.COV2.S PRIME IN SOUTH AFRICA

Background: Given the paucity of data on safety and effectiveness of mRNA COVID-19 booster vaccinations in lower income settings with high HIV prevalence, we evaluated a heterologous mRNA-1273 (Moderna) boost after priming with 1 or 2 doses of Ad26.COV2.S (Janssen, Johnson & Johnson) vaccine among health care workers (HCWs) in South Africa. Method(s): SHERPA is an open-label, phase 3 mRNA-1273 booster study, nested in the Sisonke Phase 3b implementation trial, that vaccinated ~500000 HCWs with 1 or 2 doses of Ad26.COV2.S from Feb and Dec 2021. Sisonke participants were offered mRNA-1273 boosters between 23 May and 12 Nov 2022 (median 17 and 8 months after 1 and 2 Ad26.COV2.S, respectively), with data cut-off on 12 Dec 2022. Reactogenicity and adverse events (AEs) were self-reported via an online data entry link shared by SMS with participants 1, 7 and 28 days after boosting. Using national databases analyses are underway to compare effectiveness against COVID-19 infections and severe disease with Sisonke participants who did not receive the booster. Result(s): 12188 HCWs (79.5% female, 28.6% with self-reported previous COVID-19 diagnosis) received a mRNA-1273 booster, of whom 44.6% and 55.4% had received 1 and 2 prior Ad26.COV2.S vaccines in Sisonke, respectively. 3056 (25.2%) reported being HIV positive, more among those receiving only 1 previous Ad26.COV2.S (26.8% vs 23.9%), and 1.4% reported not being on antiretroviral therapy. 17.0% of participants reported hypertension and 6.4% diabetes mellitus. 262 participants (2.1% of women, 2.5% of men) reported 234 reactogenicity events and 95 AEs post-vaccination, with more reported by those with prior COVID-19 infection (3.5% vs 1.6%), HIV negative status (2.5% vs 1.2%) and those who received 2 prior doses of Ad26.COV2.S (2.4% vs 1.8%) (Table). Among 159 (1.3%) reporting injection site reactions the commonest were pain (59.7%), swelling (42.1%) and induration (20.1%). Of 177 (1.5%) systemic reactogenicity events (all grade 1 or 2 severity), the commonest were myalgia (69.5%), headache (67.8%) and fever (37.9%). 14 participants had AEs of special interest or serious AEs, of which 4 (all AESIs of ageusia or anosmia) were deemed related to the booster. 13 COVID-19 infections occurred a median of 125 days post booster vaccination (IQR 90-154) after 3477 person-years of follow up. Conclusion(s): A mRNA-1273 booster administered after 1 or 2 doses of Ad26. COV2.S was well tolerated regardless of HIV status, other chronic conditions or prior COVID-19 infection.

Drivers of early marriage and teenage pregnancy in Kenya and Uganda during COVID-19 lockdown period: A systematic review

The present study aimed to explore the drivers of early marriage and teenage pregnancy in Kenya and Uganda during COVID-19 lockdown period. A systematic review design was adopted. The major online databases utilized were PubMed, Google Scholar, Uganda and Kenya Ministry of Health repositories, ScienceDirect, and Scopus. Studies that were originating from Kenya and Uganda that were publicly available in electronic format published from March 2020 to March 2022 were used. The thematic analysis identified major concepts that were drivers to the present research problem which were as follows: (1) school closure and (2) loss of income by parents. The COVID-19 containment measures introduced in the two countries were noted as major contributing factors. During the pandemic, lockdown led to school closures which meant the teenagers being idle at home with an increased opportunity to indulge in sexual risk behaviors. Schools have been noted to be a safe place protecting this vulnerable population. However, with their prolonged closure, the teenagers were exposed to sexual predators. Parents lost income, and this might have contributed to early marriages and teenagers' dependency on their sexual partners. Based on the reviewed evidence, the present study furthers the advocacy for the reduction of early marriages and teenage pregnancy, especially in the current COVID-19 pandemic era. The study calls upon the governments to intensify efforts toward the present research problem as the COVID-19 pandemic is eroding the earlier gains made within the region. © Medknow. All rights reserved.

Pivoting during the pandemic: adapting research priorities to address community engagement with COVID-19 in Western Kenya

Among the many profound disruptions created by COVID-19 around the world, the pandemic has greatly tested community-based research endeavours that rely upon international collaboration and face-to-face interactions in rural communities. Our group of Kenyan and American investigators based on remote Mfangano Island on Lake Victoria experienced numerous challenges due to travel restrictions, safety guidelines, and funding interruptions, forcing us to rapidly adapt objectives as conditions evolved in real time. Here we describe our effort to adjust the priorities of the MOMENTUM study, a longitudinal maternal health study, to support a community-driven response to the initial COVID-19 surge in 2020 and the subsequent Delta wave in 2021. Through a dynamic participatory process, our group identified and implemented three COVID-19 engagement strategies including, (i) printed COVID-19 factsheets for local distribution, (ii) vernacular radio programming on a popular local radio station, and (iii) targeted COVID-19 vaccine promotion among key community opinion leaders. We provide a review of the strengths, challenges, and local perspectives regarding these strategies. Due to notable limitations, such as our inability to compare outcomes with similar control populations, and the nature of the specific strategies designed to address the unique needs of these island populations, this report is not intended to provide definitive or generalizable conclusions regarding the impact of a COVID-19 intervention. We present our experience as an illustrative example of how community-based research collaborations can utilize their embedded networks to develop adaptive responses to unexpected public health threats. Most notably, the transition to virtual collaboration facilitated a long-overdue recentering of operational and strategic leadership into the hands of our Kenyan team. This aligned reality on the ground with our long-stated rhetoric regarding North-South equity in design and implementation. Ultimately, our experience in Kenya suggests that amid ongoing disruptions created by a pandemic, there exists both a responsibility to respond to evolving community needs and an opportunity to remodel global health partnerships for improved equity and long-term impact.

Sisonke phase 3B open-label study: Lessons learnt for national and global vaccination scale-up during epidemics

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID-19, including hospitalisations and deaths. The Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies: (i) consistently advocate for vaccination to reduce public hesitancy;(ii) an electronic vaccination data system (EVDS) is critical;(iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres;(iv) let digitally literate people help elderly and marginalised people to register for vaccination;(v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators;(vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres;(vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks;(viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system;(ix) develop efficient systems to monitor and investigate COVID-19 breakthrough infections;and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.

Sisonke phase 3B open-label study: Lessons learnt for national and global vaccination scale-up during epidemics.

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID­19, including hospitalisations and deaths. The  Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies:(i) consistently advocate for vaccination to reduce public hesitancy; (ii) an electronic vaccination data system (EVDS) is critical; (iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres; (iv) let digitally literate people help elderly and marginalised people to register for vaccination; (v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators; (vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres; (vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks; (viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system; (ix) develop efficient systems to monitor and investigate COVID­19 breakthrough infections; and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.

COVID-19 outbreak, social distancing and mass testing in Kenya-insights from a mathematical model

As reported by the World Health Organization (WHO), the world is currently facing a devastating pandemic of a novel coronavirus (COVID-19), which started as an outbreak of pneumonia of unknown cause in the Wuhan city of China in December 2019. Since then, the respiratory disease has exponentially spread to over 210 countries. By the end of April, COVID-19 had caused over three million confirmed cases of infections and over 200,000 fatalities globally. The trend poses a huge threat to global public health. Understanding the early transmission dynamics of the infection and evaluating the effectiveness of control measures is crucial for assessing the potential for sustained transmission to occur in new areas. We employed a SEIHQRD delay differential mathematical transmission model with reported Kenyan data on cases of COVID-19 to estimate how transmission varies over time and which population to target for mass testing. The model is concise in structure, and successfully captures the course of the COVID-19 outbreak, and thus sheds light on understanding the trends of the outbreak and the vulnerable populations. The results show that, the government should target population in the informal settlement for mass testing and provide affordable sanitizers and clean water to this population. The model results also indicate that people with pre-existing non-communicable diseases (NCDs) should be identified and given special medical care. Given the absence of vaccine at the moment, non-pharmaceutical intervention is needed to effectively reduce the final epidemic size. © 2021, African Mathematical Union and Springer-Verlag GmbH Deutschland, ein Teil von Springer Nature.