Infection prevention and control and related practices in African neonatal units: The Pan-African neonatal care assessment study (PANCAS).

BACKGROUND: The burden of neonatal mortality is primarily borne by low- and middle-income countries (LMICs), including deaths due to healthcare-associated infections (HAIs). Few studies have assessed infection prevention and control (IP&C) practices in African units caring for small and/or sick newborns aimed to reduce HAIs. METHODS: We performed a mixed-methods study composed of a survey and virtual tour to assess IP&C and related practices. We created a survey composed of multiple-choice and open-ended questions delivered to site respondents via Zoom or video equivalent. Respondents provided a virtual tour of their unit via video and the study team used a checklist to evaluate specific practices. RESULTS: We recruited 45 units caring for small and sick newborns in 20 African countries. Opportunities to optimize hand hygiene, Water, Sanitation and Hygiene (WASH) practices, Kangaroo Mother Care, and IP&C training were noted. The virtual tour offered further understanding of IP&C challenges unique to individual sites. All respondents expressed the need for additional space, equipment, supplies, education, and IP&C staff and emphasized that attention to maternal comfort was important to IP&C success. DISCUSSION: This study identified opportunities to improve IP&C practices using low-cost measures including further education and peer support through learning collaboratives. Virtual tours can be used to provide site-specific assessment and feedback from peers, IP&C specialists and environmental engineering experts.

Diagnosis, Treatment, and Prevention Resources for Infectious Diseases in Sub-Saharan African Hospitals Caring for Children.

Objective. The Children's Hospitals in Africa Mapping Project survey was developed and implemented to assess the readiness of hospitals in sub-Saharan African to respond to emergencies, epidemics, and pandemics affecting children. Methods. This sub-study analyzed 56 survey questions that characterized the hospitals and assessed resources for diagnosis, treatment, and prevention of community-acquired infections and healthcare-associated infections (HAIs). Results. Twenty-four sites were recruited and 20 (from 15 countries) completed the survey in 2018 to 2019. Overall, 90% to 100% of sites reported that diagnostic assays were available for malaria, tuberculosis, and HIV. Periodic shortages of antibiotics, antimalarial drugs, and vaccines were reported by 45%, 25%, and 20% of sites, respectively. Sites reported formal programs for infection prevention and control (79%), monitoring HAIs (17%), and antimicrobial stewardship (53%). Conclusions. Opportunities to improve care for hospitalized African children were identified. These included resources for HAI surveillance and antimicrobial stewardship which can facilitate epidemic and pandemic preparedness.

Building global vaccine manufacturing capacity: Spotlight on Africa.

Africa is set to experience a three-fold increase in vaccine demand by 2040, yet the continent possesses few domestic capabilities for vaccine production. This lack of production capacity, heavy reliance on foreign aid, disruptions of hard-won immunization progress due to the effects of the COVID-19 pandemic, and fluctuating vaccine market dynamics threaten to hinder ongoing efforts to increase vaccination rates on the continent. In order meet the vaccine demands of a rapidly growing population, and to be able to provide novel vaccines to its population in the future, the African continent must develop a sustainable vaccine manufacturing infrastructure. The African Union, in partnership with the Africa Centres for Disease Control and Prevention, recently set forth its Program for African Vaccine Manufacturing Framework for Action, which sets the goal of Africa producing 60 % of its vaccine needs by 2040. To meet these goals, African governments and their multinational, philanthropic, and private sector partners must work to secure low-cost financing and provide a favourable regulatory environment for nascent African vaccine manufacturers. Doing so will save lives, safeguard the health of the continent's current and future citizens, and contribute to economic growth through the development of local bioeconomies.

A Qualitative Study Exploring Motivators and Barriers to COVID-19 Vaccine Uptake among Adults in South Africa and Zimbabwe.

While vaccines are a well-established method of controlling the spread of infectious diseases, vaccine hesitancy jeopardizes curbing the spread of COVID-19. Through the Vaccine Information Network (VIN), this study explored barriers and motivators to COVID-19 vaccine uptake. We conducted 18 focus group discussions with male and female community members, stratified by country, age group, and-for Zimbabwe only-by HIV status. Participants' median age across both countries was 40 years (interquartile range of 22-40), and most (65.9%) were female. We conceptualized the key themes within the World Health Organization's Strategic Advisory Group of Experts on Immunization (SAGE) 3C (convenience, confidence, complacency) vaccine hesitancy model. Barriers to vaccine uptake-lack of convenience, low confidence, and high complacency-included inaccessibility of vaccines and vaccination sites, vaccine safety and development concerns, and disbelief in COVID-19's existence. Motivators to vaccine uptake-convenience, confidence, and low complacency-included accessibility of vaccination sites, user-friendly registration processes, trust in governments and vaccines, fear of dying from COVID-19, and knowing someone who had died from or become infected with COVID-19. Overall, vaccine hesitancy in South Africa and Zimbabwe was influenced by inconvenience, a lack of confidence, and high complacency around COVID-19 vaccines.

Investigating Attitudes, Motivations and Key Influencers for COVID-19 Vaccination Uptake among Late Adopters in Urban Zimbabwe.

The rapid development of vaccines in response to the COVID-19 pandemic has provided an effective tool for the management of COVID-19. However, in many African countries there has been a poor uptake of COVID-19 vaccines with only 32.5% first vaccine dose coverage compared to the WHO global target of 70%. As vaccine access improves, one of the important drivers of low uptake has been vaccine hesitancy, driven by levels of confidence, convenience, and complacency. Between 4 January-11 February 2022, we conducted a survey of vaccine late adopters to assess factors that influenced adults in Harare, Zimbabwe to present for their first COVID-19 vaccine dose almost 12 months after the vaccination program began. Of the 1016 adults enrolled, 50% were female and 12.4% had HIV co-infection. Binary logistic regression models were developed to understand factors associated with vaccine confidence. Women were more likely to have negative views about the COVID-19 vaccine compared to men (OR 1.51 (95%CI 1.16, 1.97, p = 0.002). Older adults (≥40 years) compared with youth (18-25 years) were more likely to have 'major concerns' about vaccines. When asked about their concerns, 602 (59.3%) considered immediate side effects as a major concern and 520 (52.1%) were concerned about long-term health effects. People living with HIV (PLWH) were more likely to perceive vaccines as safe (OR 1.71 (95%CI: 1.07, 2.74, p = 0.025) and effective (1.68 (95%CI: 1.07, 2.64, p = 0.026). Internet users were less likely to perceive vaccines as safe (OR 0.72 (95% CI: 0.55, 0.95, p = 0.021) compared to non-Internet users; and social media was a more likely source of information for youth and those with higher education. Family members were the primary key influencers for 560 (55.2%) participants. The most important reason for receiving the COVID-19 vaccine for 715 (70.4%) participants was the protection of individual health. Improving vaccine coverage will need targeted communication strategies that address negative perceptions of vaccines and associated safety and effectiveness concerns. Leveraging normative behavior as a social motivator for vaccination will be important, as close social networks are key influences of vaccination.

Vaccine Adverse Events Following COVID-19 Vaccination with Inactivated Vaccines in Zimbabwe.

Vaccination is one of the most effective methods for preventing morbidity and mortality from COVID-19. Vaccine hesitancy has led to a decrease in vaccine uptake; driven by misinformation, fear, and misperceptions of vaccine safety. Whole inactivated vaccines have been used in one-fifth of the vaccine recipients in Africa, however there are limited real-world data on their safety. We evaluated the reported adverse events and factors associated with reported adverse events following vaccination with whole inactivated COVID-19 vaccines-BBiBP-CorV (Sinopharm) and CoronaVac (Sinovac). A quantitative survey evaluating attitudes and adverse events from vaccination was administered to 1016 adults presenting at vaccination centers. Two follow-up telephone interviews were conducted to determine adverse events after the first and second vaccination dose. Overall, the vaccine was well tolerated; 26.0% and 14.4% reported adverse events after the first and second dose, respectively. The most frequent local and systemic adverse events were pain at the injection site and headaches, respectively. Most symptoms were mild, and no participants required hospitalization. Participants who perceived COVID-19 vaccines as safe or had a personal COVID-19 experience were significantly less likely to report adverse events. Our findings provide data on the safety and tolerability of whole inactivated COVID-19 vaccines in an African population, providing the necessary data to create effective strategies to increase vaccination and support vaccination campaigns.

Attitudes to Vaccine Mandates among Late Adopters of COVID-19 Vaccines in Zimbabwe.

Despite sufficient supply, <25% of the population in sub-Saharan Africa has received at least one dose of COVID-19 vaccine. Vaccine mandates have previously been effective in increasing vaccine uptake. Attitudes to COVID-19 vaccine mandates and vaccines for children in African populations are not well understood. We surveyed late-adopters presenting for COVID-19 vaccination one year after program initiation in Zimbabwe. Logistic regression models were developed to evaluate factors associated with attitudes to mandates. In total, 1016 adults were enrolled; 690 (67.9%) approved of mandating vaccination for use of public spaces, 686 (67.5%) approved of employer mandates, and 796 (78.3%) approved of mandating COVID-19 vaccines for schools. Individuals of lower economic status were twice as likely as high-income individuals to approve of mandates. Further, 743 (73.1%) participants indicated that they were extremely/very likely to accept vaccines for children. Approval of vaccine mandates was strongly associated with perceptions of vaccine safety, effectiveness, and trust in regulatory processes that approved vaccines. Vaccine hesitancy is an important driver of low vaccine coverage in Africa and can be mitigated by vaccine mandates. Overall, participants favored vaccine mandates; however, attitudes to mandates were strongly associated with level of education and socioeconomic status.

Prioritizing the needs of children in a changing climate.

In a Perspective, Lawrence Stanberry and colleagues discuss impacts of climate change on children.

Pregnant women's attitudes about topical microbicides for the prevention and treatment of bacterial vaginosis during pregnancy.

We sought to understand pregnant women's product preference and likelihood of use of topical microbicides for bacterial vaginosis (BV) prevention and treatment. Pregnant women (N = 196) in a obstetrics clinic completed a survey between June 2014 and January 2015 about vaginal product use for BV. This cross-sectional study explored product preferences, likelihood of product use for BV management and father of the baby (FOB) involvement. Most participants were under 30 (68%) and underrepresented minorities (47% Hispanic, 21% African-American). Most women preferred the gel (69%). Only 30% were likely to use either product for prevention of BV; 76% if high risk for BV; 83% treatment of BV. Anticipated FOB involvement in decision-making included that 46% would ask his opinion, 38% would inform him of the decision and 7% would need approval. Most (87%) would ask the FOB for reminders and 66% for insertion help. Those under 30 were more likely to agree to ask the FOB for reminders (p < 0.01) and insertion help (p = 0.05). African-American women were less likely to have their FOB help with insertion (p < 0.01). Product preferences may be less critical than risk perception. Involvement of the FOB in decision-making may be vital.

Vaccination of special populations: Protecting the vulnerable.

One of the strategic objectives of the 2011-2020 Global Vaccine Action Plan is for the benefits of immunisation to be equitably extended to all people. This approach encompasses special groups at increased risk of vaccine-preventable diseases, such as preterm infants and pregnant women, as well as those with chronic and immune-compromising medical conditions or at increased risk of disease due to immunosenescence. Despite demonstrations of effectiveness and safety, vaccine uptake in these special groups is frequently lower than expected, even in developed countries with vaccination strategies in place. For example, uptake of the influenza vaccine in pregnancy rarely exceeds 50% in developed countries and, although data are scarce, it appears that only half of preterm infants are up-to-date with routine paediatric vaccinations. Many people with chronic medical conditions or who are immunocompromised due to disease or aging are also under-vaccinated. In the US, coverage among people aged 65years or older was 67% for the influenza vaccine in the 2014-2015 season and 55-60% for tetanus and pneumococcal vaccines in 2013, while the coverage rate for herpes zoster vaccination among those aged 60years or older was only 24%. In most other countries, rates are far lower. Reasons for under-vaccination of special groups include fear of adverse outcomes or illness caused by the vaccine, the inconvenience (and in some settings, cost) of vaccination and lack of awareness of the need for vaccination or national recommendations. There is also evidence that healthcare providers' attitudes towards vaccination are among the most important influences on the decision to vaccinate. It is clear that physicians' adherence to recommendations needs to be improved, particularly where patients receive care from multiple subspecialists and receive little or no care from primary care providers.

Vaccine hesitancy and healthcare providers.

While most people vaccinate according to the recommended schedule, this success is challenged by individuals and groups who delay or refuse vaccines. The aim of this article is to review studies on vaccine hesitancy among healthcare providers (HCPs), and the influences of their own vaccine confidence and vaccination behaviour on their vaccination recommendations to others. The search strategy was developed in Medline and then adapted across several multidisciplinary mainstream databases including Embase Classic & Embase, and PschInfo. All foreign language articles were included if the abstract was available in English. A total of 185 articles were included in the literature review. 66% studied the vaccine hesitancy among HCPs, 17% analysed concerns, attitudes and/or behaviour of HCPs towards vaccinating others, and 9% were about evaluating intervention(s). Overall, knowledge about particular vaccines, their efficacy and safety, helped to build HCPs own confidence in vaccines and their willingness to recommend vaccines to others. The importance of societal endorsement and support from colleagues was also reported. In the face of emerging vaccine hesitancy, HCPs still remain the most trusted advisor and influencer of vaccination decisions. The capacity and confidence of HCPs, though, are stretched as they are faced with time constraints, increased workload and limited resources, and often have inadequate information or training support to address parents' questions. Overall, HCPs need more support to manage the quickly evolving vaccine environment as well as changing public, especially those who are reluctant or refuse vaccination. Some recommended strategies included strengthening trust between HCPs, health authorities and policymakers, through more shared involvement in the establishment of vaccine recommendations.

Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile.

Inclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections: A Review of Existing Registered Studies.

PURPOSE: Despite their heightened risk of sexually transmitted infections, minor adolescents (<18 years old) are often excluded from clinical trials. The results of trials of adults should not be assumed to generalize to minors. METHODS: Two public clinical trial registries were first searched using microbicide or PrEP with STD, STI, HIV, or HSV and with gel, ring, or film, and then searched using prevention/sexually transmitted diseases with gel. Studies were classified based on the information provided in the registry. RESULTS: The searches yielded 111 unique studies. Only 9.0% (n = 10) included minors. They were under-represented in Phase 0-II studies and over-represented in studies of individuals infected with human immunodeficiency virus. CONCLUSIONS: Minor adolescents should be included during all stages of development and before they have acquired an infection. Future studies should examine the challenges of including minor adolescents in trials and how to overcome these barriers.

Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.

BACKGROUND: Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development. METHODS: CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens. RESULTS: 402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95%CI: -36; 76, p=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95%CI: -9; 72, p=0.08. CONCLUSION: The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al. N Engl J Med 2009;360:1191) using the same formulation.