Effectiveness of COVID-19 Pfizer-BioNTech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: A systematic review and meta-analysis.

The rapid emergence of COVID-19 variants of concern (VOCs) has hindered vaccine uptake. To inform policy, we investigated the effectiveness of the BNT162b2 vaccination among adolescents against symptomatic and severe COVID-19 diseases using mostly real-world data (15 studies). We searched international databases until May 2022 and used Cochrane's risk of bias tools for critical appraisal. Random effects models were used to examine overall vaccine effectiveness (VE) across studies (general inverse-variance) and the effect of circulating VOCs on VE (log relative ratio and VE). Meta-regression assessed the effect of age and time on VE (restricted-maximum likelihood). BNT162b2 VE against PCR-confirmed SARS-CoV-2 was 82.7% (95%CI: 78.37-87.31%). VE was higher for severe (88%) than non-severe (35%) outcomes and declining over time improved following booster dose in omicron era [73%(95%CI:65-81%)]. Fully vaccinated adolescents are protected from COVID-19 circulating VOCs by BNT162b2 especially for the need of critical care or life support.

Systematic review and meta-analysis of myocarditis and pericarditis in adolescents following COVID-19 BNT162b2 vaccination.

Myocarditis and pericarditis are frequent complications of COVID-19, but have also been reported following vaccination against COVID-19 in adolescents. To build vaccine confidence and inform policy, we characterized the incidence of myocarditis/pericarditis in adolescents following BNT162b2 vaccination and explored the association with dose and sex. We searched national and international databases for studies reporting the incidence of myocarditis/pericarditis following BNT162b2 vaccination as the primary endpoint. The intra-study risk of bias was appraised, and random-effects meta-analyses were performed to estimate the pooled incidence by dose stratified by sex. The pooled incidence of myocarditis/pericarditis was 4.5 (95%CI: 3.14-6.11) per 100,000 vaccinations across all doses. Compared to dose 1, the risk was significantly higher after dose 2 (RR: 8.62, 95%CI: 5.71-13.03). However, adolescents experienced a low risk after a booster dose than after dose 2 (RR: 0.06; 95%CI: 0.04-0.09). Males were approximately seven times (RR: 6.66, 95%CI: 4.77-4.29) more likely than females to present myocarditis/pericarditis. In conclusion, we found a low frequency of myocarditis/pericarditis after BNT162b2, which occurred predominantly after the second dose in male adolescents. The prognosis appears to be favorable, with full recovery in both males and females. National programs are recommended to adopt the causality framework to reduce overreporting, which undercuts the value of the COVID-19 vaccine on adolescent life, as well as to extend the inter-dose interval policy, which has been linked to a lower frequency of myocarditis/pericarditis.

Immunogenicity and reactogenicity of COVID-19 Pfizer-BioNTech (Bnt162b2) mRNA vaccination in immunocompromised adolescents and young adults: a systematic review and meta-analyses.

BACKGROUND: This study aimed to evaluate the safety and effectiveness of the BNT162b2 vaccine in immunocompromised adolescents and young adults. RESEARCH DESIGN AND METHODS: The study conducted a meta-analysis of post-marketing studies examining BNT162b2 vaccination efficacy and safety among immunocompromised adolescents and young adults worldwide. The review included nine studies and 513 individuals aged between 12 and 24.3 years. The study used a random effect model to estimate pooled proportions, log relative risk, and mean difference, and assessed heterogeneity using the I2 test. The study also examined publication bias using Egger's regression and Begg's rank correlation and assessed bias risk using ROBINS-I. RESULTS: The pooled proportions of combined local and systemic reactions after the first and second doses were 30% and 32%, respectively. Adverse events following immunization (AEFI) were most frequent in rheumatic diseases (40%) and least frequent in cystic fibrosis (27%), although hospitalizations for AEFIs were rare. The pooled estimations did not show a statistically significant difference between immunocompromised individuals and healthy controls for neutralizing antibodies, measured IgG, or vaccine effectiveness after the primary dose. However, the evidence quality is low to moderate due to a high risk of bias, and no study could rule out the risk of selection bias, ascertainment bias, or selective outcome reporting. CONCLUSIONS: This study provides preliminary evidence that the BNT162b2 vaccine is safe and effective in immunocompromised adolescents and young adults, but with low to moderate evidence quality due to bias risk. The study calls for improved methodological quality in studies involving specific populations.

Integrating civil liberty and the ethical principle of autonomy in building public confidence to reduce COVID-19 vaccination inequity in Africa.

Concerns regarding the safety of COVID-19 vaccination have caused hesitancy and lowered uptake globally. While vaccine hesitancy is documented globally, some continents, countries, ethnic groups and age groups are disproportionately affected, resulting in significant global inequities. To date, Africa has the lowest COVID-19 coverage globally, with only 22% of its population completely vaccinated. It might be argued that the difficulty with COVID-19 vaccine acceptance in Africa was triggered by the anxiety created by misinformation on social media platforms, particularly with the misinformation regarding depopulating Africa, given the significance of maternity in the continent. In this work, we examine numerous determinants of poor vaccination coverage that have received little attention in primary research and that may need to be considered by various stakeholders engaged in the COVID-19 vaccine strategy at the national and continental levels. Our study also emphasizes the importance of a multidisciplinary team when introducing a new vaccine, for people to trust that the vaccine is truly helpful to them and to be convinced that immunization is, all things considered, worthwhile.

Contextualising missed opportunities for children's vaccination: A theory-informed qualitative study in primary care settings in Cape Town, South Africa.

This study aimed to explore the contextual factors that may be associated with missed opportunities for vaccination (MOV) from the perspectives of healthcare providers and caregivers attending primary healthcare facilities in the Cape Town Metro Health District, South Africa. The ultimate goal of the assessment was to help inform the design and implementation of a contextually appropriate quality improvement programme targeted at reducing MOV in primary healthcare settings. We used a theory-informed exploratory qualitative research design involving focus group discussions with caregivers of children aged 0-23 months; and in-depth interviews of facility staff. A thematic template analysis approach, integrating the theoretical domains framework (TDF) and the capability, opportunity and motivation model of behavior (COM-B) was used to code and analyze the data. Three focus group sessions were conducted, each consisting of 5-8 caregivers and five in-depth interviews involving facility staff. Capability factors comprised caregivers' knowledge, attitude and behavior toward children's immunization. Opportunity factors included the organization of immunization services, long waiting time, vaccine stock out, staff shortage and health workers' attitude, knowledge and capability to assess children's immunization status and needs. Motivation factors included optimism and beliefs about immunization, fear of vaccine-preventable diseases and immunization safety concerns. This study identified important caregiver-, provider- and health system-related factors, which influence immunization outcomes; offering useful contextual insights for informing quality improvement strategies for reducing MOV at primary healthcare level.

Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: A systematic review and meta-analysis.

The COVID-19 pandemic has severely affected adolescents. Safe and effective vaccines are pivotal tools in controlling this pandemic. We reviewed the safety profile of the BNT162b2 COVID-19 vaccine in adolescents using mostly real-world data to assist decision-making. We used random-effects model meta-analysis to derive pooled rates of single or grouped adverse events following immunization (AEFI) after each primary and booster dose, as well as after combining all doses. Reporting on over one million participants with safety data were included. The most-reported local and systemic AEFIs were pain/swelling/erythema/redness and fatigue/headache/myalgia, respectively. AESIs were rarely reported but were more frequent after the second dose than they were after the first and the booster doses. Health impact was less common among adolescents after receiving BNT162b2 vaccine. Rare life-threatening AEFIs were reported across all doses in real-world studies. Our findings highlight the significance of enhancing national and regional vaccination programs to ensure public confidence.

Addressing COVID-19 vaccine hesitancy in South Africa- moving beyond a reliance on information-based responses.

It has been over a year since South Africa officially began its national COVID-19 vaccination programme. Yet, currently only half of the adult population is fully vaccinated. While supply-related challenges continue to contribute to suboptimal vaccination coverage, so too does vaccine hesitancy. Drawing on research conducted over the last year, we highlight some overarching insights around the nature and drivers of COVID-19 vaccine hesitancy in South Africa and how this complex phenomenon might be addressed. We have found multiple socio-economic and political root causes of COVID-19 vaccine hesitancy, many of which are not knowledge-related. These include inter alia fear and uncertainty, practical challenges around access, experiences of poverty and marginalization, and the ongoing geopolitics surrounding the pandemic. Intervention strategies therefore need to form part of broader development and trust-building measures that focus on relationships, transparency, inclusion, equity and justice. This is essential if we hope to bolster acceptance of and demand for vaccines during and beyond the COVID-19 pandemic.

Overview of Tools and Measures Investigating Vaccine Hesitancy in a Ten Year Period: A Scoping Review.

The challenge of vaccine hesitancy, a growing global concern in the last decade, has been aggravated by the COVID-19 pandemic. The need for monitoring vaccine sentiments and early detection of vaccine hesitancy in a population recommended by the WHO calls for the availability of contextually relevant tools and measures. This scoping review covers a ten year-period from 2010-2019 which included the first nine years of the decade of vaccines and aims to give a broad overview of tools and measures, and present a summary of their nature, similarities, and differences. We conducted the review using the framework for scoping reviews by Arksey and O'Malley (2005) and reported it following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews' guidelines. Of the 26 studies included, only one was conducted in the WHO African Region. Measures for routine childhood vaccines were found to be the most preponderant in the reviewed literature. The need for validated, contextually relevant tools in the WHO Africa Region is essential, and made more so by the scourge of the ongoing pandemic in which vaccination is critical for curtailment.

Influenza Vaccination Uptake and Hesitancy among Healthcare Workers in Early 2021 at the Start of the COVID-19 Vaccine Rollout in Cape Town, South Africa.

Vaccination attitudes among healthcare workers (HCWs) predict their level of vaccination uptake and intention to recommend vaccinations to their patients. To our knowledge, no study has been conducted in South Africa to assess hesitancy toward influenza vaccines among HCWs. We adapted a questionnaire developed and validated by Betsch and colleagues and used it to conduct online and face-to-face interviews among HCWs at the start of the COVID-19 vaccine rollout. Multivariate logistic regression was used to assess predictors of influenza vaccine hesitancy. Of 401 participants, 64.5% were women, 49.2% were nurses, and 12.5% were physicians. A total of 54.9% were willing to accept, 20.4% were undecided, and 24.7% intended to refuse influenza vaccination. Participants who were above 25 years of age and physicians were more likely to accept the vaccine. Key predictors of vaccine acceptance were confidence in the effectiveness, consideration of benefits and risks, and willingness to be vaccinated to protect others. Influenza vaccine hesitancy was highest in those who did not trust that influenza vaccines are safe. For future flu seasons, tailored education programs on the safety and effectiveness of flu vaccines targeting younger HCWs, could be vital to improving vaccine uptake.

Early Impact of SARS-CoV-2 Pandemic on Immunization Services in Nigeria.

BACKGROUND: By 11 March 2022, there were 450,229,635 coronavirus disease (COVID-19) cases and 6,019,085 deaths globally, with Nigeria reporting 254,637 cases and 3142 deaths. One of the essential healthcare services that have been impacted by the pandemic is routine childhood immunization. According to the 2018 National Demographic and Health Survey, only 31% of children aged 12-23 months were fully vaccinated in Nigeria, and 19% of eligible children in the country had not received any vaccination. A further decline in coverage due to the pandemic can significantly increase the risk of vaccine-preventable-disease outbreaks among children in Nigeria. To mitigate such an occurrence, it is imperative to urgently identify how the pandemic and the response strategies have affected vaccination services, hence, the goal of the study. METHODS: The research method was qualitative, including in-depth interviews of healthcare workers and focus group discussions (FGDs) with caregivers of children aged 0-23 months. We selected one state from each of the three zones of Nigeria: northern, central, and southern. Within each state, 10 local government areas and 20 healthcare facilities were purposively selected. In each facility, 10 healthcare workers were invited for interviews. Overall, 517 healthcare workers were interviewed. For the focus group discussion, 30 communities were selected. Within each selected community, six consenting caregivers were included. Overall, 180 caregivers participated. The data were analyzed using thematic inductive content analysis. RESULTS: Three significant impacts that were observed are: difficulties in accessibility to immunization services, declining immunization demand and uptake among caregivers due to varying factors, and erosion of vaccine confidence among both caregivers and healthcare workers. Movement restriction and lockdown had numerous major impacts, such as decreased general healthcare service delivery, increased transportation costs, fewer engagements that promote vaccine uptake, and cessation of mobile vaccination campaigns that target hard-to-reach communities. Moreover, misinformation, conspiracy beliefs about the pandemic and COVID-19 vaccines, and risk perception negatively influenced general vaccine confidence. CONCLUSION: The results of this early impact study show that immunization was directly affected by the pandemic and provide insights into areas where interventions are needed for recovery.

Randomised trials of COVID-19 vaccines in Africa – charting the path forward

Vaccines have played a critical role in controlling disease outbreaks, hence the proliferation of the development and testing of multiple vaccine candidates during the COVID-19 pandemic. Randomised trials are gold standards for evaluating the safety and efficacy of pharmaceutical interventions such as COVID-19 vaccines. However, contextual differences may attenuate effects of COVID-19 vaccines. Thus, the need to conduct COVID-19 vaccine trials in all settings, including in Africa. We conducted a crosssectional analysis of planned, ongoing, and completed COVID-19 vaccine trials in Africa. We searched the South African National Clinical Trials Register, Pan African Clinical Trials Registry, and International Clinical Trials Registry Platform (ICTRP) on 12 January and 30 April 2022: and complemented this with a search of ClinicalTrials.gov on 17 May 2022. We screened the search output and included randomised trials with at least one recruitment site in Africa. We identified only 108 eligible trials: 90 (83%) evaluating candidate COVID-19 vaccines, 11 (10%) assessing if existing vaccines could prevent SARS-CoV-2 infection, and 7 (7%) evaluating interventions for improving COVID-19 vaccination coverage. South Africa had the highest number of trials at 58 (54%). Beyond South Africa, countries with more than 10 trial sites include Kenya, Ghana, Egypt, Uganda, and Zimbabwe. Among the trials, 14 (13%) do not have principal investigators based in Africa, 39 (30%) are funded by industry, and 91 (84%) are funded by institutions based outside the host country. COVID-19 vaccine trials with recruitment sites in Africa represented only 7% of the 1453 COVID-19 vaccine trials in the ICTRP The paucity of COVID-19 vaccine trials conducted on the African continent is a cause for concern. This has implications for the role that Africa may play in future pandemics.

Non-COVID-19 vaccine hesitancy among migrant populations worldwide: a scoping review of the literature, 2000-2020.

INTRODUCTION: Migration can be linked to the transmission of vaccine-preventable diseases. Hence, monitoring migrants' vaccination-related concerns can inform needed interventions to support vaccine acceptance. AREAS COVERED: Along with Google and Google Scholar, we searched 13 bibliographic databases between 1 January 2000 and 10 October 2020, to identify published studies of vaccine hesitancy among migrant populations. From a total of 8,915 records, we screened 745 abstracts and included 112 eligible articles. We summarized extracted data using figures, tables, and narrations. Of the 112 articles, 109 were original quantitative (48%), qualitative (45%), and mixed-methods (7%) research, originating mainly from the United States (US) (68%), the United Kingdom (UK) (12%), and Scandinavia (6%). Most articles addressed human papillomavirus (63%), measles (13%), and influenzas (9%) vaccinations, and the leading sponsor of funded research was the US National Institutes of Health (50%). Discernable migrant groups with vaccine-specific concerns included Somali diasporas, UK-based Poles and Romanians, and US-based Haitians and Koreans. Among US-based Latina/Latino immigrants, lower vaccine uptake frequency was mostly associated with awareness levels, knowledge gaps, and uninsured status. EXPERT OPINION: Migrants' vaccine-related apprehensions may cascade well beyond their proximate social connections and influence vaccine attitudes and behaviors in their countries-of-origin.

Missed Opportunities for Vaccination and Associated Factors among Children Attending Primary Health Care Facilities in Cape Town, South Africa: A Pre-Intervention Multilevel Analysis

Despite the substantial efforts at ensuring universal access to routine immunisation services among children in South Africa, major gaps in immunisation coverage remain. This study assessed the magnitude of missed opportunities for vaccination (MOV) and associated factors among children aged 0–23 months attending primary health care (PHC) facilities in Cape Town. We used multilevel binomial logistic regression models to explore individual and contextual factors associated with MOV, with children aged 0–23 months at Level 1, nested within PHC facilities (Level 2). A total of 674 children and their caregivers were enrolled. MOV prevalence was 14.1%, ranging from 9.1% to 18.9% across sub-districts. Dose-specific MOV prevalence was highest for the second dose of measles vaccine (9.5%) and lowest for the first dose of rotavirus vaccine (0.6%). The likelihood of a child experiencing MOV was significantly associated with caregivers’ low level of education (Odds ratio (OR) = 3.53, 95% credible interval (CrI): 1.13–11.03), recent receipt of immunisation messages (OR = 0.46, 95%CrI: 0.25–0.87), shared immunisation decision making by both parents (OR = 0.21, 95%CrI: 0.07–0.62) and health facility staff number (OR = 0.18, 95%CrI: 0.06–0.61). The burden of MOV among children in Cape Town is influenced by individual and contextual factors, which provide important opportunities for quality improvement and broader strategies to improve routine immunisation service delivery.

Enhancing Routine Childhood Vaccination Uptake in the Cape Metropolitan District, South Africa: Perspectives and Recommendations from Point-of-Care Vaccinators.

Vaccination, and particularly childhood vaccination, is widely acknowledged as one of the greatest public health interventions in history. Nevertheless, challenges exist that threaten the progress of childhood vaccination in many parts of the world. We investigated challenges to vaccination experienced by point-of-care vaccinators in the Cape Town Metropolitan District (Cape Metro), and reported on their current and proposed efforts to combat these challenges. Semi-structured interviews were conducted with 19 vaccinators in 16 purposively selected healthcare facilities in the Cape Metro from September to November 2019. Interviews were transcribed and analysed using thematic and narrative analysis methods. Challenges of both the demand and the supply side of routine vaccination were reported by the study participants, as were contextual challenges such as community safety issues. Defaulting was the most common challenge encountered, reported by 16 of the 19 participants. The use of computerized appointment systems, the enlistment of community health workers to track down defaulters, and the use of certificates to incentivize caregivers are part of the creative ways of mitigating some of the challenges encountered by these vaccinators. Their insightful recommendations can positively influence the landscape of childhood vaccination uptake in the Cape Metro and beyond if adapted and applied.

COVID-19 vaccine acceptance and hesitancy among healthcare workers in South Africa.

BACKGROUND: We assessed willingness to accept vaccination against coronavirus disease 2019 (COVID-19) among healthcare workers(HCWs) at the start of South Africa's vaccination roll-out. RESEARCH DESIGN AND METHODS: We conducted a cross-sectional survey among HCWs in Cape Town in March-May 2021 and assessed predictors of vaccination intentions. RESULTS: We recruited 395 participants; 64% women, 49% nurses, and 13% physicians. Of these, 233(59.0%) would accept and 163 (41.0%) were vaccine hesitant i.e. would either refuse or were unsure whether they would accept COVID-19 vaccination. People who did not trust that COVID-19 vaccines are effective were the most hesitant (p = 0.038). Older participants and physicians were more likely to accept vaccination than younger participants (p < 0.01) and other HCWs (p = 0.042) respectively. Other predictors of vaccine acceptance were trust that vaccines are compatible with religion (p < 0.001), consideration of benefits and risks of vaccination (p < 0.001), willingness to be vaccinated to protect others (p < 0.001), and viewing vaccination as a collective action for COVID-19 control (p = 0.029). CONCLUSIONS: COVID-19 vaccine hesitancy is high among HCWs in Cape Town. Reducing this would require trust-building interventions, including tailored education.

COVID-19 vaccines.

COVID-19 is a pandemic of unprecedented proportions in recent human history. Less than 18 months since the onset of the pandemic, there are close to two hundred million confirmed cases and four million deaths worldwide. There have also been massive efforts geared towards finding safe and effective vaccines. By July 2021 there were 184 COVID-19 vaccine candidates in pre-clinical development, 105 in clinical development, and 18 vaccines approved for emergency use by at least one regulatory authority. These vaccines include whole virus live attenuated or inactivated, protein-based, viral vector, and nucleic acid vaccines. By mid-2021 three billion doses of COVID-19 vaccine have been administered around the world, mostly in high-income countries. COVID-19 vaccination provides hope for an end to the pandemic, if and only if there would be equal access and optimal uptake in all countries around the world.

Estimating Vaccine Confidence Levels among Healthcare Staff and Students of a Tertiary Institution in South Africa.

Healthcare workers were the first group scheduled to receive COVID-19 vaccines when they became available in South Africa. Therefore, estimating vaccine confidence levels and intention to receive COVID-19 vaccines among healthcare workers ahead of the national vaccination roll-out was imperative. We conducted an online survey from 4 February to 7 March 2021, to assess vaccine sentiments and COVID-19 vaccine intentions among healthcare staff and students at a tertiary institution in South Africa. We enrolled 1015 participants (74.7% female). Among the participants, 89.5% (confidence interval (CI) 87.2-91.4) were willing to accept a COVID-19 vaccine, 95.4% (CI 93.9-96.6) agreed that vaccines are important for them, 95.4% (CI 93.8-96.6) that vaccines are safe, 97.4% (CI 96.2-98.3) that vaccines are effective, and 96.1% (CI 94.6-97.2) that vaccines are compatible with religion. Log binomial regression revealed statistically significant positive associations between COVID-19 vaccine acceptance and the belief that vaccines are safe (relative risk (RR) 32.2, CI 4.67-221.89), effective (RR 21.4, CI 3.16-145.82), important for children (RR 3.5, CI 1.78-6.99), important for self (RR 18.5, CI 4.78-71.12), or compatible with religion (RR 2.2, CI 1.46-3.78). The vaccine confidence levels of the study respondents were highly positive. Nevertheless, this could be further enhanced by targeted interventions.

COVID-19 and the Gaping Wounds of South Africa's Suboptimal Immunisation Coverage: An Implementation Research Imperative for Assessing and Addressing Missed Opportunities for Vaccination.

Despite South Africa's substantial investments in and efforts at ensuring universal access to immunisation services, progress has stalled and remains suboptimal across provinces and districts. An additional challenge is posed by the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has disrupted immunisation services globally, including in South Africa. While there is growing evidence that missed opportunities for vaccination (MOV) are a major contributor to suboptimal immunisation progress globally, not much is known about the burden and determinants of MOV in the South African context. Herein, we make a case for assessing MOV as a strategy to address current immunisation coverage gaps while mitigating the adverse impacts of the COVID-19 pandemic on immunisation services. We illustrate a practical implementation research approach to assessing the burden of MOV among children in primary care settings; for understanding the factors associated with MOV; and for designing, implementing, and evaluating context-appropriate quality improvement interventions for addressing missed opportunities. Such efforts are vital for building health system resilience and maintaining immunisation programme capacity to optimally deliver essential health services such as routine childhood immunisation, even during pandemics.