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Immunisation against herpes zoster is recommended for adults aged ≥ 50 years. Two vaccines, a live attenuated (ZVL, Zostavax®) and an adjuvant recombinant subunit (HZ/su, Shingrix®), are available in Australia. Immunisation guidelines are shifting their recommendations towards HZ/su because of higher efficacy in preventing herpes zoster and associated complications. However, there are limited post-marketing data comparing the safety profiles of these vaccines. Data from SmartVax, an active surveillance system for monitoring adverse events following immunisation (AEFIs) utilised by > 450 clinics throughout Australia, were analysed. Data from patients aged ≥ 50 years, who received ZVL or HZ/su, from 1 June 2021 to 31 May 2022, at clinics that utilised SmartVax were included. The proportion of records where patients who reported any, local, and systemic AEFIs after receiving ZVL or HZ/su were compared using multivariable logistic regression models. Data from 10,392 immunisation records (n = 8341 ZVL; n = 2051 HZ/su) were included. The proportion of AEFIs reported was higher with HZ/su (41.9 % [any], 33.8 % [local], 25.2 % [systemic]) than with ZVL (8.7 % [any], 6.2 % [local], 3.5 % [systemic]). After controlling for demographic variables, HZ/su presented a 6-fold increase in the odds (OR 6.44; 95 %CI: 5.57–7.46) of a reported AEFI compared to ZVL. Only 59 (0.6 %) of vaccinations lead to medical attention being sought due to an AEFI. While rates of AEFIs was higher with HZ/su than ZVL, most AEFIs were mild and did not require medical attention. Our findings support the change in vaccine recommendations and the use of HZ/su in immunisation programs. [ABSTRACT FROM AUTHOR]

Some post-licensure studies have shown a potential increased risk of intussusception following vaccination with rotavirus vaccines. This is the first study that aimed to assess the incidence and risk of intussusception within 90 days after vaccination with RotaTeq in Chinese infants. A population-based birth cohort from 27th November 2018 to 30th June 2021 included all newborns in Ningbo city. The records of intussusception were identified through the ICD-10 code K56.1 or Chinese keywords “Chang Tao” from all hospital discharge records. Each episode was confirmed in line with the Brighton criteria, and only Brighton level 1 cases were included. The association of RotaTeq vaccination and intussusception was evaluated using the Poisson regression. A total of 108,405 eligible subjects from birth cohort were eligible, with 52.30% males. Among them, 26, 847 (24.77%) infants received at least one dose of RotaTeq, and 95.52% of them were fully vaccinated, with 76, 934 doses in total. After adjudication, none of the cases occurred post first, or second dose, the cumulative number of cases that occurred 1–7, 1–14, 1–21, 1–42, and 1–90 days post third dose was 0, 1, 1, 3, and 7, respectively. Adjusting for age, sex, birth year, birth season and location, the incidence rate ratio of intussusception after RotaTeq vaccination was 0.90 (90% two-sided CI: 0.46, 1.75). Increasing age and male gender were associated with higher risk of intussusception. In summary, no increased risk of IS was observed following 3 months of RotaTeq vaccination in this study.

Interprofessional education (IPE) allows students in health professional programs to practice providing collaborative patient care before graduating. Understanding the perceptions and experiences of health care professionals' IPE received prior to entering the workforce is key for improving IPE programs. This study investigated participants' post-licensure interprofessional collaboration (IPC) experiences, how IPE helped prepare them for IPC post-licensure, their perceptions of the IPE they received as students, and their suggestions for improving IPE. This qualitative descriptive study included 20 healthcare workers from seven professions who graduated from two of three co-located post-secondary educational institutions. Data were collected using semi-structured interviews, which were audiotaped and transcribed verbatim. Inductive thematic analysis revealed five themes and six sub-themes: (a) Quality of care; (b) Role clarification; (c) Interpersonal skills (sub-themes: communication and self-confidence); (d) Co-location; and (e) Need for IPE improvements (sub-themes: additional IPE exposures, shadowing experiences, mandatory IPE, and informal peer learning). These findings appear to reinforce the perception that pre-licensure IPE may support the development of skills for IPC among practicing health professionals. [ABSTRACT FROM AUTHOR]

Two quadrivalent meningococcal conjugate vaccines (MenACWY) that prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W have been licensed in the U.S. in the past 10–15 years. We systematically reviewed published studies conducted in the U.S. to evaluate the real-world safety evidence of meningococcal conjugate vaccines. We performed a literature search in PubMed of publications from 01/01/2005 to 02/29/2020 and identified 18 studies meeting inclusion criteria. Populations included high-risk persons aged 2 months to 10 years, adolescents/adults aged ≥11 years, pregnant populations, and hematopoietic cell transplant recipients. We extracted information about study setting, study design, exposure, outcomes, comparison group, follow-up/look back period, study population, sample size, available demographic/indication information, results, key conclusion, and reference. These published studies found no new significant safety concerns related to MenACWY. Consideration for future research includes a post-licensure safety evaluation of a new MenACWY product approved in April 2020.

• Pharmacovigilance confirms the safety of recombinant pertussis vaccine post-licensure. • Genetically detoxified pertussis vaccine is well-tolerated by adolescents and adults. • Recombinant aP and its TdaP combination can be used safely in pregnant women. A new generation of recombinant acellular pertussis vaccine containing genetically inactivated pertussis toxin (PTgen) was licensed as a monovalent pertussis vaccine (aP gen ; Pertagen®) and in combination with tetanus and reduced-dose diphtheria (TdaP gen ; Boostagen®) for active immunization in individuals aged 11 years and older in Thailand in 2016. We here report post-marketing safety data on the use of the vaccines in individuals in the community obtained through active pharmacovigilance surveillance including pregnant women participating in a prospective observational study. Between May 2017 and February 2020 for TdaP gen and between June 2018 and February 2020 for aP gen , participating health care providers vaccinated and collected safety data for 11,429 exposed adolescents and adults. This included 1778 pregnant women. The incidence rate of adverse events following immunization (AEFIs) was 11.5 per 1000 of vaccinated individuals (95% confidence interval (95% CI) 9.7–13.6). AEFIs mostly concerned local pain at the injection site and muscle pain, and symptoms were mild and mostly resolved within a few days with no complications. The incidence rate of AEFIs in women vaccinated during pregnancy was 1.1 per 1000 (95% CI 0.3–4.1). Of 833 pregnant women vaccinated with recombinant aP gen or TdaP gen , 91.4% (95% CI 89.3–93.3) had uncomplicated pregnancies and 98.7% (95% CI 97.7–99.4) of the 855 babies delivered by these women were born healthy, which exceeds rates generally reported in Thailand. There were no vaccine-related serious adverse events reported during the surveillance period. In conclusion, active pharmacovigilance confirms that the recombinant pertussis vaccines aP gen (Pertagen) and TdaP gen (Boostagen) are safe in adolescents and adults, including pregnant women vaccinated in the second or third trimester of pregnancy. [ABSTRACT FROM AUTHOR]

Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile.

Abstract: Purpose: The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY‐D using the tree‐temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a large distributed safety data setting. Methods: Traditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting AEs based on pre‐defined sets of conditions or diagnoses. Using a newly developed tree‐temporal scan statistic data mining method, we performed a pilot study to evaluate the safety profile of the meningococcal conjugate vaccine Menactra® (MenACWY‐D), screening thousands of potential AE diagnoses and diagnosis groupings. The study cohort included enrolled participants in the Vaccine Safety Datalink aged 11 to 18 years who had received MenACWY‐D vaccination(s) between 2005 and 2014. The tree‐temporal scan statistic was employed to identify statistical associations (signals) of AEs following MENACWY‐D at a 0.05 level of significance, adjusted for multiple testing. Results: We detected signals for 2 groups of outcomes: diseases of the skin and subcutaneous tissue, fever, and urticaria. Both groups are known AEs following MENACWY‐D vaccination. We also identified a statistical signal for pleurisy, but further examination suggested it was likely a false signal. No new MENACWY‐D safety concerns were raised. Conclusions: As a pilot study, we demonstrated that the tree‐temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine‐AE associations within a large health care data network. [ABSTRACT FROM AUTHOR]

Since December 2015, the first dengue vaccine has been licensed in several Asian and Latin American countries for protection against disease from all four dengue virus serotypes. While the vaccine demonstrated an overall good safety and efficacy profile in clinical trials, some key research questions remain which make risk-benefit-assessment for some populations difficult. As for any new vaccine, several questions, such as very rare adverse events following immunization, duration of vaccine-induced protection and effectiveness when used in public health programs, will be addressed by post-licensure studies and by data from national surveillance systems after the vaccine has been introduced. However, the complexity of dengue epidemiology, pathogenesis and population immunity, as well as some characteristics of the currently licensed vaccine, and potentially also future, live-attenuated dengue vaccines, poses a challenge for evaluation through existing monitoring systems, especially in low and middle-income countries. Most notable are the different efficacies of the currently licensed vaccine by dengue serostatus at time of first vaccination and by dengue virus serotype, as well as the increased risk of dengue hospitalization among young vaccinated children observed three years after the start of vaccination in one of the trials. Currently, it is unknown if the last phenomenon is restricted to younger ages or could affect also seronegative individuals aged 9 years and older, who are included in the group for whom the vaccine has been licensed. In this paper, we summarize scientific and methodological considerations for public health surveillance and targeted post-licensure studies to address some key research questions related to live-attenuated dengue vaccines. Countries intending to introduce a dengue vaccine should assess their capacities to monitor and evaluate the vaccine’s effectiveness and safety and, where appropriate and possible, enhance their surveillance systems accordingly. Targeted studies are needed, especially to better understand the effects of vaccinating seronegative individuals. [ABSTRACT FROM AUTHOR]

Background: Assessments of vaccine efficacy and safety capture only the minimum information needed for regulatory approval, rather than the full public health value of vaccines. Vaccine efficacy provides a measure of proportionate disease reduction, is usually limited to etiologically confirmed disease, and focuses on the direct protection of the vaccinated individual. Herein, we propose a broader scope of methods, measures and outcomes to evaluate the effectiveness and public health impact to be considered for evidence-informed policymaking in both pre- and post-licensure stages.Discussion: Pre-licensure: Regulatory concerns dictate an individually randomised clinical trial. However, some circumstances (such as the West African Ebola epidemic) may require novel designs that could be considered valid for licensure by regulatory agencies. In addition, protocol-defined analytic plans for these studies should include clinical as well as etiologically confirmed endpoints (e.g. all cause hospitalisations, pneumonias, acute gastroenteritis and others as appropriate to the vaccine target), and should include vaccine-preventable disease incidence and 'number needed to vaccinate' as outcomes. Post-licensure: There is a central role for phase IV cluster randomised clinical trials that allows for estimation of population-level vaccine impact, including indirect, total and overall effects. Dynamic models should be prioritised over static models as the constant force of infection assumed in static models will usually underestimate the effectiveness and cost-effectiveness of the immunisation programme by underestimating indirect effects. The economic impact of vaccinations should incorporate health and non-health benefits of vaccination in both the vaccinated and unvaccinated populations, thus allowing for estimation of the net social value of vaccination.Conclusions: The full benefits of vaccination reach beyond direct prevention of etiologically confirmed disease and often extend across the life course of a vaccinated person, prevent outcomes in the wider community, stabilise health systems, promote health equity, and benefit local and national economies. The degree to which vaccinations provide broad public health benefits is stronger than for other preventive and curative interventions. [ABSTRACT FROM AUTHOR]

Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeableHaemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile. [ABSTRACT FROM PUBLISHER]

Abstract: Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues. [Copyright &y& Elsevier]

Abstract: Post-licensure evaluation of vaccines plays an important role in monitoring the progress of immunization programs, demonstrating population impact of vaccines, and providing data for ongoing policy decisions. Two human papillomovirus (HPV) vaccines are licensed and recommended for use in females in the United States, a quadrivalent human HPV vaccine, licensed in 2006 and a bivalent vaccine HPV vaccine licensed in 2009. HPV vaccination is recommended for females 11 or 12 years of age with catch-up vaccination through age 26 years. Post-licensure monitoring of the HPV vaccine program has included some of the same systems established for other vaccines, such as those for vaccine safety and coverage monitoring. However, monitoring HPV vaccine impact on infection and disease outcomes has required new efforts. While there are well established cancer registries in the United States, it will take decades before the impact of vaccine on cervical cancer is observed. More proximal measures of vaccine impact include outcomes such as prevalence of HPV vaccine types, incidence of cervical precancers and genital warts. We review systems in place or being established for post-licensure monitoring of HPV vaccine in the United States. [Copyright &y& Elsevier]

Abstract: GARDASIL® has been shown to reduce the incidence of pre-cancerous cervical, vulvar, and vaginal lesions, and external genital warts causally related to HPV6/11/16/18. Because of its expected public health benefit on reduction of cervical cancer and other HPV-related diseases, this vaccine has been rapidly implemented in the routine vaccination programs of several countries. It is therefore essential to assess its impact and safety through post-licensure surveillance programs. Here, we present a summary of 16 post-licensure safety and impact studies across 20 countries. These studies address general safety, including autoimmune disorders, long-term effectiveness, and type replacement. A summary of the surveillance efforts of the Unites States Centers for Disease Control and Prevention can be found in the accompanying article by Markowitz et al. [Copyright &y& Elsevier]

Abstract: Over 70 years of experiential evidence suggests that a specific form of advanced driver training, one based on an explicit system of car control, improves driver situation awareness (SA). Five experimental hypotheses are developed. They propose that advanced driving should increase the number of information elements in the driver''s working memory, increase the interconnection between those elements, increase the amount of ‘new’ information in memory as well as the prominence of existing information, and that finally, it should stimulate behaviours that help drivers evolve better situations to be aware of. An approach to SA based on Neisser''s perceptual cycle theory is anchored to a network based methodology. This is applied within the context of a longitudinal on-road study involving three groups of 25 drivers, all of whom were measured pre- and post-intervention. One experimental group was subject to advanced driver training and two further groups provided control for time and for being accompanied whilst driving. Empirical support is found for all five hypotheses. Advanced driving does improve driver SA but not necessarily in the way that existing situation focused, closed loop models of the concept might predict. [Copyright &y& Elsevier]

Integrated interprofessional care teams are the focus of Canadian and American recommendations about the future of health care. Keeping with this, a family medicine teaching site developed an educational initiative to expose trainees to interprofessional care processes and learning (Interprofessional Care Review; IPC). A formative evaluation pilot study was completed using one-on-one interviews and a focus group ( n = 6) with family medicine residents. A semi-structured guide was utilized regarding: knowledge, skills and attitudes related to interprofessional care; their experience of the processes utilized in IPC. Data were analyzed using content analysis. Residents' perspectives on their learning revolved around four themes: changes to understanding and practice of interprofessional care; personal impact of IPC; learning about other health professionals; tension and challenges of IPC learning and clinical implementation. Residents valued the educational experience, but identified that faculty supervisors provided “mixed messages” in the value of collaborating with other health professionals. Implications regarding future educational and research opportunities are discussed. [ABSTRACT FROM AUTHOR]

Abstract: Adverse events following immunization, while rare, unfortunately do occur. And when they do, the public''s faith in vaccines waves. It''s a known fact, for example, that vaccine safety concerns are among the most important factors contributing to parents refusing vaccination for their children. How best, then, to tackle these concerns and increase public confidence in the vaccine safety system? In an effort to contribute to identifying the right mechanisms, the International Alliance for Biological Standardization organized an international symposium on "Post-Licensure Evaluation of Vaccine Safety" in Barcelona in early Spring. Delegates from 24 countries took a close look at the current status of this challenging problem and identified several practical measures which could help address the situation. They suggested an integrated vaccine safety program to be in place in all countries and standardized so that information and data can be exchanged on a routine basis. Another proposal was to put in place simple measures such as the use of bar codes on vaccine vials. [Copyright &y& Elsevier]

Abstract: Human papillomavirus virus-like particle (HPV VLP) HPV vaccines currently evaluated for licensing are likely to be available soon. Licensure will be based on evidence that the vaccine is well tolerated and provides near complete type-specific protection against HPV infections and their resulting lesions in the first few years after vaccination. Several important questions will remain to be answered after licensure to guide vaccine implementation and to permit the rational evaluation of vaccination in cancer prevention programs. These include the long-term safety and efficacy of vaccination, the optimal ages for vaccination, efficacy against HPV types not included in the vaccine and against existing infections, and efficacy in males. Modulators of vaccine efficacy (e.g., HIV infection) and immune mechanisms of long-term protection also remain to be defined. The real-world effectiveness of vaccination programs will need to be assessed. Issues related to the implementation of a vaccine that targets pre-adolescents and early adolescents and to the acceptability of a cancer vaccine targeted against a sexually transmitted infection will need to be understood before vaccination programs can be successful. It is hoped that continued improvements to the current HPV vaccines will lead to the introduction in future years of second generation vaccines that simplify delivery and/or expand its coverage. Finally, the natural history of HPV types not covered in the candidate vaccines will need to be carefully studied following vaccination. Public health authorities in various countries will play a pivotal role in determining if these questions are answered in a timely manner. [Copyright &y& Elsevier]

The healthcare workers having seroprotection at 3 weeks (n = 127) following Pandemic H1N1 2009 influenza vaccination were followed up for antibody persistence. Seroprotection at 12 mo (60.2%) was significantly lower as compared with 3 weeks (74.7%), 3 mo (77.8%) and 6 mo (75.4%). The vaccine provided seroprotection up to one year.