Safe vaccines are critical for biosecurity protection, yet adverse events—rightly or wrongly attributed to immunization—potentially cause rapid loss of confidence, reduced vaccine uptake, and resurgence of preventable disease. Effective vaccine safety incident management is essential to provide assessment and lead appropriate actions to ensure vaccination programs are safe and mitigate unwarranted crisis escalation that could damage vaccine programs and the effective control of vaccine preventable disease outbreaks or pandemics. Incident management systems (IMS) are used globally to direct emergency management response, particularly for natural disasters of fire, flood, and storm. Public health is equally an emergency response and can therefore benefit from these command control constructs. While examples of IMS for outbreak response and mass immunization logistics exist, there is little to no information on their use in vaccine safety. We describe Australia’s vaccine safety Alert Advisory Group establishment in Victoria during the COVID-19 pandemic and onward embedding into routine practice, anticipant of new vaccines, and the next biosecurity threat.

In the UK, the incidence and prevalence of inflammatory bowel disease (IBD) is increasing in paediatric populations. Environmental factors including acute gastroenteritis episodes (AGE) may impact IBD development. Infant rotavirus vaccination has been shown to significantly reduce AGE. This study aims to explore the association between vaccination with live oral rotavirus vaccines and IBD development. A population-based cohort study was used, analysing primary care data from the Clinical Practice Research Datalink Aurum. Participants included children born in the UK from 2010 to 2015, followed from a minimum of 6 months old to a maximum of 7 years old. The primary outcome was IBD, and the primary exposure was rotavirus vaccination. Cox regression analysis with random intercepts for general practices was undertaken, with adjustment for potential confounding factors. In a cohort of 907,477 children, IBD was recorded for 96 participants with an incidence rate of 2.1 per 100,000 person-years at risk. The univariable analysis hazard ratio (HR) for rotavirus vaccination was 1.45 (95% confidence interval (CI) 0.93–2.28). Adjustment in the multivariable model attenuated the HR to 1.19 (95% CI 0.53–2.69). This study shows no statistically significant association between rotavirus vaccination and development of IBD. However, it provides further evidence for the safety of live rotavirus vaccination.

In the development of vaccines for tuberculosis (TB), the combination of the will, funding, scientific rigor, new tools, refined animal models and improved clinical trial designs are all converging at an opportune moment. The lack of optimism that has surrounded the likelihood for finding novel TB vaccines has resulted from a lack of correlates of vaccine-induced protection, a lack of tool candidate vaccines to probe the immunologic space, which may be needed, and the negative result of one recent trial. A vaccine for TB that can be delivered at a reasonable cost to the marketplace will have greater impact on the incidence of new cases of TB than any intervention in world history. Now is the time to increase resources, both financial and human intellectual capacity, for a global tuberculosis vaccine effort.

Infection with dengue, the most prevalent mosquito-borne virus, manifests as dengue fever (DF) or the more fatal dengue haemorrhagic fever (DHF). DHF occurs mainly when an individual who has acquired antibodies to one serotype is inoculated with another serotype. It was reported that mosquito control may have increased the incidence of DF and DHF due to age-dependency in manifesting these illnesses or an immunological mechanism. Tetravalent dengue vaccine is currently being tested in clinical trials. However, seroconversions to all four serotypes were achieved only after three doses. Therefore, vaccines may predispose vaccinees to the risk of developing DHF in future infections. This study employed an individual-based computer simulation, to emulate mosquito control and vaccination, incorporating seroconversion rates reported from actual clinical trials. It was found that mosquito control alone would have increased incidence of DF and DHF in areas of high mosquito density. A vaccination programme with very high coverage, even with a vaccine of suboptimal seroconversion rates, attenuated possible surges in the incidence of DF and DHF which would have been caused by insufficient reduction in mosquito abundance. DHF cases attributable to vaccine-derived enhancement were fewer than DHF cases prevented by a vaccine with considerably high (although not perfect) seroconversion rates. These predictions may justify vaccination programmes, at least in areas of high mosquito abundance. In such areas, mosquito control programmes should be conducted only after the vaccination programme with a high coverage has been initiated.

The self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995–2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.