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Born in fire. Raised by monsters. Destined to smash! On an alien planet shattered by war, no one is stronger than Skaar -- the savage Son of Hulk! But as a warlord and a princess spread chaos through the wastelands, will Skaar save the puny survivors -- or eat them? Skaar seeks the mysterious Old Power, but can even he stop the coming of the Silver Surfer-and Galactus the Devourer? The soothsayers sing: One day, monsters will clash -- the boy will confront the man who abandoned him. When the Son of Hulk seeks vengeance on his father, will Earth be turned into Planet Skaar?

Background Maintaining high levels of childhood vaccinations is important for public health. Success requires better understanding of parents' perceptions of diseases and consequent decisions about vaccinations, however few studies have considered this from the theoretical perspectives of risk perception and decision-making under uncertainty. The aim of this study was to examine the utility of subjective risk perception and decision-making theories to provide a better understanding of the differences between immunisers' and non-immunisers' health beliefs and behaviours. Methods In a qualitative study we conducted semi-structured in-depth interviews with 45 Australian parents exploring their experiences and perceptions of disease severity and susceptibility. Using scenarios about 'a new strain of flu' we explored how risk information was interpreted. Results We found that concepts of dread, unfamiliarity, and uncontrollability from the subjective perception of risk and ambiguity, optimistic control and omission bias from explanatory theories of decision-making under uncertainty were useful in understanding why immunisers, incomplete immunisers and non-immunisers interpreted severity and susceptibility to diseases and vaccine risk differently. Immunisers dreaded unfamiliar diseases whilst non-immunisers dreaded unknown, long term side effects of vaccines. Participants believed that the risks of diseases and complications from diseases are not equally spread throughout the community, therefore, when listening to reports of epidemics, it is not the number of people who are affected but the familiarity or unfamiliarity of the disease and the characteristics of those who have had the disease that prompts them to take preventive action. Almost all believed they themselves would not be at serious risk of the 'new strain of flu' but were less willing to take risks with their children's health. Conclusion This study has found that health messages about the risks of disease which are communicated as though there is equality of risk in the population may be unproductive as these messages are perceived as unbelievable or irrelevant. The findings from this study have implications beyond the issue of childhood vaccinations as we grapple with communicating risks of new epidemics, and indeed may usefully contribute to the current debate especially in the UK of how these theories of risk and decision-making can be used to 'nudge' other health behaviours.

About the Authors: Leonard C. Harrison * E-mail: harrison@wehi.edu.au Affiliation: Walter and Eliza Hall Institute for Medical Research, University of Melbourne, Melbourne, Victoria, Australia ORCID logo http://orcid.org/0000-0002-2500-8944 Kirsten P. Perrett Affiliation: Vaccine and Immunization Research Group, Murdoch Children’s Research Institute and the Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia ORCID logo http://orcid.org/0000-0002-5683-996X Kim Jachno Affiliation: Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia ORCID logo http://orcid.org/0000-0003-2550-9674 Terry M. Nolan Affiliation: Vaccine and Immunization Research Group, Murdoch Children’s Research Institute and the Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia ORCID logo http://orcid.org/0000-0001-6018-3863 Margo C. Honeyman Affiliation: Walter and Eliza Hall Institute for Medical Research, University of Melbourne, Melbourne, Victoria, Australia ORCID logo http://orcid.org/0000-0002-8926-5384 Introduction Rotavirus (RV) remains the major cause of infantile gastroenteritis worldwide, although the advent of vaccination has substantially decreased associated mortality [1]. In testing the ability of peptides to stimulate blood T cells from islet autoantibody-positive T1D relatives, we identified a dominant epitope, VIVMLTPLVEDGVKQC (amino acid [aa] 805–820) in IA-2, which had 56% identity and 100% similarity over 9 aa with a sequence (aa 40–48) in the major immunogenic viral protein 7 (VP7) outer-capsid protein of human RV serotype genotype 3 (G3), strain P (Fig 1A) [6,7]. Mimicry between amino acid sequences in islet autoantigens IA-2 (A) and GAD65 (B) and rotavirus genotype 3 viral protein 7 (VP7). https://doi.org/10.1371/journal.ppat.1007965.g001 In addition to mimicry with IA-2, a neighbouring sequence in VP7 (aa 17–25) (Fig 1B) had 78% identity and 100% similarity over 9 aa with a known HLA-DR4-restricted T-cell epitope in GAD65 [7]. [...]these IA-2 and GAD65 DR4-restricted epitopes encompassed T-cell epitopes for HLA class I–restricted CD8+ T cells in T1D [10], for which we coined the term “combitope.” Population-level data suggest RV vaccination may be associated with a decrease in the incidence of T1D The live oral RV vaccines Rotarix (G1P[8], monovalent, GSK) and RotaTeq (G1-4, P[8], pentavalent, Merck) were introduced into the Australian National Immunisation Program in 2007 and had high uptake (http://www.ncirs.org.au/sites/default/files/2018-11/Rotavirus-history-August-2017.pdf) with a substantial herd immunity effect [24].

The Strategic Advisory Group of Experts (SAGE) on Immunization advises WHO on global policies for vaccines. In April, 2016, SAGE issued recommendations on the use of the first licenced dengue vaccine, CYD-TDV. In November, 2017, a retrospective analysis of clinical trial data, stratifying participants according to their dengue serostatus before the first vaccine dose, showed that although in high seroprevalence settings the vaccine provides overall population benefit, there was an excess risk of severe dengue in seronegative vaccinees. SAGE's working group on dengue vaccines met to discuss the new data and mainly considered two vaccination strategies: vaccination of populations with dengue seroprevalence rates above 80% or screening of individuals before vaccination, and vaccinating only seropositive individuals. We report on the deliberations that informed the recommendation of the pre-vaccination screening strategy, in April, 2018. Important research and implementation questions remain for CYD-TDV, including the development of a highly sensitive and specific rapid diagnostic test to determine serostatus, simplified immunisation schedules, and assessment of the need for booster doses.

mRNA-lipid nanoparticle (LNP) medicinal products can be considered a platform technology because the development process is similar for different diseases and conditions, with similar noncoding mRNA sequences and lipid nanoparticles and essentially unchanged manufacturing and analytical methods often utilised for different products. It is critical not to lose the momentum built using the platform approach during the development, regulatory approval and rollout of vaccines for SARS-CoV-2 and its variants. This review proposes a set of modifications to existing regulatory requirements for mRNA products, based on a platform perspective for quality, manufacturing, preclinical, and clinical data. For the first time, we address development and potential regulatory requirements when the mRNA sequences and LNP composition vary in different products as well. In addition, we propose considerations for self-amplifying mRNA, individualised oncology mRNA products, and mRNA therapeutics. Providing a predictable development pathway for academic and commercial groups so that they can know in detail what product characterisation and data are required to develop a dossier for regulatory submission has many potential benefits. These include: reduced development and regulatory costs; faster consumer/patient access and more agile development of products in the face of pandemics; and for rare diseases where alternatives may not exist or to increase survival and the quality of life in cancer patients. Therefore, achieving consensus around platform approaches is both urgent and important. This approach with mRNA can be a template for similar platform frameworks for other therapeutics and vaccines to enable more efficient development and regulatory review.

Our understanding of the immune responses that follow SARS-CoV-2 infection and vaccination has progressed considerably since the COVID-19 pandemic was first declared on the 11 th of March in 2020. Recovery from infection is associated with the development of protective immune responses, although over time these become less effective against new emerging SARS-CoV-2 variants. Consequently, reinfection with SARS-CoV-2 variants is not infrequent and has contributed to the ongoing pandemic. COVID-19 vaccines have had a tremendous impact on reducing infection and particularly the number of deaths associated with SARS-CoV-2 infection. However, waning of vaccine induced immunity plus the emergence of new variants has necessitated the use of boosters to maintain the benefits of vaccination in reducing COVID-19 associated deaths. Boosting is also beneficial for individuals who have recovered from COVID-19 and developed natural immunity, also enhancing responses immune responses to SARS-CoV-2 variants. This review summarizes our understanding of the immune responses that follow SARS-CoV-2 infection and vaccination, the risks of reinfection with emerging variants and the very important protective role vaccine boosting plays in both vaccinated and previously infected individuals.

The Australian Government has implemented new arrangements for public funding of vaccines over the past 5 years. By utilising the standard Pharmaceutical Benefits Advisory Committee (PBAC) application process, whether for funding under the National Immunisation Program Schedule (NIP) or under the Pharmaceutical Benefits Scheme (PBS), a predictable and transparent process for vaccine funding recommendations has been established. This process uses the high-level technical resources available through the Australian Technical Advisory Group on Immunisation (ATAGI) to ensure that both vaccine manufacturers and the PBAC are optimally informed about all relevant aspects of population benefits and delivery of vaccines. ATAGI has a long-standing and mutually beneficial dialogue with State and Territory Governments, providers, and vaccine manufacturers to ensure that pipeline awareness, supply issues, and all relevant scientific and clinical details are well understood.

The COVID‐19 pandemic and the measures taken to mitigate its spread have had a dramatic effect on the circulation patterns of other respiratory viruses, most especially influenza viruses. Since April 2020, the global circulation of influenza has been markedly reduced; however, it is still present in a number of different countries and could pose a renewed threat in the upcoming Northern Hemisphere winter. Influenza vaccination remains the most effective preventive measure that we have at our disposal against influenza infections and should not be ignored for the 2021–2022 season.

Maternal immunization has undergone a paradigm shift in recent years, as women and healthcare providers accept and recognize the benefits of this strategy not only for the pregnant woman but also for the developing fetus and young infant. This article reviews the evidence for active immunization during pregnancy, with an emphasis on perinatal and infant outcomes. Current recommendations for immunization during pregnancy are presented, with particular focus on the routinely recommended vaccines during pregnancy: influenza and Tdap (tetanus, diphtheria, and pertussis). We discuss future research directions, maternal vaccines in development, and considerations for optimizing and advancing this underutilized strategy.

Background: Children are at high risk of influenza infections and may spread the disease to vulnerable family members. Quadrivalent influenza vaccines (QIV) provide protection against four strains of influenza recommended annually by the World Health Organization (WHO) and have the potential to provide improved protection during seasons with B-strain mismatch between vaccine and circulating virus strains. Methods: We evaluated the reactogenicity and safety of a QIV (Afluria Quad and Afluria Quad Junior, Seqirus, Parkville, Australia) in children aged 6 months to <3 years and 3 to <9 years over two Southern Hemisphere influenza seasons (2019 and 2020). The rates of solicited local and systemic adverse events (AEs) occurring on Days 1–7 after each vaccine dose were compared between three vaccine batches during each of the two seasons. Results: Overall, 73.7% of participants aged 6 months to <3 years and 77.5% of those aged 3 to <9 years reported any solicited AE between Day 1 and 7 of SH2019, and 66.7% and 69.2%, respectively, reported any solicited AE in SH2020, consistent with results from prior paediatric studies of QIV. The majority of solicited AEs were mild to moderate in severity. No consistent patterns of batch variation in solicited local or systemic reactogenicity were observed, suggesting no clinically significant differences between vaccine batches. No serious AEs or AEs of special interest (i.e., anaphylactic reaction or febrile convulsion) were reported during Days 1–7 after each vaccination, and no new safety concerns were identified. Conclusions: Together, these results support a clinically acceptable safety and tolerability profile of QIV in children aged 6 months to <9 years.