Principles of vaccine development

Vaccines are biological products that protect against pathogens such as bacteria and viruses by eliciting an immune response. Antigens foster the response within the vaccine, generated either naturally or synthetically. Antigens are one of several components that comprise a vaccine and aid in its classification. The type of virulence factors can influence its classification as either live or nonlive. Types of vaccines may be classified based on their main content, such as protein-polysaccharide conjugate vaccines or nucleic acid vaccines. With the essential role vaccines serve and their developmental intricacies, it is understood that there is a federal entity that oversees vaccine development. In the United States the vaccine development process is regulated by the Food and Drug Administration (FDA). The beginning stages typically involve submitting an investigational new drug application (IND) for approval. Through submitting an IND, the FDA provides vaccine developers critical information regarding factors such as trial design and quality testing. Evaluation of vaccine safety and efficacy is performed during the clinical trial period. Foreign clinical, human challenge, and pediatric clinical studies are the most common types of studies recommended by the FDA. This review discusses the details regarding the general key features of vaccines and the overall federal regulation of vaccine development. © 2023 Elsevier Inc. All rights reserved.

How the COVID-19 Pandemic Affected Young People's Mental Health and Wellbeing in the UK: A Qualitative Study

There is emerging evidence of the detrimental impact of the pandemic and associated restrictions on young people's mental health in the UK but to date, these data have been largely quantitative. The aim of the current study was to gain a deeper understanding of young people's experiences in relation to their mental health and wellbeing during the pandemic. Seventeen young people, aged 11 to 16 years, sampled for diverse characteristics, and living in the UK, were interviewed virtually between December 2020 and February 2021. Reflexive thematic analysis was carried out by the research team, which included two young people, and five themes were developed: (1) positives;(2) worries and anxiety;(3) sadness and anger about losses;(4) mental exhaustion;and (5) support from others. Aspects of young people's individual circumstances (e.g., pre-existing mental health difficulties;special educational needs and neurodevelopmental disorders) appeared to play a role in their experiences. Continued measurement of young people's mental health, initiatives to identify young people who have been struggling and the provision of support (including evidence-based and accessible interventions) will be important for protecting young people from future adversities as we emerge from the pandemic.