Vaccines

The safety of COVID-19 vaccines, as was the case last year, remains a large part of the focus in this volume. COVID-19 placed a large magnifying glass on both vaccines, specifically vaccine safety. This was most readily apparent as the number of records in VAERS ballooned to about 10 times the size from 2020 to 2021 (Vaccine Adverse Event Reporting System (VAERS), 2022) [S]. While we have added and/or improved VAERS during COVID-19, including adding or improving other vaccine safety surveillance tools like v-safe and vaccine safety datalink (Blumenthal, Phadke, et al., 2021) [MC], there is still room for improvement in these pharmacovigilance tools (Rizk et al., 2021) [r]. A major global initiative in this realm is the Global Vaccines Safety Blueprint 2.0 (GVSB2.0) (Organization, 2021, pp. 2021–2023) [S]. We wholeheartedly endorse these initiatives, which could significantly improve vaccine safety. As noted in past SEDA issues, clinicians should be mindful of the risks of AEs and SAEs associated with each individual vaccine.

Moving beyond Titers.

Vaccination to prevent and even eliminate disease is amongst the greatest achievements of modern medicine. Opportunities remain in vaccine development to improve protection across the whole population. A next step in vaccine development is the detailed molecular characterization of individual humoral immune responses against a pathogen, especially the rapidly evolving pathogens. New technologies such as sequencing the immune repertoire in response to disease, immunogenomics/vaccinomics, particularly the individual HLA variants, and high-throughput epitope characterization offer new insights into disease protection. Here, we highlight the emerging technologies that could be used to identify variation within the human population, facilitate vaccine discovery, improve vaccine safety and efficacy, and identify mechanisms of generating immunological memory. In today's vaccine-hesitant climate, these techniques used individually or especially together have the potential to improve vaccine effectiveness and safety and thus vaccine uptake rates. We highlight the importance of using these techniques in combination to understand the humoral immune response as a whole after vaccination to move beyond neutralizing titers as the standard for immunogenicity and vaccine efficacy, especially in clinical trials.

Vaccines

In this volume of the Side Effects of Drugs Annual, although other vaccines will be covered, the safety of COVID vaccines is the focus as COVID-19 has led to heightened attention on vaccine safety in general. As such, this chapter will be more relevant than ever before. As noted in past SEDA issues, clinicians should be mindful of the risks of AEs and SAEs associated with each vaccine.