Emerging heterologous mRNA-based booster strategies within the COVID-19 vaccine landscape.

Messenger RNA (mRNA)-based vaccine platforms used for the development of mRNA-1273 and BNT162b2 have provided a robust adaptable approach to offer protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, as variants of concern (VoCs), such as omicron and associated sub-variants, emerge, boosting strategies must also adapt to keep pace with the changing landscape. Heterologous vaccination regimens involving the administration of booster vaccines different than the primary vaccination series offer a practical, effective, and safe approach to continue to reduce the global burden of coronavirus disease 2019 (COVID-19). To understand the immunogenicity, effectiveness, and safety of heterologous mRNA-based vaccination strategies, relevant clinical and real-world observational studies were identified and summarized. Overall, heterologous boosting strategies with mRNA-based vaccines that are currently available and those in development will play an important global role in protecting individuals from COVID-19 caused by emerging VoCs.

Insights for Oncology Trials Garnered From the Rapid Development of an mRNA COVID-19 Vaccine.

ABSTRACT: The sudden emergence of the coronavirus disease 2019 (COVID-19) pandemic in early 2020 stimulated unprecedented scientific initiatives to rapidly develop effective treatments and vaccines. One example was the development of vaccines based on messenger RNA platforms, which received emergency use authorization in the United States less than 1 year after the primary sequence of the severe acute respiratory syndrome coronavirus 2 virus was published. Novel practices arose from the collaborative efforts and inclusive clinical studies that facilitated the vaccines' rapid development and clinical testing. I describe insights gained from the experience of mRNA-1273 vaccine development that may be applied to or adapted for oncology research. These insights include clinical study design, diversity and inclusion initiatives, speed, and real-world evidence generation, as well as close partnership among regulatory agencies, government, and pharmaceutical companies.

How New Models Of Vaccine Development For COVID-19 Have Helped Address An Epic Public Health Crisis.

Coronavirus disease 2019 (COVID-19) vaccine development and manufacturing have proceeded at a historically unprecedented pace. This speed may be accounted for by the unprecedented scale of resources being devoted to addressing COVID-19; an unusual intensity of cooperation, encompassing the public and private sectors and occurring both within and across national borders; and innovation with respect to both technologies (for example, new vaccine platforms) and processes (for example, vaccine clinical trials). In this article we describe and analyze how resources, cooperation, and innovation have contributed to the accelerated development of COVID-19 vaccines. Similar levels and types of public investment, models of cooperation, and harnessing of innovative processes and technologies could be applied to future epidemics and other global health challenges.