Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines

Abstract

Since the onset of the COVID-19 pandemic, there has been a significant surge in interest of COVID-19 vaccines in particular, and other traditional vaccines in general. This strong interest is expected to continue as the industry strives to manufacture safer and more efficacious vaccines against COVID-19 and other infectious diseases. Vaccines are a unique class of products, being biologicals that are administered to healthy individuals to prevent diseases. The equitable distribution and availability of safe, efficacious and good quality vaccines are of utmost importance in preventing and controlling infections and safeguarding public health. The continued existence of poor-quality vaccines suggests a lack of control of manufacturing, storage, distribution, and possibly, their associated regulation. Nonetheless, all these situations – whether positive or negative, present opportunities for improvements. As regulatory authorities step up efforts in regulating existing traditional vaccines, advancements in vaccine research and development churn out novel vaccines that pose further manufacturing and regulatory challenges. This manuscript provides an overview of vaccines, both traditional and novel, and strives to identify challenges in the manufacture, storage, distribution, handling and their associated regulation. It also evaluates whether current regulatory frameworks are adequate, and where applicable, recommends areas for improvements. International harmonization and convergence of national regulatory framework with the view to facilitate quicker approval of safe, efficacious and good quality vaccines, that are accessible and affordable to patients worldwide, are also explored.