Scalable Production of a Covid-19 Injectable Vaccine: Still a Transparency Blackbox

For the last year, the vaccine manufacturing process has been at the forefront of conversations between public health officials, policymakers, industry experts and the public. Although much attention has been paid to the development and distribution of a COVID-19 vaccine, the fill and finish manufacturing process is critical to the process. The fill and finish manufacturing process is one that is fraught with proprietary knowledge, the details of which are usually only known by the manufacturer; in short, this information is not available to the public. This process also differs regionally; a fill and finish line in the United States may look different from a line in Europe, India or China. Additionally, the availability of specialized equipment and materials is also highly regional and adds another layer of complexity to a global vaccine supply chain issue. Furthermore, the regulations and legal requirements to produce a vaccine vary substantially based on the country. In the United States, the FDA requires a very strict timeline and safety measures before a vaccine is authorized to be administered on human subjects, whereas other countries like Canada, The United Kingdom and the European Union have more relaxed standards compared to the United States. These factors coupled with the politicized nature of COVID-19 response and reporting have left the public with more questions than answers. This report aims to clarify these points and illuminate the complexity of the fill and finish manufacturing process in vaccine development.