Emerging outbreaks and epidemic threats: The practicality and limitations in the development and manufacturing of treatments for Coronavirus (COVID-19)

Coronavirus SARS-CoV-2 vaccine

Abstract

The goal of this article is not to comment on the approach or route to treat the coronavirus. While a lot of articles, blogs and posts have been published on the virology, epidemiology, the biology of disease, potential diagnosis, evaluation, and management; the perspective that is missing is the production/manufacturing and supporting studies and analysis that will be critical for meeting the demands of potential treatment for this coronavirus. While many companies have jumped into the fray with the promise of delivering an effective treatment (prevention or cure) and diagnosis, what is unclear is the timeline, resources and effort required in the production and development of a COVID-19 vaccine and the time by which a released vialed, licensed product will become accessible to the global community. Most importantly, aspects related to the GMP manufacturing for different phases, fill/finish and release, the product analytics, consistency and critical quality attributes including the potency/functionality of the product, formulation and product presentation, non-clinical evaluations, and long-term stability are big unknowns. These aspects gain significance from a stockpiling point of view, as the stability window (product expiry) and analytics over a period of time become extremely critical factors in supply availability and which will dictate how soon new batches of product doses will have to be manufactured and restocked in order to alleviate the drug shortage or the severity of a shortage.