The journey of a lifetime - development of Pfizer's COVID-19 vaccine

Abstract

It would be apt to say that one of the greatest accomplishments in modern medicine has been the development of vaccines against COVID-19, which had paralyzed the entire world for more than a year. Pfizer and BioNTech codeveloped the first COVID-19 vaccine that was granted emergency-use authorization or conditional approval in several regions globally. This article is an attempt to go 'behind-the-scenes' of this development process and highlight key factors that allowed us to move with this unprecedented speed, while adhering to normal vaccine-development requirements to generate the information the regulatory authorities needed to assess the safety and effectiveness of a vaccine to prevent an infectious disease, including quality and manufacturing standards. This is also a story of how Pfizer and BioNTech leveraged our combined skill sets and experience to respond to the global health crisis to progress this program swiftly while ensuring the compliance with our high-quality standards and keeping patient safety at the forefront. We will also highlight multiple other factors that were instrumental in our success.

Graphical abstract

Figure 1

Selection of Pfizer/BioNTech COVID-19 vaccine BN162b2, SARS-Cov-2 spike-protein 3D- structure image produced from Wrapp et al. .

Figure 2

Timeline for the development of the COVID-19 mRNA vaccine.

Figure 3

Proposed mechanism depicting cellular uptake of mRNA-loaded LNPs, spike-protein synthesis, and activation of the immune system to provide long-term protection against SARS-CoV-2 virus.

Figure 4

The mRNA drug-product platform process: mixing of the aqueous stream with the organic stream via a proprietary T-mixing process at fixed ratios and flow rates through a set flow path, provides self-assembly of the LNP formulation with the mRNA into nm-sized particles .