The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective

Abstract

At the outset of the coronavirus disease 2019 (COVID-19) pandemic, it was clear that a vaccine would be crucial for global health efforts. The Pfizer and BioNTech teams came together in a race against the virus, working to design, test, manufacture, and distribute a safe and efficacious vaccine in record time for people around the world. Here, we provide backstory commentary from the pharmaceutical scientist perspective on the challenges and solutions encountered in the development of the Pfizer-BioNTech mRNA COVID-19 vaccine (BNT162b2; b2; Comirnaty®; tozinameran). We discuss the foundational science that led to the decision to use an mRNA-based approach. We also describe key challenges in the identification of an optimal vaccine candidate and testing in clinical trials, the continuous efforts to improve the vaccine formulation in response to changing global health priorities and facilitate vaccine accessibility, and how vast quantities of vaccine doses were manufactured and safely delivered to every corner of the globe, all without compromising quality, science, and safety. The key to successfully delivering a safe and efficacious vaccine within nine months was a result of extraordinary, real-time, parallel effort and across-the-board collaboration between stakeholders on a global scale.

Keywords: Global Health; Lipid Nanoparticles; Vaccine; Vaccine delivery; mRNA.

Fig. 1

Timeline of key events.^,,, , , , , , , , , , Figure shows US FDA milestones; other country approvals not shown for simplicity.

Fig. 2

Schematic of the BNT162b2 (A) mRNA and (B) lipid nanoparticle. *Lipid attached to polyethylene glycol. PEG, polyethylene glycol; S, spike; UTR, untranslated region.

Fig. 3

Vaccine formulations evolved to address changing global priorities and needs., , , *PBS and Tris are buffering agents that help maintain the pH and stability of the product.

Fig. 4

Steps in the manufacturing of the mRNA drug substance and vaccine drug product.

Fig. 5

The Comirnaty® development process was accelerated without compromising compliance or safety. DP, drug product; EUA, Emergency Use Authorization; IVT, in vitro transcription; LNP, lipid nanoparticle; mRNA, messenger RNA; pDNA, plasmid DNA.