The Final Hurdle Is Bureaucracy

An alphabet soup of regulators raises the prospect of vaccine chaos

- Vernon Silver, James Paton, and Suzi Ring

Making vaccines that are safe and effective is certainly the hard part of the race to pull humanity from the pandemic brink. Promising results are pouring in. On Nov. 9, Pfizer Inc. and its German partner BioNTech SE said early findings indicated their vaccine prevented more than 90% of symptomatic infections among volunteers. On Nov. 16, Moderna Inc. reported a 94.5% prevention rate for its vaccine. Two days later, Pfizer-BioNTech matched that with a final analysis of its data.

Yet if triumph in this scientific, corporate, and nationalistic contest is defined as the first vaccine to get approved and administered on a large scale, the victory is still anyone’s to win. The final phase will require navigating the maze of regulators, scattered across continents and agencies, who will determine when, which, and where shots of the most promising candidates will be approved, produced, and distributed. Indeed, Pfizer-BioNTech said it would file for the first approval of a Covid shot with the U.S. Food and Drug Administration.

These gatekeepers are an overlooked logistical reality of the vaccine contest. This isn’t just a single race among a handful of corporate front-runners but a more fractured process in which individual nations hold the power of approval. Yes, the FDA is important, but the contours of a splintered final push are already coming into focus—and they are global.