The Final Hurdle in the Covid-19 Vaccine Race Is Bureaucracy

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 showed their vaccine prevented more than 90% of symptomatic infections in a trial of tens of thousands of volunteers. On Nov. 16, Moderna Inc. reported a 94.5% prevention rate for its vaccine, with a 30,000-plus test group. Today, Pfizer-BioNTech announced that a final analysis of its trials showed that its vaccine was 95% effective. AstraZeneca Plc is expected to report on its candidate vaccine in a few days.

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, simultaneously with the latest update on its vaccine, Pfizer-BioNTech said it would file within days with the U.S. Food and Drug Administration for the first U.S. regulatory approval of a coronavirus shot.