Developing New Drugs for the COVID-19 Emergency: Anatomy of the U.S. Response.

Abstract

Context: To meet the need for effective treatments during the COVID-19 Public Health Emergency, the U.S. government sought to accelerate the discovery and development of new antiviral treatments-a process that normally took 4-12 years. The government changed many features of the established system, selecting the investigational drugs, sponsoring or conducting the clinical testing, and purchasing and managing the distribution of the successful products.

Methods: We focused on novel therapeutic agents for COVID-19 that were funded, clinically tested, and/or received Emergency Use Authorization during the Public Health Emergency from January 2020 to May 2023. The primary sources were the public records of the National Institutes of Health, the U.S. Food and Drug Administration, and the Biomedical Advanced Research and Development Authority. Excluded were vaccines, devices, diagnostic tests, and new indications for approved drugs.

Results: In less than 24 months, the emergency program developed, tested, approved, and distributed eight new therapeutic products, including six monoclonal antibodies and two new oral antivirals. In addition, 11 other investigational agents were funded or tested under the emergency program but did not receive Emergency Use Authorization. More than 30 million courses of treatment were distributed at a cost of $29 billion or $881 per patient. By the end of the emergency, viral mutations and rapidly growing population immunity rendered the new products ineffective in almost all patients.

Conclusions: The emergency program was dramatically effective in finding and testing new drug treatments using a variety of clinically relevant endpoints and serving varied patient populations. Planning for future pandemics should include a global network of clinical testing centers that were key to a rapid response. Research is needed to discover more durable antiviral treatments, especially in settings where mutation and population immunity are subject to rapid change.