Below please find a summary and link(s) of new coronavirus-related content published today in Annals of Internal Medicine. The summary below is not intended to substitute for the full article as a source of information. A collection of coronavirus-related content is free to the public at http://go.annals.org/coronavirus.
Ethical and Scientific Considerations Regarding the Early Approval and Deployment of a COVID-19 Vaccine
The COVID-19 pandemic demands early licensing and deployment of a vaccine that provides worthwhile efficacy, but accomplishing this goal could compromise two ethical principles that guide clinical research: scientific validity and social value.
Currently, five Western companies are conducting placebo-controlled, phase 3, randomized clinical trials (RCTs) whose primary outcome is the prevention of clinical disease. As soon as two months of data from one of these RCTs establishes vaccine efficacy, the U.S. Food and Drug Administration (FDA) could license the vaccine or provide Emergency Use Authorization (EUA) within a few days or weeks. The authors of this commentary point out this scenario will not answer questions about long-term efficacy and safety, which would require more months of data. To understand how to deploy different vaccines in the most optimal way, we must know their different characteristics and especially their long-term effects.
While vaccinating everyone in the U.S. who wants a vaccine by April 2021 as recent predictions state would be a great achievement, it would also intensify concerns about ethical issues surrounding early vaccine approval and deployment. The authors stress that it is important for us to plan to deal with those issues. This commentary is published in Annals of Internal Medicine. Read the full text: https://www.acpjournals.org/doi/10.7326/M20-7357.
Media contacts: A PDF for this article is not yet available. Please click the link to read the full text. The lead author, Rafael Dal-Ré, MD, PhD, MPH, can be reached directly at [email protected].