COVID-19 Update January 2, 2021
These articles on COVID-19 were published across the JAMA Network in the last week.
Mandating COVID-19 Vaccines
Lawrence O. Gostin, JD; Daniel A. Salmon, MPH, PhD; Heidi J. Larson, PhD
…From EUAs to BLA Approvals
Mandating COVID-19 vaccines under an EUA is legally and ethically problematic. The act authorizing the FDA to issue EUAs requires the secretary of the Department of Health and Human Services (HHS) to specify whether individuals may refuse the vaccine and the consequences for refusal. Vaccine mandates are unjustified because an EUA requires less safety and efficacy data than full Biologics License Application (BLA) approval. Individuals would also likely distrust vaccine mandates under emergency use, viewing it as ongoing medical research.
Should SARS-CoV-2 Vaccines Be Mandatory?
Once SARS-CoV-2 vaccines receive a BLA, policy makers must determine to which, if any, populations mandates should apply. Vaccine mandates could be imposed in multiple sectors, each with their own legal and ethical considerations…