Off-label use of COVID-19 vaccines was once discouraged but has become common amid new guidelines
Following the federal government’s changes to COVID-19 vaccine eligibility and recommendations in 2025, many people are wondering whether they can get COVID-19 vaccines for themselves or their children.
In May 2025, the U.S. Food and Drug Administration limited eligibility for updated COVID-19 vaccines to people ages 65 years and up and to those under 65 with a “high-risk” condition. In September, the Centers for Disease Control and Prevention adopted an “individualized decision-making” approach to COVID-19 vaccination instead of broadly recommending the vaccines.
It’s not just the public that is confused. Many physicians and pharmacists also have questions about whether and how they can administer COVID-19 vaccines.
As philosophers with expertise in bioethics and legal philosophy, we have been following the ethical and regulatory landscape for COVID-19 vaccines since they first became available in late 2020.
In the fall of 2025 that landscape looks a bit different in light of the new guidelines. While it is causing understandable confusion, most people who want to get a COVID-19 vaccine can do so. Broad access is possible, in part, through what in health care is called “off-label use.”
“Off-label” refers to using an FDA-approved product for a different purpose, or with a different population, than that for which it received approval. Off-label prescriptions are common in health care, particularly in pediatrics.
People likely recall that COVID-19 vaccines were developed faster than any vaccine had been previously, thanks to efforts such as the U.S. government’s Operation Warp Speed. Initially limited in supply, the vaccines first became available through “emergency use........© The Conversation





















Toi Staff
Gideon Levy
Tarik Cyril Amar
Sabine Sterk
Stefano Lusa
Mort Laitner
Mark Travers Ph.d
Ellen Ginsberg Simon
Gilles Touboul
Daniel Orenstein