Richard H. Hughes, IV, and William Walters,* attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Health Affairs, titled “The Advent and Future of Self-Administered Vaccines.”
Following is an excerpt:
The Food and Drug Administration’s (FDA) recent authorization of FluMist for at-home administration marks the beginning of a new chapter in vaccine access and delivery. Before now, self-administered vaccines have been as elusive as they are full of promise. The FDA’s decision will be the first to allow self-administration, beginning with the 2025–26 respiratory season and will require a prescription.
Traditionally, patients received vaccinations at a physician’s office, but vaccination is becoming increasingly de-medicalized. While most young children still receive regular vaccinations in their pediatrician’s office, adolescent and adult patients are now able to access vaccines across many different settings of care. The ever-increasing role of pharmacies as vaccination sites is reflective of the shift. The home represents yet a further shift that stands to improve patient vaccine access.
However, before self-administration can become more widespread, there are legal, policy, and regulatory barriers that must be overcome: Who will prescribe self-administered vaccines? How will vaccines be prescribed and dispensed? How will vaccination be verified?
*Sara Devaraj, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green’s Washington, DC, office, also contributed to the preparation of this article. (Sara will be joining Epstein Becker Green in the fall of 2025 as a first-year Associate.)
