Health Secretary Robert F. Kennedy Jr. is ending emergency declarations for COVID-19 vaccines, treatments, and medical devices, after determining that the circumstances that resulted in the declarations are no longer in place.
The health secretary in office in early 2020 issued emergency declarations, providing liability protections for companies that made products for COVID-19 and enabling regulators to issue emergency authorizations, which have a lower evidentiary threshold than regular approval.
The declarations were extended multiple times, most recently in 2024 by then-Health Secretary Xavier Becerra through the end of 2029. They provided broad immunity to manufacturers of the products, as well as people who administered them to others.
“Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,” Kennedy said in a statement. “By ending these COVID-19 emergency use authorization declarations, we’re reinforcing public confidence that emergency authorities are temporary and targeted.”
To terminate emergency declarations, a health secretary has to provide advance notice that would give a reasonable amount of time to companies to withdraw the products that have been generated under the declarations.
The Food and Drug Administration determined that 12 months is a sufficient period of time, according to health officials. The declarations for vaccines and drugs will thus terminate effective June 29, 2027.
The declarations for medical devices such as COVID-19 tests will only stay in place for 180 days, or until Dec. 26, 2026.
The FDA has been working with manufacturers of all products still under emergency authorization about seeking approval for continued use, and it is reasonable to conclude that manufacturers will be able to generate data that would support fresh filings to regulators, the notice stated.
Officials plan to notify Congress of the development, the Department of Health and Human Services said.
