Federal health officials have renewed a key protocol allowing continued compassionate use of the antiviral drug tecovirimat (TPOXX) for patients with severe monkeypox. The move ensures that the treatment remains available through an expanded access program for those at highest risk of life-threatening complications from the virus.
The Centers for Disease Control and Prevention's Institutional Review Board has approved the annual continuation of its Expanded Access Investigational New Drug (EA-IND) protocol. This program serves as a critical safety net, providing tecovirimat to adults and children with laboratory-confirmed or suspected monkeypox who meet specific eligibility criteria. The protocol offers umbrella regulatory coverage, meaning individual clinicians and facilities do not need to secure their own complex IND approvals to administer the drug.
Eligibility is focused on patients most in need. This primarily includes individuals with severe immunocompromise, who are at high risk for severe or prolonged illness regardless of their initial symptoms. Treatment is also for patients who already have severe, protracted, or life-threatening manifestations of monkeypox. For these high-risk groups, the guidance recommends administering tecovirimat early in the course of illness, alongside supportive care. In certain severe cases, clinicians may consider combining it with other antivirals like cidofovir or brincidofovir, or with Vaccinia Immune Globulin Intravenous (VIGIV).
With the closure of the large NIH-sponsored STOMP clinical trial in late 2024, this expanded access program is now a principal route for obtaining oral tecovirimat. Healthcare providers with eligible patients must contact their state or local health department to locate any remaining supplies of the previously deployed drug that are still within their expiry date. To participate, providers and their facilities must register online through the CDC's tecovirimat IND Online Registry, which streamlines the submission of required forms. The program also operates under the PREP Act, which provides liability protections for qualified providers.
The continuation of this protocol represents a sustained commitment to managing severe monkeypox cases. While the program is designed for specific high-risk scenarios, its renewal ensures that a vital therapeutic tool remains accessible for clinicians fighting the most serious outcomes of the virus, offering a hopeful option for vulnerable patients during outbreaks.