The White House on Thursday announced a round of new research commitments aimed at better understanding how to to diagnose, treat and prevent monkeypox with new clinical trials being done both in the U.S. and in countries where the virus is endemic.
During a press briefing, chief White House medical advisor Anthony Fauci acknowledged there are “a number of unanswered questions” when it comes to the monkeypox response.
There are currently no Food and Drug Administration (FDA)-approved treatments specifically meant to treat and prevent monkeypox. The treatments that have been utilized throughout the outbreak — mainly the Jynneos vaccine and the antiviral tecovirimat or TPOXX — are both approved to treat and prevent smallpox infections.
Their current use to combat the monkeypox outbreak is permitted through Emergency Use Authorizations from the FDA. Smallpox and monkeypox are closely related, coming from the same family of viruses, and prior studies have indicated that smallpox treatments are effective against monkeypox as well, though no large-scale studies specifically looked into either Jynneos or TPOXX before.
“As we implement the interventions that we have, simultaneously, we still pursue some unanswered questions. Namely addressing gaps in basic biology and immunology and immune correlates, understanding better transmission as well as the issue of animal reservoirs, not only potentially here in the United States, but also globally,” said Fauci.
The longtime director of the National Institute of Allergy and Infectious Diseases (NIAID) further noted the importance of developing better diagnostic methods for the monkeypox virus. Current monkeypox tests can only be used once lesions have formed on the skin which can then be swabbed.
Fauci noted that this prevents the diagnosis of people who may be pre-symptomatic or asymptomatic entirely.
Earlier this month, the the National Institutes of Health (NIH) announced it was launching a Phase 3 trial to determine the efficacy of TPOXX in treating monkeypox.
Fauci on Thursday shared more details on the U.S. trial, including the involvement of at least 60 clinical sites across the country as well as a target enrollment of 530 people.
A second Phase 3 trial is also being launched in the Democratic Republic of the Congo, where monkeypox is endemic. This trial in Africa will be co-led by the NIAID and the DRC’s National Institute for Biomedical Research.
Funding for the responses to the ongoing monkeypox outbreak as well as the COVID-19 pandemic has had to be stretched thin in recent months as Congress has yet to approve any more, with the White House requesting nearly $4 billion for the monkeypox response.
White House officials have repeatedly called on Congress to pass more funding and Fauci acknowledged the current financial limits, saying the money for these clinical trials came from several different sources.
“The money that we’re using on the clinical trials is money that we’ve taken from our poxvirus portfolio as well as others. So we hope that we get supplemental funding to be able to do the things that I’m talking about,” he said.
