Officials at the Food and Drug Administration and Centers for Disease Control and Prevention are also working to make tecovirimat, the only treatment available for monkeypox (though only FDA–approved for smallpox), easier for physicians to prescribe to patients. A more streamlined process to get the antiviral is expected to be announced to providers next week.
The White House will also use a new research agenda, which was announced Thursday and consists of $140 million in ongoing projects, to study stretching limited monkeypox vaccine doses, find new testing methods and expand treatment options, three White House officials told POLITICO.
“The reality is [vaccine] doses are relatively limited in the near term,” said Andrew Hebbeler, principal assistant director of the Office of Science and Technology Policy’s Health and Life Sciences division. “And so there are open questions about whether we can extend the limited supply that we have to go further by either administering a single dose instead of two or diluting the doses that we have to vaccinate more.”
The administration is still standing behind FDA guidance for two doses — even as some cities and states are currently only offering one dose per person to better spread limited supply.
“This would be an FDA and CDC, but primarily FDA decision,” Jha said, adding that the agencies currently believe both doses are needed. “Second doses should be arriving relatively soon.”
Much of the research will focus on Jynneos, the newest vaccine used for monkeypox. ACAM2000, an older vaccine with a higher risk of side effects — but in larger supply — will be used as a control more than a subject of research, Hebbeler said.
Researchers will study how the vaccine affects those who have already been treated for smallpox or those who are immunocompromised — as well as how to best allocate limited doses in a large population.
“This outbreak is looking different than historical outbreaks and it’s really been prioritized to better understand what is happening on the ground in these large observational studies,” said Anastasia Lambrou, senior policy advisor for Pandemic Prevention. “The second bucket that is a really high priority is the real world effectiveness and observation of these medical countermeasures in our toolkit.”
Researchers will also consider the sensitivity and limits of current PCR tests, as well as explore developing tests that could be used closer to the point of care.
And treatments will also be considered in the research, particularly antivirals. Though tecovirimat is available, Matt Hepburn, pandemic preparedness lead, said they’re looking to expand options if possible.
“Even though we have vaccines and treatment now, we should be preparing for scenarios where, what if the vaccine no longer works, or what if the virus becomes resistant to treatment,” he said, noting there is no indication that current vaccines or treatments would be less effective in the future.
Covid-19 has paved the way for this work, Hepburn said, showing the importance of setting research priorities in an outbreak.
“There are a lot of really really important questions,” he said. “A really well designed research agenda… can get at those answers and can get to those answers fairly expeditiously.”