Food and Drug Administration and Centers for Disease Control and Prevention officials are also working to make tecovirimat, the only treatment available for monkeypox (although only FDA-approved for smallpox), easier to prescribe to people. patients by doctors. A more streamlined process for obtaining the antiviral is expected to be announced to vendors next week.
The White House will also use a new research program, which was announced Thursday and consists of ongoing $140 million projects, to study stretching limited doses of the monkeypox vaccine, find new methods of testing and expanding treatment options, three White House officials told POLITICO.
“The reality is [vaccine] doses are relatively limited in the short term,” said Andrew Hebbeler, senior deputy director of the Health and Life Sciences Division of the Office of Science and Technology Policy. “And so there are open questions about whether we can expand the limited supply we have to go further by giving one dose instead of two or by diluting the doses we need to vaccinate more.”
The administration still stands behind FDA guidelines for two doses — even though some cities and states are currently only offering one dose per person to better distribute the limited supply.
“It would be a decision of the FDA and the CDC, but primarily the FDA,” Jha said, adding that the agencies currently believe both doses are necessary. “The second doses should arrive relatively soon.”
Much of the research will focus on Jynneos, the newest vaccine used against monkeypox. ACAM2000, an older vaccine with a higher risk of side effects — but in larger quantities – will be used as a control more than a research subject, 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 best to allocate limited doses in a large population.
“This outbreak is different from historical outbreaks and it’s really been prioritized to better understand what’s happening on the ground in these large observational studies,” said Anastasia Lambrou, senior policy adviser for pandemic prevention. “The second bucket that is a very high priority is the effectiveness and real-world observation of these medical countermeasures in our toolkit.”
Researchers will also examine the sensitivity and limitations of current PCR tests, and explore the development of tests that could be used closer to the point of care.
And treatments will also be considered in research, including antivirals. Although tecovirimat is available, Matt Hepburn, head of pandemic preparedness, said they are looking to expand the options if possible.
“Even though we now have vaccines and treatments, we should prepare for scenarios where, what if the vaccine no longer works, or the virus becomes resistant to treatment,” he said, noting that nothing is indicates that current vaccines or treatments would be less effective in the future.
Covid-19 paved the way for this work, Hepburn said, showing the importance of setting research priorities during an outbreak.
“There are a lot of really, really important questions,” he said. “A really well-designed research program…can get those answers and can get there pretty quickly.”