September 30, 2022

Officials from the Food and Drug Administration and Centers for Disease Control and Prevention are also working to make tecovirimat, the only available treatment for monkeypox (although only FDA-approved for smallpox), easier for doctors 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, announced Thursday, consisting of $140 million in ongoing projects, to study limited vaccine doses against monkeypox, find new testing methods and expand treatment options, three White House officials said. to POLITICO.

“The reality is [vaccine] doses are relatively limited in the short term,” said Andrew Hebbeler, chief assistant director of the Division of Health and Life Sciences at the Office of Science and Technology Policy. “And so there are open questions about whether we can further expand the limited supply that we need by either administering a single dose instead of two or diluting the doses that we need to vaccinate more.”

The administration still stands behind FDA guidelines for two doses — even while some cities and states currently offer only one dose per person to better spread the limited supply.

“This would be an FDA and CDC decision, but primarily an FDA decision,” Jha said, adding that authorities currently believe both doses are necessary. “Second doses should arrive relatively quickly.”

Much of the research will focus on Jynneos, the latest monkey pox vaccine. ACAM2000, an older vaccine with a higher risk of side effects but in a wider range — will be used more as a control than as a subject of research, Hebbeler said.

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Researchers will study how the vaccine affects those already treated for smallpox or those who are immunocompromised — as well as how best to assign limited doses to a large population.

“This outbreak looks different from historical outbreaks and a real priority has been given to better understand what is happening in these large observational studies,” said Anastasia Lambrou, senior policy advisor for Pandemic Prevention. “The second bucket that is really a high priority is the actual 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 to develop tests that can be used closer to the point of concern.

And treatments will also be considered in the study, especially antivirals. While tecovirimat is available, pandemic leader Matt Hepburn said they want to expand the options if possible.

“While we now have vaccines and treatments, we need to prepare for scenarios where, what if the vaccine no longer works, or what if the virus becomes resistant to treatment,” he said, pointing out that there is no evidence that current vaccines are available. whether treatments would be less effective in the future.

Covid-19 has paved the way for this work, Hepburn said, demonstrating 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 those answers and can get to those answers pretty quickly.”