Biden administration is considering imposing a public health emergency over monkeypox as cases rise

Officials from the Food and Drug Administration and the Centers for Disease Control and Prevention are also working to make tecovirimat, the only monkeypox treatment available (albeit FDA-approved for smallpox only), to make it easier for doctors to prescribe it. patients. Providers are expected to announce a more streamlined antivirus acquisition process next week.

The White House will also use a new research program announced Thursday, which includes $140 million in ongoing projects, to study increasing limited doses of the monkeypox vaccine, finding new testing methods and expanding treatment options, the three told Politico. White House official.

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

The administration is still adhering to the FDA’s two-dose recommendations — even though some cities and states are now only offering one dose per person to better distribute limited supplies.

“It will be a decision by the FDA and the CDC, but first and foremost by the FDA,” Jha said, adding that the agencies currently believe both doses are needed. “The second doses should arrive relatively soon.”

Much of the research will focus on Jynneos, the latest vaccine used against monkeypox. ACAM2000, an older vaccine with a higher risk of side effects but more will be used as a control rather than a study subject, Hebbeler said.

The researchers will study how the vaccine affects those already treated for smallpox or those who are immunocompromised, as well as how best to distribute limited doses to a large population.

“This outbreak looks different than historical outbreaks, and in these large observational studies, the priority has really been to better understand what is happening on the ground,” said Anastasia Lambrou, Senior Policy Adviser for Pandemic Prevention. “The second area that really has a high priority is the actual effectiveness and monitoring of these medical countermeasures in our toolbox.”

The researchers will also review the sensitivity and limitations of existing PCR tests, as well as explore the development of tests that could be used closer to the point of care.

The studies will also look at treatments, especially antivirals. While tecovirimat is available, Matt Hepburn, head of pandemic preparedness, said they are looking to expand capacity if possible.

“Even though we have vaccines and treatments now, we must prepare for scenarios where the vaccine stops working or the virus becomes resistant to treatment,” he said, noting that there is no indication that existing vaccines or treatments will be less effective in the future.

Covid-19 paved the way for this work, Hepburn said, showing the importance of prioritizing research during an outbreak.

“There are a lot of really, really important questions,” he said. “A really well-designed research program … can provide answers to these questions, and quite quickly.”