Officials at the Food and Drug Administration and the Centers for Disease Control and Prevention are also working on making tecovirimate, the only monkeypox treatment (albeit only FDA-approved for smallpox), easier for doctors to prescribe to patients. A more streamlined process for getting antivirus is expected to be announced next week with providers.
The White House will also use a new research agenda announced Thursday that includes $140 million in ongoing projects to study limited doses of the monkey vaccine, 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 Hebeler, assistant principal for the Office of Science and Technology Policy’s Division of Health and Life Sciences. “And so there are open questions about whether we can extend the limited supply that we need to go further, either by giving one dose instead of two, or by diluting the doses that we need to vaccinate more.”
The administration still stands outside FDA guidelines of two doses — although some cities and states currently offer just one dose per person to better distribute the limited supply.
“It will be the FDA and the CDC, but primarily the FDA’s decision,” Jha said, adding that the agencies currently believe both doses are needed. “The second doses should be coming relatively soon.”
Much of the research will focus on Jynneos, the newest monkeypox vaccine. ACAM2000, an older vaccine with a higher risk of side effects – But with a larger supply — it will be used as a control rather than a study subject, Hebeler said.
Researchers will study how the vaccine works in those who have already been treated for chickenpox or in people who are immunocompromised – as well as how to best administer limited doses to large populations.
“This outbreak is different from historical outbreaks, and it’s really a priority to better understand what’s happening on the ground in these large observational studies,” said Anastasia Lambrew, senior policy advisor for pandemic prevention. “The other bunch, which is a really high priority, is the real-world effectiveness and observation of these medical countermeasures in our tools.”
Researchers will also discuss the sensitivity and limits of current PCR tests, as well as explore the development of tests that can be used near the point of care.
And treatments are also being considered in the study, particularly antiviral drugs. While tecovirimat is available, Matt Hepburn, head of pandemic preparedness, said they are looking to expand options if possible.
“Even though we have vaccines and treatments now, we have to prepare for scenarios of what happens if the vaccine no longer works, or what happens if the virus becomes resistant to treatment,” he said, noting there is no indication that Current vaccines or treatments will be less effective in the future.
Covid-19 paved the way for that work, Hepburn said, showing the importance of prioritizing research during an epidemic.
“There are a lot of really important questions,” he said. “A really well-designed research agenda … can get those answers and get those answers pretty quickly.”
Biden administration considers public health emergency as monkeypox cases rise
Source link Biden administration considers public health emergency as monkeypox cases rise