Facing a groundswell of criticism for its sluggish response to monkeypox, the Biden administration declared a public health emergency on Thursday, potentially unlocking resources to expedite vaccine availability in the U.S.
Why it matters: It's likely the first step toward asking Congress for more money, but also allows the federal health department to tap into other resources as it seeks to beef up countermeasures.
“It’s absolutely welcome. It’s many weeks overdue, but it's the right move," University of California, Irvine epidemiologist Andrew Noymer told Axios.
Driving the news: Among other things, the move gives the Centers for Disease Control and Prevention access to state and local jurisdictions' data on the number of people vaccinated, hospitalizations and testing.
- It also gives HHS and its agencies more flexibility in the response.
The intrigue: The Food and Drug Administration is also eyeing plans to stretch the current vaccine supply by administering doses intradermally, between skin layers, instead of as a traditional shot, FDA Commissioner Robert Califf told reporters Thursday.
- This plan would use about a fifth of a current Jynneos vaccine vial per dose, expanding the number of people who could get vaccinated. The FDA plans to issue an emergency use authorization for this approach in the coming days.
- That may raise some eyebrows as it's not even clear yet how effective getting full doses are at preventing monkeypox.
- "It's daring. I'm not saying it won't work, but it's ballsy," Noymer said.
Be smart: The FDA stopped short of promising that TPOXX, a stockpiled treatment for monkeypox, would be authorized under the public health emergency or released from the Strategic National Stockpile.
- Califf emphasized the importance of testing the drug in clinical trials for its effectiveness in treating monkeypox in humans, since it was approved after trials using animals.
- The AIDS Clinical Trial Group is working with the National Institute of Allergy and Infectious Diseases to develop the U.S.-based clinical trial, a spokesperson for ACTG confirmed to Axios.
- More than 10,000 courses of TPOXX have been distributed to local jurisdictions, per the CDC, and at least 279 patients have been treated with it so far.
What's next: Federal officials did not say whether they are going to move funds within accounts or ask Congress for more. But lawmakers could add money for the response to Democrats' reconciliation bill now being hashed out in the Senate.
- A recent survey of sexual health clinics responding to the outbreak found that the vast majority would use funding to hire additional staff and create educational materials to increase awareness about the virus.
- "New funding is urgently needed to support states, cities and clinics in providing the intensive care required to diagnose and treat patients with monkeypox and prevent cases from spreading," Daniel P. McQuillen, president of the Infectious Diseases Society of America, said in a statement.
Health editor Tina Reed contributed to this report.
