Administration declares monkeypox a public health emergency

Health officials think case number is higher than 6,600 in official count

FDA Commissioner Robert Califf said the agency aims to eventually make the monkeypox treatment available with less bureaucracy but first needs to collect more data. (Tom Williams/CQ Roll Call file photo)
FDA Commissioner Robert Califf said the agency aims to eventually make the monkeypox treatment available with less bureaucracy but first needs to collect more data. (Tom Williams/CQ Roll Call file photo)
Posted August 4, 2022 at 4:34pm

The Health and Human Services Department declared monkeypox a national public health emergency on Thursday, a move aimed at helping to direct more funds toward stemming the outbreak and giving agencies more flexibility to set nationwide policies.

The declaration followed the World Health Organization’s July 23 declaration that monkeypox is a public health emergency of international concern. California, Illinois and New York declared states of emergency over the virus early this week.

As of Wednesday evening, the Centers for Disease Control and Prevention had recorded more than 6,600 cases of monkeypox in the U.S. Federal and state public health officials say the actual number is likely higher because of testing limitations.

Leading lawmakers on Capitol Hill had been pushing the administration to declare such an emergency.

Senate Health, Education, Labor and Pensions Chair Patty Murray, D-Wash., has repeatedly criticized the administration’s response, and ranking member Richard M. Burr, R-N.C., called the administration’s delay in doing so a “failure.”

“A communicable disease outbreak following so closely on the heels of COVID-19 should be met with a swift, decisive, and organized response,” Burr said in a statement Thursday. “HHS appears to have learned nothing from the tragedy of the last three years.”

More than 99 percent of the monkeypox cases in the U.S. during the current outbreak have occurred among men who have sex with men. It spreads largely through close skin-to-skin contact and causes painful lesions.

Unlike COVID-19, monkeypox has caused no deaths in the U.S. in the current outbreak. But the virus has sent several Americans to the hospital because of lesions around the genitals and mouth. The illness has roughly a four-week recovery period.

“This virus outbreak is spreading faster than previous outbreaks,” Robert Fenton, the White House coordinator of the national monkeypox response, told reporters Thursday.

Though the disease is less deadly than COVID-19 and isn’t considered a pandemic, physicians and government officials say they are concerned about uncontained community spread.

The monkeypox treatment, Tpoxx, is difficult to access and is available to patients and doctors only under a special CDC status because it is usually used to treat smallpox, not monkeypox.

Physicians have to work through hours of paperwork and await a response from the CDC before giving a patient a Tpoxx prescription, a process many have found frustrating.

As of Thursday, the administration had distributed 14,000 monkeypox tests and has 1.7 million tests in the Strategic National Stockpile. Right now, the U.S. is testing at only 10 percent of capacity, CDC Director Rochelle Walensky told reporters. She urged physicians to be proactive about testing patients who may have monkeypox.

FDA Commissioner Robert Califf said the agency aims to eventually make the drug available with less bureaucracy but that it first needs to collect more data and so is leaving the current process in place. He said the FDA hopes to conduct a Tpoxx clinical trial for monkeypox, which could eventually lead to its full approval.

New vaccination approach

The FDA is considering a new approach, called dose sparing, to distribute the vaccine, a change that would allow physicians to get five doses out of every one-dose vial of Jynneos, a vaccine typically used to prevent smallpox that can also be used to prevent monkeypox.

The new approach would involve injecting the vaccine within the skin rather than directly into the bloodstream. Califf said the FDA would make a final decision in the next few days.

“In recent days, it's become clear to all of us that given the continued spread of the virus, we're at a critical inflection point, dictating the need for additional solutions to address the rise in infection rates,” Califf said.

The U.S. has 1.1 million Jynneos vaccine doses on hand to inoculate the most vulnerable, and is currently prioritizing vaccinating men who have sex with men. More than 600,000 doses have been sent to states as of Thursday.

The administration also has materials for an additional 11 million Jynneos vaccine doses in storage, Dawn O’Connell, assistant secretary for preparedness and response at HHS, told reporters July 28, but HHS needs more money from Congress to ready them for use.