US health officials weigh emergency declaration over monkeypox

The Biden administration is considering whether to declare the monkeypox outbreak a public health emergency as cases in the US soared to more than 2,800 on Friday, a White House official said.

“Certainly it’s a conversation that’s ongoing,” Ashish Jha, the White House Covid response coordinator told reporters. “We’re looking at that, looking at what are the ways in which the response could be enhanced by declaring a public health emergency.”

Jha added that any declaration would come from the Department of Health and Human Services.

His remarks came as the World Health Organization has been debating whether to take similar action, expected as soon as Saturday, after the number of infections reported globally surpassed 16,000. Around the world, monkeypox is still primarily affecting men who have sex with men and those who identify as gay or bisexual.

In the US, health officials said that about 99% of cases involve men who have sex with men and that the median age of patients is 36. But the US Centers for Disease Control and Prevention said earlier Friday that two pediatric patients had been identified this week, raising concerns that the virus is finding its way into other populations.

Jennifer McQuiston, the CDC’s deputy director of high consequence pathogens and pathology, said that infections of people who are not part of the LGBTQ community aren’t surprising.

“While this outbreak is spreading in a particular social network right now, I think we’ve messaged from the start that there could be cases that occur outside those networks,” McQuiston said. “We need to be vigilant and ready to respond.”

As part of that effort, US health officials said they’re clarifying how to use Siga Technologies’s smallpox antiviral medication, Tpoxx, in pediatric patients.

Earlier Friday, the CDC said it’s streamlining the process health-care providers must go through in order to prescribe Tpoxx. The change occurred after clinicians expressed frustration with the hefty amount of paperwork required to give patients the drug under what’s called an expanded access protocol, a regulatory mechanism that allows for drugs to be used outside of their approval. The new process will allow for clinicians to prescribe Tpoxx virtually and, ideally, dramatically cut the time spent filling out forms.

Despite the US having 1.7 million doses available through the Strategic National Stockpile, physicians have had trouble actually getting the drugs to patients.

Earlier in July, Mary Foote, an infectious disease specialist at New York City’s Department of Health and Mental Hygiene, said about 20% to 25% of the monkeypox patients she had seen needed antivirals because their symptoms are so uncomfortable or painful. Foote also said that her patients have all responded well to the drug, the most common side effect being a mild headache.

Vaccine Distribution Challenges

The government has also said its looking to deploy another antiviral called Tembexa made by Chimerix Inc. It comes, however, with some serious side effects and has been little-studied in humans.

Mordechai Levovitz, the clinical director of Jewish Queer Youth, a nonprofit, called the government’s response “unacceptable.” Levovitz said she has friends whose symptoms are so severe they’ve had to seek prescriptions for painkillers. Some patients must isolate while they have lesions, and for those whom remote work isn’t an option, that can mean a month away from a job.

The Biden administration has also faced challenges allocating Bavarian Nordic A/S’s Jynneos vaccine to states and jurisdictions because of limited supply of the shots. To date, health officials have deployed 300,000 doses of Jynneos with more shots expected to arrive soon.

The US Food and Drug Administration recently completed an inspection of one of Bavarian’s vaccine-manufacturing facilities in Denmark where about 800,000 doses are destined for the US. Jha said earlier this week that half of those doses would arrive in this week, and the rest next week.

The US has a contract agreement with Bavarian Nordic for enough bulk vaccine to make roughly 13 million doses. This month, HHS announced two separate 2.5 million-dose orders; however, the majority of those shots won’t actually be ready until 2023. According to the White House’s recently released research priorities for monkeypox, health officials intend to better understand vaccine effectiveness and whether using a one-dose strategy to conserve the supply could still offer ample protection against the virus.

Demographic Gap

Another concern has been the government’s lack of demographic information regarding vaccine distribution. HHS has said its vaccine strategy gives priority to at-risk communities, but state health departments are not required to report demographic details about cases to the CDC.

During a Washington Post Live event Friday, CDC Director Rochelle Walensky said that the “CDC currently have no data on who’s been vaccinated.”