Monkeypox Declared a US Health Emergency, Freeing Up Funding (1)

US health officials declared monkeypox a public health emergency, a step aimed at raising access to treatments, services and funds to fight the virus, and are eyeing ways of extending available doses as demand for vaccines outstrips supply.

“We’re prepared to take our response to the next level in addressing this virus,” Health and Human Services Secretary Xavier Becerra said Thursday in a press conference. “We urge every American to take monkeypox seriously and to take responsibility to help us tackle this virus.”

Monkeypox has spread to more than 26,000 people globally in just a few months, leading the World Health Organization to declare the outbreak a public health emergency on July 23. The US leads the world in known cases, according to the Centers for Disease Control and Prevention, with more than 6,600. The virus spreads primarily through close contact with lesions and so far, 99% of US cases have been in men who have sex with men.

The emergency declaration in the US will free up federal funding for health agencies and can also fast-track the development and shipment of therapeutics and diagnostics. The declaration will also help raise awareness about the virus and encourage people to get tested, which helps stop onward spread, CDC Director Rochelle Walensky said on the call.

Read More: Understanding Monkeypox and How Outbreaks Spread

It will help federal officials get more data from states and jurisdictions to “effectively track and attack this outbreak,” said Robert Fenton, who was named White House monkeypox response coordinator on Tuesday. Health officials said they estimate as many as 1.7 million Americans are at highest risk for infection.

Gaps in demographic data have made it difficult to understand how various communities are affected by the outbreak and whether vaccines and antivirals are being equitably distributed. Some 51 health jurisdictions have already signed data-use agreements, health officials said, but the declaration may help facilitate broader sharing of case data.

Turning Point

The declaration could be a major turning point in the US response, Lawrence Gostin, director of Georgetown University’s national and global health law institute, said in an interview.

“The window for containing monkeypox is rapidly closing, but I think it is possible to contain the outbreak,” Gostin said. “But we need a revved-up response at the federal and state level. And that includes declaring a national emergency.”

Some 600,000 doses of Bavarian Nordic A/S’s Jynneos, a vaccine that can be used against monkeypox, have been delivered to states, Becerra said in the briefing. Appointments have filled up quickly in places like New York City and San Francisco, and demand still far exceeds supply. Health officials said Thursday that they have expedited the shipment of another 150,000 Jynneos doses, which they expect to arrive in September. Continued deliveries of additional doses are also expected in October, November and December.

The Bavarian Nordic vaccine requires two shots to be fully effective, but some local health officials have scrapped the two-dose regimen to get as many first doses in arms as possible. Commissioner Robert Califf said the Food and Drug Administration is exploring a strategy that would help ease some of the supply strain. The approach involves injecting a smaller dose of vaccine between skin layers, rather than deeper, under the fat layer of the skin, which has helped spare doses of the influenza vaccine during prior shortages.

The agency also plans to conduct a clinical trial with Siga Technologies Inc.’s smallpox antiviral Tpoxx, which can be used for monkeypox, to collect much-needed data on safety and efficacy. This type of clinical trial could help get the drug fully approved, making it easier to prescribe. Obtaining the drug can be cumbersome for health providers because of its limited approval.

“It’s critical as we roll it out through expanded access -- and make no mistake, our goal is to make it available without excess bureaucracy and paperwork,” Califf said. “But it’s critical that we collect data because we don’t know about the risk of the drug.”

Health officials said that about 14,000 doses of Tpoxx have been made available so far, but the US has about 1.7 million in the Strategic National Stockpile.

Shares of companies that manufacture monkeypox drugs and vaccines, including Bavarian Nordic, Siga and Chimerix, rose Thursday.

(Updates from press call throughout)

--With assistance from Jeannie Baumann.

To contact the reporter on this story:
Madison Muller in New York at mmuller84@bloomberg.net

To contact the editors responsible for this story:
Cynthia Koons at ckoons@bloomberg.net

John Lauerman, Catherine Larkin

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