On August 4, the U.S. federal government declared monkeypox—with more than 6,600 cases in the country—a public health emergency. Monkeypox is now the second simultaneous public health emergency in the U.S.; the other is COVID-19.
The emergency status allows the Secretary of Health and Human Services, Xavier Becerra, more discretion in accessing additional funds and resources for the outbreak, including personnel to combat it. That could lead to increased testing as well as more vaccine doses. Several states—including New York, which currently has about a quarter of U.S. cases—have already declared states of emergency to release state funds to help control the outbreak.
“We’re prepared to take our response to the next level in addressing this virus, and we urge every American to take monkeypox seriously and to take responsibility to help us tackle this virus,” Becerra said during a briefing announcing the declaration.
Perhaps the most critical need, Becerra said, is to educate more doctors and health professionals about how to recognize monkeypox and therefore test more people. U.S. Centers for Disease Control and Prevention director Dr. Rochelle Walensky, who also participated in the briefing, said the U.S. is currently only using about 10% of available testing capacity; in recent weeks, only about 8,000 tests for monkeypox have been performed per week on average. Reaching more health providers and providing information about when and how to test for monkeypox could increase testing and improve access to vaccination or treatments.
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U.S. health authorities advise people who are at high risk for monkeypox—including healthcare workers and men who have sex with men, among whom the virus has been spreading most quickly during this outbreak—to get vaccinated as soon as possible with one of the two available vaccines, ACAM2000 or Jynneos. Both have been released from the Strategic National Stockpile, the nation’s store of supplies for health emergencies. About 1.6 million people in the U.S. are considered high risk for monkeypox, according to Walensky, and the Stockpile contains 1.7 million doses of vaccine. Becerra said the government has ordered an additional 2.5 million doses of the Jynneos vaccine from the manufacturer, Bavarian Nordic.
Until additional doses are available, Dr. Robert Califf, commissioner of the U.S. Food and Drug Administration, said the agency is reviewing data to extend the available doses through a practice called “dose sparing.” That involves injecting the monkeypox vaccine into the outermost layers of skin rather than deep into the muscles. This can speed up the circulation and distribution of the vaccine to stimulate the immune system, said Califf, and therefore would require only one-fifth the current vaccine dose. (The rabies vaccine is currently given this way.) That would extend the number of doses available, and so far the strategy appears “promising,” he said. But scientists are still studying whether using this type of intradermal injection would maintain the potency of the vaccine and provide the same protection as the original dose.
The public health emergency designation could also increase access to an antiviral drug called TPOXX, which is approved for treating smallpox but may also be effective against monkeypox since the two viruses belong to the same family. Currently, getting the drug requires doctors to register to dispense the drug and patients to sign informed consent forms, since the pill-based treatment is not approved for treating monkeypox and is therefore investigational. Under the public health emergency, Becerra could decide to issue an emergency use authorization for TPOXX, which would remove that paperwork process and allow any physician and any pharmacy to stock the medication. Such steps have not yet been taken, as Becerra, Califf, and Walensky noted that the drug must first be proven safe and effective. Studies exploring how effective TPOXX is among monkeypox patients are being planned and could launch soon.
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Contributor: Alice Park