HHS Secretary Robert F. Kennedy Jr. has signed a Public Readiness and Emergency Preparedness Act declaration, providing liability protection to manufacturers, distributors and healthcare providers involved in the development and use of medical countermeasures against Andes hantavirus.
The declaration covers favipiravir as the named countermeasure — an antiviral not currently FDA-approved in the United States, according to a May 22 Federal Register notice. HHS said there are no FDA-approved antiviral treatments or vaccines for hantavirus pulmonary syndrome. Researchers at UCLA have found that favipiravir inhibits the Andes hantavirus in human cells, and the drug is conditionally approved in Japan for influenza treatment.
Under the PREP Act, covered persons — including manufacturers, distributors, program planners, and qualified health professionals — are shielded from lawsuits related to the administration or use of favipiravir, except in cases of willful misconduct. The declaration is effective through July 18, 2026, with an additional one-month period for manufacturers to arrange disposition of the drug.
Liability protections apply to the voluntary administration of favipiravir under an approved investigational new-drug application, and are limited to individuals possibly exposed to Andes hantavirus aboard the M/V Hondius and their close contacts. The protections apply without geographic limitation.
Before issuing the declaration, the secretary determined that the spread of Andes hantavirus and resulting hantavirus pulmonary syndrome constitutes a credible risk of a future public health emergency. The case fatality rate among patients with severe respiratory symptoms has been estimated at approximately 38%.
Here are four more updates on the outbreak:
1.As of May 24, ECDC reported 12 total cases — 10 confirmed and two probable — with one new case and no new deaths since its prior update. Three deaths remain the total.
2. A Canadian passenger tested presumed positive. Two of the detailed cases remain hospitalized, one in an ICU in Johannesburg.
3. The CDC issued quarantine orders for two of the 18 Nebraska passengers after one woman indicated plans to leave. The remaining 16 were asked to stay through May 31, marking the 21-day point of their monitoring period.
4. The UK Health Security Agency launched a study on Andes hantavirus transmission through the International Severe Acute Respiratory and Emergency Infection Consortium, with 20 British nationals from the ship volunteering. None had tested positive as of May 21, though the incubation period means new cases remain possible.
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