Federal Register #2026-10539

Liability Protection for Favipiravir as a Medical Countermeasure Against Andes Virus

The Department of Health and Human Services (HHS), Office of the Secretary, has issued a PREP Act Declaration providing liability protection for activities related to medical countermeasures against the Andes virus: - Government Buyer: - Department of Health and Human Services (HHS), Office of the Secretary - OEMs and Vendors: - Favipiravir is specifically named as a covered countermeasure; OEMs include manufacturers of favipiravir (notably Toyama Chemical/Fujifilm in Japan) - Products/Services Requested: - Favipiravir (antiviral drug) - Part number: favipiravir - Quantity: Not specified - Designated for treatment or prevention of hantavirus pulmonary syndrome (HPS) caused by Andes virus - Unique or Notable Requirements: - Liability immunity applies to manufacturers, distributors, program planners, and qualified persons involved in manufacture, testing, development, distribution, and voluntary administration of favipiravir for Andes virus - Coverage includes activities for individuals exposed or potentially exposed, including those repatriated from the M/V Hondius cruise ship - Immunity extends to countermeasures obtained for the Strategic National Stockpile - No FDA-approved treatments or vaccines currently exist for HPS - Compensation for injuries from covered countermeasures is available under the Countermeasures Injury Compensation Program (CICP) - Places of Performance/Delivery: - U.S. embassies, military installations abroad (including bases, ships, camps), NATO installations, and the M/V Hondius cruise ship - HHS headquarters in Washington, DC

Description

The Secretary of Health and Human Services is issuing a Declaration under the Public Readiness and Emergency Preparedness (PREP) Act to provide liability protection for activities related to medical countermeasures against Andes virus. This Declaration covers manufacturers, distributors, program planners, and qualified persons involved in the manufacture, distribution, administration, or use of these countermeasures. Andes virus causes Hantavirus Pulmonary Syndrome (HPS), a severe respiratory disease with a high fatality rate, and there are currently no FDA-approved treatments or vaccines. The Declaration is effective as of the date of signature and extends liability immunity through July 18, 2026, with an additional one-month coverage period to allow for disposition of the countermeasures.

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