Health and Human Services Secretary Robert F. Kennedy Jr. signed a targeted Public Readiness and Emergency Preparedness (PREP) Act declaration for Andes virus—a rare hantavirus strain linked to an outbreak aboard the MV Hondius cruise ship—sparking immediate constitutional criticism from experts and advocates.
The declaration, effective May 10, 2026, grants legal immunity to manufacturers of favipiravir, an antiviral drug not currently approved for U.S. use, under specific conditions: voluntary administration, exposure risk to Andes virus, and a two-month window ending July 18, 2026. Kennedy characterized the move as “targeted,” emphasizing it applies only to this single outbreak involving eight confirmed cases—six patients with documented infections and two suspected cases, including three deaths—on a ship carrying 147 passengers from 23 countries.
The U.S. government repatriated 18 passengers on May 10–11 following the World Health Organization’s confirmation of Andes virus as the cause of severe respiratory illness. The virus, which spreads primarily through rodents in South America and occasionally via person-to-person contact, carries a mortality rate of approximately 38 percent among severe cases. Crucially, no American infections have been confirmed to date, and the CDC reports no evidence of rodent presence in the United States.
Critics immediately challenged the declaration’s legal foundation. Former Army officer Brad Miller condemned it as “unconstitutionally unnecessary” despite its narrow scope, arguing it sets a dangerous precedent for future emergency power abuse. Attorney Tom Renz questioned why liability immunity was granted for a drug with no confirmed safety data during a outbreak involving just three deaths. Dr. Sasha Latypova, a former pharmaceutical executive, asserted the declaration’s primary purpose is legal shielding rather than medical necessity, warning it could enable “a hospital murder protocol” to create false pandemic threats ahead of elections.
The backlash intensified as critics highlighted the PREP Act’s history under post-9/11 biodefense policies. Dr. Henry Ealy challenged Kennedy to revoke Covid vaccine emergency authorizations, while attorney Nicolas Hulscher noted the declaration’s constitutional flaws despite its limited application. Many opponents stressed that the U.S. military and health authorities have already abused similar emergency powers during previous crises, making this instance a slippery slope for institutional overreach.
Kennedy later clarified the declaration did not mandate treatments, cover vaccines, or provide “blanket immunity” to pharmaceutical companies—addressing claims of expanding emergency powers. Yet opponents maintained that invoking the PREP Act at all for such a contained outbreak undermines public trust in federal health authority and risks normalizing constitutional compromises during crises.