红领巾瓜报

On May 8, the听Centers for Disease Control and Prevention (CDC)听听a statement on the U.S. government鈥檚 response to the recent hantavirus outbreak on the M/V听Hondius听cruise ship, in which three people听died听and five others were known to be infected at the time. On May 10,听the U.S. Department of Health and Human Services (HHS)听听a subsequent statement that it is working to support the U.S. Department of State in the repatriation of American citizens from the M/V听Hondius听cruise ship affected by the Andes variant of hantavirus, in addition to CDC鈥檚 efforts to provide public health guidance and risk assessment.听

In the statements, HHS states that the risk posed by the hantavirus to the American public is 鈥渆xtremely low,鈥� as 鈥渢ransmission is rare and limited to close-contact settings.鈥�听

Since CDC and HHS鈥檚 formal statements, on May 11, HHS provided an听听on social media stating that 17 Americans who were on the ship have since been transported to the University of Nebraska Medical Center/Nebraska Medicine鈥疪egional Emerging Special Pathogen Treatment Center (RESPTC) on a U.S. government medical repatriation flight, and then later听听that an 18th听passenger, a dual U.S.-British citizen, had been transported to the Center. HHS听听that two of the passengers travelled in the plane鈥檚 biocontainment units out of an abundance of caution, as one passenger 鈥渃urrently has mild symptoms and another passenger tested mildly PCR positive for the Andes virus.鈥� CDC also announced that two of the passengers have since been transported to Emory University鈥檚 RESPTC in Atlanta.听

In the May 8 statement, and in several posts on social media, CDC notes additional actions taken to address the outbreak, including the development of health guidance for impacted American passengers and state health departments, as well as a 听to inform clinicians and health departments about the cluster. The agency has also deployed epidemiologists to the Canary Islands where the ship will dock to conduct a risk assessment.听

Public health experts have expressed听听regarding听the CDC鈥檚 timeliness in issuing official statements and guidance, as well as the ability of the U.S. government to respond to the outbreak, following the reductions in force听impacting听CDC and the听 of U.S. membership in the World Health Organization (WHO). Upon听terminating听the membership, the Trump Administration听indicated听it would continue to collaborate with other countries and selected health institutions through 鈥渄irect, bilateral and results-driven partnerships鈥� to advance global health security. In the statement听regarding听the hantavirus outbreak, CDC states that it is 鈥渃ontinuing to work closely with international partners to develop consistent monitoring guidance,鈥� but does not provide further details on which international partners the agency has communicated with. In an with CNN on May 9, Acting CDC Director听Dr. Jay Bhattacharya stated that CDC has been 鈥渋n touch with the WHO鈥� and other international health organizations.听

The agencies are also navigating the situation without permanent leadership. Since Dr. Susan Monarez was fired in August 2025 and several senior career officials also left, the CDC has been led by acting directors. The career officials that left when Dr. Monarez was fired were among the remaining senior leaders who had been involved in the agency鈥檚 response to COVID-19, including the repatriation and quarantine efforts. The Assistant Secretary for Preparedness and Response position is also still vacant. The White House nominated individuals for these positions in recent weeks, but Senate HELP Committee hearings have not yet been announced.听

On May 10, the Departments of Labor, HHS, and Treasury听听a proposed rule that would create a new category of limited excepted benefits, allowing employers to offer fertility benefits to employees outside the framework of ACA market reforms and certain other federal health coverage laws.听The proposal, issued by the Department of Labor’s Employee Benefits Security Administration (EBSA), follows the February 2025 Executive Order, 鈥�,鈥� which directed the Assistant to the President for Domestic Policy to submit to the President policy recommendations 鈥渙n protecting IVF access and aggressively reducing out-of-pocket and health plan costs for IVF treatment.鈥� The proposed rule would allow employers to offer fertility benefits as a鈥�鈥渓imited excepted benefit,鈥� to employees outside of non-excepted group health plans, similarly to coverage for vision and dental. The Administration states that the proposed benefit can include 鈥渘ot just IVF, but also diagnostics, counseling, medications, surgical treatments, and services addressing underlying causes of infertility,鈥� so long as the benefits meet three requirements:听

• Substantially all听of the benefits must be for the diagnosis, mitigation, or treatment of infertility or related reproductive health conditions;听
• Benefits would be capped at a combined lifetime maximum of up to $120,000 for the participant and their beneficiaries, indexed for inflation for plan years starting after 2028; and听
• Employers would听be required听to provide a notice clearly describing the coverage and meeting other specified requirements.听

The departments note that most workers of reproductive age receive health coverage through their employers, but the majority do not have 鈥渞obust鈥� fertility coverage. Acting Secretary of Labor Keith Sonderling and HHS Secretary Robert F. Kennedy, Jr.听characterized听the proposal as expanding access to fertility care and supporting family formation. Comments on the proposed rule are due听60 days听after publication in the Federal Register.听

The Administration highlighted the proposed rule, as well as several other initiatives, during a Mother鈥檚 Day event on May 10, which also included the听听of Moms.gov, a new government website intended to provide resources on fertility, pregnancy, and infant health for mothers.听

On May 8, FDA issued a听听for industry,鈥�,鈥� aimed at improving the collection of safety data on already-approved drugs and biological products when used during pregnancy. This guidance听finalizes听FDA鈥檚 draft issued in听May 2019, and听provides recommendations for听postapproval听study designs to better assess product safety and pregnancy-related risks. It describes pregnancy-safe data collection methods, complementary studies, descriptive studies, and pregnancy registries, with the goal of generating information that can be incorporated into product labeling to support informed decision-making by patients and clinicians.鈥�听

On May 6, FDA听听the launch of ELSA 4.0, an upgrade to the agency鈥檚 internal AI tool available to FDA staff and the completion of a data platform consolidation that integrates more than 40 application and submission data sources, systems, and portals across all FDA centers into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data). According to the agency, Elsa is built within a FedRAMP High secure Google Cloud Platform environment, does not train on input data or any data submitted by regulated industry, and is not connected to the internet, though its enhanced search capability allows it to access refreshed secured data web; FDA also states that staff remain involved at every stage of the AI work process, with human subject matter experts verifying all inputs, analytic processes, and output implementation. FDA Commissioner Marty Makary and Chief AI Officer Jeremy Walsh characterized the announcement as a step to streamline agency operations and accelerate regulatory science, with Walsh noting that Elsa will become 鈥渢he main entr茅e into the FDA’s systems and data.鈥� FDA launched Elsa 1.0 in June 2025.听