The U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra today amended the Public Readiness and Emergency Preparedness Act (PREP Act) declaration for smallpox medical countermeasures to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox, monkeypox virus, and other orthopoxviruses in a declared emergency.
“As our supply of JYNNEOS vaccine steadily increases, we are exceeding demand in all 50 states,” said HHS Assistant Secretary for Preparedness and Response Dawn O’Connell. “By expanding the pool of providers who can administer monkeypox vaccines, we can increase equitable access for people at high risk for monkeypox infections who have not yet had an opportunity to get vaccinated.”
This declaration expands the types of providers who, with outlined training and supervision, are covered persons authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses, in addition to the professionals already licensed or authorized under their state laws to administer these vaccines and therapeutics. The list of authorized providers now includes:
- advanced or intermediate emergency medical technicians,
- licensed or certified professional midwives,
- nurses, advanced practice registered nurses, registered nurses, licensed practical nurses,
- pharmacy interns, pharmacy technicians,
- physician assistants,
- respiratory therapists,
- veterinarians, and
- recently retired healthcare professionals and students of the listed professions.
Subject to certain limitations, a covered person is immune from suit and liability under federal and state law with respect to all claims for loss resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure.
All authorized providers must administer all countermeasures in accordance with all relevant requirements and recommendations of Centers for Disease Control and Prevention (CDC), and consistent with the scope of the U.S. Food and Drug Administration’s (FDA’s) approval, authorization, and any applicable expanded access requirements of FDA’s protocol.
The amendment announced today also:
- Makes explicit that the declaration applies to public health threats arising from smallpox (variola virus), monkeypox virus, and other orthopoxviruses. In 2008, the HHS Secretary issued a declaration under the PREP Act for smallpox medical countermeasures which was amended in 2016 to provide liability coverage for “smallpox countermeasures against variola virus or other orthopoxviruses” which includes monkeypox.
- Extends the effective time period of the declaration to December 31, 2032. This extension allows coverage for manufacturers, distributors and other covered persons through that date.
- Allows coverage for the administration of countermeasures by subcutaneous, intradermal, or intramuscular injections, dermal/percutaneous scarification, orally or intranasally in response to a declared emergency by authorized qualified persons to be extended during the relevant emergency or December 31, 2032, whichever occurs first. A declared emergency can be any federal, state, regional, or local declaration.
Jurisdictions across the country have ordered approximately 835,700 vials of the approximately 1.1 million vials of JYNNEOS vaccine HHS had allocated to prevent monkeypox.
Also at the request from jurisdictions, ASPR has distributed approximately 38,000 patient courses of the drug TPOXX to treat patients infected with monkeypox, particularly those with severe disease, or at risk for severe disease, such as immunocompromised, and pediatric cases. TPOXX is approved to treat smallpox and is only available under an expanded access investigational new drug protocol to treat monkeypox infections.