HHS revises PREP Act declaration to increase number of people able to administer monkeypox vaccines

In order to expand the number of providers able to administer vaccines against monkeypox, smallpox, and other orthopoxviruses, the U.S. Department of Health and Human Services (HHS) this week amended its declaration of the Public Readiness and Emergency Preparedness (PREP) Act.

HHS Secretary Xavier Becerra made that declaration earlier this year in direct response to the monkeypox outbreak that was spreading globally. Initially, this allowed a small number of licensed or authorized professionals to provide affiliated vaccines and therapeutics throughout the states. With the update, that authorization spread to emergency medical technicians, dentists, midwives, nurses, optometrists, paramedics, pharmacists, pharmacy interns and technicians, physicians, physician assistants, podiatrists, respiratory therapists, veterinarians, as well as recently retired healthcare professionals and students of these professions.

“As our supply of JYNNEOS vaccine steadily increases, we are now exceeding demand in all 50 states,” Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response, said. “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.”

Nationwide orders for the JYNNEOS monkeypox vaccine have reached approximately 835,700 vials, while the total U.S. supply sits at around 1.1 million. Another 38,000 patient courses of the drug TPOXX – a treatment approved for smallpox and operating under an investigational drug protocol for those infected with monkeypox – have also been distributed to jurisdictions by the Administration for Strategic Preparedness and Response (ASPR).

Notably, the amendment to the PREP Act will allow the newly authorized medical personnel to administer countermeasures with immunity from suit and liability. Additionally, it emphasized the declaration applies to public health threats from orthopoxviruses, expanded the declaration’s timeframe to Dec. 31, 2032, and added coverage of the allowance to subcutaneous, intradermal or intramuscular injections, dermal/percutaneous scarification, oral or intranasal uses of countermeasures.