As the Centers for Disease Control and Prevention (CDC) continues to track and investigate multiple cases of monkeypox in the United States and support health care providers and state and local health departments, ASPR is prepared with vaccines and treatments to respond to the current outbreak.

We have been preparing for moments like this through the ongoing work of the Biomedical Advanced Research and Development Authority (BARDA) and the Strategic National Stockpile (SNS), both of which reside within ASPR.

BARDA supported the development of a vaccine called JYNNEOS that is FDA approved to prevent smallpox and monkeypox. ACAM2000, which was developed with support from the SNS, is FDA approved to prevent smallpox but could also be used to vaccinate at-risk individuals under an appropriate regulatory mechanism outside of its labeled indication. CDC currently has an expanded access Investigational New Drug protocol, which allows its use for monkeypox.

The SNS holds enough vaccine – both JYNNEOS and ACAM2000 – to vaccinate millions of Americans, if needed. As of June 14, the SNS holds more than 72,000 doses of JYNNEOS in its immediate inventory. To ensure we have enough vaccine for a variety of scenarios, last week BARDA announced an order placed with Bavarian Nordic for an additional 500,000 liquid-frozen doses of JYNNEOS to be manufactured from existing bulk vaccine. The additional doses will be delivered later this year. Bavarian Nordic also holds over one million additional government-owned doses and the equivalent of 15.9 million doses that could be filled and finished upon request by the government. The SNS also has more than 100 million doses of ACAM2000 available for vaccination against monkeypox.

In addition, the SNS has a supply of the smallpox antiviral drug TPOXX, which was developed with BARDA support and can be used to treat individuals with monkeypox with an appropriate regulatory mechanism. CDC currently has an expanded access Investigational New Drug protocol which allows its use for monkeypox.

The SNS, in coordination with CDC, is responding to requests from a number of jurisdictions for vaccines and treatments to support those affected by monkeypox. We will continue to work with jurisdictions to support their response; however, at this time, we do not anticipate the need for widespread, mass deployment of vaccines and treatments.