SNS Products: Vaccines and Treatment Available for Use in the Monkeypox Response

ASPR’s Strategic National Stockpile (SNS), in coordination with the Centers for Disease Control and Prevention, has deployed vaccines and continues to deploy treatments to a number of jurisdictions across the United States to support communities affected by monkeypox.
 

Vaccines

The SNS holds both JYNNEOS and ACAM2000 vaccines that could be used to protect people from monkeypox infections. ASPR’s Biomedical Advanced Research and Development Authority (BARDA) supported the development of JYNNEOS, which is approved by the U.S. Food and Drug Administration (FDA) to prevent both smallpox and monkeypox. ACAM2000®, which was developed with support from SNS, is also FDA approved for smallpox and monkeypox.

JYNNEOS vaccine may be shipped either frozen or refrigerated and requires specific cold chain requirements for storage. The requirements for shipment and storage differ from the package insert. Before requesting product, read Bavarian Nordic’s letter on storage requirements for JYNNEOS vaccine and ensure you have a plan to meet these requirements.  

Following a Section 564 determination, the FDA announced an alternate strategy that allows health care providers to draw up to five doses of JYNNEOS vaccine from a single vial when administered intradermally.

 

Table 1: Lot Numbers and Expiration Dates for SNS-provided JYNNEOS vaccine stored under appropriate conditions at -25°C to -15°C (-13°F to +5°F):
 

Antiviral Drug
 

The SNS has a supply of the smallpox antiviral drug TPOXX® (tecovirimat), 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 that allows its use for monkeypox.

The smallpox antiviral drug TPOXX® supplied by the SNS does not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label, and refer to the table below to identify the corresponding expiration date.

Table 2: Lot Numbers and Expiration Dates for SNS-held oral TPOXX (tecovirimat) 
 

Table 3: Lot Numbers and Expiration Dates for SNS-held intravenous TPOXX (tecovirimat)
 

As of October 26, 2022, the SNS holds Brincidofovir (also known as Tembexa or CMX001). Brincidofovir is an antiviral medication that was approved by the FDA [PDF – 21 pages] for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

Clinicians with monkeypox patients necessitating brincidofovir treatment need to submit an e-IND request to FDA by email (DDI.EIND@fda.hhs.gov) or phone 301-796-3400 or 1-855-543-3784 during normal business hours (8 am-4:30 pm ET M-F). During after hours, call the FDA Emergency Coordinator at 1-866-300-4374 or 301-796-8240 or email CDER-EIND@fda.hhs.gov and call the call the CDER Emergency Coordinator at 301-796-9900.

Treatment Information for Healthcare Professionals | Monkey​pox | Poxvirus | CDC.

Table 1: Lot Numbers and Expiration Dates for SNS-held Tembexa 100mg tablets

Table 2: Lot Numbers and Expiration Dates for SNS-held Tembexa 10mg/ml oral suspension, 65ml