The U.S. Department of Health and Human Services (HHS) ordered an additional 2.5 million doses of Bavarian Nordic's JYNNEOS, an FDA-licensed vaccine indicated for prevention of smallpox and monkeypox, for use in responding to current or future monkeypox outbreaks and as part of U.S. smallpox preparedness, according to a news release.
Deliveries from this latest order will begin arriving at the Strategic National Stockpile (SNS) later this year and will continue through early 2023.
The additional supply of vaccines is part of the Biden-Harris Administration's broader strategy to combat the monkeypox virus and protect those most at risk, including by accelerating the production and distribution of vaccines, making testing more accessible and convenient, and communicating regularly with health and community leaders about the virus.
"We are working around-the-clock with public health officials in states and large metro areas to provide them with vaccines and treatments to respond to the current monkeypox outbreak," said HHS Secretary Xavier Becerra. "This order of additional JYNNEOS vaccine will help us push out more vaccine quickly, knowing that we have more doses on the way in the coming months – and is only possible because of our longstanding investment in smallpox and monkeypox preparedness."
The order announced is in addition to the 500,000 doses of government-owned vaccine the company is producing in 2022 for use in the current response to monkeypox in the U.S and brings the total vaccine doses to be delivered in 2022 and 2023 to more than 4 million. The company will produce these doses in liquid frozen form using vaccine already manufactured in bulk under an existing 10-year contract with the Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR); that contract was part of ongoing national preparedness efforts against smallpox.
"The medical countermeasures available to help respond to the current outbreak are the result of years of investment and planning made possible through the ongoing work between HHS and private industry," said Gary Disbrow, Director of the Biomedical Advanced Research and Development Authority. "We are pleased that we have been able to work with our partners at Bavarian Nordic to accelerate delivery of vaccines that can help keep people safe and stem the spread of the virus."
BARDA supported the development of JYNNEOS, which is approved by the FDA to prevent smallpox and monkeypox. The U.S. government owns enough smallpox vaccine – JYNNEOS and ACAM2000 – to vaccinate millions of Americans, if needed.
As of June 24, ASPR's SNS held approximately 65,000 doses of JYNNEOS in immediate inventory with delivery of an additional 300,000 doses in the coming days. On June 28, HHS announced that it would immediately make available 56,000 doses and soon after would make available 240,000 additional doses. The SNS also has more than 100 million doses of ACAM2000 which was developed with SNS support and is approved by FDA for use in preventing smallpox. The Centers for Disease Control and Prevention (CDC) currently has an expanded access Investigational New Drug protocol which allows use of ACAM2000 for monkeypox.
In addition, the SNS has over 1.7 million treatment courses of the smallpox antiviral drug TPOXX, which was developed with BARDA support and can be used to treat individuals with monkeypox under an appropriate regulatory mechanism. CDC currently has an expanded access Investigational New Drug protocol which allows its use for monkeypox.
As of June 29, the CDC has received reports of approximately 350 cases of monkeypox in the U.S., primarily among men who have sex with men.