A Newly FDA-Licensed Vaccine for the Prevention of Smallpox and Monkeypox Marks a Major Milestone in Domestic and Global Health Security

Our nation and the world marked a significant milestone in global health security and emergency preparedness today with the U.S. Food and Drug Administration licensure of a novel vaccine to prevent both smallpox and monkeypox, a virus related to smallpox, in adults at high risk for infection. The FDA granted the application Priority Review status.

Smallpox once reigned as one of the deadliest diseases known to humankind, infecting approximately 50 million people a year and killing an estimated 300 million people around the world in the 20^th century alone.

Edward Jenner, an English surgeon, is credited with development of the first smallpox vaccine in 1796. He and others observed that dairymaids who were exposed to the cowpox virus, which is similar to smallpox, were protected against smallpox disease. More than a hundred years later, Jenner’s discovery led to a mass vaccination campaign against smallpox. The World Health Organization declared the disease eradicated worldwide in the 1980s, a testament to what can be accomplished with an effective vaccine and international cooperation on public health vaccination campaigns. However, the virus remains a potential global security threat for the following reasons:

1. we do not know for certain that all other virus samples in the world were destroyed and the virus could be released accidentally or intentionally;
2. samples of the variola virus continue to exist at two high-security laboratories approved by the World Health Organization for limited research use; and
3. advances in synthetic biology also may allow other nations or terrorist organizations to create the virus in a sophisticated laboratory.

Because routine smallpox vaccination ended in the United States in the early 1970s and worldwide in the 1980s, billions of people born after that time are not immune to the disease. The limited immunity to smallpox worldwide drives our commitment to developing vaccines and treatments to prepare for and mitigate a smallpox emergency.

The newly licensed vaccine resulted from years of dedication and collaboration between the private sector and the U.S. government. Developed and manufactured by Bavarian Nordic A/S of Denmark, initial research on the vaccine was funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, in 2003, and transitioned to the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, for late-stage development support in 2007, under Project BioShield. With ongoing technical and funding support from BARDA, the vaccine progressed through clinical development Phases 2 and 3, and procurement under our Project BioShield portfolio placing the vaccine in the Strategic National Stockpile.

Throughout the clinical development of the vaccine, FDA’s scientific and regulatory expertise and advice to Bavarian Nordic ensured an application inclusive of clinical and non-clinical data that would support the vaccine’s safety and effectiveness for the prevention of smallpox. During the expedited (Priority) review of the licensure application, FDA recognized that the data would support use of the vaccine not only for prevention of smallpox but also for prevention of monkeypox, paving the way for inclusion of monkeypox as an approved indication.

During the later stages of clinical development, partnerships with the Centers for Disease Control and Prevention and the Department of Defense supported licensure of the vaccine.

ASPR began stockpiling the vaccine in 2010 to make it available for special populations, if needed, under an Emergency Use Authorization from the FDA. This is an example of the commitment and work by both agencies to support the availability of critical medical products under the authorities available to FDA. We will continue to stockpile the vaccine and work with Bavarian Nordic on licensure of a lyophilized (freeze-dried) formulation of the vaccine that has a longer shelf life. We want to make storage, distribution, and administration of the smallpox vaccine as quick and easy as possible.

One of BARDA’s goals is to work with our industry partners to obtain FDA approval for their products that prepare our nation against health security threats. We are honored to have helped achieve that goal with Bavarian Nordic A/S for JYNNEOS, which is the 49^th product supported by BARDA to achieve FDA approval in the past 12 years. The progress marked today demonstrates what can be accomplished through public-private partnership and HHS’ ongoing commitment to protect the American people from smallpox, monkeypox and all health security threats.