Bavarian Nordic A/S today announced that the U.S. Food and Drug Administration (FDA) has approved JYNNEOS™ (Smallpox and Monkeypox Vaccine, Live, Non-replicating) (MVA-BN®, liquid-frozen) for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. JYNNEOS is the only approved non-replicating smallpox vaccine in the U.S. and the only approved monkeypox vaccine anywhere in the world.

Monkeypox Image/CDC

JYNNEOS is approved for use broadly, including in people with weakened immune systems and those with eczema or with household members with eczema. This approval is a major breakthrough in meeting the U.S. government’s long-standing commitment to developing a vaccine that can be administered to people who are at high risk of adverse reaction to traditional, replicating smallpox vaccines.

“The licensure of this vaccine not only enhances domestic biodefense and global health security but also demonstrates what can be accomplished for the American people through public-private partnerships,” said Rick Bright, Ph.D., HHS deputy assistant secretary for preparedness and response and director of the Biomedical Advanced Research and Development Authority (BARDA). “The years of dedication working with Bavarian Nordic on this vaccine ultimately mean that the U.S. is better prepared to save lives if an emergency occurs involving one of the deadliest diseases the world has ever known.”

“The FDA approval of JYNNEOS is a tremendous milestone for both our company and the U.S. Department of Health and Human Services,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “Together, we have shown that it is possible to develop a safe and effective medical countermeasure for national security threats like smallpox. JYNNEOS is the culmination of a fifteen-year partnership that started with a call from the NIH for a safer smallpox vaccine, successfully transitioned to BARDA and was delivered to the Strategic National Stockpile for use in an emergency. We are committed to the continued supply of vaccines to the U.S. and thank them for their global leadership on biodefense. We are also particularly pleased with the additional indication to protect against monkeypox that creates new commercial opportunities for JYNNEOS.”

Concurrent with the approval, FDA granted Bavarian Nordic a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure PRV program. A PRV can be used to accelerate the FDA’s review of a future human drug application and is also transferrable. The Company intends to sell the voucher to a third party.

JYNNEOS is a suspension for subcutaneous injection (0.5 mL) based on a live, attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), incapable of replicating in the body, yet still capable of eliciting a potent immune response.