The U.S. Food and Drug Administration (FDA) last week approved Bavarian Nordic to market a new, alternative smallpox vaccine known as JYNNEOS.
JYNNEOS is a live, non-replicating vaccine specifically made for adults. It is an alternative to the existing ACAM2000, which though licensed, cannot be used by certain compromised populations, like those with atopic dermatitis or HIV. Its monkeypox benefit is a bonus, and now, the only FDA-approved vaccine for that disease.
“In addition to its public health importance, this vaccine will have a direct impact on improving force health protection for U.S. service members who are required to be immunized against smallpox,” Col. E. Darrin Cox, commander of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), said.
USAMRIID played a key role in testing the vaccine, under the direction of Dr. Phillip Pittman. They organized a Phase 3 clinical trial for U.S. service members in South Korea, comparing immune responses across 440 treated participants. Those participants were organized into two groups, with one group treated with JYNNEOS, the other, with ACAM2000.
In that testing, JYNNEOS proved to possess a statistically superior immune response.
“The FDA approval of JYNNEOS is a tremendous milestone for both our company and the U.S. government,” Paul Chaplin, president and CEO of Bavarian Nordic, said. “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 with numerous agencies across the U.S. government, including USAMRIID, who played a pivotal role in conducting the final clinical study to support the registration of the vaccine. We are committed to the continued supply of vaccines to the U.S. and thank them for their global leadership on biodefense.”
The new vaccine will be added to the Strategic National Stockpile — a national supply of pharmaceuticals and medical supplies for use in public health emergencies.