The international biotechnology company Bavarian Nordic recently announced positive results from its phase 3 trial of an investigational, nonreplicating smallpox vaccine Imvamune. The results position the company to submit the vaccine for FDA approval later this year.
“The success of this study represents a hallmark achievement at Bavarian Nordic,” Paul Chaplin, the company’s president and CEO, said in a press release. “These and earlier study results validate the promise of Imvamune for the prevention of smallpox and support product registration with the U.S. FDA.”
According to the company, the only currently licensed vaccine in the United States, ACAM2000 (Sanofi Pastuer), is contraindicated in up to 66 million people, including those with atopic dermatitis and patients living with HIV. Imvamune is being developed, it said, for those who cannot receive a traditional replicating smallpox vaccine. The vaccine has been approved for use in Canada and the European Union.
In a randomized, open-label study of 440 participants at a U.S. military garrison in South Korea, the peak neutralizing antibodies induced by Imvamune was twice that of ACAM2000, meeting its co-primary endpoint of noninferiority, according to Bavarian Nordic. The vaccine resulted in a “statistically superior immune response,” the company said. The study also showed that vaccination with Imvamune resulted in a highly attenuated take, measured by a reduction in lesion size, and prevented vaccine take in a most participants.
The study was funded by the Biomedical Advanced Research and Development Authority. The company said it shipped 28 million doses of liquid-frozen Imvamune to the U.S. Strategic National Stockpile for emergency use.
The vaccine so far has been administered to more than 7,800 participants in 21 clinical studies, including two phase 3 studies. Bavarian Nordic said it plans to file a biologic license application in the second half of 2018.
In 2015, the CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended that anyone with possible exposure to orthopoxvirus be evaluated by a health care provider in consultation with public health officials to determine if smallpox vaccination or other postexposure treatment is necessary.
Disclosure: Chaplin is employed by Bavarian Nordic.