HHS to purchase freeze dried smallpox vaccine for use by pregnant women, special populations

The U.S. Department of Health and Human Services (HHS) recently announced it will purchase a lyophilized, or freeze-dried, smallpox vaccine for use by women who are pregnant or nursing and for people of any age who have HIV or atopic dermatitis.

The vaccine, developed by Denmark-based pharmaceutical manufacturer Bavarian Nordic, will be purchased via the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioSheid funding and will cover a period of five years for a total of $100 million.

Under the Project Bioshield Act of 2004, BARDA has the ability to research, develop, and purchase various medical countermeasures needed to mitigate and stop threats to public health. Should all options be pursued, including additional studies needed for U.S. Food and Drug Administration (FDA) licensure, the contract would be brought to a total of more than $539 million.

If approved by the FDA, the vaccine could be used during a smallpox-related public health emergency. Similar to its liquified counterpart currently stored at the U.S. Strategic National Stockpile, the freeze-dried version of the vaccine extends its shelf life, resulting in lower life-cycle costs overall.

According to recently-conducted clinical trials, a two-dose regimen of the vaccine has been tested safely in approximately 7,000 individuals, with additional studies showing the freeze-dried version having similar effectiveness compared to the liquefied version.

“A critical component of preparedness is making sure effective medical countermeasures are available for a range of populations,” BARDA Director Rick Bright said. “In addition to the long-term cost savings realized with extended shelf-life, this vaccine could help protect certain populations for which other stockpiled smallpox vaccine may be less appropriate.”