Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2017/09/bioterror-scan-sep-28-2017
Bioterror Scan for Sep 28, 2017
Smallpox vaccine buy; Rapid anthrax test
Filed Under:
Bioterrorism; Smallpox; Anthrax
[h=3]HHS invests up to half a billion in freeze-dried smallpox vaccine[/h] Using Project BioShield funding, the US Department of Health and Human Services (HHS) is investing up to $539 million in a freeze-dried (lyophilized) smallpox vaccine for women who are pregnant or nursing and for people with HIV or atopic dermatitis, HHS said in a press release today.
The HHS's Biomedical Advanced Research and Development Authority (BARDA) will buy doses of the Imvamune vaccine from Denmark's Bavarian Nordic over 5 years for a total of $100 million. BARDA has the option of using Project BioShield funding to support any additional studies needed for Bavarian Nordic to apply for Food and Drug Administration (FDA) licensure of the lyophilized vaccine and to buy additional doses. Pursuing these options would bring the total award to more than $539 million.
"A critical component of preparedness is making sure effective medical countermeasures are available for a range of populations," said BARDA Director Rick Bright, PhD. "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."
Pending FDA approval, the freeze-dried vaccine could be used during a public health emergency involving smallpox if the FDA allows for emergency use. The vaccine is a freeze-dried formulation of the liquid frozen vaccine already stockpiled by the US government. The lyophilized vaccine is expected to be stable over a longer period, resulting in lower taxpayer costs, HHS said.
In clinical studies, a two-dose vaccine regimen has been tested safely in more than 7,000 people, and the vaccine has had a similar safety profile and immune response as the liquid-frozen vaccine. The Project BioShield Act of 2004 allows BARDA to research, develop, and buy medical countermeasures such as vaccines, therapeutics and diagnostics.
This is the third such HHS award to manufacture Imvamune in bulk, Bavarian Nordic said in a news release. The two previous orders totaled $233 million.
Sep 28 HHS news release
Sep 28 Bavarian Nordic news release
[h=3]BARDA awards $8 million for rapid point-of-care anthrax test[/h] In other BARDA news, the agency earlier this week awarded an $8.1 million contract to InBios International, Inc, of Seattle to advance research and development on a rapid point-of-care test for the bacterium that causes anthrax, according to a separate HHS news release.
The 3-year contract will support the studies needed for the company to apply for FDA licensure, as well as for studies needed to support submission of the test for pre?Emergency Use Authorization from the FDA. The test might be able to determine within 15 minutes whether a patient has been infected with Bacillus anthracis, which causes anthrax, HHS said.
"Inhalational anthrax is a deadly disease and a significant biological threat to our nation," said BARDA Director Bright. "To save lives during an anthrax emergency, health care providers must be able to screen patients rapidly to provide treatment as quickly as possible. That's our goal in supporting development of point-of-care tests like this."
InBios's test, a lateral flow immunoassay, detects B anthracis by identifying specific proteins from the bacterium in a few drops of blood. In studies, the test has identified the proteins within about 15 minutes. It could be used by first responders and in healthcare settings.
Sep 26 HHS press release
Bioterror Scan for Sep 28, 2017
Smallpox vaccine buy; Rapid anthrax test
Filed Under:
Bioterrorism; Smallpox; Anthrax
[h=3]HHS invests up to half a billion in freeze-dried smallpox vaccine[/h] Using Project BioShield funding, the US Department of Health and Human Services (HHS) is investing up to $539 million in a freeze-dried (lyophilized) smallpox vaccine for women who are pregnant or nursing and for people with HIV or atopic dermatitis, HHS said in a press release today.
The HHS's Biomedical Advanced Research and Development Authority (BARDA) will buy doses of the Imvamune vaccine from Denmark's Bavarian Nordic over 5 years for a total of $100 million. BARDA has the option of using Project BioShield funding to support any additional studies needed for Bavarian Nordic to apply for Food and Drug Administration (FDA) licensure of the lyophilized vaccine and to buy additional doses. Pursuing these options would bring the total award to more than $539 million.
"A critical component of preparedness is making sure effective medical countermeasures are available for a range of populations," said BARDA Director Rick Bright, PhD. "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."
Pending FDA approval, the freeze-dried vaccine could be used during a public health emergency involving smallpox if the FDA allows for emergency use. The vaccine is a freeze-dried formulation of the liquid frozen vaccine already stockpiled by the US government. The lyophilized vaccine is expected to be stable over a longer period, resulting in lower taxpayer costs, HHS said.
In clinical studies, a two-dose vaccine regimen has been tested safely in more than 7,000 people, and the vaccine has had a similar safety profile and immune response as the liquid-frozen vaccine. The Project BioShield Act of 2004 allows BARDA to research, develop, and buy medical countermeasures such as vaccines, therapeutics and diagnostics.
This is the third such HHS award to manufacture Imvamune in bulk, Bavarian Nordic said in a news release. The two previous orders totaled $233 million.
Sep 28 HHS news release
Sep 28 Bavarian Nordic news release
[h=3]BARDA awards $8 million for rapid point-of-care anthrax test[/h] In other BARDA news, the agency earlier this week awarded an $8.1 million contract to InBios International, Inc, of Seattle to advance research and development on a rapid point-of-care test for the bacterium that causes anthrax, according to a separate HHS news release.
The 3-year contract will support the studies needed for the company to apply for FDA licensure, as well as for studies needed to support submission of the test for pre?Emergency Use Authorization from the FDA. The test might be able to determine within 15 minutes whether a patient has been infected with Bacillus anthracis, which causes anthrax, HHS said.
"Inhalational anthrax is a deadly disease and a significant biological threat to our nation," said BARDA Director Bright. "To save lives during an anthrax emergency, health care providers must be able to screen patients rapidly to provide treatment as quickly as possible. That's our goal in supporting development of point-of-care tests like this."
InBios's test, a lateral flow immunoassay, detects B anthracis by identifying specific proteins from the bacterium in a few drops of blood. In studies, the test has identified the proteins within about 15 minutes. It could be used by first responders and in healthcare settings.
Sep 26 HHS press release