* Emergent BioSolutions Inc.(NYSE:EBS) gained 14.5% to close at $50.14 after the company was awarded a 10-year HHS contract to deliver ACAM2000
smallpox vaccine to the U.S.
Department of Health and Human Services, or HHS, valued at approximately $2B over 10 years for the continued supply of ACAM2000
, or Smallpox Vaccine, into the U.S.
The regulatory submission is based on a development program comprising 22 clinical studies, including two Phase III studies, the latter of which showed non-inferiority of MVA-BN compared to ACAM2000
, the current U.S.
Reportedly, this study achieved both of its primary endpoints, demonstrating IMVAMUNE's efficacy in comparison to ACAM2000
, the current US licensed replicating smallpox vaccine.
On February 4, 2016, the New Mexico Department of Health (NMDOH) was contacted regarding a patient who had received ACAM2000
* smallpox (vaccinia) vaccine 12 days earlier as part of an institutional review board-approved study at a plasma donation center and had numerous lesions surrounding the inoculation site and on the opposite arm, back, and abdomen.
In June 2015, ACIP, having reviewed recent clinical data, reaffirmed the CDC's standing recommendations that the live vaccinia virus smallpox vaccine ACAM2000
(which replaced Dryvax in 2008) be administered routinely to those with occupational exposure to orthopox viruses (eg, laboratory personnel who work with monkeypox, variola, or smallpox viruses).
Currently unlicensed third-generation smallpox vaccines may be considered (pending licensure) as replacements to ACAM2000
(Sanofi Pasteur Biologics, Lyon, France), the currently licensed vaccinia vaccine, for laboratory workers at national variola testing sites or perhaps an even broader population of laboratory workers throughout the United States.
Since then, the immunosignature evoked by three different vaccines (Acam2000
, Dryvax, and MVA) in the mouse, rabbit, macaque, prairie dog, and humans have been defined [47-50].
Another example is also the Acambis ACAM2000
smallpox vaccine which is made in a Vero cell line using disposable production technology.
Vaccinia virus was confirmed in all four patients, and gene sequencing in three of the cases linked the virus to the ACAM2000
The Food and Drug Administration has approved a new smallpox vaccine, ACAM2000
, for active immunization against smallpox in individuals determined to be at high risk for smallpox infection.