United States SAFEVAX
Adverse Event Reporting Solution
"Advances in technology have the capacity to revolutionize both clinical care and public health. We found that recipients of smallpox vaccine were able to accurately assess their reaction to smallpox vaccine, and to report it using telephone and web-based technology. We believe that such emerging technologies can play an important role in the consideration of future vaccination campaigns."
- Stuart S. Olmsted, PhD, RAND Corporation
Customer Profile
With approximately 2,000,000 personnel, our customer is the nation's largest employer.
Situation and Challenges
In the aftermath of September 11th, concern about weaponized smallpox led our customer to vaccinate its personnel against the disease. Because data on the effects of the smallpox vaccine was more than 30 years old, and because of changing demography and health status of the US population, our client wanted to monitor the recipients of the vaccine closely. The project objectives were to "protect the individual against infection, but also to protect the individual from the adverse effects of the vaccine."
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| User Card to Submit Report Via Phone
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Solution
In collaboration with Abt Associates, Voxiva developed SAFEVAX,
an adverse event reporting solution that enables rapid identification
of vaccine reactions, analysis of reaction patterns and trends,
and automatic alert and notification. Criteria can be specified
(e.g., fever over 103 degrees) that results in an automatic telephone
or e-mail notification being sent to the appropriate person. Each
vaccinee, using a secure ID and Password, reports "Take"
and reaction data on a daily basis via phone or the Internet. If
vaccinees don't report on schedule, they receive a reminder call
from a call center operator who can help them submit their data.
To ensure security, Voxiva hosts SAFEVAX at a carrier grade, HIPAA-compliant
facility. Data collected is available only to designated and authorized
personnel. The data is collected and stored in a centralized database
where it can be viewed or exported in common formats for further manipulation
and analysis.
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| Screen to Submit Report Via Web |
Benefits
SAFEVAX was designed to meet DoD's requirements for actively monitoring, recording, and analyzing responses to smallpox vaccination. The benefits of the SAFEVAX solution include:
 Flexible and Scalable: The system is able to serve an undetermined number of vaccine recipients, and can reach troops at installations both in the US and abroad.
Easy to Use: Simple, easy to use interface that ensures high rates of compliance with reporting protocols and eases stress on overburdened clinics and vaccine recipients.
Increased Safety of Vaccinees: Rapidly identify possible reactions experienced by individuals, or associated with specific vaccine lots or vaccine administration sites.
Increased Data for Decision-Making: Provide more complete, accurate and timely statistics on post-vaccination reactions to guide policy and planning for any future widespread vaccination program.
"With this cohort, the electronic system could have reduced the number of return take check visits by 73%. In addition, the system is designed with the ability to automatically notify a health care professional when a vaccinee reports a symptom of concern, such as chest pain."
- Stuart S. Olmsted, PhD, RAND Corporation
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