Naval Health Research Center Concludes Six-year Vaccine Study With FDA

Story Number: NNS141230-08Release Date: 12/30/2014 1:04:00 PM
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By Anna Hancock, Naval Health Research Center Public Affairs

San Diego (NNS) -- The Naval Health Research Center (NHRC) recently concluded one of the largest vaccine safety studies in the command's history, contributing to the fourth and final phase of the U.S. Food and Drug Administration's (FDA) smallpox vaccine safety trials.

For more than six years, NHRC led the six military facilities across the nation taking part in this effort. About 16,000 samples were collected when the FDA decided NHRC's team had enough data to support the study.

"Even though the smallpox vaccine is an FDA approved vaccine, many vaccines undergo this post-marketing vaccine safety study [phase four]," said Lt. Cmdr. Lori Perry, a preventive medicine physician with NHRC and the study's principal investigator. "It's an extra measure to track all potential adverse effects."

The smallpox vaccine, according to the Center for Disease Control and Prevention, is safe and effective and given to people determined to be at high risk for smallpox infection. Routine vaccination against smallpox stopped in 1972 after the disease was eradicated in the United States.

"Military service members still receive the vaccine if they are deploying to an area where the threat of smallpox is present," noted Perry.

In collaboration with the FDA and the vaccine manufacturer Sanofi Pasteur, NHRC established vaccine surveillance sites at Marine Corps Base Twentynine Palms, California, Fort Campbell, Kentucky, Fort Bliss, Texas, Fort Hood, Texas, Fort Stewart, Georgia and Joint Base Lewis-McChord, Washington, in 2008. Since then, NHRC's teams diligently collected data each time a vaccine was administered and closely monitored the health and well-being of the person who received it.

The data was then reported to the manufacturer and ultimately the FDA who has the final authority on the vaccine's safety.

"When we closed the surveillance sites down, it took the expertise from our quality assurance specialist and clinical trial program manager to ensure each applicable standard operating procedure was followed," said Perry. "Every detail to safeguard personally identifiable information and ensure patient privacy was accounted for."

This month, NHRC's team is carrying out the administrative details in the turnover to its collaborative partners. This work will continue until the summer of 2015 but for now, NHRC's Commanding Officer Capt. Jacqueline Rychnovsky lauds the team responsible for executing the study.

"This study directly contributed to the safety and readiness of our service men and women," explained Rychnovsky. "We appreciate the collaborative efforts from our Army, Marine Corps and Air Force counterparts at the surveillance sites. Their roles were integral to the success of the study."

As the DoD's premier deployment health research center, NHRC's cutting-edge research and development is used to optimize the operational health and readiness of the nation's armed forces. Within close proximity to more than 95,000 uniformed service members, world-class universities, and industry partners, NHRC's expert team sets the standards in joint ventures, innovation, and practical application.

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