Biosecurity Scan for Aug 31, 2015

Further lab biosafety lapses
Smallpox vaccine response

USA Today: 6 labs secretly sanctioned over biosecurity lapses

Federal regulators have privately threatened to revoke permits to study select agents (potential bioterror pathogens) from at least six labs for safety and security violations, including at Brigham Young University (BYU) in Provo, Utah, the University of Hawaii-Manoa (UHM), and the California Department of Public Health (CDPH), USA Today reported late last week in its continuing probe of US lab biosecurity breaches.

The labs failed to take actions to ensure the trustworthiness of their workers, among other violations, the report said. Federal officials did not name any of the six labs—citing a 2002 bioterrorism law—but USA Today reporters determined the identity of the three and are working to pinpoint the rest.

In a letter to BYU, regulators said last year that they had "significant concerns" about whether lab staff could work with select agents without endangering public health. In a letter to the UHM, federal regulators cited the university for "widespread regulatory non-compliance" and a "serious disregard" for lab security and safety regulations.

The CDPH lab in Richmond allowed unapproved staffers to have key cards that granted them access to restricted areas and "failed to address safety issues over the course of the last four years," according to the regulators. The CDPH was the only organization to share inspection results with the newspaper, which said that some violations involved potential safety issues, but many "appear to involve missing language in policy manuals found during paperwork reviews."

In response to those findings, David Franz, a former commander of the US Army Medical Research Institute of Infectious Diseases in Fort Detrick, Md., said, "Sure, we need regulations and oversight. But safety and security are not enhanced by nit-picking bureaucratic policy manual reviews, arbitrary interpretation of regs and agonizingly slow communication with the labs."

The story said the significance of violations cited by the regulators is difficult to determine because of the cloak of secrecy surrounding the labs and their oversight. Officials with the three named labs refused to be interviewed for the story but said the violations have been corrected. BYU said its violations involved administrative and paperwork issues.

The Centers for Disease Control and Prevention and the US Department of Agriculture, which jointly operate the Federal Select Agent Program, are each in the middle of a review of how they regulate lab biosecurity in the wake of the USA Today investigation.
Aug 28 USA Today story


Study says men have stronger immune response to smallpox vaccine

Men's immune response to smallpox vaccine—used in those susceptible to a bioterror attack—is about 27% stronger than women's, according to a new study in Vaccine.

US researchers measured the immune response to Imvamune smallpox vaccine in 136 men and 139 women from three randomized trials conducted at 13 US medical centers. The volunteers received the standard dose of the liquid formulation of the vaccine and had not been vaccinated for smallpox before.

The data showed that the men had a higher peak geometric mean titer—a measure of immune response of about 27% higher than the women did. The difference was statistically significant.

The authors say the results indicate that sex should be considered in the development and deployment of this and similar smallpox vaccines.
Aug 28 Vaccine study

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