FDA to hire top lab safety official after report details gaps
The US Food and Drug Administration (FDA) is hiring a top official to ensure lab safety after a report released late last week highlighted biosafety weakness in the agency's labs, USA Today reported yesterday.
The report was conducted by the External Laboratory Safety Workgroup (ELSW), which was formed by the Centers for Disease Control and Prevention (CDC) after neglected smallpox vials were discovered at an FDA lab in 2014. The ELSW found that FDA labs are deficient in safety data, training, and consistent procedures. The report is dated Jul 17 but was quietly posted Sep 18 on the FDA Web site with a statement but no press release.
The agency is addressing the issues raised in the report by hiring a director of lab safety and security, whom it hopes to have in place next month, Luciana Borio, MD, the FDA's acting chief scientist, told USA Today. Borio also said the agency is developing a core curriculum of lab safety training and for the first time is consolidating many of its lab operations onto one large campus in Silver Spring, Md.
The FDA said in its Sep 18 statement, "FDA is pleased to have received the ELSW report detailing the agency's current laboratory and research safety programs, as well as recommendations for improvement. . . . The report's recommendation to enhance communications throughout the agency is a top priority."
Sep 23 USA Today story
Sep 18 FDA statement
Full ELSW report
Global rubella down 95% in 15 years as vaccination expands
Global cases of rubella (German measles) have been cut 95% since 2000 as the number of vaccinated countries grew by 40%, the CDC said today in an update in Morbidity and Mortality Weekly Report (MMWR).
Reported rubella cases fell from 670,894 cases in 102 countries in 2000 to 33,068 cases in 162 countries in 2014, the CDC said, while noting that reporting across countries is inconsistent. The numbers decreased in all World Health Organization regions except Africa and Southeast Asia, but in both instances the numbers included substantially more countries: from 865 cases in 7 countries to 7,402 cases in 44 countries in Africa and from 1,165 cases in 3 countries to 9,263 cases in 10 countries in Southeast Asia.
The report also noted that the number of nations in which rubella-containing vaccine has been introduced rose from 99 in 2000 to 140 in 2014. Eight of those countries had been added since the CDC's previous update, which covered 2000 through 2012. The CDC also noted that 42 of the 54 nations where rubella vaccine is not in the immunization schedule are eligible for GAVI Alliance funding support. The non-profit is a major source of vaccination funding.
The disease, also called German measles, usually causes a mild fever and rash in children and adults, but infection during pregnancy can result in fetal death or congenital malformations.
Sep 25 MMWR report
Study shows 2 flu B lineages behave similarly in households
The two major lineages of influenza B behave similarly in households, with one strain possibly exhibiting age-group differences, according to a new study by University of Hong Kong experts in Clinical Infectious Diseases.
Influenza B viruses split into two lineages—called Victoria and Yamagata—in the early 1980s. The researchers in the current study enrolled 75 households that had a Yamagata-infected index patient and 34 households with a Victoria strain in 2007 through 2011. Patients and household contacts were monitored for 7 to 10 days.
The scientists found that the two lineages produced similar clinical illness and led to similar virus shedding. They did find, however, that the risk of within-household infection among household contacts 15 years old and younger was significantly higher than that for older contacts, but subset numbers were small.
Sep 22 Clin Infect Dis abstract