Advisors seek clarity on fed's gain-of-function research funding pause
The committee that advises the federal government on biosecurity and dual-use research today approved a statement detailing its concerns about the US government moratorium on funding for "gain-of-function" (GOF) studies on influenza, MERS-CoV (Middle East respiratory syndrome coronavirus), and SARS (severe acute respiratory syndrome).
The Obama administration announced the moratorium on Oct 17 to allow assessment of the risks and benefits of the controversial research and the development of federal policies on it. The National Science Advisory Board for Biosecurity (NSABB) is playing a lead role in the review, expected to last almost a year, and has been asked to issue a report on the design of a risk-benefit assessment and to draft recommendations for GOF research that will be reviewed by the life sciences community.
The NSABB's report today comes amid questions and confusion about the moratorium, some of which was aired by several researchers at the last NSABB meeting, held just 5 days after federal officials made their announcement. The officials estimate that the pause affects 18 research projects, a number that federal officials said today could change slightly. Some of the main concerns revolve around the pause's scope and criteria.
The statement approved today still needs final tweaks, but it will be forwarded to Health and Human Services Secretary Sylvia Mathews Burwell. In a related development, the National Institutes of Health (NIH) Office of Biotechnologies Activities today released a Q and A for researchers that clarifies some issues related to the moratorium.
At today's meeting, NSABB chair Samuel Stanley, MD, said that a 13-member working group has been formed to draft recommendations about the risk-benefit assessment. The next step in the process is a National Academy of Sciences (NAS) workshop on Dec 15 and 16.
Nov 25 NSABB agenda
Nov NIH Q and A on GOF research funding pause
Oct 17 CIDRAP News scan "US suspends funding for 'gain-of-function' studies of flu, MERS, SARS"
MSF opens 2 cholera treatment centers in Haiti
The medical aid group Doctors Without Borders (MSF) has opened two cholera treatment centers in the Haitian capital of Port-au-Prince, according to an MSF update yesterday.
Cholera cases in Haiti are currently increasing owing to the start of the rainy season, lack of sanitation and water chlorination practices, and a decline in population immunity to the disease, the group said. Bed shortages and lack of urgent care centers represent a significant challenge to treating new patients.
MSF said that approximately 2,000 people with cholera symptoms have required hospitalization in Port-au-Prince since Oct 10. Haiti's national health system has been unable to provide urgent care due to lack of dedicated funding.
MSF provided nearly 320 beds for cholera patients in two treatment centers located in the Martissant and Delmas neighborhoods of Port-au-Prince. The aid group is also staffing several care centers initially opened by Haiti's Ministry of Health. MSF sees about 100 patients each day at the Martissant center.
Haiti saw its first cases of cholera in Oct 2010, almost 10 months following the earthquake that destroyed much of the nation's healthcare and sanitation infrastructure. Since 2010, more than 711,558 cholera cases have been reported in the country.
Nov 24 MSF article
AAP recommends PCV13 for high-risk kids
The American Academy of Pediatrics (AAP) recommended a single dose of 13-valent (13-strain) pneumococcal vaccine (PCV13) for children 6 through 18 years old who have compromised immune systems and other high-risk conditions, according to a statement yesterday in Pediatrics.
The guidance is similar to what the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended on Feb 20. The ACIP move followed the Food and Drug Adminstration's (FDA's) approval on Jan 25 of the use of PCV13 in children ages 6 through 17, according to a Mar 6 AAP News story.
The AAP said children in that age-group with high-risk conditions should receive a single dose of PCV13 whether or not they've received the seven-valent version (PCV7) or the 23-valent pneumococcal polysaccharide vaccine (PPSV23). High-risk conditions include asplenia, sickle cell disease, HIV, malignancy, transplant, cerebrospinal fluid (CSF) leaks, and cochlear implants. The agency added that PCV13 "may be considered" for those with diabetes, lung disease, and heart disease.
The AAP added that its recommendations for the use of PCV13 in healthy children and for PPSV23 remain unchanged. In addition to the groups for which PCV13 is now recommended, children with chronic heart or lung disease and diabetes should receive PPSV23 beginning at 2 years, AAP News reported yesterday. For kids with immunocompromising conditions, a second dose of PPSV23 is recommended 5 years after the first dose, but not for those with CSF leaks, cochlear implants, chronic heart or lung disease, or diabetes.
Nov 24 AAP statement in Pediatrics
Nov 24 AAP News story
Mar 6 AAP News story on ACIP's PCV13 recommendations