News Scan for Jul 24, 2014

CDC lab biosafety update
;
GM mosquitoes to fight dengue
;
GSK's malaria vaccine
;
Cholera vaccination in Haiti
;
Global hepatitis progress

CDC names external biosafety advisers, lifts hold on TB samples

In its ongoing response to safety lapses at two of its high-containment labs, the US Centers for Disease Control and Prevention (CDC) today announced the members of an external lab safety work group. The 11-person group will advise CDC Director Tom Frieden, MD, MPH, and the CDC's new director of lab safety, Michael Bell, MD, according to a statement.

Some of the group's duties include reviewing corrective steps based on a recent inspection by the US Department of Agriculture's Animal and Plant Health Inspection Services, identifying possible weaknesses based on experiences at labs outside the CDC, and targeting ways to boost the agency's culture of safety.

The group's chair is Kenneth Berns, PhD, professor emeritus in the Department of Molecular Genetics and Microbiology at the University of Florida, and its co-chair is Joseph Kanabrocki, PhD, associate vice-president for research safety and associate professor of microbiology at the University of Chicago. The group will meet for the first time in August.
Jul 24 CDC statement on external advisory group

In related developments, the CDC has lifted a moratorium on the movement of materials from its clinical tuberculosis lab, based on safety plan reviews from an internal group, Frieden, and Bell, the agency said in a separate statement today.

In the wake of the safety lapses, the CDC put a moratorium on the movement of samples from its high-containment labs, but said it would remove them lab by lab based on safety reviews that prioritize facilities that support patient care.

The CDC said the biosafety level 3 (BSL-3) TB lab uses a "heat kill" process to inactivate bacterial samples from patients, which are then handed off to a BSL-2 lab for rapid genetic analysis to assess drug resistance and assist with drug treatment selection.
Jul 24 CDC statement on lifting of TB sample moratorium

Meanwhile, the former head of the CDC's anthrax lab that was involved in one of the safety lapses has resigned, the New York Times reported yesterday. Tom Skinner, a CDC spokesman, said Michael Farrell, PhD, stepped down voluntarily.

In late June, media reports said the CDC had reassigned Farrell while it was investigating the incident.
Jul 23 Times story

 

Brazil plans large-scale use of GM mosquitoes to fight dengue

Next week a factory designed to raise millions of genetically modified (GM) mosquitoes will open in Brazil as the country prepares to use the altered bugs to fight dengue fever, according to a Jul 23 report in New Scientist.

The hope is that the GM mosquitoes, once released, will mate with females in the wild, whose offspring will die before reaching adulthood. That should reduce the number of Aedes aegypti mosquitoes, which carry the dengue virus.

The step marks the first commercial-scale use of GM mosquitoes, the story said. It was approved by Brazil's National Technical Commission for Biosecurity in April.

The factory, in Campinas state, will be run by the biotech firm Oxitec, based in Abingdon, UK. The company will release millions of the mosquitoes in Jacobina, a town in Brazil's Bahia state, in an expanded research program. A larger release could follow if approved by the government.

But it is uncertain whether the plan will succeed, the story says. A trial release of the mosquitoes in Jacobina last year led to a 92% reduction in mosquito eggs, but this has not yet reduced dengue cases, according to preliminary study results.

An Oxitec official said every trial so far has led to excellent control of mosquitoes in urban settings. But two Brazilian observers, an agronomist and an economist, said the release of the mosquitoes should not have been approved without a fuller evaluation of the trial releases done so far.
Jul 23 New Scientist report

 

GSK seeks approval of world's first malaria vaccine

Drug maker GSK announced today that it has filed for European Union approval of its experimental malaria vaccine, called RTS,S, which is intended for use in Africa and could become the world's first licensed vaccine for the disease.

The company filed under special rules that allow the European Medicines Agency (EMA) to evaluate the safety and efficacy of a vaccine or medicine made in Europe but intended exclusively for use outside Europe to combat a disease recognized by the World Health Organization (WHO) as a major public health problem, according to a GSK press release. The EMA will collaborate with the WHO in evaluating the vaccine.

RTS,S is intended for use only against Plasmodium falciparum malaria, which is most common in sub-Saharan Africa, GSK said. It said about 90% of estimated deaths from malaria occur in that region, and 77% of those are in children under age 5.

GSK said it has been working on the vaccine for 30 years. A Reuters report today said hopes for the vaccine were dampened when a phase 3 trial in babies aged 6 to 12 weeks showed that it reduced malaria episodes by only 30% compared with a control vaccine.

GSK said in the release, "An effective vaccine for use alongside other measures such as bednets and anti-malarial medicines would represent a [sic] advance in malaria control."

If the EMA approves the vaccine, the WHO could make a formal policy recommendation about its use by the end of 2015, GSK said. Clearance by the EMA, the firm said, would also be the basis for seeking marketing authorizations from African governments.
Jul 24 GSK press release
Jul 24 Reuters story

 

Haiti to launch cholera vaccination campaign

Next month Haiti will begin to vaccinate 200,000 people in three departments considered at highest risk for the disease, according to a statement yesterday from the Pan American Health Organization (PAHO/WHO).

The immunization campaign will involve Artibonite, Central, and West departments and use vaccines from a global stockpile. PAHO/WHO will oversee the storage and distribution of the vaccines as well as training, supervision, monitoring, and evaluation of the campaign.

"Vaccination is an important complementary measure in the fight against cholera," said PAHO/WHO Assistant Director Francisco Becerra. "But the long-term objective is to eliminate cholera, which will require sustained improvements in access to water and sanitation for the population."

Although cholera cases in the first half of 2014 were only a quarter of what they were in the same period in 2013, the disease still sickened 6,730 people and killed 51 through Jul 5, the two agencies said. Since the outbreak first started in 2010, Haiti has seen more than 703,000 cholera cases and 8,562 deaths.

Last week, United Nations (UN) Secretary-General Ban Ki-moon presented 400,000 doses of oral cholera vaccine to the country from the global stockpile. Ban said last week that the UN has a "moral responsibility" to help Haiti halt the outbreak.
Jul 23 PAHO/WHO statement
Jul 14 CIDRAP News scan on Ban visit to Haiti

 

WHO notes global progress against viral hepatitis

The world is starting to see progress in the battle against viral hepatitis, including advances in treatment of chronic hepatitis C, the WHO said yesterday in a news release to mark World Hepatitis Day, which will be observed Jul 28.

"For years, viral hepatitis has been largely neglected," said WHO Director-General Margaret Chan, MD, MPH, in the statement. "But now we are beginning to see greater awareness and global momentum building to tackle it."

Recent steps included the endorsement by 194 countries at the World Health Assembly (WHA) this year of a resolution to intensify efforts to prevent, diagnose, and treat viral hepatitis. The resolution emphasizes the importance of comprehensive national plans. The WHA added that testing is key to combatting the disease and emphasized prevention steps, such as programs geared toward injected-drug users.

One of the most significant developments in the past year, the WHO said, has been the dramatic advances in the treatment of chronic hepatitis C, including new drugs, with others in the pipeline. "But major challenges remain to make such treatment affordable and accessible to those populations in greatest need," the agency added.

The WHO also noted that World Hepatitis Day coincides this year with the 20th International AIDS Conference in Melbourne, where multiple sessions have addressed viral hepatitis and HIV co-infection.
Jul 23 WHO news release

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