News Scan for Sep 26, 2018

News brief

FDA proposes expanding retailer information in certain food recalls

The US Food and Drug Administration (FDA) today released new draft guidance that spells out when it's appropriate to disclose retail information for recalled products.

In a statement, Scott Gottlieb, MD, FDA commissioner, said the agency hasn't typically released lists of retailers where recalled food was sold, because certain supply chain information between suppliers and retailers is confidential. Also, he said that in most cases recalls typically include enough information—such as bar codes and labels—for consumers to identify and avoid the affected products.

Sometimes, however, the product isn't easily pinpointed, such as when the food isn't identified by retail packaging. And examples would be a product sold directly to consumers that doesn't have a universal product code (UPC) or bar code, such as deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruit and vegetables sold individually.

The new guidance also specified that the FDA may disclose retail lists in certain recall situations, including when the food is related to a foodborne illness outbreak and when the information is most useful to consumers. For example, the FDA said it might release information for a packaged food that was sold in a particular geographic region or through a specific online retailer, if providing those details would help consumers protect their health and wellbeing by avoiding the recalled food bought at one of the establishments.

Gottlieb said that in recent months the FDA has already taken steps that align with the new approach, such as in July when it released detailed retail distribution information by state during a recall of precut melon that had been linked to a Salmonella outbreak.

He added that identifying retail locations can be complex, because it involves many parts of the supply chain. "But we also know this information can be very important to consumers. Knowing where a recalled product was sold during the most dangerous food recalls can be the difference between a consumer going to the hospital or not," Gottlieb said.

The FDA posted the 6-page draft document on its website and said comments and suggestions should be submitted within 60 days of publication in the Federal Register.
Sep 26 FDA statement
Sep 26 FDA draft guidance


Study: Classroom flu transmission may fall with higher humidity

A study yesterday in PLoS One shows that raising a room's humidity levels could be a non-pharmaceutical intervention (NPI) for reducing the transmission of influenza A. 

Mayo Clinic researchers conducted the study at a preschool in Rochester, Minn., from January to March of 2016. They used identical classrooms with separate heating/air conditioning systems, raising humidity to an average of 9.89 mb in test rooms compared with 6.33 mb in control rooms. The difference between the two rooms represented a relative humidity increase of 42% to 45%.

The researchers collected a total of 650 samples from the rooms (320 in control rooms, 330 in humidified rooms) of which 112 (17%) were positive for influenza A. The authors said there were fewer samples positive for influenza A virus in humidified rooms compared with control rooms for both fomites and for total air.

"The mean influenza A genomic copies per sample for humidified rooms was 24.6 compared to 34.5 for control rooms for fomites. For air (total) the mean influenza A genomic copies per cubic meter of air was 36.1 for humidified rooms compared to 79.1 for control rooms," the authors said.

This is the first study to suggest exogenous humidification as an NPI for flu, and the authors said modifying humidity should be further investigated.
Sep 25 PLoS One study


PTgen pertussis vaccines found non-inferior to Tdap

Results of a phase 2/3 trial of monovalent and combined acellular pertussis vaccines show them to be non-inferior to the existing Tdap (tetanus, diphtheria, and pertussis) vaccine. Results of the trial, conducted in Thailand, are published in The Lancet Infectious Diseases.

The study included 450 adolescents who were followed for 1 year after vaccination with either two acellular pertussis vaccines containing PTgen (genetically inactivated pertussis toxin) or the standard Tdap vaccine. One of the vaccines containing PTgen was a monovalent vaccine, and the other was the same vaccine in combination with tetanus and reduced-dose diphtheria toxoids.

Fifty study participants from each group provided blood samples at 1-year follow-up to test for antibodies. The seroconversion rates for pertussis toxin neutralizing antibodies were substantially higher in participants who received the PTgen vaccines compared with Tdap (76% and 81% vs 8%).

"At 1 year after vaccination, we saw persistent antibody responses, suggesting that the vaccines containing PTgen induce longer-lasting immunity than the comparator," the authors said.
Sep 25 Lancet Infect Dis study


World leaders agree to raise $13 billion a year for TB care, prevention

Acknowledging that there hasn't been enough progress made against the world's deadliest infectious disease, heads of state and government at the United Nations (UN) General Assembly today committed to raising $13 billion a year by 2022 for tuberculosis (TB) prevention and care and an additional $2 billion for research into new TB drugs, diagnostics, and vaccines.

The commitments came at the UN's High-Level Meeting on TB, which was the culmination of an effort to get world leaders to pick up the pace in meeting global targets to end TB and ensure sufficient and sustainable funding for diagnosis, treatment, and prevention. Infectious disease experts and advocacy groups have complained that global efforts to end the TB epidemic have not been moving quickly enough, and that funding has been insufficient.

Last week, the World Health Organization's (WHO's) 2018 Global TB Report indicated that the amount of global funding for TB since 2014 has been in the range of $6 billion to $7 billion annually, an amount the agency said needs to double by 2022 to achieve the goals set out in the End TB strategy.

According to the WHO report, an estimated 10 million people were infected with TB in 2017, and 1.6 million people died from the disease. The End TB Strategy aims to reduce TB incidence by 80% and TB deaths by 90% by the year 2030.

"Today is a landmark in the long war on TB," WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said in a statement. "These are bold promises—to keep them, partnership is vital. WHO is committed to working with every country, every partner, and every community to get the job done."

The WHO says $13 billion annually will be enough to provide care for 40 million people with TB by the end of 2022, and will also enable 30 million people to get preventive treatment.

World leaders also agreed to take action against drug-resistant TB, build accountability, and end the stigma around TB that exists in many countries.
Sep 26 WHO news release

Stewardship / Resistance Scan for Sep 26, 2018

News brief

Stakeholders recommend incentivizing antibiotic development

Twelve European third-party stakeholders made recommendations for ensuring antibiotic development and the equitable availability and responsible use of effective antibiotics, focusing on new incentives, according to a commentary yesterday in Clinical Infectious Diseases.

Unlike patients or providers, third-party stakeholders represent governments, regulatory agencies and professionals working in research and development. In interviews, the 12 stakeholders emphasized the lack of sufficient financial incentives for the development of new antibiotics.

The experts, interviewed in 2016 and 2017, recommended a new model of antibiotic development, one not based on the volume of sales (which promotes overuse) but instead one that rewards the discovery of new antimicrobial agents. The stakeholders also said there was a need for "better" drugs (eg, single-dose oral regimens with fewer side effects).

The stakeholders also recommended sustained global coordination to ensure antibiotic access throughout the world, in line with the World Health Organization's Medicines and Health Products Programme Strategic Framework 2016-2030.

"The recommendations presented here should be further developed in to cross-sectoral international policies to address these challenges. Indeed, no single sector can possibly curb [antimicrobial resistance] on its own," the authors concluded.
Sep 26 Clin Infect Dis commentary


Auto-fecal transplant shown effective in stem cell transplant patients

US scientists have used auto–fecal microbiota transplantation (FMT) to successfully restore the integrity of the gut microbiome in a vulnerable population—stem cell transplant patients who receive antibiotics—according to the results of a phase 2 clinical trial published today in Science Translational Medicine.

Antibiotics wipe out beneficial bacteria vital to patients' gut microbiomes and their ability to fight infection, so the findings present a potential strategy to counter the persistent problem.

The researchers' approach aims to reestablish gut bacteria in patients who received antibiotics after a form of stem cell transplantation known as allo-HSCT. The team used a type of transplantation known as autologous FMT, which involves taking stool samples from a patient before a procedure and reintroducing them into the intestines afterward.

The investigators sequenced fecal samples from a cohort of allo-HSCT patients and confirmed that antibiotic treatment reduced microbial diversity. The scientists then gathered and froze stool samples from 25 patients who underwent allo-HSCT and performed auto-FMT on 14 of the patients after stem cell transplantation. The other 11 served as controls.

Analysis of stool samples taken over the course of a year showed that auto-FMT was associated with a higher diversity of bacterial species and restored microbial composition, an effect not seen with the 11 controls.
Sep 25 Sci Transl Med study

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