News Scan for Nov 18, 2019

News brief

Ebola sickens 4 more in the DR Congo

After 3 days with no new cases, the Democratic Republic of the Congo (DRC) today reported 4 more Ebola cases, raising the outbreak total to 3,296 illnesses, according to the World Health Organization (WHO) online Ebola dashboard.

Health officials are still investigating 422 suspected cases. Two more people died from their infections, bringing the fatality count to 2,195.

In other outbreak developments, following the Nov 14 launch of the second Ebola vaccine—the two-dose regimen (Ad26.ZEBOV, MVA-BN Filo) from Johnson & Johnson—in Goma, 147 people have received it, the DRC's Ebola technical committee (CMRE) said yesterday in its daily update. The number of people who have received Merck's VSV-EBOV vaccine since August 2018 has risen to 253,234.
WHO online Ebola dashboard
Nov 17 CMRE report

Camel contact noted in latest Saudi MERS case

Saudi Arabia's Ministry of Health (MOH) today reported one more MERS-CoV case, which involves a 71-year-old man in the city of Al Khurma in Taif region, located in the western part of the country.

An investigation found that the man had contact with camels, and his MERS-CoV (Middle East respiratory syndrome coronavirus) exposure is classified as primary, meaning he probably wasn't exposed to another sick patient.

So far this month, Saudi Arabia has reported 10 MERS-CoV cases, compared with 14 in October and 4 in September.

As of the end of October, the WHO has received reports of 2,482 cases, at least 854 of them fatal. Saudi Arabia has been by far the hardest-hit country.
Nov 18 Saudi MOH report

FDA clears duodenoscope with fewer parts needing disinfection

The Food and Drug Administration (FDA) has cleared a new type of duodenoscope that has fewer parts needing disinfection, according to an agency news release.

The Pentax Medical Video ED34-i10T2 duodenoscope, made by Pentax of America, Montvale, New Jersey, is designed to provide visualization of the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. It contains a disposable "elevator component," which is a lever that allows the operator to raise or lower accessories from the scope's tip to perform biopsies and other procedures.

"Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. "We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess."

The duodenoscope, which is threaded through a patient's mouth into the top of the small intestine, has many small working parts that can be difficult to clean. The device can trap contaminated tissue or fluid in its crevices, and if not thoroughly cleaned and disinfected it can transmit pathogens between patients, the FDA said.
Nov 15 FDA news release

Phase 4 trial in China shows 90% protection for enterovirus 71 vaccine

A phase 4 postmarketing study in China has demonstrated a 90% effectiveness and a good safety profile for of an inactivated enterovirus 71 (EV71) vaccine against hand, foot, and mouth disease (HFMD) in children under 6 years old, according to results published today in Clinical Infectious Diseases.

The large trial involved 155,995 children aged 6 months to 71 months from 70 healthcare facilities, with 40,724 receiving two doses of an inactivated EV71 vaccine 1 month apart and the rest serving as the control group. The researchers monitored the children for HFMD for 14 months after the second dose. The EV71 HFMD vaccine is licensed in China but not in the United States.

The investigators found an overall vaccine effectiveness of 89.7% (95% confidence interval, 24.0% to 98.6%), with a 4.58% rate of adverse events. Passive surveillance showed a 0.31% rate of common minor reactions.

The authors say the results are similar to those found in a phase 3 trial of the vaccine and conclude, "The clinical protection and safety of the EV71 vaccine were demonstrated in the immunization of a large population."
Nov 18 Clin Infect Dis study

Stewardship / Resistance Scan for Nov 18, 2019

News brief

Audit finds EU efforts to fight antibiotic resistance are lacking

A new report from the European Court of Auditors (ECA) argues that while some progress has been made, European Union (EU) leaders need to do more to address the health burden of antibiotic resistance.

In their assessment of the European Commission and European Centre for Disease Prevention and Control's management of key antibiotic resistance activities and resources, the auditors found that support for the "one health" approach was having some positive impacts, including more prudent use of veterinary antibiotics in most member states. But they also noted that there are big differences between the member states, that veterinary antibiotics use overall is still too high, and that gaps in collecting data and monitoring resistance in food animals and food remain. Incomplete surveillance data on hospital infections and insufficient knowledge of antibiotic-resistant pathogens in the environment were also cited as issues.

In addition, the auditors pointed out that while 99% of the EU's antibiotic-resistance budget is devoted to research, there has not yet been any breakthrough in the development of new antibiotic classes, and the specific market challenges for new antibiotics have not been addressed.

"Antimicrobial resistance is a serious threat to public health," ECA member Nikolaos Milionis said in a press release. "While there has been some progress on veterinary issues, the European Commission, together with the Member States, need to further step up their efforts to tackle this growing threat."

The report calls on the European Commission to provide more support for member state national action plans, promote better monitoring and use of veterinary antibiotics, and strengthen strategies for boosting antibiotic-resistance research.
Nov 15 ECA report
Nov 15 ECA press release

New guidance on drug-resistant TB prioritizes oral antibiotics

The American Thoracic Society (ATS), US Centers for Disease Control and Prevention (CDC), European Respiratory Society, and Infectious Diseases Society of America have published a practice guideline on treating drug-resistant tuberculosis (TB) that includes new recommendations for the choice and number of drugs in a regimen and duration of therapy, as well as the role of injectable drugs in multidrug-resistant TB (MDR-TB).

Writing in the American Journal of Respiratory and Critical Care Medicine, experts from the four organizations note that they analyzed data from 50 studies involving 12,030 patients total across 25 countries to develop the guideline.

The guideline makes clear that treatment should be tailored based on drug-susceptibility testing, and that patients should not receive medicines to which the Mycobacterium tuberculosis strain is resistant. It also prioritizes the use of oral medications.

The guideline recommends treatment with a later-generation fluoroquinolone for all infected contacts of patients who have MDR-TB, rather than watchful observation, and it provides evidence-based guidance for treating pregnant women who have MDR-TB. The experts also spell out the role of surgery in treating MDR-TB and advice for treating isoniazid-resistant TB.

"Having the participation of committee members from multiple medical societies and the CDC, as well as patient advocate perspectives, was absolutely critical to discussing the balance between desirable and undesirable health effects of interventions, making certain they were favorable for MDR-TB patients, including for children and pregnant women," said Payam Nahid, MD, MPH, chair of the guideline committee, in an ATS news release.
Nov 15 Am J Respir Crit Care Med guideline
Nov 18 ATS news release