News Scan for Oct 04, 2018

New Saudi MERS case
Baloxavir benefits for high-risk groups
Oral flu vaccine trial
Coconut Salmonella outbreak

Saudi MOH records new MERS case in Najran

The Saudi Arabian Ministry of Health (MOH) today recorded a new case of MERS-CoV for epidemiologic week 40, which is this week.

A 49-year-old man from Najran was diagnosed as having  MERS-CoV (Middle East respiratory syndrome coronavirus). The MOH said the man was hospitalized and likely exposed to the virus in a community setting. He had not reported recent contact with camels, a known risk factor.

The new case raises the global number of MERS-CoV cases reported since 2012 to 2,255 cases, at least 800 of them fatal, according to data from the World Health Organization.
Oct 4 MOH update


Study: New antiviral shortens flu symptoms in high-risk patients

The novel antiviral baloxavir marboxil shortened flu symptoms in people at high risk for flu complications, according to the latest phase 3 trials findings from the drug's developer Roche, according to a statement today. The company said it will detail the results on Oct 6 in a presentation during the IDWeek meeting in San Francisco.

The drug (Xofluza) was discovered in Japan by Shionogi, and earlier this year, Japan's health ministry approved it. In June, the US Food and Drug Administration (FDA) granted fast-track approval for the drug. In early September, results from phase 2 and 3 trials published in The New England Journal of Medicine suggested that baloxavir reduced flu symptoms by about a day and also found that the drug showed superior antiviral activity to oseltamivir .

The latest trial included people at high risk for flu complications, including adults age 65 and older and those with underlying health conditions such as asthma, chronic lung disease, morbid obesity, or heart disease. When compared to placebo, baloxavir significantly reduced the time to improvement of flu symptoms. The median time was 73.2 hours compared to 102.3 hours, similar to the two earlier studies, and the drug was well-tolerated with no new safety signals.

Sandra Horning, MD, Roche's chief medical officer and head of global product development, said in the statement, "This study adds to the growing body of evidence supporting baloxavir marboxil as a potential first-in-class antiviral flu treatment, and we plan to discuss these data with health authorities around the world."

The investigational drug, the first to be available as a single-dose treatment, represents the first new antiviral class in nearly 20 years. Roche said the FDA is expected to make its approval decision by Dec 24.
Oct 4 Roche press release
Sep 5 CIDRAP News story "New single-dose antiviral cuts flu symptoms, viral loads"


Phase 2 flu challenge finds mucosal protection for oral flu vaccine tablet

Vaxart, a biotechnology company based in South San Francisco, today announced the latest phase 2 flu challenge study findings for its oral tablet recombinant H1 flu vaccine, which suggest that it generates a strong mucosal immune response when compared to the Fluzone injectable quadrivalent flu vaccine. In a press release, the company said it would detail the findings on Oct 6 at the IDWeek meeting in San Francisco.

Sean Tucker, PhD, Vaxart's chief scientific officer, said in the statement that the vaccine elicited a significant expansion of mucosal homing receptor (β7+) plasmablasts to about 60% of all activated B cells, compared to Fluzone, which maintained a 20% baseline level. "We believe these β7+ plasmablasts are a key indicator of a protective mucosal immune response and a unique feature of our oral recombinant vaccines," he said. Tucker said the study found that the vaccine generates protective hemagglutinin inhibition (HAI) antibodies like conventional flu vaccines, but primary protection is through the mucosal mechanism, which provides a 39% reduction in illness compared to placebo. He said by comparison, Fluzone provided a 27% reduction in illness versus placebo, protecting primarily though HAI antibodies.

Wouter Latour, MD, Vaxart's chief executive officer, said mucosal immunity is the first line of defense against mucosal infections, and oral vaccines based on the company's system could help protect against a range of health threats, including flu, norovirus, and RSV.

The phase 2 study was supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services.
Oct 4 Vaxart press release
Oct 30, 2017, CIDRAP News scan "Vaxart's oral flu vaccine tablet shows promise in human challenge trial"


Scientists describe probe of first coconut-linked Salmonella outbreak

An investigation into clusters of Salmonella Chailey infections in the United States and Canada in 2017 found that the culprit was precut coconut pieces from a grocery chain, marking the first time coconut has been linked to a Salmonella outbreak in either country. Officials from the US Centers for Disease Control and Prevention (CDC) and their partners in Oregon and Canada reported their findings today in the latest issue of Morbidity and Mortality Weekly Report (MMWR).

Following the outbreak, two other outbreaks from different Salmonella subtypes have been reported in the United States, one involving dried coconut and the other frozen shredded coconut.

In early May of 2017, the CDC's PulseNet system identified a cluster of 14 matching isolates that had a rare pulsed-field gel electrophoresis (PFGE) pattern. Later that month, Canadian officials said they were investigating five Salmonella Chailey infections in British Colombia with the same PFGE pattern. Whole-genome sequencing found that all cases were highly related.

Patient interviews suggested the source was precut coconut pieces from one grocery store chain, and trace-back investigations in the United States and Canada implicated a single lot of the food imported from Indonesia, received frozen and repacked into smaller tubs for sale in the produce department, as the outbreak source. The authors said the grocery chain voluntarily recalled the coconut from their stores, which probably limited the outbreak's size and scope.

The group said recent Salmonella outbreaks have been caused by foods not typically associated with the bacteria, and they noted that yellowfin tuna imported from Indonesia in 2010 had the same PFGE pattern, providing more support that a food product from Indonesia was the source of the outbreak.

"In light of this finding, public health officials might consider raw coconut in investigations of Salmonella outbreaks among consumers of fresh foods," the authors wrote.
Oct 5 MMWR report

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