News Scan for Aug 01, 2018

News brief

Zika immune globulin treatment trial launches

Yesterday Emergent BioSolutions announced the start of a phase 1 clinical trial for ZIKV-IG, the company's anti-Zika virus immune globulin. The double-blind, randomized, and placebo-controlled clinical study will enroll about 30 healthy volunteers at a single site.

The US Food and Drug Administration (FDA) granted fast-track designation to ZIKA IG in December of 2017. ZIKA-IG is a purified human immunoglobulin which contains Zika-neutralizing antibodies. Emergent BioSolutions has applied similar immunoglobulin and antibody technology to products aimed at treating anthrax bacteria and vaccinia virus.

"Our program, initiated in 2017, seeks to accelerate development of a Zika-specific immune globulin that leverages our proven platform technology, four decades of patient experience with hyperimmunes, and core competencies in advanced development and manufacturing," said Laura Saward, PhD, senior vice president and antibody therapeutics business unit head at Emergent BioSolutions in a press release.
Jul 31 Emergent BioSolutions press release

Third case of H9N2 reported in China

A woman from Shenzhen is the third human case of H9N2 avian influenza recorded in China this year, according to Avian Flu Diary (AFD), an infectious disease news blog. The blog published a translated notice of the case from Macao's Government Information Bureau.

Officials in Guandong Province confirmed the case in a 24-year-old woman who was hospitalized on Jul 23 after symptoms began 2 days earlier.

There is no mention of poultry exposure in the case notice, but most cases of H9N2 occur after human-bird contact, and most resolve after mild illness. The two cases reported earlier this year involved a child from Guangdong province and a woman Beijing.

Only three countries, China, Pakistan, and Egypt, have reported human cases of H9N2 in the past 20 years.
Aug 1 AFD post
Mar 19 CIDRAP News scan "Three H9N2 infections reported in China"

Foodborne Disease Scan for Aug 01, 2018

News brief

FDA: New testing method turns up Cyclospora in salad mix distributed to McDonald's

The US Food and Drug Administration (FDA) announced yesterday that tests involving a newly validated method to detect Cyclospora in fresh produce have confirmed the parasite in an unused package of expired salad mix processed by Fresh Express in Streamwood, Ill., that had been distributed to McDonald's. A multistate Cyclospora outbreak linked to McDonald's salads as of Jul 26 has sickened 286 people from 15 states.

The salad mix contained romaine lettuce and carrots, and its expiration date of Jul 19 had already passed. On Jul 27, the FDA notified Fresh Express of the results and asked it to determine if the potentially contaminated product may still be on the market. The company said romaine from the same lot was not packaged for direct retail sale and had already expired and that it would use recall procedures to inform companies that received potentially contaminated products. It said the carrots in the sampled salad mix only went to McDonald's.

Earlier this week, the US Department of Agriculture's Food Safety and Inspection Service issued a public health alert for beef, pork, and poultry salad and wrap products distributed by Caito Foods due to possible Cyclospora contamination. The FDA said Fresh Express had notified Caito Foods that the chopped romaine in the products was being recalled.

McDonald's has stopped using Fresh Express salad mix at impacted restaurants in fourteen states: Illinois, Iowa, Indiana, Wisconsin, Michigan, Ohio, Minnesota, Nebraska, South Dakota, Montana, North Dakota, Kentucky, West Virginia, and Missouri.

The FDA said in 2015 it set up a work group to prioritize the development, validation, and implementation of a method for detecting Cyclospora in fresh produce. The FDA said it began using the newly validated Cyclospora testing method this year. "The availability of this method is a significant advancement in FDA's ability to investigate outbreaks of cyclosporiasis and identify the parasite in food," it said, adding that its investigation continues as it reviews distribution and supplier information for romaine and carrots.
Jul 31 FDA Cyclospora outbreak update
Jul 31 CIDRAP News scan "FSIS issues warning about Cyclospora risk in sandwich wraps"

Salmonella outbreak tied to pasta salad expands to 79 cases from 9 states

In an update today on a Salmonella outbreak linked to pasta salad from Hy-Vee grocery stores, the US Centers for Disease Control and Prevention (CDC) said it has received 58 more illness reports, raising the total to 79. Also, four more states (Illinois, Kansas, North Dakota, and Tennessee) reported cases, lifting the affected number of states to nine.

In another new development with the outbreak, health officials are also tracking Salmonella enterica subspecies IIIb, because two people were infected with the strain alongside the Salmonella Sandiego outbreak strain. The CDC's PulseNet database, a national subtyping network, identified six more people infected with Salmonella enterica IIIb, and the cases have been added to the outbreak total.

So far,18 people have been hospitalized and no deaths have been reported. The latest illness onset was Jul 15.

The CDC first announced the outbreak on Jul 18. Hy-Vee recalled the pasta salad sold in eight states on Jul 17. It contained shell pasta, carrots, celery, cucumbers, green pepper, onion, and mayonnaise.
Aug 1 CDC outbreak update