News Scan for Jun 05, 2019

News brief

ECDC spotlights NDM-producing CRE outbreak in Tuscany region, Italy

Since November 2018, hospitals in the Tuscany region of Italy have reported 350 cases of New Delhi metallo-beta-lactamase (NDM)-producing carbapenem-resistant Enterobacteriaceae (CRE), the European Centre for Disease Prevention and Control (ECDC) reported yesterday in a rapid risk assessment.

"Due to its size and the resulting change in the epidemiology of CRE, the reported outbreak is a significant event, despite previous endemicity of Klebsiella pneumoniae carbapenamase (KPC)-producing CRE in this geographic area," the ECDC said. "The change in the type of carbapenemase further reduces treatment options because NDM-producing CRE are not susceptible to some of the new beta-lactam/beta-lactamase inhibitor combinations such as ceftazidime-avibactam and meropenem-vaborbactam."

The 350 cases were reported by seven Tuscan hospitals from November 2018 through May 2019. Of the infections, 242 are gastrointestinal, 50 bloodstream, 43 urinary tract, and 15 respiratory tract. The isolates are resistant to aminoglycosides but susceptible to fosfomycin and colistin.

The ECDC said that sporadic cases of NDM-producing CRE acquired outside of hospitals have been reported in other European countries, but cases have mostly been tied to healthcare settings. "Therefore, the risk of acquisition of NDM-producing CRE related to this outbreak is likely restricted to persons with recent healthcare," the agency said.

Response steps include further epidemiologic analysis of the cases, assessment of active surveillance for CRE carriage at the hospitals, and a meeting with hospital directors in Tuscany to relay information and reinforce infection control measures.
Jun 4 ECDC rapid risk assessment

 

Vaccitech announces launch of universal flu vaccine challenge trial

Vaccitech, a biotechnology company based in Oxford, England, today announced that it has vaccinated the first participants in a phase 2b flu challenge trials of its universal influenza A vaccine MVA-NP+M1 (VTP-100).

In a press release, the company said it is conducting the trial in Antwerp, Belgium, among 155 participants who will randomly receive VTP-100 or placebo, of which 134 will be challenged with the A/Belgium/4217/2015 H3N2 influenza virus strain. Results are expected in early 2020.

The trial has been approved by the US Food and Drug Administration (FDA) and the Belgium Regulatory Authority. The flu challenge study is partly funded by the US Department of Health and Human Services Biomedical Advances Research and Development Authority (BARDA).

Also, Vaccitech said its Australian subsidiary has finished vaccinating 2,200 participants in the first year of a phase 2b field trial designed to assess if VTP-100 may provide added protection when given as an adjunct to current licensed quadrivalent seasonal flu vaccines.

The company—a University of Oxford spin-off—is developing the VPT-100 both as a prepandemic vaccine and an add-on to a seasonal vaccine, especially in people at high risk for flu complications. The vaccine targets MVA, a replication-deficient pox virus vector that has been shown to prompt a strong immune response against matrix 1 (M1) and nucleoprotein (NP) flu antigens, which are highly conserved among influenza A subtypes.
Jun 5 Vaccitech press release

 

FDA approves storage change for Emergent's oral cholera vaccine

Emergent BioSolutions yesterday announced that the FDA has approved a change in storage conditions for Vaxchora, its oral cholera vaccine. The step allows storage of the vaccine to shift from frozen to refrigerated at 2°C to 8°C (35.6°F to 46.4°F).

In a statement, the company also said the FDA's approval allows the transfer of bulk drug substance manufacturing from Emergent's product development facility in San Diego to its manufacturing facility in Bern, Switzerland. It also covers labeling changes related to the two developments.

Vaxchora is the only FDA-licensed vaccine to prevent Vibrio cholerae serogroup O1.

Sean Kirk, Emergent's executive vice president of manufacturing and technical operations, said in the statement, "Emergent is pleased with this FDA approval that enables a more robust supply chain process for our oral cholera vaccine and maximizes capacity utilization of our manufacturing facilities." He added that the step also better positions the company for a 2020 launch of the vaccine in Europe.
Jun 4 Emergent BioSolutions press release

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