News Scan for Apr 24, 2018

News brief

Lawmakers air pros, cons of shifting stockpile oversight to ASPR

The Trump administration plan to shift oversight of the nation's Strategic National Stockpile (SNS) and its $575 million budget from the Centers for Disease Control and Prevention (CDC) to the Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) is set to occur in October, but some observers worry that the plan could impede deployment when supplies are needed and that decisions to acquire products might become more politicized, the Washington Post reported today.

Administration officials have said the change is being made to streamline operations, but lawmakers raised concerns about the impending change at an Apr 18 oversight hearing on HHS biodefense activities before the House Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. According to the report, currently ASPR awards contracts to companies that develop and make medicines and the CDC purchases and replenishes the materials. However, when the change takes place, ASPR will both chose and purchase the products.

According to the Post, some public health officials and bipartisan members of Congress raised concerns about how the change might affect the complex interplay between the federal government and the groups that distribute SNS materials: state and local health departments.

Other experts quoted in the story, however, said consolidating the purchasing and maintenance of the SNS at ASPR makes sense and could boost its ability push for more funding.
Apr 24 Washington Post story
Apr 18 House oversight hearing materials

Nigeria's Lassa fever outbreak shows more signs of slowing

In its latest Lassa fever outbreak update, Nigeria's Centre for Disease Control (NCDC) reported one new confirmed case, the lowest weekly total since January.

From Jan 1 to Apr 22, the NCDC has confirmed 416 Lassa fever cases, along with 105 deaths. The case-fatality rate is 25.2 %. Aside from the new case, which appears to involve a health worker infected at a private facility in Edo state, the total includes two retrospective cases from the same state. So far, 37 healthcare workers from eight states have been sickened in the outbreak.

Only three people are still hospitalized for treatment, which the NCDC said is the lowest since the outbreak began.

The World Health Organization (WHO) Regional Office for Africa said today in a weekly disease and health emergencies update that although the general trend with Lassa fever in Nigeria is encouraging, the peak transmission season isn't over, so authorities should stay vigilant.

Lassa fever is endemic in Nigeria, and though it is mainly transmitted by rats, human spread can occur from contact with infected bodily fluids.
Apr 22 NCDC report
Apr 22 WHO report

Pfizer gets FDA priority review for meningococcal B vaccine in young kids

Pfizer announced yesterday that the US Food and Drug Administration (FDA) has approved its request for breakthrough therapy designation for its meningococcal group B vaccine (Trumenba) in children ages 1 though 9 years, a way of granting priority review if early clinical trials signal that the therapy may offer substantial benefits over existing treatments for patients with serious—including life-threatening—medical conditions.

In a press release, Pfizer said that when the FDA approved Trumenba as the first meningococcal B vaccine in October 2014, it required the company to assess the safety and effectiveness in children as young as 1 year. The company has completed phase 2 studies in this age-group, and that data supported its request for breakthrough therapy designation. Trumenba had previously received breakthrough therapy designation for preventing Neisseria meningitidis meningococcal B illness in children and young adults ages 10 through 25 years.

Luis Jodar, PhD, chief medical and scientific affairs officer in Pfizer's vaccine development unit, said despite occurrence of invasive serogroup B disease in children ages 1 through 9, there is no vaccine licensed in the United States for the age-group. "We look forward to working closely with the FDA toward our goal to extend the range of individuals who may benefit from immunization with Trumenba," he added.

In 2017, the FDA expanded the approval of Trumenba to include children as young as 10 based on a three-dose schedule, but the vaccine can be administered as a two- or three-dose schedule based on exposure risk. Pfizer said a study to confirm the effectiveness of a two-dose schedule is ongoing.
Apr 23 Pfizer press release

Stewardship / Resistance Scan for Apr 24, 2018

News brief

ECDC urges adapting Candida auris lab testing, early control measures

In an updated risk assessment on Candida auris, an emerging difficult-to-treat fungus that can spread in healthcare settings, the European Centre for Disease Prevention and Control (ECDC) said yesterday that the rising number of cases in Europe is concerning because of problems with lab identification and overall lack of awareness.

The antimicrobial-resistant fungus, first reported in Japan, has spread to five continents, and the ECDC said that from 2013 through 2017, 620 cases have been reported in six European countries. The illnesses are often resistant to multiple classes of antifungal medications. The ECDC published an initial risk assessment in December 2016.

In a press release, Dominique Monnet, PharmD, PhD, who leads the ECDC's Antimicrobial Resistance and Healthcare-associated Infections Disease Program, said there's a need to raise awareness in European health facilities, so they can adapt lab testing strategies and implement control measures early enough to stem more hospital outbreaks.

"The occurrence of new outbreaks can be expected. It is therefore of concern that some countries lack national laboratory reference capacity for mycology, or have no information on Candida auris cases available at national level," he said.
Apr 23 ECDC press release
Apr 23 ECDC risk assessment

Antimicrobial resistance evolution tied to regulatory gene

Researchers from Oxford University have uncovered the genetic catalysts behind antibiotic resistance evolution. The work was published yesterday in Nature Ecology & Evolution.

The scientists tested the hypothesis that different bacteria develop resistance at different rates by challenging species of the Pseudomonas genus—bacteria that cause disease in humans, animals, and plants—with the antibiotic ceftazidime.

They found that different species of Pseudomonas developed resistance to ceftazidme at different rates because of the actions of a master regulatory gene, called ampR.

"Species that carry the ampR gene evolve resistance at a higher rate than species that lack this gene," said lead author Craig MacLean, PhD, from Oxford's department of zoology, in a press release. "ampR has this effect because it makes it easier for random mutations to increase the expression of antibiotic resistance genes."

The researchers then blocked the development of ampR in P aeruginosa with an enzyme inhibitor called avibactam. When used with ceftazidime, avibactam helped slow antibiotic resistance, a technique, the authors said, that will need to be replicated in in-vivo experiments.
Apr 23 Nat Ecol Evol study
Apr 23 University of Oxford press release