News Scan for Oct 04, 2021

News brief

FDA clears new rapid molecular test for antibiotic resistance genes

Diagnostics company OpGen announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a new rapid molecular diagnostic tool that could aid in treating antibiotic-resistant or non-susceptible infections.

The Acuitas AMR Gene Panel detects 28 genetic antibiotic resistance markers in bacterial isolates from 26 different pathogens, according to a company press release, and can rapidly and simultaneously test for resistance to select drugs in nine antibiotic classes. OpGen, of Rockville, Maryland, says it's the broadest AMR panel cleared by the FDA.

"The benefits of this AMR panel for predicting antibiotic resistance include the provision of genomic profile data much sooner in about 2.5 hours versus conventional phenotypic information which can take 1-4 days, supports the goal of antimicrobial stewardship, institution of infection control and prevention measures, and alerts the provider to resistant genes representing nine classes of antibiotics," James Snyder, PhD, director of microbiology and molecular diagnostics at the University of Louisville Hospital, said in the release.

OpGen says it plans to launch the device before the end of the year.
Oct 4 OpGen press release

 

WHO: Risk of spread high in Nigeria's yellow fever outbreak

A yellow fever outbreak in Nigeria, under way since November 2020, has led to 1,321 suspected cases across all 36 of its states, as well as the Federal Capital Territory that includes Abuja, the country's capital, the World Health Organization (WHO) said in a recent update.

The yellow fever outbreak is part of ongoing activity since 2017. In the latest outbreak, of 45 blood samples sent to the Pasteur Institute in Dakar, 31 were positive based on plaque reduction neutralization testing. Of those, 12 were vaccinated and 19 were unvaccinated and were from 7 different states. Two deaths were reported among the unvaccinated group.

Nigeria has gaps in immunity against yellow fever, with a 2020 estimate suggesting that national immunization coverage was 54%, well below the 80% threshold needed to protect against outbreaks. The WHO said other factors include poor performance of reactive mass immunization activities and suboptimal surveillance.

The risk of spread is high due to those factors and challenges responding to other outbreaks such as COVID-19, Lassa fever, and cholera. "Additionally, the recent relaxation of COVID-19 measures could increase population mobility and the potential risk for spreading yellow fever to urban areas," the WHO said.

Nigeria is a priority country for vaccination, and preventive campaigns are being implemented in six phases with a goal of completing the steps by 2024. The WHO urged countries to take steps to keep travelers safe and aware of yellow fever symptoms and the need to quickly seek care if sick. The US Centers for Disease Control and Prevention (CDC) has instituted an alert level 2 (practice enhanced precautions) for people traveling to Nigeria.
Oct 1 WHO outbreak update
CDC travel notice for Nigeria

 

Dynavax, DoD advance next-generation plague vaccine

Dynavax Technologies, a pharmaceutical company based in Emeryville, California, today announced that it has executed an agreement with the US Department of Defense (DoD) worth $22 million over 30 months to develop a recombinant adjuvanted vaccine against plague.

The agreement covers a phase 2 clinical trial, slated to begin in 2022, that combines Dynavax's CpG 1018 adjuvant with the DoD's rF1V vaccine, according to a company statement.

Ryan Spencer, Dynavax's chief executive officer, said the CpG 1018 adjuvant is used in a two-dose hepatitis B vaccine approved by the FDA. Multiple late-stage COVID-19 vaccine candidates also use the adjuvant.

Col. Ryan Eckmeier, with the DoD, said the military hopes the vaccine will protect service members with fewer doses administered over a shorter period.

As part of the agreement, the company would also submit an investigational new drug application to the FDA and generate more clinical trial results to add to its existing data. Plague is caused by Yersinia pestis found in fleas and rodents. The bacterium can cause the often-deadly pneumonic form of plague, and aerosolized Y pestis is considered a bioterror threat.
Oct 4 Dynavax press release

COVID-19 Scan for Oct 04, 2021

News brief

Model predicts natural COVID-19 immunity wanes fast, re-infection likely

Reinfection from SARS-CoV-2 under endemic conditions will most likely occur at a median of 16 months, according to a modeling study published late last week in The Lancet Microbe.

The researchers looked at the human-infecting coronaviruses SARS-CoV-2, SARS-CoV, MERS-CoV, HCoV-229E, HCoV-OC43, and HCoV-NL63 from Feb 12 to Jun 15, 2020, analyzing about 58 alphacoronavirus, 105 betacoronavirus, 11 deltacoronavirus, and 3 gammacoronavirus genome sequences. They compared peak-infection and reinfection data in endemic scenarios. The method also used antibody optical density data spanning 128 days to 28 years post-infection from 1984 to 2020.

According to the model they derived from the data, reinfection by SARS-CoV-2 under endemic conditions would likely occur from 3 months and 5.1 years after peak antibody response, with a median of 16 months. This is less than half the time for other endemic human-infecting coronaviruses (e.g., HCoV-OC43 was associated with 15 months to 10 years). Even for SARS-CoV, the virus that causes SARS and is closest in time range, the model projected a range of 4 months to 6 years.

"Reinfection can reasonably happen in three months or less," said lead author Jeffrey Townsend, PhD, in a University of North Carolina (UNC) at Charlotte press release. "Therefore, those who have been naturally infected should get vaccinated. Previous infection alone can offer very little long-term protection against subsequent infections."

The study author conclude, "Our results caution that reinfection will become increasingly common as pandemic disease transitions into endemic disease."
Oct 1 Lancet Microb study
Oct 1 UNC at Charlotte press release

 

Screen time, physical activity linked to youth mental health in pandemic

More screen time and suboptimal physical activity during the pandemic were linked to more mental health difficulties in US children ages 6 to 17, according to a JAMA Network Open study late last week.

The researchers looked at survey data regarding mental health, COVID family impact, and physical activity among 1,000 children from Oct 22 to Nov 2, 2020, with parents filling out all information for those 6 to 10 years and supplemental information for older children. Out of the cohort, 52.7% were boys and 31.6% were not White. Half (50.6%) attended school virtually, 22.2% attended it online, and 27.2% had a hybrid arrangement.

About one in five children (20.9%) had at least 60 minutes of physical activity every day, but 8.4% didn't reach that benchmark any day of the week (average, 3.9 days). Children also reported an average of 4.4 hours per day of recreational screen time.

After accounting for COVID-19 stressors, more screen time was associated with higher total difficulties among younger and older children (beta coefficients, 0.3 and 0.4, respectively). Engaging in 7 days per week of physical activity compared with 0 was linked with fewer externalizing symptoms (those affecting others) in younger children. In older children, at least 1 day of physical activity was linked with fewer externalizing and internalizing (affecting the child, not others) symptoms.

Behavioral issues and hyperactivity were considered externalizing symptoms, while emotional issues were considered internalizing symptoms. Overall, 13.7% of the children were being evaluated or were diagnosed as having anxiety, 10.4% depression, 15.0% attention-deficit hyperactivity disorder, and 11.4% a behavioral problem.

"Notably, children who were exposed to more pandemic-related stressors engaged in less physical activity and had more screen use than their peers who were less exposed," the researchers write. "Better health behaviors, in turn, were associated with better mental health, even when accounting for differences in exposure to pandemic-related stressors and demographic factors."

They added that, while middle schoolers and high schoolers engaged in less physical activity, even 1 day a week of physical activity was associated with better mental health.
Oct 1 JAMA Netw Open study

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