News Scan for Jul 02, 2020

News brief

Fatal Ebola case reported in latest DRC outbreak

One more Ebola case has been confirmed in an outbreak in the Democratic Republic of the Congo's (DRC's) Equateur province, raising the total to 34, according to a statement from the country's multisectoral Ebola technical committee (CMRE).

The patient is from Mbandaka, the provincial capital, and apparently died from his or her infection. The death raises the outbreak total to 14. A small but steady stream of cases continues to be reported in the outbreak, the DRC's 11th, which was first detected in early June.

In another Ebola development, the European Commission yesterday approved Johnson & Johnson's two-dose Ebola vaccine known as Ad26.ZEBOV/MVA-BN-Filo. The announcement follows a recommendation from the European Medicines Agency (EMA) in late May that the vaccine be approved. The European Commission usually follows the EMA recommendations.

The vaccine, the second to be approved for Ebola alongside VSV-EBOV, was introduced for use in the DRC in November 2019 as part of a clinical trial. The vaccine's two doses are given 8 weeks apart.
Jul 2 CMRE report
Jul 1 European Commission press release

 

Review details protocols for decontamination, reuse of N95 respirators

Amid scarcity of N95 respirators for healthcare workers due to the COVID-19 pandemic, exposure to ultraviolet light, microwave steam, dry oven heat, ethylene oxide, or vaporized hydrogen peroxide, as well as allowing 72 hours for the virus to become nonviable before reuse, appear to be feasible options for decontamination, according to a review published today in JAMA Otolaryngology-Head & Neck Surgery.

Led by researchers from the University of California, Los Angeles, the literature review comprised studies of N95 respirator decontamination methods published from 2009 to 2020. Noting that N95 respirators are manufactured for single use and thus are vulnerable to contamination and structural degradation, the authors said that only respirators without gross viral exposure and worn under a face shield or another surgical mask should be considered for decontamination and reuse.

The researchers recommend that healthcare workers wash their hands before and after donning and doffing the respirators and refrain from touching them while in use. They advise against sterilization with bleach, alcohol, or soap and water, as bleach imbues a toxic odor, and alcohol and soap and water significantly reduce filtration efficiency.

The authors, who provide detailed decontamination protocols using different methods, caution that each method has its advantages and disadvantages and that, due to the wide variation in manufacturing and materials used in N95 respirators, their findings may not apply to all of them.
Jul 2 JAMA Otolaryngol Head Neck Surg  

 

Pfizer, BioNTech release encouraging data on COVID vaccine candidate

Pfizer and BioNTech yesterday released data on a phase 1/2 trial that showed some promising results for their investigational COVID-19 vaccine candidate.

The study, published on the preprint server medRxiv and not yet peer reviewed, was conducted in 45 healthy volunteers randomly assigned to receive either two doses of BNT162b1—one of four mRNA vaccine candidates the companies are investigating—at different dose levels (10 μg and 30 μg) on days 1 and 21 or one 100 μg dose on day 1. Nine volunteers received a placebo. The study population consisted of men and nonpregnant women aged 19 to 54 years.

Receptor binding domain (RBD)–binding immunoglobulin G (IgG) and SARS-CoV-2 neutralizing titers were assessed at baseline and at 7 and 21 days after the first dose and 7 days and 14 days after the second dose.

A clear dose-level response was observed after doses 1 and 2, with RBD-binding IgG concentrations detected 21 days after the first dose and substantially increased concentrations detected after the second dose of 10 μg and 30 μg. After the first dose in 10-μg recipients, the RBD-binding IgG geometric mean concentrations (GMCs) were similar to those observed in 38 convalescent serum samples obtained from COVID-19 patients.

After the second dose with 10 μg or 30 μg, the RBD-binding IgG GMCs were 8- to 50-fold higher than in the convalescent serum samples. At day 21 after the single dose of 100 μg, the RBD-binding IgG GMCs were three times that of the convalescent serum samples but did not increase after that.

Neutralization titers were measurable after a single vaccination at day 21 for all dose levels. At Day 28 (7 days after dose 2), the virus-neutralizing geometric mean titers (GMTs) at 10 µg and 30 µg were, respectively, 1.8-fold and 2.8-fold the GMT of the convalescent serum panel.

Adverse reactions included pain at the injection site and low-grade fever, and reactions were more common after the second dose at 10 µg and 30 µg. Given that more volunteers in the 100-µg group experienced adverse reactions without a significant increase in immunogenicity, they were not administered a second dose.

"These clinical findings for the BNT162b1 RNA-based vaccine candidate are encouraging and strongly support accelerated clinical development and at-risk manufacturing to maximize the opportunity for the rapid production of a SARS-CoV-2 vaccine to prevent COVID-19 disease," the authors concluded.
Jul 1 medRxiv study

 

Study finds increased risk of stroke in COVID-19 patients

Patients with COVID-19 appear to have a higher risk of acute ischemic stroke than influenza patients, researchers with Weill Cornell Medicine in New York reported today in JAMA Neurology.

In a retrospective cohort study conducted at two New York City hospitals, the researchers compared the rate of ischemic stroke between adult patients with emergency department (ED) visits or hospitalizations for COVID-19 from Mar 4 to May 2 and patients hospitalized with flu from January 2016 through May 2018.

While some data have emerged from New York, China, and France that raise the possibility of increased risk of stroke in COVID-19 patients, the previous studies have lacked an appropriate control group. Flu patients were selected as contros because flu is a known stroke risk factor. A panel of neurologists reviewed the medical records to adjudicate a final diagnosis of acute ischemic stroke.

Among the 1,916 patients with ED visits or hospitalizations for COVID-19, 31 had an acute ischemic stroke (1.6%; 95% confidence interval [CI], 1.1% to 2.3%). Median duration from COVID-19 symptom onset to stroke was 16 days. Median age of COVID-19 and stroke patients was 69 years. More than one third of strokes occurred in patients with severe COVID-19. In comparison, 3 of 1,486 patients with flu (0.2%; 95% CI, 0.0% to 0.6%) had an acute ischemic stroke. Median age of flu patients with stroke was 62 years.

After adjustment for age, sex, and race, the likelihood of stroke was more than seven times higher in COVID-19 patients (odds ratio, 7.6; 95% CI, 2.3 to 25.2). The association persisted across sensitivity analyses that adjusted for vascular risk factors, viral symptoms, and intensive care unit admission, with the magnitude of relative associations ranging from 4.0 to 9.3.

The authors of the study suggest several possible explanations for the link between COVID-19 and stroke, including a vigorous inflammatory response accompanied by coagulopathy, heightened risk of medical complications that contribute to the risk of ischemic stroke, and a severe respiratory syndrome observed in flu.

"These findings suggest that clinicians should be vigilant for symptoms and signs of acute ischemic stroke in patients with COVID-19 so that time-sensitive interventions, such as thrombolysis and thrombectomy, can be instituted if possible to reduce the burden of long-term disability," the authors conclude.
Jul 2 JAMA Neurol study

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