Study finds 11-fold hike in COVID-linked inflammatory syndrome in UK kids
A multicenter observational study published late last week in The Lancet Child & Adolescent Health identified 78 cases of the pediatric inflammatory multisystem syndrome tied to COVID-19 in the United Kingdom from Apr 1 to May 10—at least 11 times more than expected.
Analyzing data from the largest known cohort of patients admitted to pediatric intensive care units (PICUs), researchers compared rates of admissions to PICUs with historical trends for four similar inflammatory diseases: Kawasaki disease, toxic shock syndrome, hemophagocytic lymphohistiocytosis, and macrophage activation syndrome.
Twenty-one of 23 PICUs reported 78 cases total of the multisystem inflammatory syndrome, otherwise known as pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2, the virus that causes COVID-19 (PIMS-TS).
Data from 2015 to 2019 revealed a mean of one admission per week for all four similar inflammatory diseases, compared with, on average, 14 admissions per week for PIMS-TS and a high of 32 admissions per week during the study period.
Median patient age was 11 years, and boys (52 of 78 [67%]) and ethnic minorities (61/78 [78%] were overrepresented. The most common signs and symptoms were fever (78 [100%]), shock (68 [87%]), stomach pain (48 [62%]), vomiting (49 [63%]), and diarrhea (50 [64%]).
Twenty-eight of 78 children (36%) had coronary artery abnormalities such as aneurysms (weakening and enlargement of an artery wall) and echogenicity (abnormal cardiac ultrasound findings). Sixty-five children (83%) needed medications to regulate their blood pressure, 36 (46%) required invasive mechanical ventilation, 3 (4%) needed oxygen added to their blood outside their body, and 2 (3%) died.
The authors noted that this emerging condition might have a social impact. "Until now, the risk of serious illness resulting from COVID-19 in children has been thought to be negligible: even though the risk is still low, there are implications for health-care resources and balancing the need for adult and paediatric intensive care units," they wrote. "Our data also have important implications for any future peaks of PIMS-TS, especially if the rise in cases coincides with a winter surge of other viral infections."
Jul 9 Lancet Child Adolesc Health study
FDA grants fast track designation to two COVID-19 vaccine candidates
Pfizer and BioNTech announced today that the US Food and Drug Administration (FDA) has granted fast track designation to two of the companies' vaccine candidates for SARS-CoV-2, the virus that causes COVID-19.
The two candidates—BNT162b1 and BNT162b2—are the most promising of the four investigational mRNA vaccines the companies are developing. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.
Recent data from a phase 1/2 trial of BNT162b1 published on the preprint server medRxiv but not yet peer-reviewed showed promising early results. More data from a German trial of BNT162b1 is expected later this month.
The FDA's fast track designation allows for expedited review of investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need.
"We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward," BioNTech Chief Medical Officer Ozlem Tureci said in a company press release.
The companies say they that if they receive regulatory approval, they expect to start a phase 2b/3 trial as soon as later this month. They anticipate enrolling as many as 30,000 participants.
Jul 13 BioNTech press release
In other COVID-19 vaccine-related developments, the National Institutes of Health (NIH) announced last week that it has established a new clinical trials network that aims to enroll thousands of volunteers in large-scale trials testing investigational vaccines and monoclonal antibodies.
The COVID-19 Prevention Trials Network (COVPN) is part of Operation Warp Speed, the US Department of Health and Human Services-led effort to develop, manufacture, and distribute COVID-19 vaccines, therapeutics, and diagnostics. The network will operate more than 100 clinical trial sites across the United States and use a harmonized vaccine protocol to enable analyses of correlates of protection across multiple vaccine trials.
The first phase 3 vaccine trial that COVPN is expected to conduct will test the mRNA-1273 vaccine developed by National Institutes of Allergy and Infectious Disease scientists in collaboration with Moderna.
Jul 8 NIH press release
Strokes with COVID more severe, tied to higher rates of death, disability
Ischemic strokes linked to COVID-19 are more severe, lead to worse functional outcomes, and are associated with a higher rate of death, according to a study published late last week in Stroke.
Researchers compared the data of 174 patients with COVID-19 and ischemic stroke treated at 28 healthcare centers in 16 countries from Jan 27 to May 19 with those of 156 matched patients with stroke alone from a Swiss stroke registry from 2003 to 2019.
Patients with the novel coronavirus had more severe strokes, with a median National Institutes of Health Stroke Scale score of 10, versus 6 in those without COVID-19. Coronavirus patients were at higher risk of serious disability after stroke, with a modified Rankin score of 4, versus 2 in non-coronavirus patients. Of 96 surviving COVID-19 patients with disability status data, 49 (51%) had severe disability at hospital release.
COVID-19 patients were also more likely to die; 48 of 174 patients (28%) died, 22 of them due to coronavirus and 26 due to stroke. Median patient age was 71 years, and 38% of the 174 coronavirus patients were women.
The authors said that worse outcomes in COVID-19 patients may be attributed to the more severe strokes in that group and called for further research on the underlying mechanisms of stroke in coronavirus patients and prehospital and in-hospital stroke pathways during this and future pandemics.
"The broad, multi-system complications of COVID-19, including acute respiratory distress syndrome, cardiac arrhythmias, acute cardiac injury, shock, pulmonary embolism, cytokine release syndrome and secondary infection, probably contribute further to the worse outcomes including higher mortality in these patients," they said in a news release from the American Heart Association, which publishes Stroke under its American Stroke Association division.
Jul 9 Stroke abstract
Jul 10 American Heart Association news release
Study: One third of young adults at risk for severe COVID-19 infections
As many as 33% of US men ages 18 to 25 and 30% of women are at risk for serious complications from COVID-19 infections, according to a new study from the University of California- San Francisco (UCSF), published today in the Journal of Adolescent Health. The risk is related to smoking, including the use of e-cigarettes.
To conduct the study, researchers compared and contrasted data from the Centers for Disease Control and Prevention’s list of conditions and associated behaviors linked to COVID-19 disease and death (eg, smoking, heart conditions, diabetes, current asthma, immune conditions) with answers from the National Health Interview Survey (NHIS), a nationally representative data set with pooled data from 2016 to 2018.
Overall, the authors said medical vulnerability for severe COVID-19 outcomes was 32% for the full sample of 8,405 young adults and half that (16%) for the nonsmoking sample. According to the NHIS, over the previous 30 days, 11% of the young adults polled had smoked a cigarette, 5% had smoked a cigar product, and 7% had smoked an e-cigarette.
"The risk of being medically vulnerable to severe disease is halved when smokers are removed from the sample," senior author Charles Irwin, Jr., MD, of the UCSF Division of Adolescent and Young Adult Medicine said in a press release. "Efforts to reduce smoking and e-cigarette use among young adults would likely lower their vulnerability to severe disease."
Jul 13 UCSF press release
Jul 13 J Adolesc Health study