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eMediNexus    21 June 2021

HCFI Dr KK Aggarwal Research Fund

With inputs from Dr Monica Vasudev

Capillary leakage syndrome, a new side effect of AstraZeneca Covid-19 vaccine

 

Capillary leak syndrome has been identified as a new side effect of the AstraZeneca vaccine The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). The committee reviewed 6 such cases in people who had received the AstraZeneca vaccine. Most of these cases were in women and occurred within 4 days of vaccination. Three patients had a history of capillary leak syndrome and one of them subsequently died.

The safety committee has cautioned against using this vaccine in people with known history of capillary leak syndrome and concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.

Capillary leak syndrome is a very rare, serious condition that causes fluid leakage from capillaries resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low serum albumin. Immediate medical attention should be sought if there is rapid swelling of the arms and legs or sudden weight gain in the days following vaccination, along with feeling faint.

(Source: EMA, 11/06/2021)

Improved outcomes with mavrilimumab in patients with severe COVID-19 pneumonia

A phase 2 study (LB0001) presented at the annual European Congress of Rheumatology has shown that mavrilimumab improves outcomes in non-mechanically-ventilated patients with severe covid-19 pneumonia and systemic hyperinflammation.  A single infusion of mavrilimumab reduced progression to mechanical ventilation and improved survival. All patients received the local standard of care (steroids, remdesivir).

No differences in outcomes were observed between the two doses (10 mg/kg and 6 mg/kg). Mavrilimumab is an inhibitor of granulocyte/macrophage–colony stimulating factor (GM-CSF), a cytokine which is vital to lung homeostasis and also important in regulating inflammation and autoimmunity.

  • At day 29, the proportion of patients alive and free of mechanical ventilation was 12.3 percentage points higher with mavrilimumab (86.7%) vs placebo (74.4%). 
  • Mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death through Day 29 (Hazard Ratio (HR) = 0.35; p=0.0175). 
  • Day 29 mortality was 12.5 percentage points lower with mavrilimumab (8%) vs placebo (20.5%).
  • Mavrilimumab recipients had a 61% reduction in risk of death through Day 29 (HR= 0.39; p=0.0726). 
  • Fewer adverse events (including secondary infections and thrombotic events) were reported in mavrilimumab-treated patients. Thrombotic events occurred only in the placebo group (5/40 [12.5%]).

(Pupim L, et al. Annals of Rheumatic Diseases, 2021)

New “game-changing” antibody tests to detect exposure to new COVID-19 variants 

New antibody tests to detect antibody responses to infection by new variants of SARS-CoV-2 virus has been developed by scientists at the University of Aberdeen, in collaboration with biotechnology group Vertebrate Antibodies Ltd and NHS Grampian. The test accuracy is more than 98% and specificity is 100%. The currently available tests have an accuracy of around 60-93% and they also cannot detect the new variants. The new tests can be used 

  • To estimate the prevalence of circulating variant strains in the community, including the Alpha and Delta variants. 
  • To evaluate the long-term immunity of the person and whether immunity is vaccine-induced or is a result of previous infection.

Professor Mirela Delibegovic from the University of Aberdeen and academic lead on the project explains: "Accurate antibody tests will become increasingly important in the management of the pandemic and this is a truly game-changing technology with the potential to dramatically change the trajectory of global recovery from the pandemic."

(Source: Medical Express.com)

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