Antibody Response After a Third Dose of the Vaccine in Kidney Transplant Recipients With Minimal Serologic Response to 2 Doses

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“Studies have reported low seroconversion rates (58% after the second dose) in solid organ transplant recipients who received a messenger RNA (mRNA) SARS-CoV-2 vaccine.1,2 Based on this evidence, the French National Authority for Health issued a recommendation in April 2021 to administer a third vaccine dose in immunosuppressed patients who did not respond after 2 doses. We examined the antibody responses of kidney transplant recipients who did not respond to 2 doses and received a third dose (100 μg) of the mRNA-1273 vaccine (Moderna).

Methods

All kidney transplant recipients followed up in the outpatient Kidney Transplantation Department of Strasbourg University Hospital between January 20, 2021, and June 3, 2021, with a negative history for COVID-19 and SARS-CoV-2 antispike IgG levels less than 50 arbitrary units (AU)/mL on the day of the first vaccine injection and 1 month after the second dose were included. All patients received a third vaccine dose between April 9, 2021, and May 12, 2021. The study protocol was approved by the local ethics committee and written informed consent was obtained.”

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CDC advisory committee voices support for immunocompromised people getting boosters

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During the last year and a half, immunocompromised people have been at extremely high risk for the virus. And for many, the COVID vaccine didn’t change that.

That’s why a group of independent Centers for Disease Control and Prevention experts at a Thursday meeting largely voiced support for allowing immunocompromised people to talk to their doctors about getting a third shot, a booster, that could increase their antibody response to vaccines.

Read more, here.

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FDA Approves Tacrolimus for Lung Transplants

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The US Food and Drug Administration (FDA) has approved the use of the transplant drug tacrolimus (Progaf) for the prevention of organ rejection in adult and pediatric patients receiving lung transplants. This is the only immunosuppressant drug approved for this patient population.

Tacrolimus has been routinely prescribed to lung transplant recipients for the past 15 to 20 years and is “the primary calcineurin inhibitor used as the backbone of immunosuppression for lung transplants,” Joshua Diamond, MD, associate medical director of the Penn Lung Transplant Program at Penn Medicine, in Philadelphia, Pennsylvania, told Medscape Medical News in an interview.

Read more, here.

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How organ transplants work

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“When a person needs an organ transplant, it is because one of their organs is working very poorly or failing. Undergoing an organ transplant can lengthen a person’s life and allow those with a chronic illness to live a normal lifespan.

Many people need an organ transplant due to a genetic condition such as polycystic kidney disease, cystic fibrosis, or a heart defect.

Infections such as hepatitis, physical injuries to organs, and damage due to chronic conditions such as diabetes may also cause a person to require a transplant.

Surgeons performed more than 36,000 organ transplants in 2018, but many more people need organs. In January 2019, more than 113,000 people in the United States were on organ transplant waiting lists. More than 2,000 children need organs.

The transplant process varies slightly depending on the organ, but the need for a matching donor is a consistent theme.”

Learn more, here.

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FDA advisory committee unanimously agrees donor liver portable system is safe, effective

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“The FDA’s Gastroenterology and Urology Devices Panel, Medical Devices Advisory Committee voted unanimously that a portable system for near-normothermic continuous perfusion of donor livers with perfusate was safe and effective.

The system will be prepared by hospital pharmacy and include compatible packed red blood cells.

The panel addressed three questions related to the premarket approval of the device Organ Care System Liver System (TransMedics). The entire 14-member panel voted that the device is safe, all voted that the device is effective and voted 12 to 1 with 1 abstaining that the benefits of the OCS Liver System outweigh the risks.”

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Even Dialysis Patients Can Maintain COVID Antibodies for Months

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“The vast majority of dialysis patients infected with COVID-19 maintained antibodies for at least 6 months, a new study found.

In a prospective analysis of over 2,000 adults on dialysis, 93% of seroprevalent patients reached an assay detectable response — a SARS-CoV-2 receptor-binding domain (RBD) IgG index value of 1 or higher — and maintained this level throughout a 6-month follow-up, reported Shuchi Anand, MD, of Stanford University in California, and colleagues.

On top of that, 60% of patients had IgG index values of 10 or greater — classified as high — the group wrote in Annals of Internal Medicine. Of these patients, 76% maintained this antibody level throughout the 6-month follow-up.”

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Safety Concerns Turn FDA Panel Thumbs Down for Novel CKD-Anemia Drug

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An FDA advisory committee almost unanimously agreed that the risks were just too high for the chronic kidney disease (CKD)-related anemia drug roxadustat in any patient population.

In a 13-1 vote Thursday, members of the Cardiovascular and Renal Drugs Advisory Committee felt that although there’s an unmet need for new anemia therapeutics, this particular drug carried too strong of a safety signal for thrombotic risk in a non-dialysis dependent patient population.

Read more, here.

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How Does Phosphate Binder Type Affect the Heart in Hemodialysis?

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“Trial compared calcium-based vs non-calcium-based binders.

Non-calcium-based phosphate binders weren’t any better at reducing cardiovascular events than calcium-based binders in dialysis patients, the LANDMARK trial determined.

In the open-label randomized trial of over 2,300 Japanese patients on hemodialysis, there were no significant differences in composite cardiovascular events between the lanthanum carbonate group versus the calcium carbonate group (HR 1.11, 95% CI 0.88-1.41, P=0.37), reported Hiroaki Ogata, MD, of Showa University Northern Yokohama Hospital in Kanagawa, Japan, and colleagues.”

Read more, here.

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Post-transplant health & wellness webinar (part 2)

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Health and wellness continues long after receiving an organ transplant. Learn about post-transplant health from UNOS Medical Director David Klassen, M.D., Filza Hussain, M.D., of Stanford University, and Koren Axelrod of CareDx. This is the third webinar in our Transplantation Journey series.

Watch the webinar, here.

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Heart, Death Risks Linked With CKD-Related Iron Deficiency

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Regardless of anemia, iron deficiency in patients with late-stage chronic kidney disease (CKD) was linked with adverse health outcomes, an observational study found.

In 5,145 patients with stage 3-5 CKD not on dialysis, a transferrin saturation (TSAT) of 15% or less was associated with a higher risk for all-cause mortality before reaching dialysis or kidney transplant, as compared to TSAT levels of 26-35% (HR 1.44, 95% CI 1.03-2.01), according to Roberto Pecoits-Filho, MD, PhD, of the Arbor Research Collaborative for Health in Ann Arbor, Michigan, and colleagues.

Read more, here.

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