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FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

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“Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.”

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.” 

Read the full press release, here.

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Taking Immunosuppressants? Fauci Says Get the COVID-19 Vaccine

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“Three researchers presented results on COVID-19 therapies and data of importance to patients with hematological conditions.

Patients with compromised immune systems, whether due to chemotherapy or a bone marrow transplant, should plan to be vaccinated against coronavirus disease 2019 (COVID-19) when they have the chance, Anthony Fauci, MD, the nation’s leading infectious disease expert, said Saturday.

Fauci, who in January will serve a seventh president as director of the National Institute of Allergy and Infectious Diseases (NIAID), told the online audience gathered for the 62nd annual American Society of Hematology (ASH) meeting that on balance, being vaccinated makes sense for the immunosuppressed, including the patients treated by ASH members.”

“It is clear that if you are on immunosuppressant agents, history tells us that you are not going to have as robust a response as if you had an intact immune system that was not being compromised,” Fauci said, in response to a question from ASH President Stephanie Lee, MD, of the Fred Hutchinson Cancer Center, Seattle. “But some degree of immunity is better than no degree of immunity. So, for me, it would be recommended that these people do get vaccinated.”

Read the full article, here.

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FDA Advisory Panel Endorses Pfizer/BioNTech Covid-19 Vaccine

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“A panel of outside experts on Thursday recommended the Food and Drug Administration issue an emergency use authorization to the Covid-19 vaccine being developed by Pfizer and BioNTech, a vaccine that appeared to be highly efficacious in a Phase 3 clinical trial.

The 17-4 vote came after a long day in which members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, discussed a wide range of issues related to the vaccine, including concerns about vaccinating people with severe allergies and 16- and 17-year-olds, as well as issues regarding vaccination during pregnancy or lactation.

Although the FDA does not have to follow the panel’s recommendation, it is widely expected to do so.”

Read the full article, here.

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Kentuckians Need Congress to Approve Lifesaving Bill for Kidney Transplant Recipients

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“The COVID-19 public health emergency has revealed painful weaknesses, inefficiencies and inequalities in our health care system. As a result, the public is looking to elected leaders to enact policies that improve our health system, protect at-risk populations and allocate government resources more wisely. Fortunately, there is a bipartisan, common-sense proposal in Congress that could achieve all of those goals for a particularly vulnerable part of the American population: kidney transplant recipients.”

Read the full article, here.

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10 Patients, 5 Kidneys, 1 Story That Will Restore Your Faith in Humanity

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“More than 100,000 people are waiting on the kidney transplant list, with some waiting for weeks, months, or even years for the call that could change their life.

That makes what happened at Houston Methodist in October even more extraordinary.

Ten people, including a husband and wife, a boss and her employee, a mother and son, two sisters, and two cousins, took part in a kidney swap. The five pairs were strangers before they walked into the hospital and left with a life-long bond.

Tara and John “HB” Berliski from Magnolia, Texas, have been married for 15 years.

HB started experiencing pain 20 years ago and thought he pulled a muscle. Doctors soon discovered his kidneys were enlarged because of polycystic kidney disease. HB had both kidneys removed, went on dialysis, and waited for a donor.”

Read the full news story, here.

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It’s time for Congress to keep its promise to kidney transplant patients

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“In 1972, as millions of Americans living with end-stage renal disease (ESRD) struggled to access care, Congress made a commitment to cover the rising costs of their treatment, including kidney transplant. Unfortunately, almost 50 years later, this commitment remains unfulfilled.

Kidney transplant patients must remain on immunosuppressive therapy for life or risk losing their transplant. For nearly two decades, the kidney, transplantation, and donation communities have been advocating to extend immunosuppressive medication coverage for kidney transplant patients beyond Medicare’s current three-year limit.”

Read the full article in POLITICO, here.

To take action and help Finish The Fight, contact your members of congress, here.

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World-first Skin Cancer Treatment Aims to Help Transplant Patients

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“The world-first treatment being developed at The University of Queensland is the only drug of its type that could prevent the incidence of skin cancers for transplant patients.

Lead researcher from UQ’s Diamantina Institute Dr. James Wells said the treatment was shown in models to clear skin tumors that grow as a consequence of taking tacrolimus—a drug that transplant patients must take to suppress their immune systems to avoid organ rejection.”

Read the full article, here.

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Trump Administration Finalizes Rule That Could Make Thousands More Organs Available for Transplant

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“The Trump administration has finalized major reforms in the way organs are collected and distributed for transplant, an effort aimed at making thousands more kidneys, livers, hearts and lungs available to the lengthy list of people waiting for them.

The changes, announced Friday evening, are aimed primarily at “organ procurement organizations,” the government-chartered network of 58 nonprofits that collects organs from deceased donors and rushes them to surgeons at transplant centers.”

Read the full article in The Washington Post, here.

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Screen Kidney Transplant Patients for Fabry, Study Recommends

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“A genetic screening study found a higher-than-expected prevalence of undiagnosed Fabry disease in people who had kidney failure and transplant without a known cause.

When the screening was extended to related family members, additional unidentified cases were found and treated early. 

The findings led researchers to recommend genetic screening for kidney transplant patients, particularly those with an unknown cause.” 

Read more about the study, here.

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