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FDA Panel Recommends Moderna’s COVID-19 Vaccine For Emergency Use

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“In a 20-0 vote, with 1 abstention, a panel of advisers to the Food and Drug Administration recommended that the COVID-19 vaccine being developed by Moderna be authorized for emergency use in adults during the pandemic.

The vote in favor of the vaccine was taken to answer the agency’s question: Do the benefits of the Moderna vaccine outweigh its risks for use in people 18 years of age and older.

The agency typically follows the advice of its expert advisers.

A quick FDA decision is expected given the state of the pandemic, of 94% effectiveness of the Moderna vaccine in preventing COVID-19 and a determination by the FDA that there are no specific safety concerns that would stand in the way. The FDA authorized the Pfizer-BioNTech COVID-19 vaccine last Friday, a day after the same panel voted in favor of it.”

Read the full article, here.

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‘Healing Is Coming’: U.S. Starts Vaccinating People Against COVID-19

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The first people in the U.S. are receiving vaccination shots against COVID-19 on Monday, as U.S. health workers started administering the vaccine developed by Pfizer and BioNTech.

The first widely publicized vaccination took place in New York City, shortly after 9 a.m. ET. The event was live-streamed and promoted by New York Gov. Andrew Cuomo, who said, “The vaccine only works if the American people take it.”

Sandra Lindsay, a critical care nurse at Long Island Jewish Medical Center, was the first person to receive the vaccine at the event. She received a shot administered by Dr. Michelle Chester, director of employee health services at Northwell Health.

“I feel like healing is coming,” she said. “I hope this marks the beginning to the end of a very painful time in our history.”

Read the full article, here.

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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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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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American Kidney Fund Statement on CBO Score for H.R. 5534, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020

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“The American Kidney Fund is pleased with the Congressional Budget Office’s (CBO) scoring of H.R. 5534, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020, which estimates the bill will reduce direct federal spending on Medicare benefits for some kidney transplant patients by $400 million over 10 years.

“H.R. 5534 will add a new Medicare coverage option solely to cover immunosuppressive drugs used by kidney transplant patients under age 65. People with transplants must take immunosuppressive drugs or their body will reject the transplanted organ. For people with a kidney transplant, the devastating impact of losing their kidney means they will have to go on dialysis or try to find another kidney-a daunting task with close to 100,000 people on the wait list.”

Read the full statement by AKF, here.

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After Chance The Rapper’s Aunt’s Wait For Kidney Donation Was Subject Of Viral Tweet, A Donor Changed Her Life

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“It is a reality for more than 3,000 people in Illinois who are waiting on a donation. CBS 2’s Tara Molina on Thursday night introduced us to one woman whose wait went viral last year – and the donor who stepped in to change her life.

Two lives changed at the University of Illinois at Chicago Medical Center. Toni Barnes Jordan got a second chance at life, while Maranda Proce got a friend for life.

And it was all because of a tweet. One single tweet from Chicago native Chancelor Johnathan Bennett, better known as Chance the Rapper.

“We were sitting on my back deck and he said, ‘I’m going to tweet this right now,’” Jordan said.
That is how it all started.”

Read the full story, here.

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U.S. Army Veteran Gets Triple the Chance At Life, with Utah’s First Triple Organ Transplant

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“Decades of planning put physicians at University of Utah Health in the position to save a United States Army veteran whose life was hanging by a thread, as three of his major organs were failing.

“He was so, so, so, so sick,” said Dr. Craig Selzman, surgical director of the heart and lung transplant program at University of Utah Hospital. “We didn’t really think he had a chance.”

Keith Baker, 58, started with heart failure, a condition that worsened over time and ultimately caused irreparable damage to his kidneys. Not long after that, the Yuma, Arizona, native was diagnosed with cirrhosis of the liver. With triple organ failure, he was not believed to be a good candidate for transplant, said Dr. Josef Stehlik, surgeon and director of the heart transplant program at the U.”

Read the full story, here.

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Covid-19 vaccine from Pfizer and BioNTech is Strongly Effective, Early Data from Large Trial Indicate

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“Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.

The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.”

Read the full article, here.

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Duke Completes 1,500th Heart Transplant

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“In the midst of the pandemic, Duke University Hospital last week completed its 1,500th heart transplant, a milestone achieved by only five other transplant centers nationwide.

Surgeons performed the first heart transplant at Duke in 1985, and the hospital recorded its 1,000th heart transplant in 2014.

“It’s taken us six years to accomplish the next milestone, which we think is of significance,” Said Dr. Chet Patel, Duke’s medical director for heart transplants.”

Read the full story, here.

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