“The National Kidney Foundation has released a statement urging the federal government to grant priority to patients with kidney disease and their contacts for receipt of COVID-19 vaccines.
According to the statement, it is a matter of “ethical allocation,” because this patient population is at high risk for severe outcomes if they contract the virus.”
Read the full article, here.
“The AST has received queries from transplant professionals and the community
regarding the COVID-19 vaccine. The following FAQ was developed to relay information
on the current state of knowledge. This document is subject to change and will be
updated frequently as new information or data becomes available.”
See full details, here.
“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.
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.
“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.
“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.
“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.
“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.