Roche's Elecsys Anti-SARS-CoV-2 antibody blood test has received emergency use authorization from the FDA. The semi-quantitative assay can measure antibody levels to the coronavirus' spike protein and can generate results in about 18 minutes when the test is performed using Roche's automated cobas e analyzers.
FDA Commissioner Stephen Hahn has been called on by White House Chief of Staff Mark Meadows to explain why the agency is not moving faster to approve Pfizer and BioNtech's COVID-19 vaccine, according to sources. The FDA is set to meet Dec. 10 to discuss the vaccine authorization request.
Moderna and Pfizer/BioNTech have applied for emergency use authorization of COVID-19 vaccines based on messenger RNA technology, which is novel for vaccines but has been studied in animals for decades. Moderna's vaccine demonstrated 100% efficacy for prevention of severe disease, according to the company. Another form of RNA therapy, RNA interference, is the basis for a drug by Alnylam that received approval in the US and EU this month to treat primary hyperoxaluria, a rare kidney condition.
A CRISPR-Cas9 gene therapy carried on a modified adenovirus reduced simian immunodeficiency virus DNA in rhesus monkeys, and the results might translate to people with HIV. The therapy targeted specific sites where HIV can linger without being detected by the immune system, such as bone marrow, lymph nodes and the brain, according to a study in Nature Communications.
More than 200 researchers conducted 30 studies on mice, insects and astronauts in space and identified six cellular and molecular changes that affect astronaut health: DNA damage, oxidative stress, changes in telomere length and the microbiome, mitochondrial dysfunction and gene dysregulation. "We now have a foundation to build on -- things we know to look for in future astronauts, including telomere length changes and DNA damage responses," said Susan Bailey, a co-author of three of the studies.
An Operation Warp Speed document sent to governors estimates that initial shipments of Pfizer and BioNTech's COVID-19 vaccine will be delivered Dec. 15, to be followed by Moderna's vaccine Dec. 22, but these distribution dates are contingent on the FDA's decision to grant emergency authorization for both vaccines. According to the document, an estimated 18 million doses of Moderna's vaccine and 22.5 million doses of Pfizer/BioNTech's vaccine will be manufactured this month.
The CDC soon will release new guidelines reducing the recommended quarantine period for people who have come in contact with COVID-19-positive individuals to between seven and 10 days, down from 14 days under current recommendations, according to senior administration officials. These "close contacts" of infected individuals would be able to end their quarantine in as early as seven days if they get a negative COVID-19 test result.
The CDC's Advisory Committee on Immunization Practices said health care workers and residents and staff at long-term-care facilities should be given the highest priority for COVID-19 vaccination once vaccines are approved. The recommendation will be sent to CDC Director Robert Redfield for approval and to HHS Secretary Alex Azar, who has said that governors will ultimately decide how to prioritize vaccinations in their states, says HHS spokesman Michael Pratt.
French liquid biopsy company ID-Solutions is partnering with Stilla Technologies to commercialize oncology detection kits. The deal's financial terms were not disclosed.
To help fight racial injustice, Zimmer Biomet has launched the Zimmer Biomet Foundation and has donated $2 million to the National Association for the Advancement of Colored People. The foundation will provide funding for "comprehensive programs that foster STEM education, building healthy communities, providing disaster relief and addressing the inequities and disparities that still cause suffering around the world," said Zimmer Biomet CEO and President Bryan Hanson.
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