ACS, ASA, AORN call for centralized, coordinated governmental action for COVID-19
Editor's Note In a November 23 letter to federal government leaders, the American College of Surgeons (ACS), American Society of Anesthesiologists (ASA), and Association of periOperative Registered Nurses (AORN) asked officials “to act collectively and quickly in support of hospitals and healthcare providers as they continue to struggle in response…
Pfizer, BioNTech COVID-19 vaccine 95% effective in final analysis, will seek EUA within days
Editor's Note Just a week after Pfizer revealed an interim analysis showing its COVID-19 vaccine to be more than 90% effective, the company on November 18 released its final efficacy analysis showing the vaccine is 95% effective, and that it protects older people who are most at risk of dying…
Moderna announces 94.5% efficacy for COVID-19 vaccine
Editor's Note Moderna Inc (Cambridge, Massachusetts) on November 16 announced that its vaccine is 94.5% effective at preventing COVID-19. Their analysis of a 30,000-person trial (half received the vaccine and half received a placebo) finds that 90 of the 95 COVID-19 documented cases are in the placebo group. The Moderna announcement…
Medicare to cover monoclonal antibody COVID-19 treatments
Editor's Note The Centers for Medicare and Medicaid Services (CMS) on November 10 announced that Medicare will cover out-of-pocket costs for monoclonal antibody drugs for COVID-19 during the public health emergency. The agency’s coverage includes Eli Lilly’s bamlanivimab, which recently received an emergency use authorization from the Food and Drug…
Pfizer, BioNTech COVID-19 vaccine more than 90% effective, EUA application could come next week
Editor's Note Pfizer and BioNTech announced November 9 that their COVID-19 vaccine is more than 90% effective 7 days after the second dose in preventing COVID-19 infection in participants without evidence of prior infection. This means that protection is achieved 28 days after initiation of the vaccination, which consists of…
CMS: How to prepare for COVID-19 vaccine
Editor's Note The Centers for Medicare and Medicaid Services (CMS) on November 5 released a set of toolkits and enrollment actions to take to administer the COVID-19 vaccine when it’s available. Many Medicare-enrolled providers don’t have to take any actions until the vaccine is available. Some Medicare-enrolled providers must also…
J&J to test COVID-19 vaccine in adolescents
Editor's Note Johnson & Johnson (J&J) has announced plans to test their COVID-19 vaccine in young individuals between the ages of 12 and 18, the October 30 Reuters reports. J&J started testing its vaccine in 60,000 volunteer adults in late September. Depending on safety, J&J also plans to test the…
CMS issues coverage plan for COVID-19 vaccines, treatments
Editor's Note The Centers for Medicare and Medicaid Services (CMS) on October 28 issued an interim final rule that requires CMS to cover any COVID-19 vaccines that receive Food and Drug Administration (FDA) authorization at no cost to beneficiaries. The rule also will increase what Medicare pays hospitals for COVID-19…
Joint Commission deletes EP on flu vaccination goal
Editor's Note The Joint Commission on October 28 announced that beginning January 1, 2021, it is eliminating the element of performance (EP) for Infection Control Standard IC.02.04.01, which sets incremental influenza vaccination goals to try and achieve the 90% rate set by national initiatives. The US Department of Health and…
FDA drafting protocols to track COVID-19 vaccine safety
Editor's Note The Food and Drug Administration’s (FDA’s) Office of Biostatistics and Epidemiology is currently developing master protocols to be used in monitoring the safety and effectiveness of a COVID-19 vaccine once it is authorized or approved, in addition to postmarket surveillance requirements, the October 22 Regulatory Focus reports. The…
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