First COVID-19 vaccinations expected latter part of December
Editor's Note On November 30, Moderna applied for an emergency use authorization (EUA) from the Food & Drug Administration (FDA) for its COVID-19 vaccine. Moderna’s vaccine was developed in collaboration with researchers at the National Institute of Allergy and Infectious Diseases, where Anthony Fauci, MD, is the director. Moderna is…
FDA authorizes first home test for COVID-19
Editor's Note The Food and Drug Administration (FDA) on November 17 issued an emergency use authorization for the first rapid COVID-19 self-test that a person can administer at home. The Lucira COVID-19 All-In-One Test Kit has to be prescribed by a healthcare provider, and the healthcare provider has to report…
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…
Editorial
Most respondents to a July 2020 American Organization for Nursing Leadership survey said they felt prepared for a future surge of COVID-19. That future is now, with nearly 150,000 new cases being reported daily across the country and multiple hospitals at capacity. Survey respondents said their biggest challenges early in…
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…
FDA issues EUA for first test to detect neutralizing antibodies after COVID-19
Editor's Note The Food and Drug Administration (FDA) on November 6 issued an emergency use authorization (EUA) for the first serology test (GenScript USA Inc) to identify patients with neutralizing antibodies after a COVID-19 infection. Neutralizing antibodies have reduced the infection of cells in the laboratory, but their effects in…
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…
FDA alerts providers on how to prevent false positive results with COVID-19 antigen tests
Editor's Note The Food and Drug Administration (FDA) on November 3 issued a letter alerting clinical laboratory staff and healthcare providers that false positive results can occur with antigen tests, including when users do not follow instructions for use of antigen tests for the rapid detection of COVID-19. Among the…
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…
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