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…
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…
ECRI warns of fast-tracking COVID-19 vaccines
Editor's Note ECRI announced October 21 that its President and CEO, Marcus Schabacker, MD, PhD, will tell the Food & Drug Administration Vaccines and Related Biological Products Advisory Committee on October 22 that a thorough review of 6 months of completed clinical trial data for COVID-19 vaccines is needed to…
FDA reissues EUA for N95 respirators manufactured in China
Editor's Note The Food and Drug Administration (FDA) on October 15 announced that it reissued the Emergency Use Authorization (EUA) for certain N95 and other filtering face-piece respirators that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety…
FDA issues guidance on EUA for COVID-19 vaccines
Editor's Note The Food and Drug Administration (FDA) on October 6 released guidance on the data and information needed to support the issuance of emergency use authorization (EUA) for COVID-19 vaccines. The recommended data and information include: chemistry, manufacturing, and controls information clinical and nonclinical data and information administration and…
HHS renews public health emergency for COVID-19
Editor's Note Secretary of Health and Human Services (HHS), Alex Azar, on October 2, renewed the national public health emergency (PHE) for COVID-19 for another 90 days. The renewal will take effect October 23. This is the third renewal of PHE, which has been in effect since late January. The…
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