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COVID-19 regulatory updates for the week of July 17 are below, and include news from HHS, the DOD, and the FDA.
The Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR) is partnering with other industry leaders to deliver a 10-week, virtual peer-to-peer learning community called “Telemedicine Hack” to accelerate implementation of telemedicine. The Telemedicine Hack will offer best practices and case studies from the field on practice workflow, documentation and reimbursement, as well as “office hour” discussion panels with case presenters, government agencies and stakeholder associations. Registration and CME/CEU credits are available for attending, at no cost to participants. See the attached flyer for additional information and session dates.
HHS is providing free COVID-19 testing in Jacksonville, Florida; Baton Rouge, Louisiana; and Edinburg, Texas. The three jurisdictions identified are seeing significant increases in COVID-19 cases and hospitalizations, and could potentially benefit from additional opportunities to identify new cases, especially for people who are asymptomatic. Surge testing efforts will temporarily increase federal support to communities where there has been a recent and intense level of new cases and hospitalizations related to the ongoing outbreak.
The Food and Drug Administration (FDA) recently granted an Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test BD Veritor Plus System. This is the second antigen test the FDA has authorized for the detection of SARS-CoV-2 antigens. This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high, moderate, or waived complexity testing, meaning it can be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Emergency use of this test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument.
HHS and the Department of Defense (DoD) announced a $1.6 billion agreement with Novavax, Inc. of Gaithersburg, Maryland, to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational vaccine. If the doses become available for use in clinical trials or, if the FDA grants an EUA or licenses the investigational vaccine, the federal government could distribute the doses as part of a COVID-19 vaccination campaign.
HHS and the DOD also entered an agreement with Regeneron, Inc. of Tarrytown, New York, to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational anti-viral antibody treatment, REGNCOV2. Both demonstration projects will take place while clinical trials are underway. By funding these manufacturing efforts, the federal government will own the doses expected to result from the demonstration project.