BinaxNOW Authorized for Home Use with a Prescription: The FDA issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription, using self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
NIH began an observational study of coronavirus infection and multisystem inflammatory syndrome in children. An observational study has launched to evaluate the short- and long-term health outcomes of SARS-CoV-2 infection in children, including multisystem inflammatory syndrome in children (MIS-C), and to characterize the immunologic pathways associated with different disease presentations and outcomes.
Distribution of $24 Billion in Phase 3 Provider Relief Funding: The Trump Administration, through the Health Resources and Services Administration (HRSA) is announcing it has completed review of Phase 3 applications from the Provider Relief Fund (PRF) program and will distribute $24.5 billion to over 70,000 providers. Up from the $20 billion originally planned, the addition of another $4.5 billion in funding is being used to satisfy close to 90 percent of each applicant’s reported lost revenues and net change in expenses caused by the coronavirus pandemic in the first half of 2020.
Phase 3 Trial of Novavax Investigational COVID-19 Vaccine Opens: The Phase 3 trial of another investigational COVID-19 vaccine has begun enrolling adult volunteers to evaluate the safety and efficacy of NVX-CoV2373, a vaccine candidate developed by Novavax, Inc.
COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions: Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19. mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine. This information aims to help people in the groups listed below make an informed decision about receiving the mRNA COVID-19 vaccine.
CDC has clarified that healthcare personnel includes dentists, dental hygienists, and dental assistants, (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/hcp.html) a departure from the initial definitions used by the Advisory Committee on Immunization Practices (ACIP).
HHS is publishing the week one allocations provided to states and jurisdictions. Operation Warp Speed is coordinating the delivery of the orders from states against the initial 2.9 million doses. The data for the allocations are currently available here. Each week on Tuesday, states and jurisdictions will be provided allocations available to ship the following week. States and jurisdictions will order against their allocation that week and direct OWS where shipments of the vaccine should be delivered. These allocations, and more related information, are located on the HHS COVID-19 Vaccines page.
The Importance of COVID-19 Vaccination for Healthcare Personnel: When healthcare personnel get sick with COVID-19, they are not able to work and provide key services for patients. CDC updated information on the importance of COVID-19 vaccination for healthcare personnel.
COVID-19 Vaccine Regulations for Dentists Map: Find vaccine allocation and administration status per state. https://success.ada.org/en/practice-management/patients/covid-19-vaccine-regulations-for-dentists-map