Wednesday, 2 March 2022

• The UK government’s “Living with COVID” plan removes the legal requirement in England for people who have COVID to self-isolate. However, government advice remains that those testing positive should stay at home and avoid contact with other people. This means that employers’ approaches to managing COVID risk in the workplace are unlikely to change significantly, at least in the short term. Read more online here. 

• FDA News: Yesterday, the U.S. Food and Drug Administration (FDA) issued three safety communication warnings over the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging, the SD Biosensor STANDARD Q COVID-19 Ag Home Test, and the ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). Last week, FDA had revised the emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis of COVID-19 in certain adults and pediatric patients. FDA also updated its FAQ web page on antibody tests for SARS-CoV-2, as well as its antibody testing information page. Last week, CDRH also added meeting materials to its Virtual Town Hall Series web page.

• U.S. News: President Biden discussed updated COVID-19 guidelines and getting the U.S. workforce back to work during last night’s State Of The Union address. Biden has extended the national emergency declaration for the COVID-19 pandemic, and the administration said it does not plan to terminate the separate “public health emergency” (PHE) designation used for Medicaid and entitlement program waivers on 15 April; instead, it will give health care groups at least 60-days’ notice when it plans to do so. The National Institute for Health Care Management Foundation held a virtual discussion yesterday on "Addressing Rural Health Needs: COVID-19, Equity and Access to Care." Last week, the Centers for Disease Control and Prevention (CDC) published a report on “Hospitalizations of Children and Adolescents with Laboratory-Confirmed COVID-19,” as well as a report on “Pediatric Emergency Department Visits Before and During the COVID-19 Pandemic.”  On 25 Feb., CDC relaxed its mask guidance for communities where hospitals are not under high strain. Also last week, Sanofi and GlaxoSmithKline said they intend to seek regulatory authorization for their COVID-19 vaccine in the U.S. and Europe amid the release of data they say is comparable to those from other authorized vaccines.