COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

In Tuesday's Report: FDA warns of false test results due to mutations, and authorizes new OTC tests; NY state clarifies paid vaccination leave law; and California requires COVID-19 paid sick leave.

Tuesday, 6 April 2021

  • The U.S. Food and Drug Administration (FDA) said last week that it is concerned that virus mutations could lead to false results with certain COVID-19 tests, and that it has found some tests are prone to lower sensitivity, publishing a new FDA webpage that aggregates information to spotlight concerns about mutations that could lead to lower test sensitivity and false results. FDA singled out four molecular tests that have been given emergency use authorization (EUA) that may be prone to giving false results due to emerging mutations. Separately, FDA authorized several over-the-counter (OTC) COVID-19 antigen tests for use without a prescription on Thursday, offering a way for schools, workplaces and other groups to conduct rapid screening. Rapid antigen tests will be especially useful for serial testing, which involves "testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test," FDA said. FDA has also indicated in public meetings that additional OTC submissions are under review. (Authored by Randy Prebula)

  • New York state passed legislation on 12 March 2021 to provide employees in the state with up to four hours of paid leave for each COVID-19 vaccination injection they receive. On 21 March, the New York Department of Labor released Frequently Asked Questions (FAQs) that clarify several aspects of the new NY paid vaccination leave law; for example, if an employee took time off to get the COVID-19 vaccination prior to 12 March, employers may voluntarily provide paid leave benefits, but the new law does not require employers to provide the benefits retroactively. We analyze these new clarifications online here. (Authored by Kenneth Kirschner)

  • On 19 March 2021, California Governor Newsom signed into law SB 95 (adding sections 248.2 and 248.3 to the Labor Code), which requires employers to pay California employees up to two weeks of COVID-19 supplemental paid sick leave (COVID-19 SPSL). This new law revives and expands the supplemental paid sick leave law that expired on 31 December 2020. As a result of these changes from the prior iteration of California’s Supplemental Paid Sick Leave law, many more California employers will be required to provide, and many more employees will be eligible for, COVID-19 SPSL. We analyze the new law online here.  (Authored by Tao Leung)

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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