COVID-19 Report for Life Sciences and Health Care Companies - August 2021

Hogan Lovells

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 Wednesday's Report: U.S. publishes new safety measures for federal contractors, CDC reinstates COVID-19 protocols, FDA revises EUA for baricitinib (Olumiant), and a new employee vaccination and testing cross-border guide.

Wednesday, 4 August 2021

  • On 29 July 2021, the Biden Administration announced a wave of White House programs to boost vaccination rates in the U.S., including programs aimed directly at federal contractors. These initiatives, summarized in a Fact Sheet released the same day, will require federal workers and “onsite contractors” to follow new safety protocols, including vaccination attestation requirements, although they do not amount to a vaccination mandate. The initiatives are not currently embodied in an executive order, and implementation is largely left to the discretion of federal agencies. Contractors will need to make judgment calls on various compliance questions that the Administration hasn't yet addressed. Read more online here. (Authored by William Ferreira)

  • Citing concerns about potential spread of the COVID-19 “Delta variant” and the fact that even fully vaccinated individuals infected with the Delta variant can spread COVID-19 to others, on 27 July 2021, the U.S. Centers for Disease Control and Prevention (CDC) reinstated some safety measures that it lifted in May, including now recommending that fully vaccinated individuals wear masks in public indoor settings in areas of substantial or high transmission. We summarized these safety measures online here. (Authored by Michael DeLarco)

  • Last week, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of  COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury). Baricitinib is not FDA-approved as a treatment for COVID-19. Additional information is available online here. (Authored by Randy Prebula)

  • As national COVID-19 related restrictions begin to ease, our new employee vaccination and testing cross-border guide provides a quick overview of the key questions and issues for employers as staff return to the workplace across a range of jurisdictions. Our color-coded guide highlights the extent to which employers have the ability and freedom to implement policies on vaccination and testing, and addresses: whether vaccination is mandatory under local law in different jurisdictions; employers’ ability to ask employees if they have been vaccinated, or require vaccination as a condition of employment; and how far employers can impose testing requirements as a condition for entry to the workplace. The guide also highlights other steps that employers can take to encourage employee vaccination where this is not mandatory under local law. (Authored by Philip Cheng)

[View source.]

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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