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Biodefense Headlines – 13 December 2020 | Global Biodefense

FDA Grants Historic Authorization to Covid-19 Vaccine, Setting Stage for Rollout A seminal moment in the effort to curb the pandemic, that has so far infected an estimated 16 million people and killed nearly 300,000 in the United States, the FDA granted the first EUA for a COVID-19 vaccine on Friday. The rollout is expected to be complex, and there remain concerns about vaccine makers’ ability to scale up manufacturing to meet demand. Still, distribution of a vaccine less than a year after the emergence of an unknown pathogen is widely considered a feat once thought impossible. STAT and Washington Post White House Threatens FDA Chief’s Job Over Vaccine Approval

Waiver of State Licensure Requirements for the Delivery of COVID-19 Countermeasures via Telehealth | McDermott Will & Emery

To embed, copy and paste the code into your website or blog: In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through telehealth and clarified the scope of liability protections provided by the PREP Act. In particular, the declaration is important to telehealth providers because it appears to preempt, under certain circumstances, state laws that have limited cross-border practice of medicine using telehealth. Healthcare providers should take note that the licensure exception and any immunity protections are limited to healthcare providers who are ordering or administering a Covered Countermeasure and there is no indication of intent to expand beyond these focused measures.

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