On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate.  Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective.  In addition to the effectiveness, there were no serious side effects among the 41,135 participants.  Limited participants had side effects, such as 3.8% had fatigue…

On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must be monitored for two months after receiving the vaccine and Pfizer anticipates seeking EUA in the third week of…

The U.S. Centers for Disease Control (“CDC”) continues to update COVID-19 guidance as more information is known about how the coronavirus spreads.   On October 21, 2020, the CDC made a significant update to the definition of “close contact”.  Individuals that have spent 15 cumulative minutes within six feet of an infected individual during a 24-hour period will now be considered a “close contact.”  The prior definition encompassed individuals that had spent 15 consecutive minutes…

On October 2, 2020, Secretary Azar of the Department of Health and Human Services (“HHS”) renewed his public health emergency (“PHE”) declaration because of “the continued consequences” of the COVID-19 pandemic. This renewal will become effective on October 23, 2020 when the previous July 23 renewal was set to expire and will continue to January 21, 2021. The reauthorization of the PHE ensures that providers can continue to rely on the flexibilities granted to them…

The Occupational Safety and Health Administration (“OSHA”), part of the U.S. Department of Labor, continues to update guidance for employers regarding protection of employees from exposure to COVID-19.  Despite their best intentions, many employers have struggled to adapt to the constantly changing safety and reporting requirements during the COVID-19 pandemic.   OSHA recently updated its COVID-19 Frequently Asked Questions and now require employers to report, within eight hours, the death of any employee due to COVID-19…