On January 6, 2021 U.S. Department of Health and Human Services Secretary Alex Azar renewed the Public Health Emergency declaration, effective January 21, 2021. In a tweet, Secretary Azar announced the renewal and stated that “[o]ur work to combat the virus will continue, as will our work to ensure a peaceful and orderly transition.” The timing is notable as the most recent extension, October 2, 2020, was set to expire the day after President-elect Biden’s inauguration. The declaration ensures the continuation of the coronavirus waivers and flexibilities issued during the global pandemic will extend through at least April 21, 2021.
The U.S. Centers for Disease Control and Prevention (“CDC”) has released a study regarding allergic reactions to the first dose of the Pfizer-BioNTech COVID-19 vaccine. The study found 21 cases of anaphylaxis out of the 1,893,360 first doses of the vaccine administered. In cases of anaphylaxis, 86 percent of cases had symptoms onset within 30 minutes and 81 percent had a history of allergies or allergic reactions. The authors noted that “[b]ased on early safety monitoring, anaphylaxis after the Pfizer-BioNTech COVID-19 vaccine appears to be a rare event; however, comparisons of anaphylaxis risk with that associated with non-COVID-19 vaccines are constrained at this time by the limited data available this early in the COVID-19 vaccination program.” Interim guidance released by the CDC provides that individuals with a history of allergic reactions to vaccinations should be observed for 30 minutes after administration and everyone else should be observed for 15 minutes. In a press briefing, Dr. Nancy Messonnier, Director of the National Center for Immunization and Respiratory Diseases, stated that “[o]f course we all would hope that any vaccine would have zero adverse events, but at 11 cases per million doses administered, it’s a very safe vaccine.”
The U.S. Department of Health and Human Services announced on January 6, 2021 that it would release $22 billion in funding to states, localities, and territories to support COVID-19 testing and vaccine distribution. More specifically, for vaccination activities Texas will receive $227,056,156, plus an additional $20,965,609 for Houston and $13,980,751 for San Antonio. Texas will receive $1,535,405,092, plus an additional $133,550,932 for Houston, for COVID-19 testing.
The incoming Biden administration announced on January 6, 2021 that Operation Warp Speed chief scientific advisor, Moncef Slaoui will continue his work as a consultant for several weeks, after previously indicating that he would likely depart government by the end of 2020 or early 2021. General Gustave Perna, Operation Warp Speed’s chief operating officer will also remain in charge of logistics for vaccine distribution.
Norton Rose Fulbright attorneys will continue to provide relevant updates on the COVID-19 PHE on the Health Law Pulse.