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impacted communities in almost every region of the country as the virus reached a point of <br />uncontrolled spread and over 3,000 people died per day due to COVID-19.38 <br />In December 2020, the Food and Drug Administration (FDA) authorized COVID-19 <br />vaccines for emergency use, and soon thereafter, mass vaccination in the United States began. At <br />the time of the interim final rule publication in May 2021, the number of daily new infections <br />was steeply declining as rapid vaccination campaigns progressed across the country. By summer <br />2021, COVID-19 cases had fallen to their lowest level since early months of the pandemic, when <br />testing was scarce. However, throughout late summer and early fall, the Delta variant, a more <br />infectious and transmittable variant of the SARS-CoV-2 virus, sparked yet another surge. From <br />June to early September, the seven-day moving average of reported cases rose from 12,000 to <br />165,000.39 <br />As of December 2021, COVID-19 in total has infected over 50 million and killed over <br />800,000 Americans.40 Preventing and mitigating the spread of COVID-19 continues to require a <br />major public health response from federal, state, local, and Tribal governments. <br />First, state, local, and Tribal governments across the country have mobilized to support <br />the national vaccination campaign. As of December 2021, more than 80 percent of adults have <br />received at least one dose, with more than 470 million total doses administered.41 Additionally, <br />more than 15 million children over the age of 12 have received at least one dose of the vaccine <br />and over 47 million people have received a booster dose.42 Vaccines for younger children, ages 5 <br />38 Centers for Disease Control and Prevention, COVID Data Tracker: Trends in Number of COVID-19 Cases and <br />Deaths in the US Reported to CDC, by State/Territory, https://covid.cdc.gov/covid-data- <br />tracker/#trends_dailytrendscases (last visited December 7, 2021). <br />39 <br />Id. <br />40 Centers for Disease Control and Prevention, COVID Data Tracker, http://www.covid.cdc.gov/covid-data- <br />tracker/#datatracker-home (last visited December 31, 2021). <br />41 Centers for Disease Control and Prevention, COVID Data Tracker: COVID-19 Vaccinations in the United States, <br />https://covid.cdc.gov/covid-data-tracker/#vaccinations (last visited December 7, 2021). <br />42 Id. <br />47 <br />