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Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Rules and Regulations
by the SARSCoV2 virus.1 On February 24, 2021, the President issued a continuation of the National Emergency concerning the COVID19
pandemic.2 Effective July 20, 2021, HHS
renewed the determination that a public health emergency exists and has existed since January 27, 2020
nationwide. 3 A more detailed background discussion of the COVID19
pandemic is found in the original temporary rule, as well as in the first extension of this rule, and USCIS
incorporates the discussions of the pandemic into this extension with modification. 85 FR 59655; 85 FR
15072.
Since publication of the original temporary rule and first extension, several variants of the virus that causes COVID19 have been, and continue to be, reported in the United States.4
Evidence suggests that these variants may spread more quickly and easily than others and at least one variant may be associated with an increased risk of death.5 The COVID19 Delta variant was first found in India in October 2020.6 Cases were discovered in the United States in late January 2021, and Delta has quickly become the predominant virus strain in the United States.7 It was labeled a Variant of Concern VOC by the HHS SARSCoV
2 Interagency Group SIG, which defines VOCs as those with evidence of increased transmissibility and severe disease, reduced effectiveness of treatments or vaccines, and diagnostic detection failures.8
1 HHS, Determination that a Public Health Emergency Exists Jan. 31, 2020, https
www.phe.gov/emergency/news/healthactions/phe/
Pages/2019-nCoV.aspx.
2 Notice on the Continuation of the National Emergency Concerning the Coronavirus Disease 2019 COVID19 Pandemic, 86 FR 11599 Feb. 26, 2021; Proclamation 9994 of March 13, 2020, Declaring a National Emergency Concerning the Coronavirus Disease COVID19 Outbreak, 85 FR
15337 Mar. 18, 2020.
3 HHS, Renewal of Determination that a Public Health Emergency Exists July 19, 2021, https
www.phe.gov/emergency/news/healthactions/phe/
Pages/COVID-19July2021.aspx.
4 Centers for Disease Control and Prevention CDC, SARSCoV2 Variant Classifications and Definitions Aug. 3, 2021, https www.cdc.gov/
coronavirus/2019-ncov/variants/variant-info.html ?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov %2Fcoronavirus%2F2019-ncov%2Fcasesupdates%2Fvariant-surveillance%2Fvariantinfo.html.
5 CDC, Variants of the Virus July 29, 2021, https www.cdc.gov/coronavirus/2019-ncov/
variants/variant.html.
6 Cov-Lineages, Global Lineage Report: B.1.617.2
May 19, 2021; CDC, SARSCoV2 Variant Classifications and Definitions Aug. 03, 2021;
CDC, Delta Variant: What We Know About the Science Aug. 06, 2021, https www.cdc.gov/
coronavirus/2019-ncov/variants/delta-variant.html.
7 Id.
8 Id.

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As of September 9, 2021, there have been approximately 222,406,582 cases of COVID19 identified globally, resulting in approximately 4,592,934
deaths. Approximately 40,152,521 cases have been identified in the United States, with about 1,297,399 new cases identified in the 7 days preceding September 5th, and approximately 646,131 reported deaths due to the disease.9 In the week preceding September 5th, the United States was the country that reported the highest number of new cases, with a 38 percent increase.10
On August 23, 2021, the U.S. Food and Drug Administration FDA granted approval for the Pfizer-BioNTech COVID19 vaccine for individuals 16
years and older, now marketed as Comirnaty.11 Prior to this, the FDA had issued emergency use authorizations EUAs for three COVID19 vaccines, including the Pfizer-BioNTech vaccine.12 The two other vaccines that continue to be authorized for emergency use are produced by Moderna and Janssen.13 The Pfizer-BioNTech and Moderna vaccines require two doses to be effective at preventing COVID19
illness.14 The Janssen vaccine is a single dose.15 As of September 9, 2021, approximately 177,433,044 people in the United States had completed a COVID19 vaccination regimen.16
While the vaccine is now widely accessible in the United States, geographic data indicates a wide 9 World Health Organization WHO, Weekly epidemiological update7 September 2021 Sept.
07, 2021, available at https www.who.int/
publications/m/item/weekly-epidemiologicalupdate-on-covid-19--7-september-2021; WHO, WHO Coronavirus COVID19 Dashboard Sept.
09, 2021, https covid19.who.int/.
10 WHO, Weekly epidemiological update.
11 FDA, FDA Approves First COVID19 Vaccine Aug. 23, 2021, https www.fda.gov/news-events/
press-announcements/fda-approves-first-covid-19vaccine.
12 FDA, Learn More About COVID19 Vaccines From the FDA content current as of July 12, 2021, https www.fda.gov/consumers/consumer-updates/
learn-more-about-covid-19-vaccines-fda.
13 Id. Janssen Biotech Inc., the manufacturer of the third vaccine granted an EUA by the FDA, is a Janssen Pharmaceutical Company of Johnson &
Johnson.
14 CDC, Moderna COVID19 Vaccine Overview and Safety updated June 11, 2021, https
www.cdc.gov/coronavirus/2019-ncov/vaccines/
different-vaccines/Moderna.html; CDC, PfizerBioNTech COVID19 Vaccine Overview and Safety updated June 24, 2021, https www.cdc.gov/
coronavirus/2019-ncov/vaccines/different-vaccines/
Pfizer-BioNTech.html.
15 CDC, Johnson & Johnsons Janssen COVID19
Vaccine Overview and Safety updated June 23, 2021, https www.cdc.gov/coronavirus/2019-ncov/
vaccines/different-vaccines/janssen.html.
16 CDC, COVID Data TrackerCOVID19
Vaccinations in the United States Sept. 09, 2021, https covid.cdc.gov/covid-data-tracker/
vaccinations_vacc-total-admin-rate-total.

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disparity in the percentages of fully vaccinated individuals by state, ranging from 39.6 percent in Alabama to 68.4
percent in Vermont, not taking into account United States territories.17
Health experts still do not know what percentage of people in the U.S. will need to be vaccinated before enough individuals in the community are protected to meaningfully reduce the spread of the disease from person to person, how effective the vaccines are against new variants, and how long the vaccines protect people.18 Furthermore, hospitalization and mechanical respiratory support may still be required in severe cases of COVID19 illness, irrespective of vaccination status.19
Ongoing research demonstrates that while there is high vaccine effectiveness, fully vaccinated individuals continue to experience breakthrough COVID19 infections and may be either symptomatic or asymptomatic.20 As of April 30, 2021, approximately 10,262 breakthrough infections were reported from 46 U.S.
states and territories.21 This is likely a substantial undercount of cases, as CDC
states that the current national surveillance system relies on voluntary reporting and data are only available for a small segment of reported cases.22 The data are further limited because on May 01, 2021, the CDC transitioned from tracking all reported COVID19 vaccine breakthrough infections to only those among patients who are hospitalized or die.23 As of August 30, 2021, CDC data from 49 U.S. states and territories indicates 12,908 patients with patients with SARSCoV2 breakthrough infections were hospitalized or died.24
Testing is available to confirm suspected cases of COVID19 infection.
At present, the time it takes to receive 17 Id.
18 CDC, Key Things to Know About COVID19
Vaccines updated June 25, 2021, https
www.cdc.gov/coronavirus/2019-ncov/vaccines/
keythingstoknow.html?CDC_AA_refVal=https %3A%2F%2Fwww.cdc.gov%2Fcoronavirus %2F2019-ncov%2Fvaccines%2F8-things.html.
19 National Insitutes of Health NIH, COVID19
Treatment Guidelines: Care of Critically Ill Adult Patients with COVID19 July 08, 2021, https
www.covid19treatmentguidelines.nih.gov/
management/critical-care/summaryrecommendations/.
20 CDC, Morbidity and Mortality Weekly Report MMWR: COVID19 Vaccine Breakthrough Infections Reported to CDCUnited States, January 1April 30, 2021 May 28, 2021, https
www.cdc.gov/mmwr/volumes/70/wr/
mm7021e3.htm.
21 Id.
22 Id.
23 Id.
24 CDC, COVID19 Vaccine Breakthrough Case Investigation and Reporting Sept. 01, 2021, https www.cdc.gov/vaccines/covid-19/healthdepartments/breakthrough-cases.html.

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