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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations
infections as of May 24, 2021, 1.8 out of every 1,000 people have died from COVID19 CDC, May 24, 2021a.
COVID19 was the third leading cause of death in the United States in 2020
among those aged 45 to 84, trailing only heart disease and cancer Woolf, January 12, 2021. During the surges in the spring and fall/winter of 2020, COVID
19 was the leading cause of death.
Despite a decrease in recent weeks, the death rate remains high 7-day moving average death rate of 500 on May 23, 2021 CDC, May 24, 2021c. Not only are healthcare employees included in these staggering figures, they are exposed to COVID19 at a much higher frequency than the general population while providing direct care for both sick and dying COVID19 patients during their most infectious moments.
The impact of morbidity and mortality on healthcare employees might also be underreported. The information associated with cases and deaths are incomplete. Only 18.37% of cases were reported with information on whether or not the infected individual was a healthcare employee CDC, May 24, 2021d. For those who were identified as healthcare personnel, only 79.58% of these cases noted whether the individual survived the illness CDC, May 24, 2021d. Despite the incomplete data, the toll on healthcare personal is clear. As of May 24, 2021, CDC reported 491,816 healthcare personnel cases 10% of cases that included information on healthcare personnel status and 1,611 fatalities 0.4% of healthcare employee cases with known death status. This number is staggering when compared with, for example, the 2018
2019 influenza season, during which only 0.1% of known influenza infections were estimated to be fatal for the entire population CDC, October 5, 2020.
The risk of mortality and morbidity from COVID19 has changed, and may continue to change over time. Viruses mutate and those mutations can result in variants of concern that may be more transmissible, cause more severe illness, or impact diagnostics, treatments, or vaccines CDC, May 5, 2021. For example, the UKs New and Emerging Respiratory Virus Threats Advisory Group NERVTAG issued a report on how risk might have changed with the development of a new variant there called B.1.1.7 February 11, 2021.
The group determined that analysis from multiple different datasets indicated that B.1.1.7 infections resulted in an increased risk of hospitalization and death compared with the ancestral virus and other variants in circulation.
Challen et al., March 10, 2021 found
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that B.1.1.7 increased mortality risk by 64%. As virus mutations result in variants of concern, the effectiveness of medical countermeasures such as therapeutics and vaccines might be affected. Lastly, depending on the variant, potential immune escape properties of the virus may increase a persons susceptibility to reinfection.
Severe and Critical Cases of COVID19
Apart from mortality, COVID19
causes significant morbidity that can result in incurable, permanent, and nonfleeting consequences. As discussed below, people who become ill with COVID19 might require hospitalization and specialized treatment, and can suffer respiratory failure, blood clots, long-term cardiovascular effects, organ damage, and significant neurological and psychiatric effects. Approximately 6.7% of COVID19 cases are severe and require hospitalization and more specialized care total hospitalizations and total cases, CDC, May 24, 2021e;
CDC, May 24, 2021f. Given that this is a novel virus, long-term effects are still unknown. A severe case of COVID19 is described as when the patient presents with hypoxia and is in need of oxygen therapy NIH, April 21, 2021a. Cases become critical when respiratory failure, septic shock, and/or multiple organ dysfunction occurs.
The majority of the data currently available on the health outcomes for hospitalized patients is derived from the first surge of the pandemic between March and May of 2020. However, newer data indicates that health outcomes for hospitalized patients have changed over the course of the pandemic. A study from Emory University reviewed COVID19 patient data from a large multi-hospital healthcare network and compared the data from the first surge early in the pandemic March 1 to May 30, 2020
with the second surge that occurred in the summer of 2020 June 1 to September 13, 2020 Meena et al., March 1, 2021. The study found that during the second surge, ICU admission decreased from 38% to 30%, ventilator use decreased from 26% to 15%, and mortality decreased from 15% to 9%.
The study authors postulated that improved patient outcomes during the second stage may have resulted in part from aggressive anticoagulation therapies to prevent venous thromboembolism.
Similar findings were reported in a retrospective study of 20,736 COVID19
patients admitted to 107 hospitals in 31
states from March through November 2020 Roth et al., May 3, 2021. The proportions of patients placed on
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mechanical ventilation dropped from 23.3% in March and April 2020 to 13.9% in September through November 2020. During those same respective time periods, mortality rates dropped from 19.1% to 10.8%. The reasons for the reductions in mechanical ventilation and mortality are not known, but study authors postulated that reductions in mechanical ventilation may have resulted from increased use of noninvasive ventilation, high flow nasal oxygen, and prone positioning. They hypothesized that the high patient count and staff unfamiliarity with infection control procedures that were being rapidly implemented in March and April could have accounted for the high mortality rate during that period. In addition, the authors noted that changes in pharmacology treatments occurred during that time period, but their impact on improved outcomes is not known.
This data on improvements in health outcomes between earlier and later stages of the pandemic is significant, but also demonstrates that overall health outcomes for hospitalized COVID19
patients still remain poor. Even with these improvements in health outcomes, COVID19 still results in considerable loss of life and significant adverse health outcomes for patients hospitalized with COVID19. The COVID19-Associated Hospitalization Surveillance Network COVIDNET, which conducts population-based surveillance in select U.S. counties, reported a cumulative hospitalization rate of 1 in 255 people between the ages of 18 and 49 as well as 1 in 123 people between the ages of 50 and 64 between March 1, 2020, and May 15, 2021 CDC, May 24, 2021g.
Patients hospitalized with COVID19
frequently need supplemental oxygen and supportive management of the diseases most common complications, which are discussed in further detail below and include pneumonia, respiratory failure, acute respiratory distress syndrome ARDS, acute kidney injury, sepsis, myocardial injury, arrhythmias, and blood clots. Among 35,302 inpatients in a nationwide U.S.
study, median length of stay was 6 days overall Rosenthal, et al., December 10, 2020. When cases required treatment in the ICU, ICU stays were on median 5
days in addition to time spent hospitalized outside of the ICU. The Roth et al., May 3, 2021 study described above reported that mean length of hospital stays decreased from 10.7 days in April and May 2020 to 7.5
days from September to November 2020, and the respective values for ICU stays over the same time period decreased from 13.9 days to 6.6 days. As discussed
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