Federal Register - June 21, 2021
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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations
Food and Drug Administration FDA. 2020, December 11. Emergency use authorization for an unapproved product review memorandum Pfizer-BioNTech COVID19 vaccine/BNT 162b2 mRNA
1273. https www.fda.gov/emergencypreparedness-and-response/coronavirusdisease-2019-covid-19/pfizer-biontechcovid-19-vaccine. FDA, December 11, 2020.
Food and Drug Administration FDA. 2020, December 18. Emergency use authorization for an unapproved product review memorandum Moderna COVID
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www.fda.gov/emergency-preparednessand-response/coronavirus-disease-2019covid-19/moderna-covid-19-vaccine.
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Food and Drug Administration FDA. 2021, February 26. Janssen COVID19
vaccine. Vaccines and Related Biological Products Advisory Committee, February 26, 2021 Meeting Briefing Document.
https www.fda.gov/media/146219/
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Gharpure, R et al., 2021, February 5. Early COVID19 first-dose vaccination coverage among residents and staff members of skilled nursing facilities participating in the pharmacy partnership for long-term care program United States, December 2020January 2021. MMWR 2021; 70: 178182. DOI:
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mmwr.mm7005e2. Gharpure et al., February 5, 2021.
Hall, VJ et al., 2021, April 23. COVID19
vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection SIREN: A prospective, multicentre, cohort study. Lancet. 2021
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Howard, J. 2021, May 22. Response to request for an assessment by the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, of the current hazards facing healthcare workers from Coronavirus Disease2019 COVID19.
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Keehner et al., 2021, May 6. SARSCoV2
infection after vaccination in health care workers in California. New England Journal of Medicine 38418. Keehner et al., May 6, 2021.
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2021.02.15.21251623v3. Pawlowski et al., February 27, 2021.
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III. Impact on Healthcare Employees Data on SARSCoV2 infections, illnesses, and deaths among healthcare employees supports OSHAs finding that COVID19 poses a grave danger to these employees. Even fairly brief exposure i.e., 15 minutes during a 24hour period can lead to infection, which in turn can cause death or serious impairment of health. Employees in healthcare settings include healthcare employees, who provide direct patient care e.g., nurses, doctors, and emergency medical technicians EMTs, and healthcare support employees, who provide services that support the healthcare industry and may have contact with patients e.g., janitorial/
housekeeping, laundry, and food service employees. Employees who perform autopsies are also considered to work in healthcare. Most employees who work in healthcare perform duties that put them at elevated risk of exposure to SARSCoV2.
SARSCoV2 is introduced into healthcare settings by infected patients, other members of the public, or employees. Workers in healthcare settings that provide treatment to patients with suspected or confirmed COVID19 face a particularly elevated risk of contracting SARSCoV2
Howard, May 22, 2021. Once the virus is introduced into the worksite, the virus can be transmitted from person-toperson at close contact through inhalation of respiratory droplets. In limited scenarios, it might also be transmitted through inhalation of aerosols, which consists of small droplets and particles that can linger in the air, especially in enclosed spaces with inadequate ventilation CDC, May 7, 2021. Less frequently, transmission is also possible when someone touches a contaminated item or surface and then touches their nose, mouth, or eyes CDC, April 5, 2021.
A 2021 cross-sectional study of 6,510
healthcare employees from the Northwestern HCW SARSCoV2
Serology Cohort Study conducted May 28June 30, 2020 in Illinois shows that infections among healthcare workers were not limited to doctors and nurses;
healthcare administrators had similar rates of seropositivity compared to physicians, and support services had the highest seroprevalence this group included healthcare facility workers in
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