Trial Outcomes & Findings for The Impact of Vaccination on Severity of Illness in COVID-19 (NCT NCT04912700)
NCT ID: NCT04912700
Last Updated: 2021-09-30
Results Overview
Number of participants with encounters at emergency center (EC) and /or hospitalizations with positive COVID-19 test
Recruitment status
COMPLETED
Target enrollment
11834 participants
Primary outcome timeframe
During the period from December 15, 2020 through April 30, 2021 (up to 5 months)
Results posted on
2021-09-30
Participant Flow
Participant milestones
| Measure |
Unvaccinated
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Overall Study
STARTED
|
10880
|
825
|
129
|
|
Overall Study
COMPLETED
|
10880
|
825
|
129
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Vaccination on Severity of Illness in COVID-19
Baseline characteristics by cohort
| Measure |
Unvaccinated
n=10880 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=825 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
COVID-19 vaccine: Full or partial reception of vaccine
|
Fully Vaccinated
n=129 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
COVID-19 vaccine: Full or partial reception of vaccine
|
Total
n=11834 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 18.2 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 18.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5750 Participants
n=5 Participants
|
425 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
6244 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5130 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
5590 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3452 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
3663 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6467 Participants
n=5 Participants
|
559 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
7134 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
961 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1037 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10880 participants
n=5 Participants
|
825 participants
n=7 Participants
|
129 participants
n=5 Participants
|
11834 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the period from December 15, 2020 through April 30, 2021 (up to 5 months)Population: Study population is defined as numbers of participants presenting to EC or hospitalized.
Number of participants with encounters at emergency center (EC) and /or hospitalizations with positive COVID-19 test
Outcome measures
| Measure |
Unvaccinated
n=10880 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=825 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=129 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Participants With Emergency Center (EC) Encounters and/or Hospitalizations With Positive COVID-19 Test
|
10880 Participants
|
825 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)Population: Analysis performed on all patients presenting to EC including those hospitalized
Patient with any of the following: ICU admission, mechanical ventilation, or in-hospital mortality
Outcome measures
| Measure |
Unvaccinated
n=10880 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=825 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=129 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Patients With Severe Infection
|
733 Participants
|
85 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)Population: Analysis performed on all patients presenting to EC including those hospitalized
Number of patients admitted to ICU during hospital stay
Outcome measures
| Measure |
Unvaccinated
n=10880 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=825 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=129 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Patients With ICU Admission
|
619 Participants
|
75 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: During EC visit or in-patient hospitalization, from date of presentation until May 15, 2021 (up to 5 months)Population: Analysis performed on all patients presenting to EC including those hospitalized
Number of patients who required mechanical ventilation
Outcome measures
| Measure |
Unvaccinated
n=10880 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=825 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=129 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Patients Requiring Mechanical Ventilation
|
398 Participants
|
42 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During EC visit or in-patient hospitalization, from date of presentation until May 15, 2021 (up to 5 months)Population: Analysis performed on all patients presenting to EC including those hospitalized
Number of patients who died during EC visit or hospital admission
Outcome measures
| Measure |
Unvaccinated
n=10880 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=825 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=129 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Patients With In-hospital Mortality
|
384 Participants
|
50 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)Population: Analysis performed only on patients hospitalized
Number of hospitalized patients requiring ECMO
Outcome measures
| Measure |
Unvaccinated
n=5250 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=515 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=95 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Hospitalized Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, from date of presentation until May 15, 2021 (up to 5 months)Population: Analysis performed only on patients hospitalized
Number of hospitalized patients requiring RRT
Outcome measures
| Measure |
Unvaccinated
n=5250 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=515 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=95 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Hospitalized Patients Requiring Renal Replacement Therapy (RRT)
|
130 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)Population: Analysis performed only on patients hospitalized
Number of hospitalized patients requiring supplemental oxygen, by type
Outcome measures
| Measure |
Unvaccinated
n=5250 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=515 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=95 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Hospitalized Patients Requiring Supplemental Oxygen
Nasal canula
|
2563 Participants
|
231 Participants
|
38 Participants
|
|
Number of Hospitalized Patients Requiring Supplemental Oxygen
High flow oxygen
|
656 Participants
|
67 Participants
|
10 Participants
|
|
Number of Hospitalized Patients Requiring Supplemental Oxygen
Non-invasive ventilation
|
428 Participants
|
56 Participants
|
10 Participants
|
|
Number of Hospitalized Patients Requiring Supplemental Oxygen
Mechanical ventilation
|
395 Participants
|
42 Participants
|
6 Participants
|
|
Number of Hospitalized Patients Requiring Supplemental Oxygen
none
|
1208 Participants
|
119 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)Population: Analysis performed only on patients hospitalized
Number of hospitalized patients requiring non-invasive ventilation
Outcome measures
| Measure |
Unvaccinated
n=5250 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=515 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=95 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Hospitalized Patients Requiring Non-invasive Ventilation
|
428 Participants
|
56 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)Population: Analysis performed only on patients hospitalized
Number of hospitalized patients with hypotension requiring vasopressors
Outcome measures
| Measure |
Unvaccinated
n=5250 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=515 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=95 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Hospitalized Patients Requiring Vasopressors
|
348 Participants
|
45 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)Population: Analysis performed only on patients who were admitted to hospital
Number of patients discharged from in-patient hospital admission to home, skilled nursing facility, rehabilitation facility, or hospice.
Outcome measures
| Measure |
Unvaccinated
n=5250 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=515 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=95 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.
Home
|
4110 Participants
|
368 Participants
|
61 Participants
|
|
Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.
Rehabilitation Institute
|
72 Participants
|
7 Participants
|
0 Participants
|
|
Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.
Skilled Nursing Home
|
514 Participants
|
66 Participants
|
20 Participants
|
|
Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.
Hospice
|
125 Participants
|
21 Participants
|
6 Participants
|
|
Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.
Transferred to another facility
|
50 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.
Death
|
379 Participants
|
49 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)Population: Analysis performed only on patients admitted to hospital after EC visit
Number of days from admission after emergency center (EC) visit and positive COVID-19 test, until discharge
Outcome measures
| Measure |
Unvaccinated
n=5250 Participants
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=515 Participants
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
|
Fully Vaccinated
n=95 Participants
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
|
|---|---|---|---|
|
Hospital Length of Stay
|
7.2 days
Standard Deviation 7.0
|
7.3 days
Standard Deviation 6.3
|
7.0 days
Standard Deviation 5.2
|
Adverse Events
Unvaccinated
Serious events: 4176 serious events
Other events: 0 other events
Deaths: 384 deaths
Partially Vaccinated
Serious events: 410 serious events
Other events: 0 other events
Deaths: 50 deaths
Fully Vaccinated
Serious events: 64 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Unvaccinated
n=10880 participants at risk
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
|
Partially Vaccinated
n=825 participants at risk
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
COVID-19 vaccine: Full or partial reception of vaccine
|
Fully Vaccinated
n=129 participants at risk
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
COVID-19 vaccine: Full or partial reception of vaccine
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
37.2%
4046/10880 • Number of events 4046 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
48.0%
396/825 • Number of events 396 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
49.6%
64/129 • Number of events 64 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
|
Renal and urinary disorders
Acute renal failure
|
1.2%
130/10880 • Number of events 130 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
1.7%
14/825 • Number of events 14 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
0.00%
0/129 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
|
Cardiac disorders
Hypotension
|
3.2%
348/10880 • Number of events 348 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
5.5%
45/825 • Number of events 45 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
4.7%
6/129 • Number of events 6 • December 15, 2020 through May 15, 2021 (up to 5 months)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place