COVID-19 Meeting # 13 Medical Staff Updates and Discussion

“Failing to prepare is preparing to fail”

Benjamin Franklin

July 22, 2020

PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM Lee Health Continuing Medical Education

Thank you for participating in the COVID Guidelines Update

• To receive CME credits for todays event: 1. Go to www.eeds.com 2. Enter code: 32drys – Code is only good for 24 hours 3. Complete the evaluation on eeds

• All attendees will be muted on entry

• Questions to the speaker: Use the chat option in WebEx Guiding Premise

 “The one thing we know- We have no idea what the ideal management of these patients really is.”

 We will continue to learn, modify and adapt our guidelines as more information and literature becomes known. AGENDA

 Provider Well Being During COVID-19  COVID-19 Convalescent Plasma Update  COVID-19 ED Disposition Algorithm Guide  COVID-19 Infectious Disease Update Physician Well Being During COVID-19

Ashely Chatigny DO, FAPA

5 “Don’t suffer in silence: get help for emotional distress”

Dr Mehta, Radiologist, Charlotte, NCCOVID-19 Pandemic Physician Protection Act Ensures mental health coverage for health care workers

http://www.chestnet.org/-/media/chesnetorg/Publications/Documents/CHEST-Physician/Vol-15- 2020/072020.ashx?la=en&hash=1A0DCDCEE946E3BC67EA0168754308144274C394 6 Current Provider Resources

Agency Phone Number Florida Crisis Line 833-848-1762 National Suicide Prevention 800-273-8255 National Help Line 800-662-4357 Samsha 877-726-4727 Healthcare Professionals Center for progress/excellence 844-395-4432 mobile crisis unit

7 8 CME Thursday, July 23, 2020

9 Contacts for You!

Please contact these providers through Voalte!

Ashely Chatigny DO, FAPA, LPG Psychiatric Services Paul Simeone, Ph.D., VP Medical Director, Behavioral & Mental Health

10 Convalescent Plasma for the Treatment and Prevention of COVID-19

Douglas Brust, MD, PhD and the Lee Health ThankResearch You Team Convalescent Plasma for the Treatment of COVID-19: The Lee Health Experience

• As of 7/20/2020, we have enrolled and transfused 296 patients

• There have been no serious adverse events thought to be associated with convalescent plasma use

• VERY QUICK AND DIRTY: For all patients < 90 yo and with at least 28 days of follow-up, compared to COVID-19 patients who did not receive convalescent plasma over the same period, there appears to be a signal (for all comers) indicating a 27% improvement in mortality when using convalescent plasma (10.8% vs. 14.8%)

“For internal Lee Health Use Only. Do Not Forward or Distribute” Convalescent Plasma for the Treatment of COVID-19: The Lee Health Experience

Additional Criteria for Referral for Enrollment in Mayo Convalescent Plasma Protocol

1) Admitted patient who has been in ED within 24 hours. 2) Radiographic evidence of pneumonia. 3) Room air oxygen saturation < 94% requiring supplemental oxygen but not mechanical ventilation.

Patients will be evaluated chronologically Monday-Friday, 9 AM - 5 PM until 10 patients have been enrolled that calendar day (if plasma available). Patients admitted on weekends and holidays cannot be offered enrollment. Convalescent Plasma for the Treatment of COVID-19: The Lee Health Experience

• Because of our extensive experience, the Mayo has asked us to submit our data as part of a multi-center, case-controlled efficacy analysis they are conducting for publication

• The goal of this analysis is to compare outcomes (e.g. improvement in clinical status, length of stay, mortality) between controls (i.e. patients who were admitted to Lee Health with COVID-19 who did not receive convalescent plasma) and convalescent plasma patients with the same disease severity Convalescent Plasma for the Prevention of COVID-19:

• Can convalescent plasma serve as a post-exposure prophylaxis (i.e. prevent infection in people who have had a significant exposure but are asymptomatic)?

• We are enrolling a clinical trial and truly appreciate your help referring potential subjects

• We need to evaluate asymptomatic people with a recent, significant exposure (within 72 hours) to an ill COVID-19 patient, but who are SARS-CoV-2 NP swab negative

• Participants will be randomized to receive either COVID-19 convalescent plasma or control plasma to determine if plasma can prevent the development of active COVID-19 Convalescent Plasma for the Prevention of COVID-19:

Participants can be:

1) Health care workers (or anyone that works in a healthcare setting--e.g. transporters, housekeeping, etc.) who were not wearing PPE and had a significant exposure to a sick COVID-19 patient

OR

2) Community members who are at high risk for serious COVID-19 who have been exposed while living with/caring for a sick patient at home.

Participants will be compensated for their time. Convalescent Plasma for the Prevention of COVID-19:

When you are seeing new COVID-19 patients, kindly let them know that family members living them, who are asymptomatic, can contact us to enroll in a trial to see if convalescent plasma can prevent them from becoming ill

To make it easy, if you identify an exposed person, just call me on my cell (239-292-7291) and I can call that person to discuss trial

Or have patient or family members contact me at 239-343-8579 or E-mail [email protected] ED DISPOSITION ALGORITHM GUIDELINE

TIM DOUGHERTY, MD, DACMT, FAAEM CCH MEDICAL DIRECTOR/CHAIR DEPARTMENT OF EMERGENCY MEDICINE LEE HEALTH MEDICAL DIRECTOR, DISASTER PREPAREDNESS QUICK REMINDERS… PRONING ORDER SET PRONING WORKS! DEXAMETHASONE SUMMARY (CONSIDER REVIEWING DR. LAFFERTY’S REVIEW 6/17)

• NIH Recommendations (6/25/20): • Covid 19 pts mechanically ventilated • Covd-19 pts who require supplemental O2 but who are not mechanically ventilated • NOT recommended for outpatient use or those who do NOT require supplement O2 • Dosage: Oral or IV 6 mg daily for 10 days • Pregnant/Breast feeding: Prednisolone po 40 mg/ Hydrocortisone 80 mg BID RECOVERY TRIAL

• 2104 patients on dexamethasone, 4321 were not • Lowered Death Risk from 40 % to 28% on Ventilators • Lowered Death Risk from 25% to 20 % for those requiring supplemental 02 • Number needed to treat: 8 pts ventilated pts, 25 pts on O2 • NOT yet published in peer reviewed article (other factors may be at play) FDA: HYDROXYCHLOROQUINE, CHLOROQUINE

• June 15, 2020 Update: Based on ongoing analysis and emerging scientific data, FDA has revoked the emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to treat COVID-19 in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible. We made this determination based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery. This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19. As a result, we determined that the legal criteria for the EUA are no longer met. Please refer to the Revocation of the EUA Letter and FAQs on the Revocation of the EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate for more information.

NEW ENGLAND JOURNAL OF MEDICINE

• Mild or Moderate Covid 19 • https://www.nejm.org/doi/full/10.1056/NEJMcp2009249 • Severe Covid 19 • https://www.nejm.org/doi/full/10.1056/NEJMcp2009575 MILD SYMPTOMS

• In China: 81% mild/moderate disease, 14% severe disease, 5 % critical disease • Mild illness usually can recover at home • Mild: Some do progress one week after onset of symptoms • New/worsening symptoms (dyspnea) – need further evaluation • Consider Home Pulse Ox to self monitor. RISK FACTORS

• Established Risk • Unclear Risk • Age greater than 65 yrs old • Kidney Disease • Cardiovascular disease • Immunosuppression • Chronic lung disease • Cancer • HTN • Uncontrolled HIV • DM • Male (?) • Obesity NEW YORK EXPERIENCE

• Fever often absent (31% Northwell Health, 25% Cornell) • At Cornell, • 31% of the patients required no supplement oxygen at presentation the ED, yet subsequently deteriorated leading to intubation. • Initial Chest X-ray clear 17%, unilateral infiltrate 16%, B/L 60% • At Columbia, • Median 3 days btw hospital admission and clinical deterioration. 80% patients intubated • Chest infiltrates present 98% X-rays (median presentation 6 days after symptoms started). ED DISPOSITION?

Source: Socionomics Institute WHAT WE (DON’T) KNOW?

• There is No literature directly address what clinical features indicate safety for discharge • Lack of current validated risk prediction tools for ED admission/discharge criteria • Admission decision driven largely by need for supplemental oxygen or factors that may put patients with mild disease at risk for sudden deterioration out of the hospital • No single laboratory test is reliable indicator who can be discharged or admission CAN WE BASE IT ON AN X-RAY?

• Chest X-ray has low sensitivity 67- 69% for diagnosis of COVID • No single investigation, including CT scanning, showed sufficient sensitivity or specificity to be used to identify patients requiring admission • Clinically hypoxic patient with clear X-ray argue against COVID as the cause of hypoxia • Slightly ill patients with normal chest X-ray still could be COVID COVID-GRAM: A CLINICAL PREDICTION RULE TO PREDICT CRITICAL ILLNESS IN HOSPITALIZED COVID-19 PATIENTS

• Liang W et al. Development and Validation of a Clinical Risk Score to Predict the Occurrence of Critical Illness in Hospitalized Patients with COVID-19. JAMA Intern Med 2020. • 10 VARIABLES: Abnl CXR, Age, Hemoptysis, Dyspnea, Unconsciousness, # Comorbidities, Cancer, LDL, Direct Bilirubin, Neutrophil to Lymphocyte count • MDCalc “This score was for hospitalized patients and did not include ED patients; it should NOT be used to suggest which patients should be admitted or discharged.” OTHER RISK CALCULATORS?

• Brescia Scale • Developed in Italy not validated • For the use in areas of of inadequate health care resources • CURB-65 • For Community Acquired Pneumonia • May not be adequately sensitive for use in predicting mortality, or need for admission • SOFA scale • Odds of in- hospital death associated w/older age W.H.O. ARE THEY TO TELL US WHAT TO DO ?

• World Health Organization • Risk Factors: Smoking, DM, HTN, Cardiac Disease, Chronic Lung Disease, CVD, Kidney Disease, Immunosuppression, and Cancer • “The presence of vulnerable persons in the household” as a consideration when deciding whether to admit a patient to the hospital EXERTIONAL O2 TEST

• Centre for Evidence Based Medicine (CEBM): • “Even a small desaturation on exercise should alert the clinician and a drop of 3% should be cause for serious concern, regardless of the amount of exercise to produce it.” • There is no scientific literature found on observation periods in the ED for decision making HOW DO WE ACCOUNT FOR OXYGEN REQUIREMENTS?

• Admissions decisions will be driven largely by the need for supplemental oxygen • BUT… • O2 requirements are not stable like in COPD, so risk sending patients home w/ oxygen compressor that may delay/mask indications to return to the ED IF PLANNING TO DISCHARGE

• Confirm ability to manage activities of • Special Needs: daily living • Homeless – Call (24/7) Lee County • Support for up to 2 weeks Dept of Health (1-866-779-6121) • Prisoners • Adequate home meds for 2 weeks • NH patients • Provide a mask to the patient • Pregnant Patients • Private ride home • Home Pulse Ox monitoring for at risk pts (NEJOM) MODERATE/SEVERE DISEASE: HOSPITALIZATION GENERALLY WARRANTED

• Moderate Disease: Dyspnea but room air sat of 94% • Severe Disease: Marked tachypnea (RR > 30), Hypoxia (<93%), Ratio of Partial Pressure of arterial oxygen to fraction on inspired Oxygen (< 300), Lung Infiltrates (> 50% of lung field involved within 24-48 hours) WHO CAN BE DISCHARGE?

• REFER BACK TO OUR GUIDING PRINCIPLE • NO RANDOMIZED STUDIES- (Anecdotal reports) • NO NATIONAL ORGANIZED CRITERIA • CAN NOT REPLACE CLINICAL JUDGEMENT • BASED ON CAPACITY, CRITERIA MAY OR MAY NOT BE POSSIBLE

• BUT…We should have some guidelines SUMMARY

• Exertional O2 monitoring may identify latent hypoxemia • No labs/x-ray are absolutely necessary or indicated if patient is clinically well unless required for alternative diagnosis. • No Validated Risk Predication Tool • 94 % now has therapeutic ramifications/options

≦ Covid 19 Severity Stage/Disposition Guidance for Covid Positive patients 7/22/2020

Stage Covid Presence SX Type CXR/CT Respiratory Hemodynamic Support Disposition Status and Support Level of SX 0 Test Only None None None/NL None None Discharge Special Needs Pts 1 + Mild Fever or chills, Cough None/NL O2 Sat > 95% at rest None Discharge (Consider SOB or difficulty work of Admit only if requiring Commercia breathing(dyspnea) Special Needs l Outpt Fatigue, H/A, Congestion, Testing) Myalgia, Sore throat/runny nose New loss of taste or smell Nausea/vomiting/diarrhea 2 + Moderate RR 20-25, HR < 110 CXR infiltrate, Requiring NC 2-6 liters None Admission/(Obs) to O2 sat 94% or CXR infiltrate peripheral to maintain O2 sat > Hospitalist (w/ 02 Sat <95%) or consolidation, 92% Failed *Exertional≦ O2 Sat or Ground Glass Failed *Exertional O2 Dyspnea but Sat > 94% or Appearance Sat Clinical Decision based on Risk Dyspnea but Sat > 94% Factors, co-morbidities, and/or special populations 3 + Severe RR > 25 or Dyspnea (increased CXR infiltrates, Pt requiring 1 Vasopressor (low dose) Admit with: work of breathing) multiple >6 LNC Pulm. consultation for Persistent afebrile tachycardia consolidations, HFNT, BIPAP, Helmet bed placement: GGO Ventilation, Invasive • If Pt 02 > 6LNC Mechanical Intubation ICU consultation for bed placement: • If Pt 02 > 10LNC, HFNT, BIPAP, Helmet Ventilation, Intubation

4 + Very Severe Hypotensive Diffuse Infiltrates See Above > 2 Vasopressors ICU Admission ARDS Pulse 0x > 97 % ED COVID Disposition Guideline Social Barriers? • Discharge with Info for homeless, long symptom monitoring MILD illness term care, hospice • Recommend 48-72 hr F/U OR Stage 0 No Ox Sat 95-97% and/or Special No • Pt Education/self isolate w/out ED testing - patient considered high Populations Labored breathing or • No other testing or imaging recommended unless for other risk Pregnancy Hypoxia ( 94 % at clinical reasons • Consider Home Pulse Ox rest) Stage 1 • Recommend 12/24 hr F/U ≦ Yes • Consider discharge with Commercial testing if patient low risk • Consider possible imaging and In-house testing before discharge of Yes Homeless (not from shelter)-In House Test + Stage 1 if patient has dyspnea and/ or risk features for • Call Florida Dept of Health - 1 (866) 779-6121 decompensation: • 24/7 to make arrangement for shelter placement • Age >50, DM, Cardiopulmonary Disease, HTN, Obesity, Nursing Home/SNF/Hospice House/Baker Act- In House Immunocompromised, Kidney Disease, Cancer, HIV Test + Needs O2 > 6LNC to • Consult Case Management maintain sat > 92% or MODERATE illness • Admit to Hospitalist if indicated/instructed Stage 2 COVID + or High Clinical Suspicion Multifocal infiltrates on No Pregnancy- In House Test + CXR or Diffuse GGO on Admit to Hospitalists: OB/GYN consult for ALL Covid + to coordinate care CT? or Vasopressors • Age >65 (02 Sat < 95%,) • O2 sat 94% or CXR infiltrate (w/ 02 Sat <95%) or • < 20 weeks: Hospitalist admit/OB/GYN Consult • Failed *Exertional O2 Sat or • > 20 weeks: Admit/Transfer to HP/CCH and will • Dyspnea≦ but Sat > 94% or follow established algorithms • Clinical Decision based on Risk Factors, co-morbidities, and/or Yes special populations Summary of Illness Severity for COVID+ Patients: SEVERE illness • Stage 0 – No symptoms, hypoxia, (Stage 3-4) Covid + or High Clinical Suspicion • Stage 1 – Symptoms but no hypoxia; nl imaging (if Admit with Pulm. consultation for bed placement: indicated) • If Patient requiring 02 > 6LNC • Stage 2 – Minimal O2 support; abnormal imaging Admit with ICU consultation for bed placement: • Stage 3 – Significant O2 requirement or resp support • If Patient requiring 02 > 10LNC, HFNT, BIPAP, Helmet Ventilation, • Stage 4 – ARDS, hypotension Intubation or This information is a guide to assist the clinician in a wide variety of • Multifocal infiltrates on CXR or Diffuse GGO on CT or circumstances. It is not intended to establish standard of care. • Vasopressors Nor is this a substitute for the clinician’s judgement, knowledge and skill in the care and treatment of any individual patient. 7/22/2020 * Exertional O2 Sat: Patient walks in place briskly for 1 min continuously. ↓ Sat 3% or Inability to complete 1 min is considered test failure COVID-19 MELANGE Mary Beth Saunders DO MPH July 22 2020 #2775 Rev . 01/17 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED 4 INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM 4 CDC Guidance Updates

45 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM CDC GUIDANCE UPDATES

CDC guidance changes as of July 17, 2020: • Except for rare situations, a test-based strategy is no longer recommended to determine when to discontinue Transmission-Based Precautions, symptom based strategy should be used • For patients with severe to critical illness or who are severely immunocompromised the recommended duration for Transmission- Based Precautions was extended to 20 days after symptom onset (or, for asymptomatic severely immunocompromised patients, 20 days after their initial positive SARS-CoV-2 diagnostic test). Other symptom-based criteria were modified as follows: • Changed from “at least 72 hours” to “at least 24 hours” have passed since last fever without the use of fever-reducing medications. • Changed from “improvement in respiratory symptoms” to “improvement in symptoms”

46 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM SYMPTOM-BASED STRATEGY

Symptom-Based Strategy for Discontinuing Transmission-Based Precautions Patients with mild to moderate illness who are not severely immunocompromised: • At least 10 days have passed since symptoms first appeared and • At least 24 hours have passed since last fever without the use of fever-reducing medications and • Symptoms (e.g., cough, shortness of breath) have improved

Patients with severe to critical illness or who are severely immunocompromised • At least 20 days have passed since symptoms first appeared and • At least 24 hours have passed since last fever without the use of fever-reducing medications and • Symptoms (e.g., cough, shortness of breath) have improved

47 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM TRANSMISSION-BASED PRECAUTIONS

Standard Precautions- the basis tenants of infection prevention to prevent spread of infection • Perform hand hygiene • PPE whenever there is expectation of possible exposure to infectious material • Appropriate patient placement • Proper handling, cleaning and disinfection of patient care equipment, devices, instruments • Cleaning and disinfection of the environment

Transmission–Based Precautions- used in addition to Standard Precautions for patients with known or suspected infections

48 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM DEFINITION OF IMMUNE-COMPROMISED

CDC used the following definition for severely immune-compromised • Some conditions, such as being on chemotherapy for cancer, untreated HIV infection with CD4 T lymphocyte count < 200, combined primary immunodeficiency disorder, and receipt of prednisone >20mg/day for more than 14 days, may cause a higher degree of immunocompromise and inform decisions regarding the duration of Transmission-Based Precautions. • Advanced age, diabetes mellitus, or end-stage renal disease, may pose a much lower degree of immunocompromise and not clearly affect decisions about duration of Transmission-Based Precautions. • Ultimately, the degree of immunocompromise for the patient is determined by the treating provider, and preventive actions are tailored to each individual and situation.

49 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM VACCINE DEVELOPMENT

50 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM Pre-COVID VACCINE DEVELOPMENT

The stages of development generally follow this timeline: Exploratory stage. This is the start of lab research to find something that can treat or prevent a disease. It often lasts 2 to 4 years. Pre-clinical stage. Scientists use lab tests and testing in animals, such as mice or monkeys, to learn whether a vaccine might work. This stage usually lasts 1 to 2 years. Many potential vaccines don’t make it past this point. But if the tests are successful and the FDA signs off, it’s on to clinical testing. Clinical development. This is a three-phase process of testing in humans. Phase I usually lasts 1 to 2 years and involves fewer than 100 people. Phase II takes at least 2 years and includes several hundred people. Phase III lasts 3 or 4 years and involves thousands of people. Overall, the clinical trial process may stretch to 15 years or more. About a third of vaccines make it from phase I to final approval. Regulatory review and approval. Scientists with the FDA and CDC go over the data from the clinical trials and sign off. Manufacturing. The vaccine goes into production. The FDA inspects the factory and approves drug labels. Quality control. Scientists and government agencies keep tabs on the drug-making process and on people who get the vaccine. They want to make sure it keeps working safely.

51 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM OPERATION WARP SPEED (OWS)

Operation Warp Speed has cut vaccine development from 15 to years to 15 months • 12- 18 months for vaccine development and market • Public/Private partnership • Collaboration of US federal government departments (HHS, NIH, Veterans Affairs and more that 18 biopharmaceutical companies • 3 candidates have been funded for phase 3 trails under OWS. Moderna’s mRNA-1273 - July The University of Oxford and AstraZeneca AZD mRNA– August Pfizer and BioNtech BNT 162 mRNA vaccine –September

52 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM PFIZER AND BIONTECH COVID VACCINE

COVID-19 Vaccine candidate trial • Conducted in Germany • Modified messenger RNA which encodes a SARS-CoV-2 receptor antigen • 60 adults (48 adults received 2 vaccines 22 days apart of different dose vaccine) (12 adults received 1 single high dose vaccine) • Participants who received the higher dose and second infection had high concentration of neutralising titers and IgG concentrations following the second dose • Concurrent stimulation of high level CD4 and CD8 T cell response

53 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM OXFORD AstraZeneca COVID-19

COVID-19 Vaccine trial • 1, 077 healthy adult volunteers • Single dose led to a four-fold increase antibiodies to the SARS-CoV-2 virus in 95% of subjects 1 month following vaccination • T-cell response that peaked by Day 14 and maintained two months was observed in all participants • Neutralising activity against SARS-CoV-2 one month after injection in 91% of participants (10 participants had received 2 dose and all had neutralising activity) • No serious adverse events reported

54 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM MODERNA COVID-19 Vaccine trial

Biotechnology company pioneering mRNA vaccines • Study led by NIH • 2 dose vaccine schedule • 3 dose levels 45 adults adults • Seroconversion by Day 15 by all participants • After two vaccination by day 57 titers exceeded convalescents titers of people confirmed to have COVID-19 • 54% of the participants had systemic adverse following second vaccination (fatigue, chills 80%)

55 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM THANK YOU

56 PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE MEMORIAL HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM Lee Health Continuing Medical Education

Thank you for participating in the COVID Guidelines Update

• To receive CME credits for todays event: 1. Go to www.eeds.com 2. Enter code: 32drys – Code is only good for 24 hours 3. Complete the evaluation on eeds

• All attendees will be muted on entry

• Questions to the speaker: Use the chat option in WebEx