COVID-19 Vaccines – Class Review Summary

AHFS Therapeutic Description: Vaccines1

AHFS Therapeutic Class: 80:121

Pharmacological Class: Vaccine, mRNA (Pfizer-BioNTech, Moderna) / TBD (Janssen)2

Pharmacology/Mechanism of Action: nucleoside-modified mRNA is formulated in lipid nanoparticles enabling delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 spike (S) antigen eliciting an immune response to the S antigen which protects against COVID-19 (Pfizer-BioNTech, Moderna)3-4 / recombinant, replication-incompetent human adenovirus type 26 vector that, after entering human cells, expresses the S antigen without virus propagation eliciting an immune response to the S antigen which protects against COVID-19 (Janssen)5 • Clinical o The Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines have emergency use authorizations (EUAs) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged ≥16 years, ≥18 years, and ≥18 years respectively. o The Pfizer-BioNTech COVID-19 Vaccine dosing is 30 mcg/0.3 mL intramuscularly (IM) twice, 3 weeks apart. The Moderna COVID-19 Vaccine dosing is 100 mcg/0.5 mL IM twice, 1 month apart. The Janssen COVID-19 Vaccine dosing is 5 x 1010 vp/0.5 mL IM once.

• Operations o The Pfizer-BioNTech COVID-19 Vaccine is available as a solution for dilution in multi-dose vials. The Moderna and Janssen COVID-19 vaccines are available as solution in multi-dose vials. o After dilution, the Pfizer-BioNTech COVID-19 Vaccine is stable for up to 6 hours at room temperature or in a refrigerator. After first use, the Moderna COVID-19 Vaccine is stable for up to 6 hours at room temperature or in a refrigerator. After first use, the Janssen COVID-19 Vaccine is stable for up to 6 hours in a refrigerator or 2 hours at room temperature. o The Pfizer-BioNTech COVID-19 Vaccine can be stored in an ultra-low temperature freezer expiration, its thermal shipper for up to 30 days, a conventional freezer for 2 weeks, and in a refrigerator for up to 5 days. The Moderna COVID-19 Vaccine can be stored in a conventional freezer until expiration and in a refrigerator for up to 30 days. The Janssen COVID-19 Vaccine can be stored in a refrigerator until expiration.

IDN/Facility Recommendation: PLEASE INPUT SPECIFIC IDN/FACILITY RECOMMENDATION HERE

This document was written 12.11.2020, updated 2.27.2021. It is the property of HealthTrust. The recommendations made within this document are subject to change. 1

COVID-19 Vaccines – Class Review

AHFS Therapeutic Description: Vaccines1

AHFS Therapeutic Class: 80:121

Pharmacological Class: Vaccine, mRNA (Pfizer-BioNTech and Moderna) / TBD (Janssen)2

Pharmacology/Mechanism of Action: nucleoside-modified mRNA is formulated in lipid nanoparticles enabling delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 spike (S) antigen eliciting an immune response to the S antigen which protects against COVID-19 (Pfizer-BioNTech, Moderna)3-4 / recombinant, replication-incompetent human adenovirus type 26 vector that, after entering human cells, expresses the S antigen without virus propagation eliciting an immune response to the S antigen which protects against COVID-19 (Janssen)5

Clinical Review Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 Generic Investigational name: BNT162b2 Investigational name: mRNA-1273 Investigational name: Ad26.COV2.S Manufacturer Pfizer & BioNTech Moderna Janssen Platform mRNA mRNA Non-Replicating Viral Vector • 30 mcg of a nucleoside-modified messenger • 100 mcg of a nucleoside-modified messenger • 5 × 1010 vp of a replication-incompetent RNA (modRNA) encoding the viral spike (S) RNA (modRNA) encoding the viral spike (S) recombinant adenovirus type 26 (Ad26) glycoprotein of SARS-CoV-2 glycoprotein of SARS-CoV-2 vector expressing the viral spike (S) protein of • Lipids • 1.93 mg lipids SARS-CoV-2 in a stabilized conformation o 0.43 mg (4- o SM-102 (grown in PER.C6 TetR cells) hydroxybutyl)azanediyl)bis(hexane-6,1- o 1,2-dimyristoyl-rac-glycero-3- • 0.14 mg citric acid monohydrate diyl)bis(2-hexyldecanoate) methoxypolyethylene glycol-2000 • 2.02 mg trisodium citrate dihydrate o 0.05 mg 2[(polyethylene glycol)-2000]-N,N- (PEG2000-DMG) • 2.04 mg ethanol ditetradecylacetamide o Cholesterol • 25.50 mg 2-hydroxypropyl-β-cyclodextrin Components (each o 0.09 mg 1,2-distearoyl-sn-glycero-3- o 1,2-distearoyl-sn-glycero-3- (HBCD) dose) phosphocholine phosphocholine (DSPC) • 0.16 mg polysorbate 80 o 0.2 mg cholesterol • 0.31 mg tromethamine • 2.19 mg sodium chloride • 0.01 mg potassium chloride • 1.18 mg tromethamine hydrochloride • May also contain residual amounts of host • 0.01 mg monobasic potassium phosphate • 0.043 mg acetic acid cell proteins (≤0.15 mcg) and/or host cell • 0.36 mg sodium chloride • 0.12 mg sodium acetate DNA (≤3 ng) • 0.07 mg dibasic sodium phosphate dehydrate • 43.5 mg sucrose • Does not contain preservative • 6 mg sucrose • Does not contain preservative • Vial stoppers are NOT made with natural • NS diluent contributes an additional 2.16 mg • Vial stoppers are NOT made with natural rubber latex sodium chloride rubber latex

This document was written 12.11.2020, updated 2.27.2021. It is the property of HealthTrust. The recommendations made within this document are subject to change. 2

Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 • Does not contain preservative • Vial stoppers are NOT made with natural rubber latex Note on differences in package insert (PI) and ACIP/CDC Guideline Recommendations The manufacturer is required to abide by the package insert, whereas the ACIP recommendations are intended for practitioners. The ACIP

recommendations for a vaccine may often be inconsistent with the approved product labeling (i.e., the package insert). From time to time, the ACIP may consider clinical studies or epidemiological data that are not (or not yet) accepted by the FDA for regulatory product approval purposes. Indications Prevention of COVID-19 caused by X (EUA/investigational) X (EUA/investigational) X (EUA/investigational) SARS-CoV-2

Patient Population Age ≥16 years Age ≥18 years Age ≥18 years Package Insert Primary vaccination Primary vaccination Primary vaccination Dosing • 30 mcg/0.3 mL IM twice, 3 weeks apart • 100 mcg/0.5 mL IM twice, 1 month apart • 5 × 1010 vp/0.5 mL IM once • Recommended use in persons aged ≥16 years • Recommended use in persons aged ≥18 years • To be determined by ACIP for the prevention of COVID-19 for the prevention of COVID-19 • Vaccination consists of 2 doses (30 mcg, 0.3 • Vaccination consists of 2 doses (100 mcg, 0.5 mL each) administered IM, 3 weeks (21 days) mL each) administered IM, 1 month (28 days) apart apart • 2nd doses administered within a grace period of 4 days earlier than recommended date are • To be determined by ACIP considered valid o 2nd doses administered earlier should not be repeated • 2nd dose should be administered as close to recommended interval as possible o If it is not feasible to adhere to recommended interval, 2nd dose may be scheduled for administration up to 6 weeks (42 days) after 1st dose Routine Guideline o If 2nd dose is administered beyond these intervals, there is no need to restart series Recommendations • Need for and timing of booster doses has not been established; no additional doses beyond the and Dosing6-8 2-dose primary series are recommended at this time • Antipyretic or analgesic medications (e.g., acetaminophen, NSAIDs) may be taken for treatment of post-vaccination local or systemic symptoms, if medically appropriate; routine prophylactic administration of these medications is not currently recommended, as information on their impact on vaccine-induced antibody responses is not available at this time • Infection prevention and control considerations are available for healthcare personnel and LTCF residents with systemic signs and symptoms following COVID-19 vaccination • Vaccinated persons should continue to follow all current guidance to protect themselves and others from COVID-19 • Interpretation of SARS-CoV-2 test results in vaccinated persons o Prior receipt of COVID-19 vaccine will not affect results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests)

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 o A positive test for spike protein IgM/IgG could indicate either prior infection or vaccination; to evaluate for evidence of prior infection in an individual with a history of COVID-19 vaccination, a test specifically evaluating IgM/IgG to the nucleocapsid protein should be used o Antibody testing is NOT currently recommended to assess for immunity to COVID-19 following COVID-19 vaccination or to assess need for vaccination in an unvaccinated person • Interpretation of tuberculosis (TB) test results in vaccinated persons o For healthcare personnel or patients who require baseline TB testing (at onboarding or entry into facilities) at same time they are to receive an mRNA COVID-19 vaccine: ▪ Perform TB symptom screening on all healthcare personnel or patients ▪ If utilizing the IGRA, draw blood for IGRA prior to COVID-19 vaccination ▪ If utilizing the TST, place prior to COVID-19 vaccination ▪ If vaccination has been given and testing needs to be performed, defer TST or IGRA until 4 weeks after COVID-19 vaccine 2-dose completion ▪ All potential recipients of COVID-19 vaccination should weigh the risks and benefits of delaying TST/IGRA with their providers o For healthcare personnel who require testing for other reasons: ▪ Perform TB symptom screening on all healthcare personnel ▪ Test for infection should be done before or at same time as administration of COVID-19 vaccination; if this is not possible, prioritization of test for TB infection needs to be weighed with importance of receiving COVID-19 vaccination based on potential COVID-19 exposures and TB risk factors ▪ Healthcare personnel with high-risk conditions for TB progression should be fully evaluated as soon as possible ▪ Healthcare personnel without high-risk conditions for TB progression should proceed with contact tracing (i.e., symptom screening, chest radiograph or other imaging, specimen for microbiologic evaluation) but delay test for TB infection (TST or IGRA) if prioritized for receiving COVID-19 vaccination ▪ All potential recipients of COVID-19 vaccination should weigh risks and benefits of delaying TST/IGRA with their providers • Persons with a current or prior history of SARS-CoV-2 infection • To be determined by ACIP o Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection o Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection for the purpose of vaccine decision-making is NOT recommended o Vaccination of persons with known current SARS-CoV-2 infection should be deferred until the Special Populations8 person has recovered from the acute illness (if the person had symptoms) and criteria have been met for them to discontinue isolation; this applies to persons who develop SARS-CoV-2 infection before receiving any vaccine doses as well as those who develop SARS-CoV-2 infection after 1st dose but before receipt of 2nd dose o While there is no recommended minimum interval between infection and vaccination, current evidence suggests risk of SARS-CoV-2 reinfection is low in the months after initial infection but

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 may increase with time due to waning immunity; thus, while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that risk of reinfection, and therefore need for vaccination, may increase with time following initial infection o For vaccinated persons who subsequently develop COVID-19, prior receipt of an mRNA COVID-19 vaccine should not affect treatment decisions (including use of monoclonal antibodies, convalescent plasma, antiviral treatment, or corticosteroid administration) or timing of such treatments • Persons who previously received passive antibody therapy o Vaccination should be deferred for at least 90 days, as a precautionary measure until additional information becomes available, to avoid interference of antibody treatment with vaccine-induced immune responses; this applies to persons who receive passive antibody therapy before receiving any vaccine doses as well as those who receive passive antibody therapy after 1st dose but before 2nd dose, in which case 2nd dose should be deferred for ≥90 days following receipt of antibody therapy o There is no recommended minimum interval between other antibody therapies (i.e., those that are not specific to COVID-19 treatment) and mRNA COVID-19 vaccination • Persons with a known SARS-CoV-2 exposure or during COVID-19 outbreaks o mRNA vaccines are not currently recommended for outbreak management or for post- exposure prophylaxis o Persons in community or outpatient setting who have had known COVID-19 exposure should not seek vaccination until their quarantine period has ended to avoid potentially exposing healthcare personnel and other persons to SARS-CoV-2 during vaccination visit o Residents with a known COVID-19 exposure living in congregate healthcare settings (e.g., LTCF), where exposure and transmission of SARS-CoV-2 can occur repeatedly for long periods of time, may be vaccinated; in these settings, healthcare personnel are already in close contact with residents (e.g., entering patient rooms for evaluation and treatment), and vaccinators should employ appropriate infection prevention and control procedures o Residents of other congregate settings (e.g., correctional and detention facilities, homeless shelters) with known COVID-19 exposure may be vaccinated, in order to avoid delays and missed opportunities for vaccination given increased risk for outbreaks in these settings; where feasible, precautions should be taken to limit mixing exposed individuals with other residents or staff (except those essential for provision of vaccination services, who should employ appropriate infection and control procedures) o Persons residing in congregate settings (healthcare and non-healthcare) with an exposure who are awaiting results of SARS-CoV-2 testing may be vaccinated if person does not have symptoms consistent with COVID-19 o In situations where facility-wide testing is being conducted to identify SARS-CoV-2 infections: ▪ Facilities should attempt to complete facility-wide testing within a period that allows for test results to be received prior to vaccination in order to isolate those patients with SARS- CoV-2 infection

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 ▪ It is not necessary to wait for test results if this would create delays in vaccination ▪ Persons without symptoms consistent with COVID-19 may be vaccinated ▪ Although not contraindicated, vaccination may be deferred pending outcome of testing in persons with symptoms consistent with COVID-19 • Persons with underlying medical conditions o Vaccine may be administered to persons with underlying medical conditions who have no contraindications to vaccination • Immunocompromised persons o Immunocompromised individuals may receive COVID-19 vaccination if they have no contraindications to vaccination o Should be counseled about unknown vaccine safety profile and effectiveness in immunocompromised populations, as well as potential for reduced immune responses and need to continue to follow all current guidance to protect themselves against COVID-19 o Antibody testing is not recommended to assess for immunity to COVID-19 following vaccination o At this time, re-vaccination is not recommended after immune competence is regained in persons who received vaccines during chemotherapy or treatment with other immunosuppressive drugs • Persons with autoimmune conditions o Persons with autoimmune conditions who have no contraindications to vaccination may receive a vaccine • Persons with a history of Guillain-Barré syndrome (GBS) o Persons with a history of GBS may receive a vaccine unless they have a contraindication to vaccination o Any occurrence of GBS following vaccination should be reported to VAERS • Persons with a history of Bell’s palsy o Persons with a history of Bell’s palsy may receive a COVID-19 vaccine unless they have a contraindication to vaccination o Any occurrence of Bell’s palsy following vaccination should be reported to VAERS • Persons with a history of dermal filler use o Infrequently, persons who have received dermal fillers may develop swelling at or near site of filler injection (usually face or lips) following administration of vaccine; this appears to be temporary and can resolve with medical treatment, including corticosteroid therapy o Vaccine may be administered to persons who have received injectable dermal fillers who have no contraindications to vaccination; no additional precautions are needed o Should be advised to contact their healthcare provider for evaluation if they develop swelling at or near site of dermal filler following vaccination • Pregnant people o If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., healthcare personnel), they may choose to be vaccinated

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 o A conversation between the patient and their clinical team may assist with decisions but is not required prior to vaccination o Pregnant people and their healthcare providers should consider level of COVID-19 community transmission, patient’s personal risk of contracting COVID-19, risks of COVID-19 to the patient and potential risks to fetus, efficacy of vaccine, side effects of vaccine, and lack of data about vaccine during pregnancy o Pregnant people who experience fever and other symptoms following vaccination may be counseled to take acetaminophen o No recommendation for routine pregnancy testing before vaccination o Those trying to become pregnant do not need to avoid pregnancy after vaccination • Lactating people o A lactating person who is part of a group recommended to receive a COVID-19 vaccine (e.g., healthcare personnel) may choose to be vaccinated • Children and adolescents o Adolescents aged 16-17 years are included among persons eligible to receive the Pfizer- BioNTech Vaccine under EUA o Adolescents aged 16-17 years who are part of a group recommended to receive a COVID-19 vaccine may be vaccinated with the Pfizer-BioNTech COVID-19 vaccine, with appropriate assent o Children and adolescents younger than 16 years of age are not authorized to receive Pfizer- BioNTech COVID-19 vaccine at this time o Children and adolescents younger than 18 years of age are not authorized to receive Moderna COVID-19 vaccine at this time • Persons with a history of allergic reaction o For the purposes of this guidance, an immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within 4 hours following administration o CDC considers a history of the following to be a contraindication to vaccination with both Pfizer-BioNTech and Moderna COVID-19 vaccines: ▪ Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components ▪ Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including PEG)* ▪ Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)* ▪ *These persons should not receive mRNA COVID-19 vaccination at this time unless they have been evaluated by an allergist-immunologist and it is determined that the person can safely receive the vaccine (e.g., under observation, in a setting with advanced medical care available)

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 o Providers should attempt to determine whether reactions reported following vaccination are consistent with immediate allergic reactions versus other types of reactions commonly observed following vaccination, such as a vasovagal reaction or post-vaccination side effects (which are not contraindications to receiving 2nd vaccine dose) o Healthcare personnel or health departments in the U.S. can request a consultation from Clinical Immunization Safety Assessment COVIDvax project for a complex COVID-19 vaccine safety question about an individual patient residing in the U.S. not readily addressed by CDC guidance o CDC considers a history of any immediate allergic reaction to any other vaccine or injectable therapy (i.e., IM, IV, or SC vaccines or therapies not related to a component of mRNA COVID- 19 vaccines or polysorbate) as a precaution but not a contraindication to vaccination ▪ These persons should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefits of vaccination ▪ Deferral of vaccination and/or consultation with an allergist-immunologist may be considered until further information on the risk of anaphylaxis is available o Allergic reactions (including severe allergic reactions) not related to vaccines, injectable therapies, components of mRNA COVID-19 vaccines (including PEG), or polysorbates, such as food, pet, venom, or environmental allergies, or allergies to oral medications (including the oral equivalents of injectable medications) are not a contraindication or precaution to vaccination with either mRNA COVID-19 vaccine o Vial stoppers of mRNA vaccines are not made with natural rubber latex, and there is no contraindication or precaution to vaccination for persons with a latex allergy o mRNA COVID-19 vaccines do not contain eggs or gelatin; persons with allergies to these substances do not have a contraindication or precaution to vaccination o Administration of antihistamines to COVID-19 vaccine recipients prior to vaccination to prevent allergic reactions is not recommended o Further information on anaphylaxis management can be found in the interim considerations for the management of anaphylaxis following COVID-19 vaccination and laboratory evaluation of persons who experience anaphylaxis after vaccination Renal: none Dose Adjustments Hepatic: none Dosing Frequency 2 doses 3 weeks apart 2 doses 1 month apart 1 dose • Not interchangeable with each other or other COVID-19 vaccines; safety and efficacy of a mixed- • There are no data available on the use of product series have not been evaluated the Janssen COVID-19 Vaccine to • Both doses of the series should be completed with the same product complete a vaccination series initiated st Vaccine • In exceptional situations in which 1 dose vaccine product cannot be determined or is no longer with another COVID-19 Vaccine Interchangeability8 available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the series • If 2 doses of different products are administered, no additional doses of either product are recommended at this time

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 • Given the lack of data on safety and efficacy of mRNA COVID-19 vaccines administered • There are no data to assess concomitant simultaneously with other vaccines, the vaccine series should routinely be administered alone, administration of a COVID-19 vaccine with a minimum interval of 14 days before or after administration with any other vaccine with other vaccines • However, mRNA COVID-19 and other vaccines may be administered within a shorter period in Concomitant situations where benefits of vaccination are deemed to outweigh potential unknown risks of Vaccine vaccine coadministration (e.g., tetanus toxoid-containing vaccination as part of wound Administration8 management, measles or hepatitis A vaccination during an outbreak) or to avoid barriers or delays to mRNA COVID-19 vaccination (e.g., in LTCF residents or healthcare personnel who received influenza or other vaccinations prior to/upon admission or onboarding) • If mRNA COVID-19 vaccines are administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine ACIP = Advisory Committee on Immunization Practices; CDC = Centers for Disease Control and Prevention; COVID-19 = coronavirus disease 2019; EUA = emergency use authorization; FDA = Food and Drug Administration; GBS = Guillain-Barré syndrome; IgG = immunoglobulin G; IgM = immunoglobulin M; IGRA = interferon gamma release assay; IM = intramuscular; IV = intravenous; LTCF = long- term care facility; NSAID = non-steroidal anti-inflammatory drug; NS = normal saline, 0.9% sodium chloride; PEG = polyethylene glycol; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; SC = subcutaneous; TB = tuberculosis; TST = Tuberculin Skin Test; VAERS = Vaccine Adverse Event Reporting System; vp = viral particles

Safety Review Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 • Injection site pain (84.1%) • Injection site pain (92.0%) • Injection site pain (48.6%) • Fatigue (62.9%) • Fatigue (70.0%) • Headache (38.9%) • Headache (55.1%) • Headache (64.7%) • Fatigue (38.2%) • Muscle pain (38.3%) • Muscle pain (61.5%) • Myalgia (33.2%) • Chills (31.9%) • Joint pain (46.4%) • Nausea (14.2%) • Joint pain (23.6%) • Chills (45.4%) • Fever (9.0%) • Fever (14.2%) • Nausea/vomiting (23.0%) • Injection site redness (7.3%) • Injection site swelling (10.5%) • Axillary swelling/tenderness (19.8%) • Injection site swelling (5.3%) Adverse Reactions • Injection site redness (9.5%) • Fever (15.5%) • Severe allergic reactions, including 1 case of • Nausea (1.1%) • Injection site swelling (14.7%) anaphylaxis in an ongoing open-label study in • Malaise (0.5%) • Injection site redness (10.0%) South Africa, have been reported following • Lymphadenopathy (0.3%) vaccine administered in clinical studies • Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema) have been reported during mass vaccination outside of clinical trials Contraindications • Known history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine • Management of acute allergic reactions Other Precautions • Altered immunocompetence • Limitation of effectiveness

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 Black Box Warnings None REMS None • Available data on vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy Pregnancy Category • Animal studies showed no vaccine-related adverse effects on female fertility, fetal development, or postnatal development Lactation Category • Data are not available to assess effects of vaccine on breastfed infant or on milk production/excretion Drug Interactions No data Laboratory No data Interactions • ISMP – no classification; “Learning from Errors with the New COVID-19 Vaccines” article Hazardous Drug • Look-alike/Sound-alike – none Classification • Beers Criteria – none • NIOSH – none COVID-19 = coronavirus disease 2019

Operations Review Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 Suspension for dilution and IM injection, Suspension for IM injection, preservative-free, Suspension for IM injection, preservative-free, preservative-free, multi-dose (6-dose*) vial multi-dose (10-dose*) vial multi-dose (5-dose*) vial • 30 mcg/0.3 mL per dose (225 mcg/0.45 mL • 100 mcg/0.5 mL per dose (1,260 mcg/6.3 mL • 5 × 1010 vp/0.5 mL per dose (3.1 x 1011 vp/3.1 Dosage Forms/ [2.25 mL after dilution] per vial*) per vial*)9 mL per vial)10 Packaging o NDC 59267-1000-01 (#1) o NDC 80777-0273-10 (#1) o NDC 59676-0580-05 (#1) o NDC 59267-1000-03 (#25) [not yet o NDC 80777-0273-99 (#10) o NDC 59676-0580-15 (#10) available] o NDC 59267-1000-02 (#195) Preparation Preparation Preparation • Thaw vaccine vial before use either by: • Remove required number of vial(s) from • Vaccine is initially stored frozen by o Thawing in refrigerator [2-8°C (35-46°F)]; a storage and thaw each vial before use either manufacturer, then shipped at 2-8°C (36- carton of 25 or 95 vials may take up to 2 or by: 46°F); if vaccine is still frozen upon receipt, 3 hours, respectively, to thaw whereas a o Thawing in refrigerator (2-8°C [36-46°F]) thaw at 2-8°C (36-46°F) or if needed fewer number of vials will thaw in less for 2.5 hours; after thawing, let vial stand immediately, thaw at room temperature time, and thawed vials can be stored in at room temperature for 15 minutes (maximally 25°C/77°F) Preparation and refrigerator for up to 5 days (120 hours) before administering o At room temperature (maximally Administration o Thawing at room temperature [up to 25°C o Thawing at room temperature (15-25°C 25°C/77°F), a carton of 10 vials will take (77°F)] for 30 minutes [59-77°F]) for 1 hour approximately 2 hours to thaw, and an • Using either thawing method, vials must • Swirl vial gently after thawing and between individual vial will take approximately 1 reach room temperature before dilution and each withdrawal; do NOT shake hour to thaw; do not refreeze once thawed must be diluted within 2 hours • Do NOT dilute the vaccine • Vaccine is a colorless to slightly yellow, clear • Before dilution, invert vaccine vial gently 10 to very opalescent suspension times; do NOT shake

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 • Liquid is a white to off-white suspension and • Vaccine is a white to off-white suspension; • Visually inspect for particulate matter and may contain white to off-white opaque may contain white or translucent product- discoloration prior to administration; if either amorphous particles; do not use if liquid is related particulates of these conditions exists, do not administer discolored or if other particles are observed • Visually inspect for other particulate matter vaccine • Obtain sterile NS; use only this as diluent and and/or discoloration prior to administration; • Before withdrawing each dose, carefully mix do NOT use bacteriostatic saline if either exists, vaccine should not be contents of multi-dose vial by swirling gently • Using aseptic technique, withdraw 1.8 mL of administered in an upright position for 10 seconds; do not diluent into transfer syringe (21-gauge or • Each dose is 0.5 mL shake narrower needle) • After 1st dose has been withdrawn, vial • Each dose is 0.5 mL • Cleanse vaccine vial stopper with single-use should be held between 2-25°C (36-77°F) • Do not pool excess vaccine from multiple antiseptic swab • Record date and time of 1st use on vial label; vials • Add 1.8 mL of NS into vaccine vial discard vial after 6 hours • Record date and time of 1st use on vial label • Equalize vial pressure before removing Administration • After 1st dose has been withdrawn, hold vial needle from vial by withdrawing 1.8 mL air • Visually inspect each dose in dosing syringe between 2-8°C (36-46°F) for up to 6 hours or into empty diluent syringe prior to administration; the white to off- at room temperature (maximally 25°C/77°F) • Gently invert vaccine vial 10 times to mix; do white suspension may contain white or for up to 2 hours NOT shake translucent product-related particulates Administration • Vaccine will be an off-white suspension; do o Verify final dosing volume of 0.5 mL • Visually inspect each dose in dosing syringe not use if vaccine is discolored or contains o Confirm there are no other particulates prior to administration; vaccine is a colorless particulate matter and that no discoloration is observed to slightly yellow, clear to very opalescent • Record date and time of dilution on vaccine o Do not administer if vaccine is discolored suspension vial label or contains other particulate matter o Verify final dosing volume of 0.5 mL • Store between 2-25°C (35-77°F) • Administer vaccine IM o Confirm there are no particulates and that • Discard any unused vaccine 6 hours after • Appropriate medical treatment used to no discoloration is observed dilution manage immediate allergic reactions must be o Do not administer if vaccine is discolored • For each dose, using aseptic technique, immediately available in the event an acute or contains particulate matter cleanse vial stopper with single-use antiseptic anaphylactic reaction occurs following • Administer vaccine IM swab, and withdraw 0.3 mL of vaccine administration • Appropriate medical treatment used to preferentially using a low dead-volume • Persons with a history of an immediate manage immediate allergic reactions must be syringe and/or needle allergic reaction of any severity to a vaccine immediately available in the event an acute • If amount of vaccine remaining in vial cannot or injectable therapy and persons with a anaphylactic reaction occurs following provide a full dose of 0.3 mL, discard vial and history of anaphylaxis due to any cause administration any excess volume should be observed for 30 minutes following • It is MANDATORY for vaccination providers to • Do not pool excess vaccine from multiple vaccination; all other persons should be report to VAERS all vaccine administration vials observed for 15 minutes8 errors, all serious adverse events, cases of • Administer immediately • It is MANDATORY for vaccination providers to MIS in adults, and hospitalized or fatal cases Administration report to VAERS all vaccine administration of COVID-19 following vaccination • Visually inspect each dose in dosing syringe errors, all serious adverse events, cases of prior to administration; vaccine will be an off- MIS in adults, and hospitalized or fatal cases white suspension of COVID-19 following vaccination

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 o Verify final dosing volume of 0.3 mL o Confirm there are no particulates and that no discoloration is observed o Do not administer if vaccine is discolored or contains particulate matter • Administer vaccine IM • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration • Persons with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy and persons with a history of anaphylaxis due to any cause should be observed for 30 minutes following vaccination; all other persons should be observed for 15 minutes8 • It is MANDATORY for vaccination providers to report to VAERS all vaccine administration errors, all serious adverse events, cases of MIS in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination • Undiluted vials: room temperature up to • Unopened vials: 8-25°C (46-77°F) for up to 12 • Unopened vials: 9-25°C (47-77°F) for up to 12 25°C (77°F) for up to 2 hours hours hours Stability • Diluted vials: 2-25°C (35-77°F) for up to 6 • Entered vials: 2-25°C (36-77°F) for up to 6 • Entered vials: 2-8°C (36-46°F) for up to 6 hours from time of dilution hours hours or room temperature (maximally • Do not refreeze • Do not refreeze 25°C/77°F) for up to 2 hours • During storage, minimize exposure to room • Store frozen between -25 to -15°C (-13 to • Store at 2-8°C (36-46°F) light, and avoid exposure to direct sunlight 5°F) • Protect from light and ultraviolet light; thawed vials can be • Do not store on dry ice or below -40°C (-40°F) • Do not store frozen handled in room light conditions • Vials can be stored refrigerated between 2- • Cartons of vaccine vials arrive in thermal 8°C (36-46°F) for up to 30 days prior to 1st Storage containers with dry ice use • Once received, remove vial cartons • Do not refreeze immediately from thermal container and • Store in original carton to protect from light preferable store in ULTF between -80 to - 60°C (-112 to -76°F) until expiry date

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 • Alternatively, vials may be stored at -25 to - 15°C (-13 to 5°F) for up to 2 weeks; may be returned 1 time to recommended storage condition of -80 to -60°C (-112 to -76°F) • Total cumulative time stored at -25 to -15°C (-13 to 5°F) should be tracked and should not exceed 2 weeks • Vials must be kept frozen and protected from light, in original cartons, until ready to use • If ULTF is not available, thermal container in which vaccine arrives may be used as temporary storage when consistently re-filled to top of container with dry ice • Refer to re-icing guidelines packed in original thermal container for instructions regarding use of thermal container for temporary storage • Thermal container maintains temperature range of -90 to -60°C (-130 to -76°F) • Storage between -96 to -60 °C (-141 to -76°F) is not considered an excursion • If local redistribution is needed and full cartons containing vials cannot be transported at -90 to -60°C (-130 to -76°F), vials may be transported at -25 to -15°C (-13 to 5°F); any hours used for transport at -25°C to -15°C (-13 to 5°F) count against the 2-week limit • Undiluted vials may be stored in the refrigerator at 2-8°C (36-46°F) for up to 5 days (120 hours) • Available data support transportation of one or more thawed vials at 2-8°C (35-46°F) for up to 12 hours; any hours used for transport at 2-8°C (35-46°F) count against the 120-hour limit Generic Available? No No No HealthTrust Contract? No No No Cost/Vial Not available (300 million ± 300 million Not available (300 million ± 200 million Not available (100 million ± 200 million ($ WAC)^ doses committed to the U.S.11) doses committed to the U.S.11) doses committed to the U.S.11)

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Pfizer-BioNTech COVID-19 Vaccine3 Moderna COVID-19 Vaccine4 Janssen COVID-19 Vaccine5 FDA-Approval Date December 2020 (EUA) December 2020 (EUA) February 2021 (EUA) *Excess volume is provided to account for variability in syringe dead space and ensure volume is always sufficient for the labeled number of doses, and FDA has advised that it is acceptable to use every full dose obtainable from each vial but product should not be pooled from multiple vials;12-13 ^pricing obtained from RedBook in February 2021; COVID-19 = coronavirus disease 2019; EUA = emergency use authorization; IM = intramuscular; MIS = Multisystem Inflammatory Syndrome; NS = normal saline, 0.9% sodium chloride; ULTF = ultra-low temperature freezer; VAERS = Vaccine Adverse Event Reporting System; vp = virus particles

Clinical Trial Data Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) The Pfizer-BioNTech COVID-19 Vaccine is being studied in multiple clinical trials as summarized below in Table 1.14 The peer-reviewed, published results for the study on which the vaccine’s EUA was based are summarized in Table 2.15

Table 1. Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) Clinical Trials14 Phase NCT Location Trial Population Publication Phase 1/2 NCT04588480 Japan Age 20-85 years, healthy --- Phase 1/2 NCT04380701 Germany Age 18-85 years, healthy doi:10.1101/2020.12.09.20245175; VRBPAC FDA Briefing Document; VRBPAC Sponsor Briefing Document Phase 2 NCT04649021 China Age 18-85 years, healthy --- Phase 2 NCT04761822 U.S. Age 18-69 years, HA/MCD --- population Phase 1/2/3 NCT04368728 U.S., Argentina, Age ≥12 years, healthy doi:10.1056/NEJMoa2027906 (phase 1); protocol; VRBPAC FDA Brazil, Germany, Briefing Document; VRBPAC Sponsor Briefing Document; South Africa, Turkey doi:10.1056/NEJMoa2034577 (phase 2/3; see Table 2) Phase 2/3 NCT04754594 U.S. Age ≥18 years, healthy, --- pregnant Phase 3 NCT04713553 Not listed Age 18-55 years, healthy ---

Table 2. Summary of Publication by Polack et al15 NCT04368728: Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine Design: Phase 2/3, multi-center, observer-blind, randomized [1:1], placebo-controlled trial in the U.S., Argentina, Brazil, and South Africa (n=43,448) Duration: median of 2 months of follow up after the 2nd dose in the main safety population Interventions: all participants were observed for 30 minutes after vaccination for any acute reactions • BNT162b2 30 mcg/0.3 mL IM in deltoid muscle twice, 21 days apart (n=21,720) • Saline placebo IM in deltoid muscle twice, 21 days apart (n=21,728) Population: participants age 12-15 years (only included in certain efficacy analyses), 16-55 years, or >55 years who were healthy or had stable chronic medical conditions, including but not limited to HIV, hepatitis B virus, or hepatitis C virus infection

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NCT04368728: Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine • Key exclusion criteria: medical history of COVID-19, treatment with immunosuppressive therapy, or diagnosis with an immunocompromising condition • Participants with HIV (n=196) were excluded from the safety analysis Baseline characteristics BNT162b2 (n=18,860) Placebo (n=18,846) Median age, years (range) 52.0 (16-89) 52.0 (16-91) Age >55 years, n (%) 7,971 (42.3%) 7,950 (42.2%) Male, n (%) 9,639 (51.1%) 9,436 (50.1%) Race, n (%) White 15,636 (82.9%) 15,630 (82.9%) Black or African American 1,729 (9.2%) 1,763 (9.4%) Asian 801 (4.2%) 807 (4.3%) American Indian or Alaska Native 102 (0.5%) 99 (0.5%) Native Hawaiian or other Pacific Islander 50 (0.3%) 26 (0.1%) Multiracial 449 (2.4%) 406 (2.2%) Not reported 93 (0.5%) 115 (0.6%) Ethnicity, n (%) Hispanic or Latinx 5,266 (27.9%) 5,277 (28.0%) Country, n (%) Argentina 2,883 (15.3%) 2,881 (15.3%) Brazil 1,145 (6.1%) 1,139 (6.0%) South Africa 372 (2.0%) 372 (2.0%) United States 14,460 (76.7%) 14,454 (76.7%) Any Charlson comorbidity, n (%) 3,934 (20.9%) 3,809 (20.2%) Obese (BMI ≥30 kg/m2), n (%) 6,556 (34.8%) 6,662 (35.3%)

Primary Outcomes: • Vaccine efficacy against confirmed COVID-19 with onset at least 7 days after the 2nd dose in participants who had been without serologic or virologic evidence of SARS-CoV-2 infection up to 7 days after the 2nd dose (age ≥16 years) • Vaccine efficacy against confirmed COVID-19 with onset at least 7 days after the 2nd dose in participants who had been with or without serologic or virologic evidence of SARS-CoV-2 infection up to 7 days after the 2nd dose (age ≥16 years) Secondary Outcomes: • Vaccine efficacy against confirmed COVID-19 with onset after the 1st dose in the mITT efficacy population (age ≥12 years) • Vaccine efficacy against severe COVID-19 with onset after the 1st dose in the mITT efficacy population (age ≥12 years) • COVID-19 associated death • Unsolicited adverse events in all enrolled participants o Adverse event data through approximately 14 weeks after the 2nd dose are included in this report

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NCT04368728: Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine • Solicited, specific local or systemic adverse events and use of antipyretic or pain medication within 7 days after the receipt of each dose, as prompted by and recorded in an electronic diary in the reactogenicity subset of participants COVID-19 Case Definitions: • Confirmed COVID-19 = respiratory specimen obtained during or within 4 days of the symptomatic period that was positive for SARS-CoV-2 by NAAT and presence of ≥1 of the following symptoms: o Fever o New or increased cough o New or increased shortness of breath o Chills o New or increased muscle pain o New loss of taste or smell o Sore throat o Diarrhea o Vomiting • Severe COVID-19 = confirmed COVID-19 definition with ≥1 of the following: o Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths per minute, HR ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 <300 mm Hg) o Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO) o Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring vasopressors) o Significant acute renal, hepatic, or neurologic dysfunction o Admission to an ICU o Death Results (Efficacy): Placebo BNT162b2 (n/N) Vaccine Efficacy (n/N) Primary outcomes Confirmed COVID-19 in those without prior SARS- 8/17,411 162/17,511 95.0% (95% CrI 90.3, 97.6; 95% CI 90.0, 97.9) CoV-2 infection Male 3/8,875 81/8,762 96.4% (95% CI 88.9, 99.3) Female 5/8,536 81/8,749 93.7% (95% CI 84.7, 98.0) Age 16-55 years 5/9,897 114/9,955 95.6% (95% CI 89.4, 98.6) Age >55 years 3/7,500 48/7,543 93.7% (95% CI 80.6, 98.8) Age ≥65 years 1/3,848 19/3,880 94.7% (95% CI 66.7, 99.9) Age ≥75 years 0/774 5/785 100.0% (95% CI -13.1, 100.0) White 7/14,504 146/14,670 95.2% (95% CI 89.8, 98.1) Black or African American 0/1,502 7/1,486 100.0% (95% CI 31.2, 100.0)

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NCT04368728: Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine Other race 1/1,405 9/1,355 89.3% (95% CI 22.6, 99.8) Hispanic or Latinx 3/4,764 53/4,746 94.4% (95% CI 82.7, 98.9) Non-Hispanic or non-Latinx 5/12,548 109/12,661 95.4% (95% CI 88.9, 98.5) Argentina 1/2,545 35/2,521 97.2% (95% CI 83.3, 99.9) Brazil 1/1,129 8/1,121 87.7% (95% CI 8.1, 99.7) United States 6/13,359 119/13,506 94.9% (95% CI 88.6, 98.2) Hypertension 2/NR 44/NR 94.6% (95% CI 68.7, 99.9) Any Charlson comorbidity or obese (BMI ≥30 4/8,030 86/8,029 95.3% (95% CI 87.7, 98.8) kg/m2) Obese (BMI ≥30 kg/m2) 3/6,000 67/6,103 95.4% (95% CI 86.0, 99.1) Confirmed COVID-19 in those with or without prior 9/18,559 169/18,708 94.6% (95% CrI 89.9, 97.3) SARS-CoV-2 infection Secondary outcomes Confirmed COVID-19 after dose 1 in mITT population 50/21,669 275/21,686 82.0% (95% CI 75.6, 86.9) After dose 1 to before dose 2 39/21,669 82/21,686 52.4% (95% CI 29.5, 68.4) Dose 2 to 7 days after dose 2 2/21,669 21/21,686 90.5% (95% CI 61.0, 98.9) ≥7 days after dose 2 9/21,669 172/21,686 94.8% (95% CI 89.8, 97.6) Severe COVID-19 after dose 1 in mITT population 1/21,669 9/21,686 88.9% (95% CI 20.1, 99.7) After dose 1 to before dose 2 0/21,669 4/21,686 100.0% (95% CI -51.5, 100.0) Dose 2 to 7 days after dose 2 0/21,669 1/21,686 100.0% (95% CI -3,800.0, 100.0) ≥7 days after dose 2 1/21,669 4/21,686 75.0% (95% CI -152.6, 99.5) COVID-19 associated death 0/NR 0/NR --- Bolded values indicate statistical significance Results (Safety): Unsolicited adverse events in all enrolled participants (n=43,252) BNT162b2 (n=21,621) Placebo (n=21,631) Any adverse event 5,770 (26.7%) 2,638 (12.2%) Serious adverse event 126 (0.6%) 111 (0.5%) Severe adverse event 240 (1.1%) 139 (0.6%) Discontinuation due to adverse event 37 (0.2%) 30 (0.1%) Death 2 (0.0%) 4 (0.0%) Lymphadenopathy 64 (0.3%) 6 (<0.1%) • Four related serious adverse events were reported among vaccine recipients: shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia • No deaths were considered by the investigators to be related to the vaccine or placebo • No stopping rules were met during the reporting period

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NCT04368728: Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine Solicited local and systemic reactions reported within 7 days after each dose in the reactogenicity subset (n=8,183) BNT162b2 Dose 1 BNT162b2 Dose 2 Placebo Dose 1 Placebo Dose 2 Pain at inj Age 16-55 years 83% 78% 14% 12% site Age >55 years 71% 66% 9% 8% Age 16-55 years 5% 6% 1% 1% Redness Age >55 years 5% 7% 1% 1% Age 16-55 years 6% 6% 0% 0% Swelling Age >55 years 7% 7% 1% 1% Age 16-55 years 47% 59% 33% 23% Fatigue Age >55 years 34% 51% 23% 17% Age 16-55 years 42% 52% 34% 24% Headache Age >55 years 25% 39% 18% 14% Muscle Age 16-55 years 21% 37% 11% 8% pain Age >55 years 14% 29% 8% 5% Age 16-55 years 14% 35% 6% 4% Chills Age >55 years 6% 23% 3% 3% Age 16-55 years 11% 22% 6% 5% Joint pain Age >55 years 9% 19% 6% 4% Fever Age 16-55 years 4% 16% 1% 0% ≥38.0°C Age >55 years 1% 11% 0% 0% Antipyretic Age 16-55 years 28% 45% 14% 13% medication Age >55 years 20% 38% 12% 10% • Local reactions were mostly mild-to-moderate in severity and resolved within 1-2 days • No participant reported a grade 4 local reaction • The proportion of participants reporting local reactions did not increase after the 2nd dose • Pain was reported less frequently among older participants than among younger participants • Among vaccine recipients, <1% of participants reported severe pain at injection site • Systemic events including fever and chills were observed within the first 1-2 days after vaccination and resolved shortly thereafter • Systemic events were reported more often by younger participants than by older participants and more often after dose 2 than dose 1 Conclusion: “A two-dose regimen of BNT162b2 (30 µg per dose, given 21 days apart) was found to be safe and 95% effective against COVID-19.” BMI = body mass index; CI = confidence interval; CrI = credible interval; COVID-19 = coronavirus disease 2019; DBP = diastolic blood pressure; ECMO = extracorporeal membrane oxygenation; HIV = human immunodeficiency virus; HR = heart rate; ICU = intensive care unit; IM = intramuscular; inj = injection; mITT = modified intention-to-treat; NAAT = nucleic acid amplification-based testing; NR = not reported; PaO2 = ratio of arterial oxygen partial pressure to fractional inspired oxygen; RR = respiratory rate; SARS-CoV-2 = Severe acute respiratory syndrome coronavirus 2; SBP = systolic blood pressure; SpO2 = oxygen saturation

Moderna COVID-19 Vaccine (mRNA-1273)

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The Moderna COVID-19 Vaccine is being studied in multiple clinical trials as summarized below in Table 3.14 The peer-reviewed, published results for the study on which the vaccine’s EUA was based are summarized in Table 4.16

Table 3. Moderna COVID-19 Vaccine (mRNA-1273) Clinical Trials14 Phase NCT Location Trial Population Publication Phase 1 NCT04283461 U.S. Age 18-99 years, healthy doi:10.1056/NEJMoa2022483; doi:10.1056/NEJMoa2028436; doi:10.1056/NEJMc2032195; VRBPAC FDA Briefing Document; VRBPAC Sponsor Briefing Document Phase 1/2 NCT04677660 Japan Age ≥20 years, healthy --- Phase 2 NCT04405076 U.S. Age ≥18 years, healthy VRBPAC FDA Briefing Document; VRBPAC Sponsor Briefing Document Phase 2 NCT04761822 U.S. Age 18-69 years, HA/MCD population --- Phase 2/3 NCT04649151 U.S. Age 12-17 years, healthy --- Phase 3 NCT04470427 U.S. Age ≥18 years, healthy Protocol; VRBPAC FDA Briefing Document; VRBPAC Sponsor Briefing Document; doi:10.1056/NEJMoa2035389 (see Table 4) HA/MCD = high-allergy/mast cell disorder

Table 4. Summary of Publication by Baden et al16 NCT04470427: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Design: Phase 3, multi-center, observer-blind, randomized [1:1], placebo-controlled trial in the U.S. (n=30,351) Duration: median of 2 months of follow up after the 2nd dose Interventions: • mRNA-1273 100 mcg/0.5 mL IM in deltoid muscle twice, 28 days apart (n=15,181) • Saline placebo IM in deltoid muscle twice, 28 days apart (n=15,170) Population: participants age 18-64 years or ≥65 years who were healthy or had stable chronic medical conditions, including HIV • Participants were in locations or circumstances that put them at an appreciable risk of SARS-CoV- 2 infection, a high risk of severe COVID-19, or both • Key exclusion criteria: known history of SARS-CoV-2 infection or immunocompromised Baseline characteristics mRNA-1273 (n=15,181) Placebo (n=15,170) Mean age, years (range) 51.4 (18-95) 51.3 (18-95) Age ≥65 years, n (%) 3,763 (24.8%) 3,749 (24.7%) Male, n (%) 7,923 (52.2%) 8,062 (53.1%) Race, n (%) White 12,029 (79.2%) 11,995 (79.1%) Black or African American 1,563 (10.3%) 1,527 (10.1%) Asian 651 (4.3%) 731 (4.8%)

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NCT04470427: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine American Indian or Alaska Native 112 (0.7%) 121 (0.8%) Native Hawaiian or other Pacific Islander 35 (0.2%) 32 (0.2%) Multiracial 315 (2.1%) 321 (2.1%) Other 321 (2.1%) 316 (2.1%) Ethnicity, n (%) Hispanic or Latinx 3,121 (20.6%) 3,114 (20.5%) Mean BMI, kg/m2 29.3 ± SD 6.9 29.3 ± SD 6.7 Risk factor for severe COVID-19, n (%) Diabetes 1,435 (9.5%) 1,440 (9.5%) Severe obesity 1,025 (6.8%) 1,021 (6.7%) Significant cardiac disease 752 (5.0%) 744 (4.9%) Chronic lung disease 710 (4.7%) 744 (4.9%) Liver disease 100 (0.7%) 96 (0.6%) HIV infection 92 (0.6%) 87 (0.6%)

Primary Outcomes: • Vaccine efficacy against a first occurrence of confirmed COVID-19 with onset at least 14 days after the 2nd dose in participants in the per-protocol population Secondary Outcomes: • Vaccine efficacy against a first occurrence of confirmed COVID-19 with onset after the 1st dose in participants in the mITT population • Vaccine efficacy against confirmed COVID-19 with onset at least 14 days after the 2nd dose, regardless of evidence of prior SARS-CoV-2 infection, in participants in the per-protocol population • Vaccine efficacy against a first occurrence of severe COVID-19 with onset at least 14 days after the 2nd dose in participants in the per-protocol population • COVID-19 associated death • Unsolicited adverse events within 28 days after the receipt of each dose in the overall safety set • Solicited, specific local or systemic adverse events within 7 days after the receipt of each dose, as collected by an electronic diary in the solicited safety set COVID-19 Case Definitions: • Confirmed COVID-19 = NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) that was positive for SARS-CoV-2 by RT-PCR and presence of either ≥2 of the following systemic symptoms or ≥1 of the following respiratory symptoms: o Systemic symptoms: ▪ Fever ▪ Chills ▪ Myalgia ▪ Headache ▪ Sore throat ▪ New olfactory and tasted disorder(s)

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NCT04470427: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine o Respiratory symptoms: ▪ Cough ▪ Shortness of breath ▪ Difficulty breathing ▪ Clinical or radiographical evidence of pneumonia • Severe COVID-19 = confirmed COVID-19 definition with ≥1 of the following: o Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths per minute, HR ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 <300 mm Hg) o Respiratory failure or ARDS (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO) o Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring vasopressors) o Significant acute renal, hepatic, or neurologic dysfunction o Admission to an ICU o Death Results (Efficacy): Placebo mRNA-1273 (n/N) Vaccine Efficacy (n/N) Primary outcome Confirmed COVID-19 in those without prior SARS-CoV-2 infection 11/14,134 185/14,073 94.1% (95% CI 89.3, 96.8) Male 4/7,366 87/7,462 95.4% (95% CI 87.4, 98.3) Female 7/6,768 98/6,611 93.1% (95% CI 85.2, 96.8) Age 18-64 years 7/10,551 156/10,521 95.6% (95% CI 90.6, 97.9) Age ≥65 years 4/3,583 29/3,552 86.4% (95% CI 61.4, 95.2) White, non-Hispanic 10/9,023 144/8,916 93.2% (95% CI 87.1, 96.4) Communities of color 1/5,088 41/5,132 97.5% (95% CI 82.2, 99.7) At risk for severe Covid-19 4/3,206 43/3,167 90.9% (95% CI 74.7, 96.7) Secondary outcomes Confirmed COVID-19 in those with or without prior SARS-CoV-2 infection 12/15,181 187/15,170 93.6% (95% CI 88.6, 96.5) Confirmed COVID-19 after dose 1 in mITT population 19/14,550 269/14,598 93.0% (95% CI 88.9, 95.6) After dose 1 to 14 days after dose 1 5/14,550 11/14,598 Not reported 14 days after dose 1 to before dose 2 2/14,550 35/14,598 Not reported After dose 2 to 14 days after dose 2 0/14,550 19/14,598 Not reported ≥14 days after dose 2 12/14,550 204/14,598 Not reported Severe COVID-19 in those without prior SARS-CoV-2 infection 0/14,134 30/14,073 100% (95% CI NE, 100) COVID-19 associated death 0/14,134 1/14,073 Not reported Bolded values indicate statistical significance Results (Safety):

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NCT04470427: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Unsolicited adverse events in overall safety set (n=30,351) mRNA-1273 (n=15,185) Placebo (n=15,166) Any adverse event 3,632 (23.9%) 3,277 (21.6%) Serious adverse event 93 (0.6%) 89 (0.6%) Severe adverse event 234 (1.5%) 202 (1.3 %) Discontinuation due to adverse event 50 (0.3%) 80 (0.5%) Death 2 (<0.1%) 3 (<0.1%) Hypersensitivity 233 (1.5%) 166 (1.1%) • In the vaccine group, the 2 deaths were from cardiopulmonary arrest (1) and suicide (1). In the placebo group, the 3 deaths were from intra-abdominal perforation (1), cardiopulmonary arrest (1), and severe systemic inflammatory syndrome in a participant with chronic lymphocytic leukemia and diffuse bullous rash (1). Solicited local and systemic reactions reported within 7 days after each dose in solicited safety set (n=30,323) mRNA-1273 mRNA-1273 Placebo Placebo Dose 1 Dose 2 Dose 1 Dose 2 Pain at inj Age 18-64 years 87% 90% 19% 19% site Age ≥65 years 74% 83% 13% 12% Age 18-64 years 3% 9% 0% 0% Redness Age ≥65 years 2% 8% 1% 0% Age 18-64 years 7% 13% 0% 0% Swelling Age ≥65 years 4% 11% 1% 0% Lymphad- Age 18-64 years 12% 16% 5% 4% enopathy Age ≥65 years 6% 9% 4% 3% Age 18-64 years 38% 68% 29% 25% Fatigue Age ≥65 years 33% 58% 23% 20% Age 18-64 years 35% 63% 29% 25% Headache Age ≥65 years 25% 46% 19% 18% Muscle Age 18-64 years 24% 62% 14% 13% pain Age ≥65 years 20% 47% 12% 11% Age 18-64 years 9% 49% 6% 6% Chills Age ≥65 years 5% 31% 4% 4% Age 18-64 years 17% 46% 12% 11% Joint pain Age ≥65 years 16% 35% 12% 11% Fever Age 18-64 years 1% 17% 0% 0% ≥38.0°C Age ≥65 years 0% 10% 0% 0% Age 18-64 years 9% 21% 8% 7%

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NCT04470427: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Nausea/ Age ≥65 years 5% 12% 4% 4% vomiting • Solicited local and systemic adverse reactions had a median duration of 2-3 days • Grade 3 solicited local adverse reactions were more frequently reported after Dose 2 than Dose 1 • No participant reported a grade 4 local reaction • Solicited adverse events were reported less frequently among older participants than among younger participants • Solicited systemic adverse reactions were more frequently reported by vaccine recipients after Dose 2 than after Dose 1 Conclusion: “The COVE trial provides evidence of short-term efficacy of the mRNA-1273 vaccine in preventing symptomatic SARS-CoV-2 infection in a diverse adult trial population.” ARDS = acute respiratory distress syndrome; BMI = body mass index; CI = confidence interval; COVID-19 = coronavirus disease 2019; DBP = diastolic blood pressure; ECMO = extracorporeal membrane oxygenation; HIV = human immunodeficiency virus; HR = heart rate; ICU = intensive care unit; IM = intramuscular; inj = injection; NE = not estimable; PaO2 = ratio of arterial oxygen partial pressure to fractional inspired oxygen; RR = respiratory rate; RT-PCR = reverse transcription polymerase chain reaction; SARS-CoV-2 = Severe acute respiratory syndrome coronavirus 2; SBP = systolic blood pressure; SD = standard deviation; SpO2 = oxygen saturation

Janssen COVID-19 Vaccine (Ad26.COV2.S) The Janssen COVID-19 Vaccine is being studied in multiple clinical trials as summarized below in Table 5.14 The released results for the study on which the vaccine’s EUA was based are summarized in Table 6.17-18

Table 5. Janssen COVID-19 Vaccine (Ad26.COV2.S) Clinical Trials14 Phase NCT Location Trial Population Publication Phase 1 NCT04509947 Japan Age ≥20 years, healthy --- Phase 1/2 NCT04436276 U.S, Belgium Age ≥18 years, healthy doi:10.1056/NEJMoa2034201 Phase 2 NCT04535453 Canada, Germany, Netherlands, Spain, UK Age ≥12 years, healthy --- Age 18-40 years, healthy, Phase 2 NCT04765384 U.S., South Africa, Spain, UK --- pregnant Protocol; VRBPAC FDA Briefing Document U.S., Argentina, Brazil, Chile, Colombia, Phase 3 NCT04505722 Age ≥18 years, healthy (see Table 6); VRBPAC Sponsor Briefing Mexico, Peru, South Africa Document; EUA fact sheet for HCPs U.S., Belgium, Brazil, Colombia, France, Phase 3 NCT04614948 Age ≥18 years, healthy --- Germany, Philippines, South Africa, Spain, UK

Table 6. Summary of NCT04505722 Released Results17-18 NCT04505722 Design: Phase 3, multi-center, double-blind, randomized [1:1], placebo-controlled trial in the U.S., Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa (n=43,783)

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NCT04505722 Duration: median of 2 months of follow up after vaccination Interventions: • Ad26.COV2.S 5 x 1010 vp/0.5 mL IM once (n=21,895) • Placebo IM once (n=21,888) Population: participants age ≥18 years who were healthy or had stable chronic medical conditions, including HIV • Key exclusion criterion: abnormal function of the immune system Baseline characteristics Ad26.COV2.S (n=21,895) Placebo (n=21,888) Mean age, years (range) 50.7 (18-100) 50.7 (18-94) Age ≥65 years, n (%) 4,259 (19.5%) 4,302 (19.7%) Male, n (%) 12,071 (55.1%) 11,982 (54.7%) Race, n (%) White 12,858 (58.7%) 12,838 (58.7%) Black or African American 4,251 (19.4%) 4,264 (19.5%) American Indian or Alaska Native 2,083 (9.5%) 2,060 (9.4%) Asian 743 (3.4%) 687 (3.1%) Native Hawaiian or other Pacific Islander 58 (0.3%) 48 (0.2%) Multiracial 1,204 (5.5%) 1,245 (5.7%) Other 308 (1.4%) 315 (1.4%) Ethnicity, n (%) Hispanic or Latinx 9,874 (45.1%) 9,963 (45.5%) Country or Region, n (%) United States 9,655 (44.1%) 9,647 (44.1%) Latin America 8,954 (40.9%) 8,951 (40.9%) South Africa 3,286 (15.0%) 3,290 (15.0%) BMI >30 kg/m2 6,277 (28.7%) 6,215 (28.4%) Comorbidities, n (%) Type 2 diabetes mellitus 1,600 (7.3%) 1,594 (7.3%) HIV infection 601 (2.7%) 617 (2.8 %) Significant cardiac disease 497 (2.3%) 511 (2.3 %) Asthma 262 (1.2%) 300 (1.4%) COPD 231 (1.1%) 206 (0.9%)

Primary Outcomes: • Vaccine efficacy against confirmed moderate to severe/critical COVID-19 with onset at least 14 days after vaccination in participants with negative RT- PCR and negative serology against SARS-CoV-2 nucleocapsid at baseline in the per-protocol population

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NCT04505722 • Vaccine efficacy against confirmed moderate to severe/critical COVID-19 with onset at least 28 days after vaccination in participants with negative RT- PCR and negative serology against SARS-CoV-2 nucleocapsid at baseline in the per-protocol population Secondary Outcomes: • Vaccine efficacy against any symptomatic (i.e. mild, moderate, or severe) COVID-19 in the per-protocol population • Vaccine efficacy against severe/critical COVID-19 in the per-protocol population • Vaccine efficacy against COVID-19 requiring medical intervention in the per-protocol population • Vaccine efficacy against COVID-19 requiring hospitalization in the per-protocol population (post hoc analysis) • Vaccine efficacy against COVID-19-related death • Vaccine efficacy against asymptomatic COVID-19 (seronegative by non-S protein at baseline then positive PCR and/or non-S protein serology with no symptoms since screening) in the full analysis population • Unsolicited adverse events within 28 days after vaccination in the full analysis population and the safety subset • Solicited local or systemic adverse events within 7 days after vaccination, as collected by an electronic diary in the safety subset COVID-19 Case Definitions: • Moderate COVID-19 = any available respiratory tract sample (e.g., nasal, throat, sputum, saliva) or other sample that was positive for SARS-CoV-2 by RT- PCR or molecular test and presence of either: o ≥2 of the following new or worsening symptoms: ▪ Fever ▪ HR ≥90 beats/minute ▪ Shaking chills or rigors ▪ Sore throat ▪ Cough ▪ Malaise as evidenced by loss of appetite, fatigue, physical weakness, and/or feeling unwell ▪ Headache ▪ Myalgia ▪ Gastrointestinal symptoms (diarrhea, vomiting, nausea, abdominal pain) ▪ New or changing olfactory or taste disorders ▪ Red or bruised looking feet or toes o Or ≥1 of the following new or worsening symptoms: ▪ RR ≥20 breaths/minute ▪ Abnormal saturation of oxygen (SpO2) but still >93% on room air at sea level ▪ Clinical or radiologic evidence of pneumonia ▪ Radiologic evidence of deep vein thrombosis ▪ Shortness of breath or difficulty breathing • Severe/critical COVID-19 = any available respiratory tract sample (e.g., nasal, throat, sputum, saliva) or other sample that was positive for SARS-CoV-2 by RT-PCR or molecular test and presence of ≥1 of the following:

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NCT04505722 o Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths per minute, HR ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 <300 mm Hg) o Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO) o Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring vasopressors) o Significant acute renal, hepatic, or neurologic dysfunction o Admission to an ICU o Death Results (Efficacy): Onset at Least 14 Days After Vaccination Onset at Least 28 Days After Vaccination Ad26.COV2.S Placebo Vaccine Efficacy Ad26.COV2.S Placebo Vaccine Efficacy (n/N) (n/N) (95% CI) (n/N) (n/N) (95% CI) Primary outcomes Centrally confirmed moderate COVID-19 in 116/19,514 348/19,544 66.9% (59.0, 73.4) 66/19,306 193/19,178 66.1% (55.0, 74.8) those without prior SARS-CoV-2 infection Non-centrally confirmed moderate COVID-19 in those with or without prior SARS-CoV-2 176/21,636 513/21,574 66.1% (59.7, 71.6) 114/21424 326/21,199 65.5% (57.2, 72.4) infection Non-centrally confirmed moderate COVID-19 28.5% (-322.8, 3/2,122 4/2,030 1/2,118 2/2021 NR in those with prior SARS-CoV-2 infection 89.5) Non-centrally confirmed moderate COVID- 19 in those without prior SARS-CoV-2 173/19,514 509/19,544 66.3% (59.9, 71.8) 113/19,306 324/19,178 65.5% (57.2, 72.4) infection Male 85/10,861 269/10,832 68.8% (60.1, 75.9) 54/10,764 176/10,649 69.8% (58.9, 78.2) Female 88/8,649 240/8,708 63.4% (53.1, 71.7) 59/8,538 148/8,525 60.3% (46.0, 71.2) Age 18-64 years 157/15544 441/15552 64.7% (57.6, 70.8) 101/15378 286/15253 65.1% (56.1, 72.5) Age ≥65 years 16/3,970 68/3,992 76.5% (59.1, 87.3) 12/3,928 38/3,925 68.6% (38.6, 85.1) White, non-Hispanic 94/12,123 288/12,133 67.6% (59.0, 74.6) 64/11,994 187/11,912 66.2% (54.8, 74.9) Black or African American 37/3,362 101/3,361 63.7% (46.6, 75.8) 21/3,330 66/3,300 68.6% (48.0, 81.8) American Indian or Alaska Native 21/1,634 41/1,621 49.4% (12.4, 71.6) 18/1,628 26/1,604 31.7% (-29.4, 64.8) Asian 6/714 12/649 54.4% (-31.1, 86.0) 2/689 7/626 74.0% (-36.5, 97.4) Native Hawaiian or other Pacific Islander 1/54 0/44 NR 1/54 0/43 NR Multiracial 10/1,028 48/1,080 78.6% (57.3, 90.4) 4/1,018 28/1,055 85.4% (58.4, 96.3) Hispanic or Latinx 81/8,733 237/8,869 65.6% (55.5, 73.6) 59/8,688 153/8,741 61.3% (47.4, 71.8) United States 51/9,119 196/9,086 74.4% (65.0, 81.6) 32/8,958 112/8,835 72.0% (58.2, 81.7) Latin America 79/7,922 223/7,962 64.7% (54.1, 73.0) 58/7,899 148/7,880 61.0% (46.9, 71.8)

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NCT04505722 South Africa 43/2,473 90/2,496 52.0% (30.3, 67.4) 23/2,449 64/2,463 64.0% (41.2, 78.7) ≥1 comorbidity 70/7,777 194/7,798 64.2% (52.7, 73.1) 44/7,684 105/7,626 58.6% (40.6, 71.6) Secondary outcomes Any symptomatic COVID-19 117/19,514 351/19,544 66.9% (59.1, 73.4) 66/19,306 195/19,178 66.5% (55.5, 75.1) Severe/critical COVID-19 14/19,514 60/19,544 76.7% (54.6, 89.1) 5/19,306 34/19,178 85.4% (54.2, 96.9) United States 4/9,119 18/9,086 78.0% (33.1, 94.6) 1/8,958 7/8,835 85.9% (-9.4, 99.7) Brazil 2/3,370 11/3,355 81.9% (17.0, 98.1) 1/3,354 8/3,312 87.6% (7.8, 99.7) South Africa 8/2,473 30/2,496 73.1% (40.0, 89.4) 4/2,449 22/2,463 81.7% (46.2, 95.4) COVID-19 requiring medical intervention 2/19,514 8/19,544 75.0% (-25.3, 97.4) 0/19,306 5/19,178 NR COVID-19 requiring hospitalization 2/NR 11/NR 81.8% (16.7, 98.0) 0/NR 6/NR 100% (15.7, 100.0) COVID-19-related death 0/NR 7/NR NR 0/NR 6/NR NR Asymptomatic COVID-19 NR NR NR 10/19,301 38/19,162 74.0% (46.8, 88.4) Bolded values indicate statistical significance • All COVID-19-related deaths were in the participants in the placebo group, in South Africa, and had ≥1 comorbidity which placed them at higher risk for severe COVID-19 Results (Safety): Unsolicited adverse events Ad26.COV2.S Placebo Safety subset (n=6,736) Any adverse event NR (13.1%) NR (12.0%) Grade ≥3 adverse event 19 (0.6%) 18 (0.5 %) Full analysis population (n=43,783) Serious adverse event 83 (0.4%) 96 (0.4%) Discontinuation due to adverse event 0 (0.0%) 0 (0.0%) Death 3 (<0.1%) 16 (0.1%) • No deaths were treatment-related as assessed by investigator Solicited local and systemic reactions reported within 7 days after vaccination in safety subset (n=6,736) Ad26.COV2.S Placebo Pain at Age 18-59 years 58.6% 17.4% injection site Age ≥60 years 33.3% 15.6% Age 18-59 years 9.0% 4.3% Redness Age ≥60 years 4.6% 3.2% Age 18-59 years 7.0% 1.6% Swelling Age ≥60 years 2.7% 1.6% Age 18-59 years 43.8% 22.0% Fatigue Age ≥60 years 29.7% 20.8%

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NCT04505722 Age 18-59 years 44.4% 24.8% Headache Age ≥60 years 30.4% 22.1% Age 18-59 years 39.1% 12.1% Muscle pain Age ≥60 years 24.0% 13.7% Age 18-59 years 12.8% 0.7% Fever ≥38.0°C Age ≥60 years 3.1% 0.5% Age 18-59 years 15.5% 8.9% Nausea Age ≥60 years 12.3% 10.8% Antipyretic Age 18-59 years 26.4% 6.0% medication Age ≥60 years 9.8% 5.1% • No participant reported a grade 4 local or systemic reaction • Solicited adverse events were reported less frequently among older participants than among younger participants Conclusion: none; no publication BMI = body mass index; CI = confidence interval; COPD = chronic obstructive pulmonary disease; COVID-19 = coronavirus disease 2019; DBP = diastolic blood pressure; ECMO = extracorporeal

membrane oxygenation; HIV = human immunodeficiency virus; HR = heart rate; ICU = intensive care unit; IM = intramuscular; NR = not reported; PaO2 = ratio of arterial oxygen partial pressure to fractional inspired oxygen; RR = respiratory rate; RT-PCR = reverse transcription polymerase chain reaction; SARS-CoV-2 = Severe acute respiratory syndrome coronavirus 2; SBP = systolic blood pressure; SpO2 = oxygen saturation; vp = virus particles

Additional Resources Links to additional resources for the COVID-19 vaccines and their key sub-resources are listed in Table 5 below.

Table 5. Links to Resources and Key Sub-Resources for the COVID-19 Vaccines Resources Key Sub-Resources Key Topics Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Providers Package insert, requirements, reporting Fact Sheet for Recipients and Caregivers Patient education EUA FAQ Various, patient education, myths VRBPAC Meeting Efficacy, safety Reimbursement, administration, storage, FAQ Commercial Website dry ice, counterfeit Product Storage & Dry Ice Storage, handling, dry ice DailyMed Label --- Package photos, package insert Training Module for Healthcare Professionals Training CDC Product Info Delivery Checklist Procedure Standing Orders Procedure

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Resources Key Sub-Resources Key Topics Preparation and Administration Summary Administration Storage and Handling Summary Storage, handling Storage and Handling Labels Labels BUD Guidance and Labels Labels Dry Ice Safety Dry ice ACIP’s Interim Recommendation for Use of --- Indication, dosing Pfizer-BioNTech COVID-19 Vaccine MMWR Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of --- Anaphylaxis, safety Pfizer-BioNTech COVID-19 Vaccine CDC COVID-19 Vaccine Distribution Allocations --- Distribution, surveillance by Jurisdiction - Pfizer Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Package insert, requirements, reporting Fact Sheet for Recipients and Caregivers Patient education EUA FAQ Various, patient education, myths VRBPAC Meeting Efficacy, safety Commercial Website FAQ Reimbursement, expiration, counterfeit DailyMed Label --- Package photos, package insert Training Module for Healthcare Professionals Training Standing Orders Procedure Preparation and Administration Summary Administration CDC Product Info Storage and Handling Summary Storage, handling Storage and Handling Labels Labels BUD Guidance and Labels Labels ACIP’s Interim Recommendation for Use of --- Indication, dosing Moderna COVID-19 Vaccine MMWR Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of --- Anaphylaxis, safety Moderna COVID-19 Vaccine CDC COVID-19 Vaccine Distribution Allocations --- Distribution, surveillance by Jurisdiction - Moderna Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Package insert, requirements, reporting EUA Fact Sheet for Recipients and Caregivers Patient education VRBPAC Meeting Efficacy, safety

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Resources Key Sub-Resources Key Topics DailyMed Label --- Package photos, package insert AstraZeneca COVID-19 Vaccine Package photos, storage, stability, inactive DailyMed Label --- ingredients FDA Statement on Following the Authorized Dosing Schedules Dosing EUA for Vaccines Explained Development The Path for a COVID-19 Vaccine from Research to EUA Development, patient education COVID-19 Vaccines Development and Licensure of Vaccines to Prevent COVID-19 Development Emergency Use Authorization for Vaccines to Prevent COVID- Development 19 CDC Clinical recommendations, dosing, interchangeability, co-administration, SARS-CoV-2 infection, underlying medical Clinical Considerations for Use of mRNA COVID-19 Vaccines conditions, pregnancy, lactation, patient education, contraindications, precautions, allergies, observation, laboratory testing Preparing for the Potential Management of Anaphylaxis Anaphylaxis, clinical recommendations Lab Tests to Collect Shortly After Severe Allergic Anaphylaxis, laboratory testing, clinical Reaction/Anaphylaxis recommendations COVID-19 Vaccination Program Interim Playbook for Allocation, distribution, requirements, Jurisdiction Operations reporting, liability Vaccines & Immunizations: COVID-19 COVID-19 Vaccination Program Interim Playbook for Allocation, vaccination clinic Vaccination Jurisdictions Operations Annex Interim Jurisdiction COVID-19 Vaccination Playbook Draft Allocation, distribution Executive Summaries Requirements, diversion, reimbursement, Provider Requirements and Support reporting COVID-19 Vaccination Reporting Data Systems Reporting, requirements Training and Education Training, provider education Training Programs and Reference Materials for Healthcare Training, provider education Professionals Recipient Education Patient education, provider education COVID-19 Vaccination Communication Toolkit for Medical Provider education, vaccine confidence, Centers, Pharmacies, and Clinicians patient education

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Resources Key Sub-Resources Key Topics LTC program, provider education, patient Long-Term Care (LTC) Facility Toolkit education Vaccinate with Confidence Vaccine confidence; patient education Prevaccination Screening Form Procedure, vaccination clinic COVID-19 Vaccination Program Provider --- Requirements, reporting, distribution Agreement Product Information Guide for COVID-19 Distribution, how supplied, ancillary --- Vaccines and Associated Products supplies, dry ice How Do I Get a Vaccine? Select State/Territory Allocation, distribution, patient education COVID-19 Data Tracker: Vaccinations Distribution, surveillance FAQ about COVID-19 Vaccination Patient education, distribution, safety Facts about COVID-19 Vaccines Patient education, myths The Importance of COVID-19 Vaccination for Healthcare Allocation, provider education, patient Personnel education Importance of COVID-19 Vaccination for Residents of LTC Allocation, provider education, patient Facilities education Vaccine Mandates & Exemptions Mandate COVID-19: Vaccines (Info for the Public) How CDC Is Making COVID-19 Vaccine Recommendations Allocation What to Expect at Your Appointment Patient education Benefits of Getting a COVID-19 Vaccine Patient education, vaccine confidence Patient education, provider education, Different COVID-19 Vaccines efficacy, mechanism of action Ensuring the Safety of COVID-19 Vaccines Safety, surveillance, v-safe v-safe Information Sheet v-safe, patient education, safety Ensuring COVID-19 Vaccines Work Efficacy, surveillance Provider education, vaccination clinic, COVID-19 Vaccination Toolkits vaccine confidence, patient education Post Vaccine Considerations for Healthcare Personnel Clinical recommendations, safety COVID-19: Healthcare Workers Post Vaccine Considerations for Residents of LTC Facilities Clinical recommendations, safety Allocation, safety, efficacy, clinical ACIP Meeting Materials --- recommendations Allocation of COVID-19 Vaccine Allocation COVID-19 Vaccination of Healthcare Personnel and LTC ACIP COVID-19 Vaccine Recommendations Allocation Facility Residents Allocating Initial Supplies of COVID-19 Vaccine Allocation

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Resources Key Sub-Resources Key Topics Demographic Characteristics of Persons Vaccinated During Surveillance, distribution the First Month of the COVID-19 Vaccination Program MMWR Novel Coronavirus Reports Early COVID-19 First-Dose Vaccination Coverage Among Residents and Staff Members of Skilled Nursing Facilities LTC program, surveillance, distribution Participating in the Pharmacy Partnership for LTC Program Vaccine Storage and Handling Toolkit (includes COVID-19 Storage, handling Vaccine Addendum) Vaccines & Immunizations: Healthcare Guidance for Planning Vaccination Clinics Held at Satellite, Vaccination clinic Providers/Professionals Temporary, or Off-Site Locations Considerations for Planning Curbside/Drive-Through Vaccination clinic Vaccination Clinics Vaccination Guidance During a Pandemic --- Procedure, vaccination clinic COVID-19 Vaccine Related Codes --- Reimbursement, how supplied Other U.S. Government Agencies DOD Operation Warp Speed (OWS) The OWS Strategy for Distributing a COVID-19 Vaccine Distribution, allocation BARDA COVID-19 Medical Countermeasure --- U.S. funding & commitments Portfolio: Vaccines HHS COVID-19 Vaccine Distribution: The --- Development, allocation, distribution Process HHS Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State- Authorized Pharmacy Interns for Childhood --- Requirements, liability Vaccines, COVID-19 Vaccines, and COVID-19 Testing CMS COVID-19 Vaccine Policies & Guidance --- Reimbursement CMS Fourth COVID-19 Interim Final Rule with --- Reimbursement Comment Period (IFC-4) HRSA Provider Relief Fund --- Reimbursement Other AMA COVID-19 CPT Vaccine and Immunization --- Reimbursement Codes ASHP COVID-19 Resource Center: COVID-19 Various, procedure, storage, handling, --- Vaccines security NASEM Framework for Equitable Allocation of --- Allocation COVID-19 Vaccine

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Resources Key Sub-Resources Key Topics ISMP COVID-19 Resources: Vaccine Learning from Errors with the New COVID-19 Vaccines Safety, medication errors Information NEJM COVID-19 Vaccine Resource Center --- Efficacy, safety, anaphylaxis The Lancet COVID-19 Resource Centre --- Efficacy, safety ACIP = Advisory Committee on Immunization Practices; AMA = American Medical Association; BARDA = Biomedical Advanced Research and Development Authority; BUD = beyond use date; CDC = Centers for Disease Control and Prevnetion; CMS = Centers for Medicare & Medicaid Services; COVID-19 = coronavirus disease 2019; DOD = United States Department of Defense; EUA = emergency use authorization; FAQ = frequently asked questions; FDA = Food and Drug Administration; HHS = United States Department of Health and Human Services; HRSA = Health Resources and Services Administration; ISMP = Institute for Safe Medication Practices; LTC = long-term care; MMWR = Morbidity and Mortality Weekly Report; NASEM = National Academies of Sciences, Engineering, and Medicine; NEJM = New England Journal of Medicine; OWS = Operation Warp Speed; PREP = Public Readiness and Emergency Preparedness; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; VRBPAC = Vaccines and Related Biological Products Advisory Committee

Pipeline of COVID-19 Vaccine Candidates Numerous additional vaccines are seeking EUA and eventual approval in the U.S. for the prevention of COVID-19. An overview of the vaccine candidates’ suppliers, platform, status in the U.S., and supply commitments to the U.S. is provided in Table 6. Clinical trials for the vaccine candidates and links to any published results or study protocols are listed in Table 7. Table 8 lists the candidates’ anticipated route, number of doses, how supplied information, and storage requirements.

Table 6. Overview of COVID-19 Vaccine Candidates Vaccine Supplier Platform U.S. Status U.S. Dose Commitments11 AZD1222 AstraZeneca & University of Oxford Non-Replicating Viral Vector Phase 3 300 million NVX-CoV2373 Novavax Protein Subunit Phase 3 100 million INO-4800 Inovio & Beijing Advaccine DNA Phase 2/3 --- CoVLP Medicago & GlaxoSmithKline Virus-Like Particle Phase 2/3 --- ARCT-021 Arcturus Therapeutics mRNA Phase 2 --- TBD Sanofi & GlaxoSmithKline Protein Subunit Phase 1/2 100 million ± 500 million AV-COVID-19 Aivita Autologous Dendritic Cells Phase 1/2 --- KBP-COVID-19 Kentucky BioProcessing Protein Subunit Phase 1/2 --- VXA-CoV2-1 Vaxart Non-Replicating Viral Vector Phase 1 --- hAd5-S-Fusion+N-ETSD ImmunityBio & NantKwest Non-Replicating Viral Vector Phase 1 --- COH04S1 City of Hope Medical Center Non-Replicating Viral Vector Phase 1 ---

Table 7. COVID-19 Vaccine Candidates Clinical Trials14 Vaccine Supplier Phase NCT Location Age Publication doi:10.1016/S0140-6736(20)31604-4; AZD1222 Phase 1/2 NCT04324606 UK 18-55 years doi:10.1038/s41591-020-01179-4;

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Vaccine Supplier Phase NCT Location Age Publication doi:10.1038/s41591-020-01194-5; doi:10.1016/S0140-6736(20)32661-1; presentation; doi:10.1016/S0140- 6736(21)00432-3 doi:10.1016/S0140-6736(20)32661-1; Phase 1/2 NCT04444674 South Africa 18-65 years presentation; doi:10.1016/S0140- 6736(21)00432-3 Phase 1/2 NCT04568031 Japan ≥18 years --- Phase 1/2 NCT04684446 Not listed ≥18 years --- AstraZeneca & Phase 2 NCT04686773 Azerbaijan ≥18 years --- University of doi:10.1016/S0140-6736(20)32466-1; Oxford doi:10.1016/S0140-6736(20)32661-1; Phase 2/3 NCT04400838 UK ≥18 years presentation; doi:10.1016/S0140- 6736(21)00432-3; preprint U.S., Argentina, Chile, Phase 3 NCT04516746 ≥18 years Protocol Colombia, Peru doi:10.1016/S0140-6736(20)32661-1; Phase 3 NCT04536051 Brazil ≥18 years presentation; doi:10.1016/S0140- 6736(21)00432-3 Phase 3 NCT04540393 Russia ≥18 years --- doi:10.1056/NEJMoa2026920; Phase 1/2 NCT04368988 U.S., Australia 18-84 years presentation NVX-CoV2373 Novavax Phase 2 NCT04533399 South Africa 18-84 years Protocol; Presentation Phase 3 NCT04583995 UK 18-84 years Protocol; Presentation Phase 3 NCT04611802 U.S., Mexico, Puerto Rico ≥18 years Protocol Phase 1 NCT04336410 U.S. ≥18 years doi:10.1016/j.eclinm.2020.100689 Inovio & Beijing INO-4800 Phase 1/2 NCT04447781 Republic of Korea 19-64 years --- Advaccine Phase 2/3 NCT04642638 U.S. ≥18 years --- Medicago & Phase 1 NCT04450004 Canada 18-55 years doi:10.1101/2020.11.04.20226282 CoVLP GlaxoSmithKline Phase 2/3 NCT04636697 U.S., Canada ≥18 years --- Phase 1/2 NCT04480957 Singapore 21-80 years Presentation Arcturus ARCT-021 Phase 2 NCT04668339 U.S., Singapore ≥18 years --- Therapeutics Phase 2 NCT04728347 Singapore 21-80 years --- Sanofi & TBD Phase 1/2 NCT04537208 U.S. ≥18 years doi:10.1101/2021.01.19.20248611 GlaxoSmithKline AV-COVID-19 Aivita Phase 1 NCT04685603 Indonesia ≥18 years ---

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Vaccine Supplier Phase NCT Location Age Publication Phase 1 NCT04690387 Indonesia ≥18 years --- Phase 1/2 NCT04386252 U.S. ≥18 years --- Kentucky KBP-COVID-19 Phase 1/2 NCT04473690 U.S. 18-70 years --- BioProcessing VXA-CoV2-1 Vaxart Phase 1 NCT04563702 U.S. 18-54 years Presentation Phase 1 NCT04591717 U.S. 18-55 years Press release hAd5-S- ImmunityBio & Phase 1 NCT04732468 U.S. 18-55 years --- Fusion+N-ETSD NantKwest Phase 1 NCT04710303 South Africa 18-50 years --- City of Hope COH04S1 Phase 1 NCT04639466 U.S. 18-55 years --- Medical Center

Table 8. Operational Information for COVID-19 Vaccine Candidates How Supplied Vaccine Supplier Dosing (Predicted)14 Distribution (Predicted) Storage & Stability (Predicted) (Predicted) AstraZeneca & • 6 months at 2-8°C 5 × 1010 vp/0.5 mL IM, Solution in 10-dose AZD1222 University of 2-8°C19-20 • Once entered, 48 hours at 2-8°C 2 doses 28 days apart vial19 Oxford or 6 hours at 20-25°C19-20 0.5 mL IM, 2 doses 21 Solution in 10-dose NVX-CoV2373 Novavax 2-8°C21 2-8°C21 days apart vial21 • 5 years under refrigeration Inovio & Beijing ID + EP, 2 doses 28 days INO-4800 --- Refrigeration22 • >1 year at room temperature Advaccine apart • >1 month at 37°C22 Medicago & 3.75 mcg/0.5 mL IM, 2 CoVLP ------GlaxoSmithKline doses 21 days apart Arcturus Lyophilized powder ARCT-021 IM, 1 or 2 doses ------Therapeutics for dilution23 Sanofi & TBD IM, 1 or 2 doses --- 2-8°C24 2-8°C24 GlaxoSmithKline AV-COVID-19 Aivita SC, 1 dose --- Cryopreserved14 Thawed onsite14 Kentucky IM, 2 doses 21 days KBP-COVID-19 ------BioProcessing apart VXA-CoV2-1 Vaxart PO, 1 or 2 doses Tablet25 Room temperature25 Room temperature25 hAd5-S- ImmunityBio & 2 doses ------Fusion+N-ETSD NantKwest

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How Supplied Vaccine Supplier Dosing (Predicted)14 Distribution (Predicted) Storage & Stability (Predicted) (Predicted) City of Hope IM, 2 doses 28 days COH04S1 ------Medical Center apart EP = electroporation; ID = intradermal; IM = intramuscular; PO = oral; SC = subcutaneous; TBD = to be determined; vp = virus particles

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