6/3/2020

Disclosures and Conflict of Interest

¥ Dr. Nikocevic declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings and honoraria.

Immunizations Update Bedrija Nikocevic, PharmD, BCACP Assistant Professor of Clinical Sciences Roosevelt University College of Pharmacy [email protected]

1 2

Objectives Pre-Test Question 1

¥ At the conclusion of this program, the pharmacist and pharmacy technician will be able to: ¥ MF-59 may contribute to a higher incidence of: ¥ Discuss the efficacy and safety of adjuvanted influenza in older adults a) Autism ¥ List the FDA approved indications for use of adjuvanted quadrivalent (aIIV4) b) Severe allergic reactions ¥ Discuss the efficacy and safety of the rVSV∆G-ZEBOV-GP vaccine c) Pain and induration ¥ Describe ACIP workgroup recommendations for pre-exposure with d) Depression rVSV∆G-ZEBOV-GP vaccine ¥ Describe ongoing COVID-19 vaccine studies in the United States ¥ Discuss CDC recommendations for administration during COVID-19 pandemic

3 4

1 6/3/2020

Pre-Test Question 2 Pre-Test Question 3

¥ Which of the following patients should receive a prophylactic dose of ¥ Which of the following is TRUE regarding vaccine administration during rVSV∆G-ZEBOV-GP according to ACIP workgroup recommendations? COVID-19 pandemic? (SELECT ALL THAT APPLY) (SELECT ALL THAT APPLY) a) Pharmacists should continue to administer when necessary a) 20 year old college student traveling to a safari in West Africa b) Pharmacists should utilize appropriate personal protective equipment (PPE) b) A 19 year old responding to an Zaire outbreak while administering vaccines c) A janitor at a biosafety-level 4 facility in the U.S. which is conducting research on c) Pharmacists should determine whether workflow changes are appropriate to species ensure safety and well-being of their staff and patients d) An 80 year old living in East Africa d) Pharmacists should delay immunization administration until COVID-19 pandemic is over

5 6

Influenza

¥ Contagious respiratory illness ¥ Symptoms ¥ Influenza A and B viruses ¥ Fever/chills Influenza ¥ Respiratory droplet transmission ¥ Cough ¥ 3-11 % of US population affected ¥ Sore throat ¥ High risk groups: ¥ Runny/stuffy nose ¥ Age ≥65 years old ¥ Muscle/body aches ¥ Chronic medical conditions ¥ Headaches ¥ Pregnant women ¥ Fatigue ¥ Children younger than 5 ¥ Vomiting and diarrhea ¥ <2 years old at even higher risk

CDC. https://www.cdc.gov/flu/about/keyfacts.htm . Accessed 5/30/2020. CID. 2018; 66(10): 1511-1518.

7 8

2 6/3/2020

Influenza Vaccines

Quadrivalent IIV (IIV4) Age Indication Viral Adjuvant Component Source Afluria Quadrivalent (Sequirus) ≥6 months* Egg None Fluarix Quadrivalent (GSK) ≥6 months Egg None FluLaval Quadrivalent ID (GSK) ≥6 months Egg None Flucelvax Quadrivalent ccIIV4 (Sequirus) ≥4 years Cell None MF-59 Adjuvanted IIV3 Studies Fluzone Quadrivalent (Sanofi Pasteur) ≥6 months* Egg None Fluad aIIV4 (Sequirus) ≥65 years Egg MF-59 Trivalent IIV (IIV3)

Fluzone HD HD-IIV3 (Sanofi-Pasteur) ≥65 years Egg None Quadrivalent RIV (RIV4)

Flublok Quadrivalent (Sanofi Pasteur) ≥18 years Recombinant None *Different formulations indicated for different ages

CDC. https://www.cdc.gov/flu/professionals/vaccines.htm . Accessed 5/8/2020. 9 10

Safety and Immunogenicity of MF-59 Effectiveness of Adjuvanted Influenza Adjuvanted Influenza Vaccine in the Elderly Vaccination in Elderly Subjects in Northern Italy Study Objective Compare the relative risk of hospitalizations for influenza or pneumonia during 3 Study Objective Evaluate the safety and immunogenicity of Fluad in healthy elderly patients over influenza seasons in patients immunized with ATIV vs. TIV 3 immunization seasons Study Design Non-randomized Study Design and Randomized, observer-blinded, controlled and Setting Northern Italy during 3 consecutive vaccination seasons beginning in 2006/2007 Setting Outpatient clinic in Milan, Italy Inclusion Criteria ≥65 years old Inclusion Criteria ≥65 years old Seeking influenza vaccine at participating sites Exclusion Criteria Known or suspected immunosuppression Exclusion Criteria Hospitalized, in a nursing home, or rehabilitation center within 30 days of Significant underlying disease immunization Interventions Non-adjuvanted inactivated subunit influenza virus vaccine (Agrippal) Receiving home health care Syringe containing the same and MF-59 (Fluad) Allergy to influenza vaccine Outcome Vaccine reactions-staff and self-monitored Interventions Adjuvanted trivalent (Fluad) Measures Antibody essays on day 0 prior to immunization and 28 days post-immunization Trivalent inactivated vaccine (Agrippal) Results Pain at injection site and induration reported more frequently with Fluad Outcome Relative risk of hospitalizations for influenza or pneumonia during a defined period No significant difference in erythema Measures (at least 3 weeks after immunization) during influenza season in ATIV vs. TIV group Systemic reactions similar overall; headache more common in Fluad Results 114 hospitalizations among 84,665 person seasons (0.135 %) in ATIV group Day 28 geometric mean titers for Fluad significantly higher than Agrippal 111 hospitalizations among 79,589 person seasons (0.139 %) in TIV group RR 0.97 (95 % CI: 0.74-1.25)

Vaccine. 1999;17:3094-3101. Am J Epidemiol. 2012;176(6):527-533. 11 12

3 6/3/2020

The Comparative Effectiveness of Adjuvanted and Unadjuvanted Trivalent Inactivated Influenza Vaccine (TIV) in the Elderly

Study Objective Determine relative vaccine effectiveness against microbiologically confirmed influenza illness in patients immunized with ATIV and TIV when compared to those who were not vaccinated Study Design and Prospective, non-blinded, community based case control Setting 3 health authorities within British Columbia, Canada Inclusion Criteria ≥65 years old as of influenza test date Influenza like symptoms, swabbed and tested for influenza, and no MF-59 Adjuvanted IIV4 Study immunodeficiency Exclusion Criteria Patients tested more than 7 days after influenza like illness (ILI) started Interventions Respiratory sample testing Outcome Measures Positive influenza test Results Univariate Vaccine effectiveness (VE) for any vaccine 24 % (CI: -42—59%, non-significant) Analysis VE of ATIV for whole population 35 % (CI: -25% - 81 %, p=0.2) VE of TIV for whole population -12 % Multivariate VE of ATIV 58 % (CI: 5-82, p<0.04) Analysis TIV ineffective

Vaccine. 2013;31:6122-6128. 13 14

Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Clinical Study to Evaluate the Efficacy, Safety and MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non- Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Influenza Vaccine Comparator in Adults ≥ 65 Years of Age Vaccine Compared to Non-Influenza Vaccine Comparator in Study Objective Evaluate immunogenicity, efficacy and safety of AIIV4 compared to non-influenza Adults ≥ 65 Years of Age vaccine comparator in patients ≥65 years old Study Design and Randomized, observer blind, controlled, multi center Setting 12 countries ¥ Data presented at ACIP February 2020 meeting Inclusion Criteria ≥65 years old Exclusion Criteria Hypersensitivity to any vaccine included in study Abnormal immune system function Influenza vaccine in 6 months prior to study or planning to receive one during study

Treatment 0.5 ml aIIV4 Interventions 0.5 ml Boostrix Outcome Primary: VE against any polymerase chain reaction (PCR) confirmed influenza Measures Secondary: VE against culture confirmed influenza Immunogenicity: measure by hemagluttinin inhibition (HI) titer 21 days after vaccination Safety: local and systemic adverse drug reactions (ADRs) from days 1-7 Unsolicited ADRs for 21 days after vaccination

Clinicaltrials.gov ID:NCT02587221 ACIP. February 2020. https://www.cdc.gov/vaccines/acip/meetings/live-mtg-2020-2.html . ACIP. February 2020. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/flu-02-Sylvester-508.pdf 15 16

4 6/3/2020

ACIP Work Group Recommendation

¥ Use a licensed, age appropriate influenza vaccine https://www.englishblog.com/2014/10/cartoon-ebola-panic.html?asset ¥ No preferential recommendation _id=6a00d8341d417153ef01b8d07cf2b9970c#.XtVD3BNKiuU for any influenza vaccine Ebola

ACIP. February 2020 . https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/flu-06-Grohskopf-508.pdf 17 18

Efficacy and Effectiveness of an rVSV-Vectored Vaccine in Preventing Ebola Virus Disease: Final Results from the Guinea , Open-Label, Cluster- Ebola Randomized Trial (Ebola Ca Suffit!) Study Objective Assess the efficacy of single IM dose of rVSV-ZEBOV vaccine in the prevention of lab confirmed Ebola virus disease (EVD)

Study Design and Setting Open label, cluster-randomized ring vaccination trial Guinea and Sierra Leone ¥ Likely carried by animals ¥ Signs and symptoms Inclusion Criteria ≥18 years old ¥ Caused by group of viruses within ¥ Fever Contacts of confirmed EVD cases the ebolavirus genus ¥ Aches and pains Exclusion Criteria Pregnant, breastfeeding or severely ill ¥ Initially spread through contact ¥ Weakness and fatigue Hx of EVD, other experimental txs In past 27 days, anaphylaxis to vaccine with blood, body fluids and tissues components ¥ GI symptoms of infected animals Serious dx resulting in being bed-ridden or hospitalized ¥ Abdominal pain Treatment Interventions Singe IM dose of rVSV-ZEBOV immediately or 21 days later ¥ Subsequent spread through direct contact with blood or body ¥ Unexplained hemorrhaging, Outcome Measures Lab confirmed case of EVD with onset 10 days or more from fluids of infected patients bleeding or bruising randomization Results 0 EVD cases in 2119 immediately vaccinated participants ¥ 11 people treated for Ebola in US 16 EVD cases in 2041 delayed vaccination participants during the 2014-2016 epidemic VE: 100 % (95% CI: 68.9-100, p=0.0045)

Adverse Effects Headache, fatigue, muscle pain

CDC. https://www.cdc.gov/vhf/ebola/symptoms/index.html . Accessed May 8, 2020. Lancet. 2017; 389 (10068): 505-518. 19 20

5 6/3/2020

The Sierra Leone Trial to Introduce a Vaccine Against Ebola: Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double Safety During the West Africa Ebola Outbreak Blind, Placebo-Controlled Randomized Study in Healthy Adults Study Objective Examine lot to lot consistency of of rVSV∆G-ZEBOV-GP and provide Study Objective Evaluate the vaccine safety and efficacy of rVSV∆G-ZEBOV-GP additional safety and immunogenicity data vaccine Study Design and Randomized, double blind, placebo controlled study Study Design and Setting Individually randomized, unblinded Phase 2/3 trial with phased Setting 40 sites in US, 1 site in Spain, 1 site in Canada vaccine introduction Inclusion Criteria Healthy subjects 18-65 years old Inclusion Criteria Healthcare and frontline Ebola response workers ≥18 years old Exclusion Criteria Immunocompromised Exclusion Criteria Hx of Ebola Illness Pregnancy/breastfeeding Pregnant/breastfeeding Immunodeficiency Received another vaccine (Ebola virus or live within 14 days) Interventions Immediate or deferred (18– 24 weeks after enrollment) Interventions 1 ml of rVSV∆G-ZEBOV-GP IM vaccination with rVSV∆G-ZEBOV-GP vaccine 0.9 % normal saline Outcome Measures Serious adverse effects (SAEs) within 6 months of vaccination Outcome Safety through 6 months post vaccination, including 42 days of solicited Results 132 out of 8651 participants with reported SAEs (1.3 % Measures adverse events vaccinated participants and 0.7 % participants during Results 81-85 % of participants in vaccine group vs. 44 % in placebo group with ≥1 unvaccinated follow up) ADR

J Infect Dis. 2018; 217(Suppl 1): S6-S15. J Infect Dis. 2017; 215: 1789-1798. 21 22

Ebola Vaccine ACIP Work Group Recommendations

Ervebo® (Ebola Zaire Live Vaccine) ¥ Pre-exposure vaccination with rVSV∆G-ZEBOV-GP vaccine is Indications Prevention of disease caused by Zaire ebolavirus in patients ≥18 recommended for healthy, non-pregnant, non-lactating adults 18 years of years age or older in the United States (U.S.) population who: Dosage and 1 ml intramuscularly ¥ Are responding to an outbreak of Ebola virus disease and are at potential risk for Zaire ebolavirus Administration exposure to Ebola virus (species ) Adverse Reactions • Injection site pain • Headache ¥ Work as healthcare personnel at a federally-designated Ebola Treatment Center • • in the U.S. who are at potential risk for exposure to Ebola virus (species Zaire Swelling Feverishness ebolavirus ) • Redness • Muscle pain • Fatigue ¥ Work as laboratorians and support staff at biosafety-level 4 facilities in the U.S. • Joint pain who are at potential risk for exposure to Ebola virus (species Zaire ebolavirus ) • Nausea • Arthritis • Sweating Storage • Freeze at -80°C to -60°C

Ervebo. Prescribing information. https://www.fda.gov/media/133748/download . Accessed 5/8/2020. ACIP. February 2020. https://www.cdc.gov/vaccines/acip/meetings/live-mtg-2020-2.html

23 24

6 6/3/2020

SARS-CoV-2 Vaccine Studies

¥ 94 trials registered with clinicaltrials.gov focusing on COVID-19 ¥ 6 vaccine trials in the United States SARS-CoV-2 Vaccine Studies ¥ 2 types of vaccines being studied: ¥ Bacile Calmette Guerin (BCG) ¥ Messenger RNA (mRNA)

Clinicaltrials.gov. Accessed 5/8/2020.

25 26

BCG Vaccine mRNA-1273 Vaccine

¥ Attenuated, live culture preparation of BCG strain of Mycobacterium bovis ¥ Indicated for prevention of tuberculosis ¥ Rationale for use in prevention of COVID-19 ¥ WHO recommendation ¥ Studies in progress

BCG Vaccine U.S.P. Prescribing information. https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert---BCG-Vaccine.pdf. Accessed 5/8/2020 . WHO. https://www.who.int/news-room/commentaries/detail/bacille-calmette-gu%C3%A9rin-(bcg)-vaccination-and-covid-19 Accessed 5/30/2020. https://www.hospimedica.com/covid-19/articles/294781771/moderna-awarded-usd-483-million-by-barda-for-advancing-mrna-vaccine-against-coronavirus.html

27 28

7 6/3/2020

Dose-Confirmation Study to Evaluate the Safety, , and Immunogenicity of mRNA- 1273 COVID-19 Vaccine in Adults Aged 18 Years and Older Study Assess the safety, reactogenicity, and immunogenicity of 2 dose levels Objective of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older Study Design 600 participants and Setting United States Immunization Administration During Inclusion ≥18 years old Criteria Not pregnant or breastfeeding and using contraception COVID-19 Pandemic Exclusion Known hx of SARS-CoV-2 or exposure Criteria Acute/chronic illness Prior administration of SARS-CoV-2 vaccine or treatment or healthcare worker Interventions mRNA-1273 50 mcg or 100 mcg on days 1 and 29 Placebo on days 1 and 29 Outcome ADRs 7 days post vaccination Measures Serious ADRs within 13 months Abnormalities in BP, temperature, HR, RR, physical examinations Immunogenicity of mRNA-1273 using ELISA Results Pending

Clinicaltrials.gov. ID: NCT04405076 29 30

CDC Guidance for Immunization CDC Guidance for Adult Administration

¥ Postpone visits unless: ¥ Consider administering if no additional risk to patient or provider ¥ In person visit scheduled for a different reason and no additional risk ¥ Prioritize high risk groups ¥ Compelling need to receive immunization ¥ Screening strategies for COVID-19 symptoms ¥ Measles and Rubella Initiative statement ¥ Standard precautions and PPE ¥ Interim guidance to prevent mother to child transmission of Hepatitis B virus ¥ Mask ¥ Eye protection ¥ Hand hygiene

CDC. https://www.cdc.gov/vaccines/schedules/hcp/schedule-changes.html . Accessed 5/8/2020. CDC. https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html . Accessed 5/8/2020.

31 32

8 6/3/2020

Flu Season Preparation Considerations Post-Test Question 1

¥ Workflow changes ¥ MF-59 may contribute to a higher incidence of: ¥ Forms filled out in advance a) Autism ¥ Claim processing b) Severe allergic reactions ¥ Managing patients virtually to minimize number of patients waiting in store c) Pain and induration ¥ Drive through d) Depression ¥ Electronic alerts ¥ Patient screening ¥ Curbside immunizations?

33 34

Post-Test Question 1 Post-Test Question 2

¥ MF-59 may contribute to a higher incidence of: ¥ Which of the following patients should receive a prophylactic dose of a) Autism rVSV∆G-ZEBOV-GP according to ACIP workgroup recommendations? (SELECT ALL THAT APPLY) b) Severe allergic reactions a) 20 year old college student traveling to a safari in West Africa c) Pain and induration b) A 19 year old responding to an Zaire ebolavirus outbreak d) Depression c) A janitor at a biosafety-level 4 facility in the U.S. which is conducting research on Zaire ebolavirus species d) An 80 year old living in East Africa

35 36

9 6/3/2020

Post-Test Question 2 Post-Test Question 3

¥ Which of the following patients should receive a prophylactic dose of ¥ Which of the following is TRUE regarding vaccine administration during rVSV∆G-ZEBOV-GP according to ACIP workgroup recommendations? COVID-19 pandemic? (SELECT ALL THAT APPLY) (SELECT ALL THAT APPLY) a) Pharmacists should continue to administer vaccines when necessary a) 20 year old college student traveling to a safari in West Africa b) Pharmacists should utilize appropriate personal protective equipment (PPE) b) A 19 year old responding to an Zaire ebolavirus outbreak while administering vaccines c) A janitor at a biosafety-level 4 facility in the U.S. which is conducting research c) Pharmacists should determine whether workflow changes are appropriate to on Zaire ebolavirus species ensure safety and well-being of their staff and patients d) An 80 year old living in East Africa d) Pharmacists should delay immunization administration until COVID-19 pandemic is over

37 38

Post-Test Question 3 Take Home Points

¥ Which of the following is TRUE regarding vaccine administration during ¥ ACIP does not indicate a preference for one flu vaccine over another COVID-19 pandemic? (SELECT ALL THAT APPLY) ¥ Any age appropriate flu vaccine may be administered to a patient a) Pharmacists should continue to administer vaccines when necessary ¥ Ebola vaccine should be administered only to certain high risk groups b) Pharmacists should utilize appropriate personal protective equipment (PPE) while administering vaccines ¥ SARS-CoV-2 vaccine studies are underway; it is highly unlikely that a vaccine will be commercially available before 2021 c) Pharmacists should determine whether workflow changes are appropriate to ensure safety and well-being of their staff and patients ¥ Pharmacists may delay non-urgent immunizations during COVID-19 pandemic, but should continue to administer immunizations when a d) Pharmacists should delay immunization administration until COVID-19 pandemic is over compelling reason exists ¥ Pharmacy staff should utilize appropriate PPE when administering vaccines during COVID-19 pandemic

39 40

10 6/3/2020

Resources and References Resources and References

¥ Influenza (flu). Centers for Disease Control and Prevention. Updated May ¥ Mannino S, Villa M, Apolone G, et al. Effectiveness of adjuvanted influenza 29, 2020. Accessed May 30, 2020. vaccination in elderly subjects in Northern Italy. Am J Epidemiol. https://www.cdc.gov/flu/about/keyfacts.htm . 2012;176(6):527-533. doi: 10.1093/aje/kws313 ¥ Tokars JI, Olsen SJ, Reed C. Seasonal incidence of symptomatic influenza in ¥ Van Buynder PG, Konrad S, Van Buynder JL, et al. The comparative the United States. Clinical Infectious Diseases. 2018; 66(10): 1511-1518. effectiveness of adjuvanted and unadjuvanted trivalent inactivated doi: 10.1093/cid/cix1060 influenza vaccine (TIV) in the elderly. Vaccine. 2013;31:6122-6128. doi: 10.1016/j.vaccine.2013.07.059 ¥ Influenza vaccines - United States, 2019-20 influenza season. Centers for Disease Control and Prevention. Updated August 22, 2019. Accessed May ¥ Clinical study to evaluate the efficacy, safety and immunogenicity of an 8, 2020. https://www.cdc.gov/flu/professionals/vaccines.htm . MF59-adjuvanted quadrivalent influenza vaccine compared to non- influenza vaccine comparator in adults ≥ 65 years of age. ClinicalTrials.gov ¥ De Donato S, Granoff D, Minutello M, et al. Safety and immunogenicity of Identifier: NCT02587221. Updated January 2, 2019. Accessed May 8, MF59-adjuvanted influenza vaccine in the elderly. Vaccine. 1999;17:3094- 2020. https://clinicaltrials.gov/ct2/show/results/NCT02587221 3101. doi: 10.1016/s0264-410x(99)00138-3

41 42

Resources and References Resources and References

¥ Sylvester GC. Older adult (65+) adjuvanted quadrivalent influenza vaccine (aIIV4) phase III ¥ Samai M, Seward JF, Goldstein ST, et al. The Sierra Leone trial to introduce a trial. Presentation delivered at: Advisory Committee on Immunization Practices; February vaccine against Ebola: an evaluation of rVSV∆G-ZEBOV-GP vaccine tolerability 26, 2020; Atlanta, GA. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides- and safety during the West Africa Ebola outbreak. J Infect Dis. 2018; 217(Suppl 2020-02/flu-02-Sylvester-508.pdf . 1): S6-S15. doi: 10.1093/infdis/jiy020 ¥ Grohskopf L Summary and work group considerations. Presentation delivered at: Advisory ¥ Halperin SA, Arribas JR, Rupp R, et al. Six-month safety data of recombinant Committee on Immunization Practices; February 26, 2020; Atlanta, GA. vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine in a https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/flu-06- phase 3 double-blind, placebo-controlled randomized study in healthy adults. J Grohskopf-508.pdf . Infect Dis. 2017;215:1789-1798. doi: 10.1093/infdis/jix189 ¥ Ebola (Ebola virus disease). Centers for Disease Control and Prevention. Updated ¥ Ervebo. Prescribing information. Merck and Co; 2019. Accessed 5/8/2020. November 5, 2019. Accessed May 8, 2020. https://www.fda.gov/media/133748/download . https://www.cdc.gov/vhf/ebola/symptoms/index.html . ¥ Choi M. Work group recommendations: proposed recommendation text for ¥ Henao-Restrepo AM, Camacho A, Longini IM, et al. Efficacy and effectiveness of an rVSV- policy options. Presentation delivered at: Advisory Committee on Immunization vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring Practices; February 26, 2020; Atlanta, GA. vaccination, open-label, cluster-randomised trial (Ebola Ca Suffit!). Lancet. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020- 2017;389(10068):505-518. doi: 10.1016/S0140-6736(16)32621-6 02/Ebola-05-Choi-508.pdf .

43 44

11 6/3/2020

Resources and References

¥ ClinicalTrials.gov . Accessed May 8, 2020. https://clinicaltrials.gov/ct2/show/results/NCT02587221 ¥ BCG Vaccine U.S.P. Prescribing information. Organon Teknika Corporation LLC. Accessed 5/8/2020. https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/publishe d/Package-Insert---BCG-Vaccine.pdf . ¥ Bacille Calmette-Guerin (BCG) vaccination and COVID-19: scientific brief. World Health Organization. Updated April 12, 2020. Accessed May 30, 2020. https://www.who.int/news-room/commentaries/detail/bacille-calmette- gu%C3%A9rin-(bcg)-vaccination-and-covid-19 . Immunizations Update ¥ Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Bedrija Nikocevic, PharmD, BCACP Older. ClinicalTrials.gov Identifier: NCT04405076. Accessed June 1, 2020. https://clinicaltrials.gov/ct2/show/study/NCT04405076?term=mrna1273&dr Assistant Professor of Clinical Sciences aw=2&rank=1 Roosevelt University College of Pharmacy [email protected]

45 46

12