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) 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. 3 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