COVID-19 Vaccine Information Efficacy at Preventing Symptomatic Additional/Booster Dose Vaccine Trial Efficacy Vaccine Specifics Infection with Variants (1 dose vs. 2 doses) Recommendations

Can overfill Looking Ahead Investigational Prevention Pediatric Stability EUA Full FDA/BLA First dose Second dose *ALPHA *BETA *GAMMA *DELTA Route/# Timing of be used as Developer (Name) Status of severe Efficacy % Population Timing Vial Size Storage requirements Preparation & Handling after Submission Approval efficacy efficacy B1.1.7 B.1.351 P.1 B.1.617 of doses Doses extra

Type (Participants) disease (95% CI) opening doses?

• 65 years and older and residents in long-term care settings should receive a booster shot • 50–64 years with •Ultra-cold storage (-80 to - underlying medical 60°C) until expiration date conditions should receive a •Thermal shippers booster shot replenished with dry ice for A single dose of Pfizer-BioNTech FDA approved • 18–49 years with 30 days EUA approved 100% (available Pfizer provided for the underlying medical •Freezer (-25 to -15°C) for (BNT162b2) for ages 12-15 for age 12+). 83% 33% - 88% •Thawing and Phase 2 & 3 with prevention of conditions may receive a At least 6 months MDV (5 doses) up to 2 weeks Stable up to 6 Expect approval for 5-11 y/o age (brand name and third dose in Vaccine was effectiveness IM/ reconstitution required. EUA COVID-19 52% 95% 95% 93% 100% booster shot at, based on after primary 0, 21 days2 / 30 •Refrigeration (2-8°C) for hours after Yes group for 2 dose pending FDA immunocompro shown to be safe against Gamma, 96% (from 2 doses •Reconstitute with 1.8 mL Comirnaty, (44,000) disease in those their individual benefits and series mcg/0.3mL13 up to 1 month.21 If not dilution. review mized in participants and second hospitalization) of 0.9% sodium chloride pronounced Koe- 16 years of age risks individuals from 5- 11 y/o dose was 98% used, discard. and older • 18-64 years who are at Mir'-na-tee) effective •Room Temp: thawed vials increased risk for COVID-19 must be used within 2 exposure and transmission hours because of occupational or •Do not refreeze once institutional setting may thawed.

mRNA receive a booster shot, based

How it works on their individual benefits and risks

Thawing required. Vaccine Under EUA: Additonal dose •Freezer (-50 to -15°C) for may be thawed in the for patients 18+ years of age 7 months refrigerator or at room Moderna vaccine Moderna vaccine who have undergone solid •Refrigeration (2-8°C) for Full BLA approval and booster Application EUA Application temperature: EUA approved antibodies antibodies organ transplantation, or who At least 28 days MDV (10 up to 3 months prior to first Stable up to dose pending FDA review. Moderna Phase 3 with submitted in submitted 6/10 IM/ •Refrigerator: 2.5 hours for ages 18 and 80% 90% 95% 88-100% 61-96% maintains 93% maintains 93% are diagnosed with following the 0, 28 days2 doses) / 100 use. 12 hours after Yes Phase 3 trial shows 93% efficacy EUA (30,000) June (pending for 12 to 17 year 2 doses •Room temperature: 1 hour (mRNA-1273). above efficacy against efficacy against conditions that are second dose mcg/0.5 mL13 •Room Temp (8-25°C): 24 puncture. through six months after second approval) olds. •Vials that have not been variants variants considered to have an hours (unpunctured) dose punctured may be kept equivalent level of •Do not refreeze once between 8°C and 25°C for immunocompromise thawed. up to 24 hours

EUA approved Safety and Single dose J&J Single dose J&J Single dose J&J (9/21 press 4x increase in 2/27 for 18 years efficacy of this 2 hours at elicted dual elicted dual elicted dual release) No antibodies when Mix contents of vial gently Full BLA approval and booster and older (11 vaccine has not room Janssen/J&J Phase 3 94% (Booster mechanisms of mechanisms of mechanisms of reduction in No authorized aditional or given at 2 mos; IM/1 Refrigerator (2-8°C ) for up by swirling before dose pending FDA review. day pause for N/A 79% 74% been established 0 day6 MDV (5 doses) temperature, No (44,325) dose data) protection protection protection effectiveness booster doses 12x increase dose to 6 months withdrawing. DO NOT Evidence of benefit with booster (Ad26.COV2.S) safety in individuals or 6 hours at 2- against COVID- against COVID- against COVID- including against when given at 6 SHAKE. dose in two Phase 1/2a trials monitoring, younger than 18 8°C 19 and variants 19 and variants 19 and variants Delta variant mos resumed 4/23) y/o

Vaccine has Vaccine has Vaccine has Vaccine has How it works Considering Considering been seen to been seen to been seen to been seen to Not in the US, but bypassing EUA bypassing EUA Oxford/AstraZen Phase 3 neutralize neutralize neutralize neutralize in the UK per IM/ MDV (10 Refrigerator (2-8°C ) for up Will seek FDA authorization in

Viral Vector approval and approval and 79% 82% 100% N/A N/A 0, 28 days 6 N/A N/A Yes (30,000) against multiple against multiple against multiple against multiple provider's 2 doses doses)6 to 6 months second half of 2021 eca (ChAdOx1) going for BLA going for BLA COVID-19 COVID-19 COVID-19 COVID-19 discretion approval approval variants variants variants variants

6 months after N/A (currently Refrigerator (2-8°C) up to 6 Novavax Phase 3 Likely seek EUA initial regimen had IM/ MDV (10 N/A Not quantified 89.70% 100% studying in 12- 93.0% 93.0% N/A N/A N/A 0, 21 days 5 months N/A N/A N/A Likely seek EUA Q4 2021 (30,000) Q4 2021 a 4.6 fold increase 2 doses doses) (NVX-CoV2373) 17 y/o) Room temp for 24 hours in antibodies Protein Protein Subunit How it works How it works

Disclaimer References Useful Resources ASHP Statement 1 https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/Operation-Warp-Speed-Timeline/ ASHP COVID Vaccine Info Website 2 https://www.vizientinc.com/-/media/documents/sitecorepublishingdocuments/public/vizient_covid_19_vaccine_tracker.pdf Centers for Disease Control and Prevention (CDC) Weekly COVID Data Tracker - Updated information on ASHP will continue to advocate on behalf of our members and support COVID-19 vaccine planning efforts; a 3 https://clinicaltrials.gov/ COVID-19 reported cases, variants, testing, and hospitalizations number of resources, including ASHP's Principles forCOVID-19 Vaccine Distribution, Allocation, and Mass 4 http://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Reports-FDA-Partial-Clinical-Hold-for-Planned-Phase-2--3-Trial-of-COVID-19-Vaccine-Candidate-INO-4800/default.aspx Johns Hopkins Coronavirus Resource Center - National and global map with up to date numbers and visualized Immunization, are available on our COVID-19 vaccine page 5 https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-3-efficacy-trial-covid-19-vaccine-united COVID-19 tracking 6 https://www.jnj.com/johnson-johnson-statement-on-fda-approval-of-shelf-life-extension-for-companys-covid-19-vaccine#:~:text=The%20decision%20is%20based%20on,on%20www.vaxcheck.jnj. Bloomberg COVID-19 Tracker - interactive world and US maps with up to date country and state vaccination 7 CDC Identifies Variants https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html rates accompanied by news and other links https://www.ashp.org/COVID-19/Vaccines 8 https://www.reuters.com/article/us-health-coronavirus-inovio-pharma/inovio-partners-with-thermo-fisher-to-bolster-covid-19-vaccine-supply-idUSKBN25Z1XS WHO Tracking Variants 9 https://www.wbur.org/commonhealth/2020/10/29/moderna-vaccine-end-of-year 10 https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-longer-shelf-life-its-covid-19-vaccine 11 https://www.biospace.com/article/warp-speed-head-slaoui-predicts-astrazeneca-vaccine-won-t-be-used-in-the-u-s-until-april/ The information contained in this vaccine informational sheet is emerging and rapidly 12 Pfizer updated EUA (April 6 2021) https://www.fda.gov/media/144413/download evolving because of ongoing research and events and is subject to the professional 13 https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough judgment and interpretation of the practitioner due to the uniqueness of the needs of 14 Janssen EUA https://www.fda.gov/media/146304/download individual patients. ASHP provides this information to help practitioners better understand the current status of Covid-19 vaccine testing. ASHP has made reasonable efforts to 15 Moderna EUA (Mar 31 2021) https://www.fda.gov/media/144637/download ensure the accuracy and appropriateness of the information presented. However, any 16 CDC Moderna Vaccine Prep and Administration Summary https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/prep-and-admin-summary.pdf reader of this information is advised that ASHP is not responsible for the currency of the information, for any errors or omissions, and/or for any consequences arising from the 17 Moderna (29 April) https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-additional-investments-increase-global-supply use of the information for any purpose. Any reader of this document is cautioned that 18 Pfizer EUA 12-15 years https://www.fda.gov/media/144412/download ASHP makes no representation, guarantee, or warranty, express or implied, as to the 19 Pfizer EUA Storage https://www.fda.gov/media/148877/download accuracy and appropriateness of the information contained in this vaccine information sheet and will bear no responsibility or liability for the results or consequences of its use. 20 Sanofi Pasteur/GSK start Phase 3 https://ml-eu.globenewswire.com/Resource/Download/c8640d60-4f51-4b9f-9be5-b7b816d80555 21 https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/ 22 https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-90-overall-efficacy-and 23 https://www.reuters.com/business/healthcare-pharmaceuticals/uk-study-finds-vaccines-offer-high-protection-against-hospitalisation-delta-2021-06-14/ 24 https://www.gov.uk/government/news/vaccines-highly-effective-against-b-1-617-2-variant-after-2-doses 25 https://covdb.stanford.edu/page/susceptibility-data/ 26 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised 27 Pfizer Vaccine Updated EUA (8/12/21): https://www.fda.gov/media/150386/download 28 Moderna Vaccine Updated EUA (8/12/21): https://www.fda.gov/media/144636/download * SARS-CoV-2 Variants of Concern (VOCs) according to WHO Updated: 09/27/2021