MRx Pipeline + COVID-19 Vaccine Front Runners

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January 2021

MRx PIPELINE

COVID-19 Vaccine Front Runners

At Magellan Rx Management, we are dedicated to providing you with timely and valuable information surrounding COVID-19. With cases and hospitalizations surging, the United States (US) government is calling for broader COVID-19 vaccine access to accelerate distribution and vaccination in larger populations. Under this new rollout, all available doses will be released to states to provide initial immunizations. Both COVID-19 vaccines currently authorized in the US require two doses, and supply for second doses will be provided through ongoing manufacturing. With the new distribution plan, the federal government recommends wider vaccine eligibility to include older adults and individuals with high-risk medical conditions. These fluid developments underscore the importance of vaccine pipeline monitoring. In the US, several vaccines are in development and expected in 2021. Globally, there are over 230 vaccine candidates under study, of which more than 60 are in human clinical phases of study. The MRx Pipeline+ provides a credible clinical snapshot of select COVID-19 vaccine front runners in the US.

Operation Warp Speed (OWS) COVID-19 Vaccine Candidates DEVELOPER (VACCINE)

STUDY PHASE

APPROXIMATE PARTICIPANTS

AGE

ROUTE OF ADMINISTRATION

SCHEDULE

DOSE

PRESENTATION

COLD CHAIN

EUA

mRNA Pfizer/BioNTech (BNT162b2)

3

44,000

12-85 years

IM

2 doses (0, 21 days)

30 mcg

MDV; requires dilution

Ultra cold freezer; thermal shippers on dry ice; refrigerator x 5 days; room temperature x 2 hours (undiluted vials)

Yes - EUA for ages ≥16 years issued December 11, 2020

Moderna/NIAID (mRNA-1273)

3

30,000

≥18 years*

IM

2 doses (0, 28 days)

100 mcg

MDV; no dilution required

Standard freezer x 6 months; refrigerator x 30 days; room temperature x 12 hours

Yes - EUA for ages ≥18 years issued December 18, 2020

Viral Vector AstraZeneca/ Oxford (AZD-1222)

3

60,000

≥18 years

IM

2 doses (0, 28 days)

N/A

MDV

Standard refrigerator temperature

Potentially April 2021

Johnson & Johnson (AD26.COV2.S)

3

45,000 (single dose)** 30,000 (2 doses)

≥18 years

IM

1 dose or 2 doses (0, 56 days)

N/A

MDV

Standard freezer & refrigerator temperatures

Potentially 1st quarter 2021 (single dose)

Protein Subunit Novavax (NVX-CoV2373) Sanofi/ GlaxoSmithKline (SCB-2019)

3 1/2

30,000^

≥18 years

IM

2 doses (0, 21 days)

N/A

N/A

Standard refrigerator temperature

Potentially 2nd quarter 2021

N/A

≥18 years

IM

1 dose or 2 doses (0, 21 days)

N/A

N/A

Standard refrigerator temperature

Potentially 4th quarter 2021

*Under study in ages 12 to 17 years. **Interim study results for single dose expected in late January 2021. ^US study launched on December 27, 2020. None of the vaccines have received full FDA licensure. Information contained in this report is fluid. Temperatures: ultra cold freezer (-70 °C ± 10°C), standard freezer (-20 °C), standard refrigerator (2-8 °C).

GLOSSARY COVID-19 – Coronavirus Disease 2019 EUA – Emergency Use Authoriztion FDA – Food and Drug Administration IM – Intramuscular EDITORIAL STAFF

MDV – Multi-dose vial N/A – Not Available NIAID – National Institute of Allergy and Infectious Diseases US – United States

Maryam Tabatabai, Pharm D VP, Clinical Information

Carole Kerzic, RPh Drug Information Pharmacist


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