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