Actionable Information - Research Briefs - 1 -Vaccination
Last updated: March 24, 2021
Suggested citation:
Medina-Cetina, Z., Pompelli, G., Cochran, M., Olivares, M., Perez-Patron, M., Alvarado, J., Duran, G., & Z-Losoya, E.. (2021). CBTS-R13: U.S.-Mexico Risk Taskforce to Support the Health Supply Chain Systems for Infrastructure and Workforce Threatened by the COVID19 Pandemic. https://r13-cbts-sgl.engr.tamu.edu/
@misc{Medina2021,
author = {Medina-Cetina, Zenon and Pompelli, Gregory and Cochran, Matt and Olivares, Miriam and Perez-Patron, Maria and Alvarado, Juan Pablo and Duran, Guillermo and Z-Losoya, Enrique},
title = {CBTS-R13: U.S.-Mexico Risk Taskforce to Support the Health Supply Chain Systems for Infrastructure and Workforce Threatened by the COVID19 Pandemic},
url={https://r13-cbts-sgl.engr.tamu.edu/},
year={2021},
month={March}
}
Pfizer, Moderna, and J&Js Janssen COVID-19 Vaccines have been granted emergency use authorization in the United States (see Table tbl. 1)
U.S. Vaccine wholesale prices have been reported to range from 10 to $50 dollars per patient as shown in Fig. 1.
Table 1: U.S. Emergency Authorized COVID-19 Vaccines Comparison as of March 14, 2021.
Vaccine
Type
Doses
Reported Efficacy
Cold Supply Storage
Price per Patient
Pfizer and BioNTech
mRNA
2x - 21 days apart
95%
-75°C
$39.0
Moderna
mRNA
2x - 28 days apart
94%
-20°C
$50.0
Johnson & Johnson
Adenovirus-based
1x
72%
7°C
$15.0
Pfizer
Expected to deliver a total of 320 million dosesto the U.S. Government:
120 million by end of March 2021
100 million by the end of May 2021
100 million by end of 2021
Pfizer’s U.S. vaccine production is vertically integrated
The most critical manufacturing step of its supply chain is combining mRNA production with lipids which occurs during the first half of the manufacturing process
Pfizer is producing DNA for the U.S. Market with plants located in Kalamazoo, Michigan, St. Louis, Missouri and Andover, Massachusetts
Critical infrastructures updates during February, 2021 caused a ~40% drop in weekly supply for that month but has since recovered
Moderna
Expected to deliver a total of 300 million dosesto the U.S. Government:
100 million by the end of March 2021
100 million by the end of May 2021
100 million by end of July 2021
The most critical manufacturing step of its supply chain is the combining mRNA production with lipids which occurs during the first half
Moderna and Lonza are producing DNA for the U.S. Market with plants located in Norwood, Massachusetts and Portsmouth, New Hampshire respectively
Moderna is subcontracting several U.S. Pharmaceutical manufacturers to handle drug production and filling
Lonza
Corden Pharma
Catelent Pharma
J&J Janssen
Expected to deliver a total of 200 million dosesto the U.S. Government:
20 million by the end of March 2021
80 million by the end of June 2021
100 million by the end of December 2021
JJ’s manufacturing cycle is the longest raging from 60 to 80 days
The most critical manufacturing step of its supply chain is the cell culture growth which occurs at the beginning of the manufacturing process
Emergent Bio Solutions and Merck Pharmaceutical are producing DNA for the U.S. Market with plants located in Baltimore, MD and Philadelphia, PA respectively
J&J is collaborating with 5 U.S. Pharmaceutical manufacturers to handle drug production and filling
Emergent Bio Solutions
Merck Pharmaceutical
Grand River Aseptic Manufactoring (GRAM)
Catalent, Inc
PCI Pharma Services
U.S. Vaccination Overview and Supply Chain
The most important manufacturing, and distribution sites involved in the COVID-19 supply chain in the U.S. are shown in Fig. 2.
Figure 2: Top U.S. COVID-19 Vaccine Supply Chain Suppliers Facilities.
Pfizer and BioNTech
Pfizer can integrate most of its manufacturing and distribution in the United States. The company, however, was part of operation warp speed for distribution (Slaoui & Hepburn, 2020). According to the company’s yearly review, the company has ten manufacturing facilities and two distribution centers, as shown in Fig. 3 . (Inc., 2018), However, only a handful of sites are directly involved in manufacturing its Pfizer-BioNTech COVID-19 Vaccine, as highlighted in Fig. 4 and Fig. 5.
Figure 5: Pfizer’s Manufacturing and Distribution Locations in the United States.
St. Louis, Missouri plant
The process starts at this manufacturing plant in the DNA production and raw materials of their COVID-19 Vaccine.
Drug Formulation in Andover, Massachusetts or Germany facility
RNA messenger through DNA incubation with genetic building blocks takes place in the Andover facility for the U.S. market while international market is supplied by facilities located in Germany
Fast shipment to next facility in helicopters or jets at the beggining of the manufacturing process
Lipidsproduction & other raw materials
U.K. Croda International
Formulation, Fill and Finish in Kalamazoo, Michigan
LNP production step in Kalamazoo is reported to be the bottleneck of the U.S. supply chain. “Combining mRNA and lipids into lipid nanoparticles is the biggest hurdle in the manufacturing process” (Lowe, 2021)
Two production lines producing 600 vials/min
Moderna
Moderna is a U.S.-based pharmaceutical company founded in 2010 with primary headquarters located in Cambridge, MA, and specialized in the research and development of mRNA-based therapeutics. The company is part of Operation Warp Speed and backed by Venture Capital investments (Moderna, 2021); other takeaways about the company are shown in Fig. 6. The company’s workforce has grown 80% over the past two years, according to LinkedIn data (LinkedIn, 2021).
Moderna’s Manufacturing Facilities and Supply Chain Overview
Catalent PharmaisModerna’s main subcontractor for COVID-19 Vaccine manufacturing in the U.S. (Moderna, 2021),(Neubert, 2021). All U.S. supply comes from Moderna’s dedicated supply chain in the U.S. Supply to locations outside of the U.S. comes from dedicated supply points based outside of the U.S.” (Moderna, 2021)
Moderna’sMain Plant in Massachusetts
This plant is involved in the mRNA production phase of the COVID-19 vaccine (Carolyn, 2020)
DNA Production in Portsmouth, New Hampshire
Moderna is subcontracting Lonza to produce DNA for their vaccines, one of the world’s largest contract development and manufacturing companies.
It is reported that at least 3 other production lines located in Visp, Switzerland with a capacity of 600k/day are supplying the international market
Lipid’s production in Boulder, Colorado
Moderna is subcontracting Corden Pharma, the largest U.S. pharmaceutical manufacturer to produce enough lipids for its vaccine
At least 2 production lines were installed in Liestal, Switzerland and Chenôve, France for international market
Formulation & Fill finishing
Moderna is utilizing the vast manufacturing network of Catelent formulation and fill finishing.
Packaging and Distribution
Moderna is part of the U.S. Operation warp speed for both development and distribution. The company uses the central distribution facility
Moderna’s Cold-Chain Distribution and packaging
10 doses of 0.5 each into tray
12 trays per package
Up to 192 packages can be shipped per pallet for a total of 230,400 doses
Moderna uses UPS, FEDEX, DHL and commercial airlines
Part of OWS for development and distribution
Moderna Distribution Efforts as of February 23, 2021
•Company has supplied45.4 million dosesofModernaCOVID-19 Vaccine to U.S. Government
•CDC Reports that approximately30.7 milliondoses of theModernaVaccine has been administered
•Additional33.2 million doseshave been produced and are filled in vials and in the final stages of final production and testing
•Expected to deliver100 million dosesto the U.S. Governmentby end of March 2021
•Expected to deliver100 million additional dosesbyend of May 2021(moved one month forward)followed byanother 100 million additional doses by end of July 2021
Figure 8: Main Moderna’s COVID-19 Vaccine U.S. Manufacturing and Distributions locations.
Johnson and Johnson Janssen COVID-19 Vaccine
Production & Shipments
•March 2021 - 20 million doses
•April to June 2021 – at least 20 million doses per month
J&J’s Janssen Vaccine Distribution Efforts as of March 12, 2021
FDA Emergency Use Authorization Granted – Feb. 27, 2021
Company has supplied 2.9 million doses of J&J’s Janssen COVID-19 Vaccine to the U.S. Government
Plans to distribute 16 million of doses more by the end of March (Services, 2021)
Johnson & Johnson hopes to have partnerships with a total of 10 manufacturing plants by the end of 2021 (House, 2021)
5 U.S. and 3 international partnerships announced as of March 8, 2021Brody (2020)
Merck will use two of its facilities to produce drug substance, formulate and fill vials (Services, 2021)
Expected to deliver 100 million dosesto the U.S. Governmentby end of June 2021(House, 2021)
Expected to deliver 100 million additional dosesbyend of 2021
J&J is using a global network of collaborators to scale up production of its COVID-19 vaccine as seen in Fig. 9, and highlighted in Fig. 10 and Fig. 11.
Production & Shipments
March 2021 - 20 million doses
April to June 2021 – at least 20 million doses per month
The vaccine can be frozen at -4° F for up to two years, and once it arrives at its final destination, can stay in a refrigerator at between 35 and 46° F for at least three months.
Each 0.5 mL dose of the Janssen COVID-19 Vaccine is formulated to contain 50 billion virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2.
COVID-19 Vaccination Landscape
The World Health Organization (WHO) provides weekly bulletins with the status of COVID-19 Vaccine clinical trials in the world. The bulletin is updated twice per week and includes information from several data sources such as Pubmed (Canese & Weis, 2013), the Cochrane vaccine mapping tool (Boutron et al., 2020), ClinicalTrials.gov (Medicine, 2021), WHO International Clinical Trials Registry Platform (ICTRP) (Organization, 2021) and other researchers in industries with registered trials for clinical information (R&D Blue Print, 2021). In addition, several news organizations and research teams have been reporting periodic updates and keeping track of changes, for instance, the New York Times (Carl Zimmer, 2021) and Bloomberg (Bloomberg, 2021), to mention some examples of such efforts to inform the general public.
According to the sources mentioned before, there are 73 vaccines being researched around the world in clinical trials on humans, 16 have reached the final stages of testing, known as Phase III. Of these, at least 182 pre-clinical vaccines are under active investigation in animals as of Feb. 23, 2021
Table 1 tbl. 2 highlights the leading vaccine manufacturers working in their clinical trials and Table tbl. 3 their corresponding vaccine administration medium.
Table 2: Vaccine landscape pipeline
Number of doses
Schedule
Candidate vaccines
Percentage
1 dose
12
16%
Day 0
12
2 doses
45
62%
Day 0 + 14
6
Day 0 + 21
17
Day 0 + 28
22
3 doses
1
1%
Day 0 + 28 + 56
1
TBD / No Data (ND)
15
21%
Total
73
100%
Table 3: COVID-19 Vaccine landscape by route of administration
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Services, U. S. D. of H. &. H. (2021). Biden administration announces historic manufacturing collaboration between merck and johnson & johnson to expand production of COVID-19 vaccines.
Slaoui, M., & Hepburn, M. (2020). Developing safe and effective covid vaccines — operation warp speed’s strategy and approach. New England Journal of Medicine, 383(18), 1701–1703. https://doi.org/10.1056/NEJMp2027405