Submitted by Devendra Mishra, Executive Director, BSMA
The uncertainty of FDA approval of vaccines for COVID-19 does not have to impede the planning required for empowering the distribution network. Operation Warp Speed is facilitating, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), FDA, the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense. Operation Warp Speed (OWS) has invested roughly $11 billion into funding the testing, manufacturing and supply of seven experimental coronavirus vaccines to ready millions of doses for use by early next year. Among the seven already identified are AstraZeneca in partnership with University of Oxford, GSK-Sanofi, Johnson & Johnson, Moderna, Novavax, Pfizer/BioNTech and Merck.
OWS Funding for CORONAVIRUS VACCINE CANDIDATES
|Company||Vaccine Type||Funding||Use of Funds||Doses Secured||Doses US has Option to Acquire|
|Moderna||mRNA||$2.48 billion||Testing, manufacturing and supply||100 million||400 million|
|Sanofi, GSK||Protein-based||$2.13 billion||Testing, manufacturing and supply||100 million||500 million|
|Pfizer, BioNTech||mRNA||$1.95 billion||Supply||100 million||500 million|
|Novavax||Protein-based||$1.6 billion||Testing, manufacturing and supply||100 million||N/A|
|J&J||Viral vector||$1.46 billion||Testing, manufacturing and supply||100 million||200 million|
|AstraZeneca||Viral vector||$1.2 billion||Testing, manufacturing and supply||300 million||N/A|
|Merck & Co.||Viral vector||$38 million (via IAVI)||Testing||N/A||N/A|
|TOTAL||$10.86 billion||800 million||1.6 billion|
SOURCE: Companies, Biomedical Advanced Research and Development Authority
MANUFACTURING BUILD UP
Global coronavirus vaccine makers have been building their manufacturing and launch plans ahead of approval of any vaccine.
Moderna and Lonza announced a worldwide strategic collaboration to manufacture its vaccine to produce millions of doses at three sites for the U.S. market. Moderna itself is turning out vaccine supplies for the U.S. market at its site in Massachusetts and with partner Lonza, which is producing supplies in New Hampshire. Its ally Catalent will handle fill and finish duties in Indiana. The company’s goal is to enable manufacturing of up to 1 billion doses per year.
GSK is leveraging its pandemic adjuvant technology to make a significant contribution against COVID-19. The company will manufacture, fill and finish adjuvant for use in COVID-19 vaccines at sites in the UK, US, Canada and Europe. It has added Canadian-based Medicago to its growing partners list.
Pfizer plans to draw on three sites in the U.S., plus one in Belgium with its BioNTecht. It plans to draw on sites in Kalamazoo, Michigan, and Andover, Massachusetts, as well as St. Louis. In addition, it has identified a plant in Puurs, Belgium, as a COVID-19 vaccine manufacturing center. Pfizer believes it can deliver millions of doses by the end of 2020 and hundreds of millions in 2021.
Novavax has partnered with FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of its COVID-19 vaccine candidate. Novavax will begin manufacturing hundreds of millions of doses of a COVID-19 vaccine as early as next year at the biotech production facility in College Station of Texas A&M University System Center for Innovation in Advanced Development and Manufacturing, which is owned and operated by Fujifilm Diosynth Biotechnologies.
Johnson & Johnson has struck multiple manufacturing deals for its own COVID-19 vaccine program with plans to produce more than 1 billion doses. The drug maker’s deal with Emergent BioSolutions is intended to ensure U.S. production for early batches. J&J has also signed a deal with Catalent while it has earmarked its Leiden, Netherlands facility for clinical vaccine production and plans to begin manufacturing the vaccine “at-risk” to support human trials.
AstraZeneca will expand its partnership with a Maryland CDMO to get its U.S. shot manufacturing up and running. Maryland-based Emergent BioSolutions will help produce bulk drug substance for AstraZeneca and Oxford’s adenovirus-based COVID-19 shot starting this year. Catalent has disclosed that its manufacturing facility in Anagni, Italy, will provide AstraZeneca with vial filling and packaging capacity. AstraZeneca and SII (formerly the Serum Institute of India) agreed to produce 1 billion of the doses for low- and middle-income countries, starting with 400 million doses by year’s end.
Merck is utilizing its subsidiary Merck KGaA in Darmstadt, Germany, a leading science and technology company, and is partnering with the Jenner Institute for large-scale production of its Covid-19 vaccine candidate.
FOUNDATION FOR THE DISTRIBUTION NETWORK
The reported plans of vaccine manufacturers in the USA, many of whom have been funded by the US Government where a purchase contract for vaccines has already been formulated, project sizeable capacity for the country. Furthermore, the foreign companies of AstraZeneca, GSK and Sanofi also have manufacturing capacity in the USA. It appears that the alliances of many American companies overseas and sometimes with presence there, potential to import vaccines is available. One wonders if the manufacturing capacity of a company failing to get their vaccine approved can be utilized to contract manufacture of an approved vaccine of another company. Collaboration is going to be the unwritten law of business in these trying times.
At the end of August, the Centers for Disease Control and Prevention, which is expected to be involved in distributing vaccines, notified U.S. states that they should be ready to launch Covid-19 vaccination campaigns by November. The U.S. government has pledged to deliver 300 million doses by January 2021 and is readying distribution. An FDA meeting of outside experts to discuss Covid-19 vaccines has been scheduled for late October.
The supply chain to emerge will be built around the network of successful manufacturing entities of the vaccines mentioned above, with McKesson as the primary distributor appointed by the U. S. Government. The likely drivers of distribution of the vaccines may turn out to be the States who have already shown remarkable leadership in establishing supply chains in their areas of authority. It appears the distribution of vaccines for the USA will depend solely on the domestic transportation network where the synchronization of demand and supply will require a Moonshot endeavor of the Government and private enterprise.