A $265 million COVID-19 vaccine manufacturing contract between the Department of Health and Human Services (HHS) and the Texas A&M University System (TAMUS) to manufacture the Novavax and other COVID-19 vaccines demonstrates that a manufacturing facility can be retrofitted to produce Current Good Manufacturing Practice (cGMP) protein subunit COVID-19 vaccines in five months or less.
The contract, Task Order No. 75A50120F33002, was obtained by KEI under the Freedom of Information Act (FOIA). It was awarded to TAMUS on July 23, 2020 to establish COVID-19 vaccine manufacturing capacity at the TAMUS Center for Innovation in Advanced Development & Manufacturing (CIADM).
Fujifilm Biosynth is the subcontractor of the task order and will manufacture “vaccines that use sF9 cells in the manufacturing process[.]” These include the Novavax vaccine candidate, NVX-CoV2373, which is currently in two Phase 3 clinical trials.
The Texas A&M CIADM
The CIADM is a public-private partnership that was established in 2012 by the Biomedical Advanced Research and Development Authority (BARDA), the component of HHS that supports the research and development and manufacture of “medical countermeasures” i.e., treatments and vaccines against emerging national security threats. The purpose of the CIADM program is to support the rapid domestic manufacture of medical countermeasures during national emergencies.
There are at least three CIADM facilities. The first is the TAMUS CIADM, which was established by Agreement No. HHSO100201200002I, the parent contract to task order no. 75A50120F33002. According to Texas A&M, the TAMUS CIADM was established in 2012 after the swine flu pandemic.
Agreement No. HHSO100201200002I is a cost-sharing contract, with TAMUS providing 38 percent of construction costs (likely meaning significantly less than 38 percent of the overall costs). The task order itself is currently valued at $264,693,063, and the parent agreement is valued at $177 million, with an upper limit of $3.3 billion. Before the task order, the TAMUS CIADM was manufacturing influenza vaccines.
Another CIADM facility is based in Maryland, pursuant to a partnership between BARDA and Emergent Biosolutions, and a third facility is located in Holly Springs, North Carolina.
The Manufacturing Timeline
The task order (at page 9) includes a timetable of the estimated time from construction of new facilities to cGMP manufacturing (pursuant to 21 C.F.R. §§ 210-211).
The color red represents construction, green represents cGMP manufacturing, and yellow represents start-up activities such as technology transfer and installing and validating equipment.
According to the infographic, construction of new manufacturing suites was slated to begin in August 2020, with cGMP manufacturing to start in January of 2021, for two of the new manufacturing suites. A news release confirms that Fujifilm began manufacturing COVID-19 vaccines at the TAMUS CIADM in January of 2021.
Amendments
HHS provided KEI with two amendments to the task order: one dated August 17, 2020 and the other dated October 9, 2020.
The August 27, 2020 amendment invokes the Defense Production Act (DPA) and converts the task order into a rated order, to take precedence over non-rated contracts. The October 9, 2020 amendment states that the contractor must reduce the unit prices in the contract if the number of personnel is reduced.
Taxpayers’ Overall Novavax Vaccine Investment
The manufacturing task order adds to the public’s understanding of the U.S. government’s overall contribution to the Novavax vaccine.
Novavax received at least two other large investments from taxpayers: a $1.6 billion research and development (R&D) and manufacturing contract, and a $60 million development and manufacturing agreement. Both were awarded by the Department of Defense (DOD) and were obtained by KEI under the FOIA.
The $1.6 billion contract includes a detailed breakdown of the costs of various sub-projects. It puts Novavax’s clinical trial costs at $1.2 billion and the cost of manufacturing 100 million doses at $418 million or a little over $4 a dose. Non-clinical (animal study) research costs were listed as $5 million.
Novavax received more money from U.S. taxpayers to perform clinical and preclinical research on its vaccine than did Moderna (which received $1 billion), and Moderna has publicly disclosed that the U.S. is paying 100% of the costs of its vaccine research program.
The Bottom Line
The task order shows that safe, reliable vaccine capacity can be established in a few months.