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NEWS | April 27, 2023

Capacity Expansion Team Bolsters Nation’s Vaccine Industrial Base in Response to COVID-19

By Stefanie Hagan, Kelly Burkhalter and Daniel Critchfield

At the height of the COVID-19 pandemic, supply chain shortfalls prevented Americans from finding basic items like toilet paper and cleaning supplies. Factory shutdowns emphasized the fact that most American manufacturing took place overseas. The domino effect was felt far and wide and was further illuminated once COVID-19 vaccines were available to be administered. The Nation already faced difficulties addressing the baseline manufacturing needs of public health; the ability to ramp up production to create needles, syringes, glass vials and other materials necessary for vaccinations, presented a new challenge.

On January 21, 2021, President Biden issued an executive order directing actions to secure the U.S. public health vaccine supply chain to reduce reliance on foreign manufacturing, and to increase the domestic capacity of vaccines with minimal disruption to the baseline public health supply chain.

The U.S. Department of Health and Human Services (HHS) was tasked with implementing the effort. Success depended on more than just an understanding of public health emergencies. Implementing the executive order required a multifaceted rapid response, and the ability to think outside the box on conventional government contracting mechanisms.

The USG needed to quickly award and execute billions of dollars in contracts with domestic companies to increase manufacturing capabilities. Due to competing priorities and the scale of this effort, HHS had limited resources to carry out this type of acquisition alone HHS requested assistance from the Defense Department (DoD) and its acquisition workforce to lend their contracting expertise to the mission, initiating a whole-of-government response to the COVID-19 effort. DoD and HHS partnered to expand the domestic industrial base capacity, setting up the USG with stronger partnerships with domestic companies, and ultimately, in a better position to prepare and respond to future public health emergencies.

As the acquisition lead of the Chemical and Biological Defense Program (CBDP), the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) had the resident expertise with developing, coordinating, and awarding large contracts to support needs addressing chemical or biological events. Thus, the DoD’s Joint Rapid Acquisition Cell (JRAC) tasked the JPEO-CBRND with the effort.

In May 2021, the DoD and HHS signed a Memorandum of Understanding (MOU) to formalize DoD acquisition support). The Joint Assisted Acquisition cell (JA2) was stood up as a temporary office to address the requirements of the MOU. JA2 included several product offices including a Capacity Expansion Product Office.

“The JA2 team supports the continued contracting and acquisition expertise needed for our Nation’s ongoing mission to fight COVID-19, including our valuable partnerships with the Federal COVID-19 Response interagency team, academia, and the American industrial base,” said Ms. Nicole Kilgore, the Deputy Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense. “We’re on a mission to support our Nation through innovative contracting at the speed of relevance; securing vaccine doses to meet evolving need; ensuring supply chain resiliency for medical countermeasure development and establishing an enduring pandemic response infrastructure.”

Kilgore led the coordination of JA2 and understood what it took to lead a whole-of-government-approach to addressing COVID-19. “To be effective, JA2 efforts required enduring – and ad hoc – resources in a multitude of areas, including strategic and acquisition planning, program management, resource planning, industry engagement, supply chain integration, logistics, facility management, and technical expertise across the acquisition framework. JA2 provides dedicated teams across the government to manage programs aligned to key areas of action, such as capacity expansion of critical consumables and raw materials to increase supply chain resiliency,” said Kilgore.

JA2’s Capacity Expansion team (CapEx )is comprised of 20 civilian program management and acquisition experts from the U.S. Army, U.S. Navy, and industry, and oversees a $2.3 billion portfolio that includes vials manufacturing, manufacturing of nucleotides and lipids used in mRNA vaccines, bioprocessing of consumables, drug formulation, filling, inspection, and packaging.  

Since the MOU was established, CapEx successfully awarded 20 Cooperative Agreements (CA) and Technology Investment Agreements (TIA) with U.S.-based companies for a total amount of $2.3 billion. These agreements allowed the USG to invest in U.S. manufacturers and support domestic interests.

The results are astounding: the U.S. now has 17 additional industry partners and is successfully constructing vaccine filling lines, increasing vaccine related manufacturing capacity and capabilities, and replicating essential vaccine manufacturing components. The companies involved were required to complete the expansion of the projects within 36 months and provide the U.S. with at least 10 years of priority access and preferential pricing. There is no USG sustainment, so the companies must rely on commercial demand.

Completing this task was not without its challenges, but the diverse team of experts made the accomplishments possible. “We have a great team of program managers and acquisition professionals from the Army, Navy, Army Contracting, and Army legal,” said Stefanie Hagan, Acting Joint Product Lead for Capacity Expansion. “Without this team, the mission would have been in jeopardy.”

Hagan acknowledges the challenges faced by the team in achieving their goals. She says, “the team worked hard to get to ‘yes,’ while also integrating complex contracting rules and regulations from two different departments [DoD and HHS], and solidifying the USG and industry needs to meet the mission.”

“On top of all that, the team was navigating waters not typically used by traditional government contracting. The fact that we were able to award 20 contracts totaling $2.3 billion, break ground, and then start the process to transition the efforts to HHS for management and completion, all within less than two years, is a true testament to the skills and tenacity of our team,” said Hagan.

In accordance with the MOU, DoD’s COVID-19 acquisition assistance is to conclude and fully transition to HHS on September 30, 2023. In preparation for this, the DoD has already started to transition the management of these efforts back to HHS.

The partnership between the DoD and HHS in creating JA2 to combat COVID-19 has captured invaluable lessons that will be used in future acquisition efforts. The success of this whole-of-government approach has unequivocally equipped the Nation with stronger interagency and industry partnerships, leaving the U.S. in a better position to prepare and respond to future public health emergencies. 


Download our press kit, which includes helpful documents to better understand our work, such as – Command Brief, Chemical Biological Defense Program's Enterprise strategy, the JPEO-CBRND's Capabilities Catalog, Leadership Biographies, COVID-19 fact sheets, and contracting overview documents.  



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