$628M HHS Task Order to Advance Manufacturing of COVID-19 Vaccines

HHS recently announced a $628 million task order with Emergent BioSolutions to advance manufacturing capabilities for potential COVID-19 vaccines and therapeutics. 

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The task order is part of the Trump Administration’s Operation Warp Speed (OWS) and exists under a previous contract with the Biomedical Advanced Research and Development Authority (BARDA), part of HHS’s Office of the Assistant Secretary for Preparedness and Response. 

At the end of May, the Trump Administration released framework and leadership for OWS, a public-private partnership to facilitate the development, manufacturing, and distribution of COVID-19 countermeasures, including vaccines, therapeutics, and diagnostics, between components of HHS.

Congress has directed almost $10 billion to Operation Warp Speed through supplemental funding, including the CARES Act. Lawmakers have also appropriated other flexible funding, HHS stated. Over $6.5 billion has been designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research.

Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.

Under the most recent task order, Emergent will commit contract development and manufacturing organization (CDMO) drug abuse and drug product manufacturing capacity for production of COVID-19 vaccine candidates, which is valued at nearly $543 million. 

Emergent also noted an investment of approximately $85.5 million for the rapid expansion of its viral and non-viral CDMO fill/finish capacity for vaccine and therapeutic manufacturing, HHS stated.

“Within weeks after announcing Operation Warp Speed, President Trump has now brought on another key manufacturing partner for an eventual COVID-19 vaccine. Before a vaccine is even approved, Emergent’s manufacturing capabilities will pave the way for drug companies with candidates approaching approval to begin turning out doses,” HHS Secretary Alex Azar said in the announcement. 

“Securing more manufacturing capacity here in America for candidates that make it to the final stages of Operation Warp Speed will help get a vaccine to American patients without a day wasted.”

Emergent originally began collaborating on development and manufacturing with Johnson & Johnson, Novavax, and Vaxart on their COVID-19 vaccine candidates.

On April 8, Novavax discovered a lead vaccine candidate, made by leveraging Novavax’s proprietary nanoparticle technology. The company enrolled its first participants in a Phase 1/2 clinical trial at the end of May. 

Novavax stated that it identified the lead COVID-19 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies. 

Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020, Novavax said. 

BARDA has invested to expand manufacturing capabilities in the US, including creating three Centers for Innovation in Advanced Development and Manufacturing, HHS said. One of the centers is managed by Emergent and became the first to be deployed for the Operation Warp Speed effort.

At the end of March, Johnson & Johnson identified a lead COVID-19 vaccine candidate and expects to initiate a Phase I human clinical trial by September 2020. 

The potential vaccine was discovered from constructs the company has been working on since January through the expansion of its existing partnership between its Janssen Pharmaceutical Companies and the Biomedical Advanced Research and Development Authority (BARDA), part of HHS.

Johnson & Johnson expanded its partnership with BARDA in mid-February and the companies stated they will commit more than $1 billion of investment to co-fund vaccine research, development, and clinical testing.

“Supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in the announcement.