Justification and Approval Other Than Full and Open Final.pdf

Control Number:

MANUFACTURE AND DISTRIBUTION OF VACCINES IN SUPPORT OF OPERATION WARP SPEED

IN RESPONSE TO THE COVID-19 PANDEMIC

Justification and Approval FAR 6.302-2 Other than Full and Open Competition

Urgent and Compelling for COVID-19

1. Contracting Activity: Army Contracting Command - Aberdeen Proving Ground (ACC-APG), Natick Contracting Division, Kansas Street, Natick, MA 01760

2. Description of Action: This is a request for approval to immediately award a new contract to Moderna, Inc., 200 Technology Square, Cambridge, MA to complete and produce up to dosages of a vaccine to prevent the general population from developing symptoms of the COVID-19 infection. The anticipated contract type is Firm Fixed Price. The Requirement and Funding are from Health and Human Services, as part of Operation Warp Speed. This effort is an assisted acquisition under Economy Act, 31 USC 1535(a), by DoD and ACC-APG on behalf of BARDA.1 DOD will be the contracting agency. The USG set aside funds specifically to develop therapeutics, treatments and vaccines against COVID-19. Those set aside funds, Public Health and Social Services Emergency Funds (5 year funds), are being used to support this effort.

3. Description of Supplies/Services:

Health and Human Service through Operation Warp Speed and the Department of Defense (DOD) requires the ability to procure mass quantities of COVID-19 vaccines from multiple vendors to support military locations and personnel throughout the Continental United States (CONUS) and outside the Continental United States (OCONUS). In addition to the DOD requirement, the U.S. Government, through HHS and Operation Warp Speed, requires the ability to procure mass quantities of COVID-19 vaccines from multiple vendors for the US population. 2 To advance the US response to COVID-19, requirements and technology continue to be identified that are crucial to addressing the public health emergency. Procurement of the products and technology, leading to obtaining sufficient vaccine dosages to vaccinate the US population, will enable the US to bring to bear the most effective measures to defeat the threat of COVID-19.

IN RESPONSE TO THE COVID-19 PANDEMIC

quantities from either Moderna or other potential vendors depending on the success and promise of the candidate vaccines. Given the circumstances of the current pandemic, pursuing parallel efforts with other companies to bring a solution to market is the best approach.

The Joint Program Executive Office Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is serving as the lead organization to coordinate multi-agency requirements from BARDA and other U.S. Government organizations. This coordination will ensure a comprehensive approach to remove the threat that COVID-19 presents to the Armed Forces and the U.S. population at large, reducing the potential for duplicative efforts while focusing efforts on timely award of urgent contract actions.

4. Authority Cited: 10 U.S.C. 2304(c)(2), as implemented by FAR 6.302-2, Unusual and compelling urgency.

5. Reason for Authority Cited:

41 U.S.C. 1903 Special Emergency Procurement authority is authorized because the President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121- 5207 (the "Stafford Act") in response to the COVID-19 pandemic on 13 March 2020.

Every day that passes, confirmed COVID-19 cases increase with a concomitant increase in the death toll. In addition, the Federal Acquisition regulation at FAR 6.302-2 allows for other than full and open competition based on urgent and compelling circumstances.

This action satisfies the requirements of FAR 6.302-2 because of the (a) the urgent threat COVID-19 poses to both national security and the public health and (b) prospect that the Moderna vaccine, if contracted for now and in this manner, could be available prior to a second wave of the pandemic in Fall 2020. By any measure, the urgent and compelling nature of this requirement is met and justified by the subsequent explanation:

There are currently seven companies being considered by Operation Warp Speed for contract awards to develop and deliver an effective vaccine against COVID-19 in sufficient quantities to protect the citizens of the United States, its service members and their families. The seven companies are;

These seven companies have been identified to possess the potential to develop an effective vaccine against COVID-19.

IN RESPONSE TO THE COVID-19 PANDEMIC

This contract will move Moderna forward to manufacturing doses early, a risk based decision by the Operation Warp Speed Leadership4, after consultation with BARDA Program Team.

The U.S. Government cannot adopt standard procurement times to an acquisition of this urgent nature. Even under the best of circumstances, a short timeline of 30-60 days to award a contract is unacceptable, and failure could result in hundreds of thousands more being infected and many more dying. Efforts to alleviate the COVID-19 pandemic threat will require multiple, simultaneous efforts, all supporting availability of vaccines, to include vaccine development and production. Failure to have the vaccine ready and available to the U.S. population will risk resurgence of the COVID-19 infections and increased mortality to affected individuals.

The goal established by President of the United States was to vaccinate the entire U.S.

population before the next wave of COVID hits the U.S.5 This requires extraordinary events to happen simultaneously. Accordingly, Operation Warp Speed was stood up as a partnership between Health and Human Services and the Department of Defense to determine how to approach this goal. Operation Warp Speed was created and looked at 14 different candidate vaccine efforts and narrowed the field to seven.6 These seven companies identified in paragraph 6 below, meet the criteria of being able to execute the development requirements to get to an FDA approved drug by Dec 2020.

This makes them uniquely positioned for timely response to the US Government needs. The next criterion to meet was which of these seven could manufacture (Produce) enough quantities of the vaccine to be ready to vaccinate the population starting at the end of December 2020 to the beginning of January 2021. Only three companies meet this criterion, . The US Government has awarded an Other Transaction Agreement under 10 USC 2371b with (awarded by HHS/BARDA) to produce doses by the end of Dec 2020, IN RESPONSE TO THE COVID-19 PANDEMIC

6. Efforts to Obtain Competition:

The US Government has not sought competition for this particular contract action due to unusual and compelling urgency to obtain sufficient vaccines for the US population in response to the unprecedented threat represented by COVID-19. This instant contract action has not been synopsized based upon the exception at FAR 5.202(a)(2). As stated above, the U.S. Government cannot adopt standard procurement times to an acquisition of this urgent nature. Even under the best of circumstances, a short timeline of 30-60 days to award a contract is unacceptable, and failure could result in hundreds of thousands more being infected and many more dying. Failure to have the vaccine ready and available to the U.S. population will risk resurgence of the COVID-19 infections and increased mortality to affected individuals.

There is currently no available vaccine or existing treatments against the novel COVID-19 virus. Failure to expeditiously obtain and have available FDA authorized vaccines to the US population could lead to grievous harm to military services members, their dependents and US citizens.

7. Actions to Increase Competition:

Despite that, to obtain sufficient quantities for the US population, the United States Government intends to procure mass quantities of COVID-19 vaccines from multiple sources.

Based upon market research, there are currently seven companies also being considered