Inactive

Description of Services or Supplies: The total estimated value of the proposed action, including all options is $992,400,000. BARDA awarded a contract to Bavarian Nordic (BN) on September 27, 2017 for... Description of Services or Supplies: The total estimated value of the proposed action, including all options is $992,400,000. BARDA awarded a contract to Bavarian Nordic (BN) on September 27, 2017 for the late- stage development and procurement of a lyophilized formulation of an MVA based smallpox vaccine. Contract options were also included to allow the procurement of the liquid frozen formulation of the vaccine, tradename JYNNEOS™ which can be filled faster during an emergency response. The JYNNEOS™ vaccine was granted licensure for the prevention of disease caused by smallpox and monkeypox making it the only vaccine ever licensed for the prevention of monkeypox. Under the base period of the BARDA contract, BN completed the clinical evaluation of the lyophilized formulation and has transferred, optimized, and will soon validate the manufacturing process for the lyophilized vaccine. Under the base period and options, BN also manufactured and stockpiled batches of bulk drug substance (BDS) that can be used to fill/finish lyophilized or liquid frozen vaccine. As of May 2022, BARDA owned 164 batches of BDS (~16.4M dose equivalents). Given that JYNNEOS™ is the only vaccine licensed to prevent monkeypox disease, it is the primary vaccine being used to stop the ongoing monkeypox outbreak. There is currently only a limited supply of JYNNEOS™ available (~550K filled vials). In response to the increasing number of cases of monkeypox within the US and globally, BARDA exercised several contract options (June – July 2022) to utilize existing BDS (55 batches ordered; 109 batches remain) to support the fill/finish of 5.5M doses of liquid frozen JYNNEOS™ vaccine. These doses will become available end CY 2022 and Q1 2023. On August 4, 2022, the Secretary of the Department of Health and Human Services declared the ongoing monkeypox outbreak a public health emergency. It is likely that additional doses (beyond 5.5M) of JYNNEOS™ may become urgently needed to support the vaccination of additional at-risk individuals. Through prior contract modifications to support activities related to the development and procurement of lyophilized vaccine as well as BDS units, the total funds obligated to date on the contract are $675,292,656 with a total estimated cost of $871M. Given the public health emergency declaration and the focus on vaccination of at-risk individuals, it is anticipated that additional doses of JYNNEOS™ vaccine will need to be procured under the BARDA contract to ensure that doses are available within the Strategic National Stockpile to support the public health response. The purpose of this modification is to add options to the contract to allow for the rapid procurement of additional JYNNEOS™ vaccine for monkeypox and to restore the USG’s preparedness to address potential smallpox outbreaks. This contract modification will: (1) Support the ability to rapidly commence fill and finish manufacturing of 11M doses of JYNNEOS™ vaccine by utilizing the 109 remaining BDS batches; (2) Support the ability to rapidly commence a technology transfer to a contract manufacture organization (CMO) to increase manufacturing capacity beyond what BN can produce at their site; and (3) Support the ability to rapidly replace the BDS that was filled and finished under previous contract actions. These requirements will be supported by the addition of unexercised/unfunded options to the contract. Authority and Rationale: The JYNNEOS vaccine is the only vaccine licensed against both monkeypox and smallpox. Bavarian Nordic A/S is the only supplier of this vaccine and therefore is the only responsible (sole) source. The addition of unexercised/unfunded options to the contract is necessary to not only allow for rapid response to the ongoing monkeypox public health emergency but also to restore the USG’s preparedness to address potential smallpox outbreaks. The proposed options will include unit prices and total costs and can be exercised in the matter of days (vs. the weeks that it would take to negotiate additional, funded line items). No other supplies or services can satisfy the requirement for additional doses of this vaccine. JYNNEOS is the only vaccine that can meet the government's desired performance parameters for use in at-risk individuals. Although companies have reached out to BARDA to present their recent work in developing vaccines against orthopox viruses (monkeypox, smallpox) there are no candidate vaccines that are readily available and licensed for use during this emergency response. There are no other vaccines that can be modified in the near future to meet this need. To address the ongoing outbreak, the USG needs to be able to rapidly use the existing contract with Bavarian Nordic to procure additional doses of vaccine. Delays in fulfilling BARDA’s urgent needs in addressing a global pandemic and national public health emergency, would jeopardize the public health mission in a way that would result in unacceptable risks to the health of the general public in the United States. JYNNEOS is the only licensed product for monkeypox now. A typical program could require as much as $1B to get to licensure, and that timeline to licensure for a new program could be 10 years or more. It would be cost prohibitive to seek additional competition for an already approved product that meets the government's requirements. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable): N/A - The JYNNEOS vaccine is the only vaccine licensed against both monkeypox and smallpox. Bavarian Nordic A/S is the only supplier of this vaccine and therefore is the only responsible (sole) source. JYNNEOS is the only licensed product for monkeypox now. A typical program could require as much as $1B to get to licensure, and that timeline to licensure for a new program could be 10 years or more. It would be cost prohibitive to seek additional competition for an already approved product that meets the government's requirements. BARDA has continued market surveillance through attendance at scientific meetings, further literature reviews, and communications with colleagues at the Department of Defense and the NIH National Institute for Allergy and Infectious Diaereses (NIAID) to stay abreast of candidates in the pipeline that are suitable for Advanced Research and Development (ARD) support in the development of new and safer smallpox vaccines, as well as the procurement of lead candidates via Project BioShield (PBS) funding. Bridge Contracts: N/A - This justification will not result in the award of a bridge contract. Actions to Increase Competition: In prior years, BARDA had a continuously open Broad Agency Announcements (BAA) and supported the ARD of vaccines against smallpox for many years. Despite the open BAA, BARDA has awarded two ARD contracts under the BAA to both Bavarian Nordic A/S and Kaketsuken (Chemo-Sera Research Institute). The Kaketsuken vaccine failed during nonclinical evaluation and the Bavarian Nordic vaccine successfully completed Phase 3 and was licensed by the FDA in 2019. The Government will continue to perform adequate market research to include reviewing responses submitted under the open BAA to determine if there is a reasonable expectation of receiving competitive offers in support of smallpox vaccines. Market Research: Market research has shown that there is only one licensed vaccine against monkeypox eligible for procurement and that is the JYNNEOS vaccine. Extensive market research to identify and support next-generation and improved vaccines against smallpox (and other orthopoxviruses) has been conducted by BARDA as well as the PHEMCE partners including the Department of Defense and the National Institutes of Health (NIH) over the last 15 years. Bavarian Nordic currently manufactures the only vaccine licensed for prevention of both smallpox and monkeypox under the trade-name JYNNEOS. Although there is another vaccine licensed for prevention of smallpox, that vaccine, ACAM2000 carries with it a black box safety warning and is not appropriate for use in the general population. It is also only licensed for prevention of smallpox and is currently stockpiled and procured by the SNS. To date only a very small number of doses of ACAM2000 have been provided during the response due to the risk/benefit ratio. The safety risks outweigh the benefit of use of ACAM2000 against monkeypox. Procurement History: HHSO100201700019C is an active contract in good standing. The 2017 contract was a sole source award and also utilized the FAR "6.302-1- Only one responsible source and no other supplies or services will satisfy agency requirements" authority. This was a sole source award because the only licensed smallpox vaccine, ACAM2000™, is a live virus vaccine that is employed to vaccinate U.S. military, lab workers, and first response personnel. There is a black box warning on this product as its use has been associated with significantly higher rates of local and/or systemic reactions among individuals receiving vaccine, especially those who are immunocompromised. To achieve the stated Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) smallpox preparedness requirement to address medical countermeasure gaps for all sectors of the American civilian population, BARDA has procured a third generation MVA based smallpox vaccine from Bavarian Nordic. Additional Information to support the justification: Bavarian Nordic is under contract with the USG to supply doses of JYNNEOS vaccine. Given the public health declaration and the ongoing response to the monkeypox outbreak, the procurement of additional doses of vaccine under the contract is well justified. This is an urgent action and the procurement CLINs are already structured and priced within the contract. The purpose of this request is to increase the contract ceiling to allow for additional procurements.