Notice of Intent for ERVEBO.pdf

NOTICE OF INTENT

Action Code: Notice of Intent to Sole Source

Agency: Department of Health and Human Services

Office: Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research & Development Authority (BARDA)

Location: 400 7th Street, SW, Washington DC 20024

The Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research & Development Authority (BARDA) intends to use other than full and open competition to award a sole source contract to Merck Sharp & Dohme LLC to procure up to 1,000,000 licensed doses of ERVEBO, a vaccine for protection against EBOV, VMI storage of doses, extending expiry of doses, and develop a new manufacturing process using bioreactors. The new manufacturing process and expiry extension development work will aid in reducing the price per licensed dose of future procurements and extending shelf life. These ERVEBO doses will replace expiring doses in the Strategic National Stockpile and aide in meeting the requirement set by the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) of 1,130,000 doses of a Zaire ebolavirus vaccine. ERVEBO is the only vaccine licensed in the US for protection against Zaire ebolavirus.

This notice of intent to award a sole source contract will be posted for fifteen (15) calendar days to verify that no other sources can meet this requirement given only one responsible source and no other supplies or services will satisfy the Government requirements. This fifteen (15) calendar day notice shall expire on 24 July 2024 at 04:00 PM Eastern Standard Time.

If no credible responses to the intent to sole source are received, the Government intends to negotiate a hybrid Cost-Plus-Fixed Fee/Firm-Fixed Price contract to Merck Sharp & Dohme LLC. The Government intends to solicit and negotiate with only one source under the authority of the Federal Acquisition Regulation (FAR) 6.302-1 entitled Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C. 3304(a)(3). This notice of intent is NOT a request for competitive proposals.

Interested parties may identify their interest and capability to respond to this requirement by submitting in writing their name, address, telephone number, email, and a statement regarding capability to provide the specified requirements for procurement of ERVEBO, VMI storage of doses, and development of new manufacturing process to extend shelf life of doses.

Responses shall be limited to ten (10) pages or less, including all attachments. Interested parties will be considered only if they respond to this notice with clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive. All capability statements, proposals, or quotes received prior to 24 July 2024 at 04:00 PM Eastern Standard Time, will be considered by the Government. The Government will not be responsible for any costs incurred by responding to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Background:

This acquisition is for the procurement and maintenance of up to 1,000,000 doses of ERVBO, a vaccine developed and manufactured by Merck for the protection against Viral Hemorrhagic Fever (VHF) caused by Zaire ebolavirus (EBOV).

The 2014-2015 West Africa outbreak of Zaire ebolavirus resulted in 28,646 confirmed, probable, and suspected cases of Zaire ebolavirus (EBOV) and 11,323 reported deaths. Multiple individuals were transported back to the US for treatment and four confirmed cases were treated in the US, highlighting the urgent need for MCMs to be developed, manufactured, and stockpiled to protect the US population.

Within the Federal Government, HHS is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective Medical Countermeasures (MCMs) to treat the adverse health effects resulting from intentional release leading to exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemics, and emerging infectious diseases. In 2006, the Department of Homeland Security (DHS) determined that EBOV is a material threat to national health security. The threat of EBOV being used as biological/bioterror weapons led the DHS to issue a Material Threat Determination (MTD) based on its Material Threat Assessment (MTA) for EBOV. Based on the assessment by DHS and medical consequence modeling by the Department of Health and Human Services (HHS), the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) determined that up to 1,130,000 post-exposure prophylaxis (PEP) treatment courses would be needed for an EBOV vaccine(s). ERVEBO is the only vaccine against EBOV licensed in the United States and Merck is the only manufacturer of

ERVEBO.

Anticipated Award Date and Period of Performance:

The Government anticipates an award date in FY2024. The estimated period of performance is 120 months.

Delivery Schedule:

The delivery schedule will be established during contract negotiations.

Contract type:

The Government proposes the award of hybrid Cost-Plus-Fixed Fee/Firm-Fixed Price contract.

Contracting Office Address:

Department of Health and Human Services (HHS), Administration for Strategic Preparedness & Response (ASPR), Biomedical Advanced Research & Development Authority (BARDA), Contract Management and Acquisition (CMA)

400 7th SW Washington, DC 20024

Place of Performance:

The place of performance will be the vendor managed inventory in their facilities.

Point of Contact:

Jonathan Gonzalez Contracting Officer Jonathan.Gonzalez@hhs.gov

Yifan Yang Contracting Officer Yifan.Yang@hhs.gov