Vaccines for Children
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- 75D30125D00195
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75D30125D00195 Federal IDV award
- Awardee
- Merck Sharp & Dohme LLC
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Atlanta, Georgia, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The CDC Office of Acquisition Services has issued a Limited/Sole Source Justification Notice for the addition of Clesrovimab (Enflonsia) vaccine to an existing pediatric vaccine contract under the Vaccines for Children program. The justification seeks to modify Merck's current pediatric contract (75D30125D00195, originally awarded April 1, 2025) to include approximately 750,000 doses of Clesrovimab, which is indicated for preventing RSV lower respiratory tract disease, hospitalization, and death in neonates and infants during their first RSV season. The sole source rationale is based on ACIP approval and accompanying VFC resolution from June 25, 2025, with Clesrovimab being only the second product currently licensed for RSV prevention in this population. The contract modification will support CDC's National Center for Immunization and Respiratory Diseases in providing vaccines to fifty state health departments, large city programs, and U.S. Territories under Section 317(j) of the Public Health Service Act and the VFC program established under the Omnibus Budget Reconciliation Act of 1993. While the notice indicates the contract was awarded to an "unknown vendor for unknown amount," it specifically identifies Merck as the intended sole source contractor for this follow-on action.
Notice text
CDC Office of Acquisition Services awarded multiple indefinite delivery, indefinite quantity (IDIQ) contracts for the National Center for Immunization and Respiratory Diseases (NCIRD) for the purchase of standard commercial pediatric & adult vaccines, manufactured under a current establishment and product license issued by the U.S. Food and Drug Administration (FDA). The vaccines awarded under these contracts will be purchased for NCIRD’s immunization awardees (the fifty state health departments, several large city program and current and former U.S. Territories) to support immunization programs as provided under Section 317(j) of the Public Health Service Act and VFC, as established pursuant to Section 13631 of the Omnibus Budget Reconciliation Act of 1993. The initial pediatric contracts, awarded in April 2025 were established to support public sector ACIP recommended routine vaccinations for children. Merck’s pediatric contract will be modified to support purchase of Clesrovimab (Enflonsia), which is indicated for the prevention of RSV lower respiratory tract disease, hospitalization, and death in neonates and infants who are born during or entering their first RSV season, in light of the ACIP approval and accompanying VFC resolution on June 25, 2025. Clesrovimab from Merck is the second product currently licensed for the prevention of RSV in neonates and infants to prevent severe RSV disease. CDC’s current pediatric contract with Merck will be modified to include ~750,000 doses required to support purchase of Clesrovimab to administer to VFC eligible neonates and newborns. CDC intends on awarding a sole source follow on action to Merck to allow for the addition of Clesrovimab. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.
Awarded contract 75D30125D00195 to unknown vendor for unknown amount on 2025-04-01.
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