Spox_VaccinesSSN-BARDA-CBRN-01262026.pdf

Sources Sought Notice (SSN)

FDA Licensed Smallpox Vaccines

SSN Number: BARDA-CBRN-01262026

Type: Sources Sought Notice (SSN) Product Service Code: 6505 - Drugs and Biologicals

To: Prospective Partners & Interested Parties

The Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this SSN to collect feedback from current and potential biopharmaceutical partners.

Information collected from this SSN will serve as continued market research for possible future acquisitions and programs.

Background: Within the USG, HHS/ASPR/BARDA is tasked with protecting the civilian population by providing leadership in research, development, and acquisition of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear threat agents, and natural exposure(s) to pandemic influenza and emerging infectious diseases.

The subject of this Sources Sought Notice is for vaccines that are licensed by the US Food and Drug Administration (FDA) for the prevention of smallpox disease in individuals determined to be at high risk of infection and do not include any boxed warnings.

Description: BARDA is issuing this SSN to assist in understanding the landscape of vaccines that are currently licensed by the FDA for prevention against disease caused by Variola virus (smallpox).

Respondents are asked to provide the following information:

1. Overview of existing FDA-licensed vaccine for protection against smallpox, including:

a. Viral antigen targeted

b. Adjuvant (if applicable)

c. Vaccine vector (if applicable)

d. Number of doses required for protection

2. Regulatory and licensure information:

a. FDA licensure date

b. FDA approved indications

c. Any contraindications, boxed warnings, and warning and precautions

d. FDA package insert as attachment

3. Manufacturing

a. Any plans for improving manufacturing capacity, sustainability, and reduced cost per dose (high level summary only in an abstract format)

b. Status of contract manufacturing organization (CMOs) (API) and (FF), and whether or not any existing or proposed capacity is US based

c. Status of adjuvant supply (if applicable)

4. Clinical

a. Any plans for expansion of the target population

b. Any specific plans to engage the US FDA on expanding the indication

Responses should be limited to five pages (or less) and shall be submitted electronically to the electronic portal. Responses are due no later than 16 Feb 2026 by 3PM US EST.

Electronic Portal Submission Instructions All submissions must be submitted to the BDR Portal via the process described below.

Respondents will be required to register for a BDR Portal account before an entry can be submitted. A BDR account can be created by visiting the BDR Portal (https://bdr.hhs.gov/) and following the applicable prompts.

The account creation process is simple but may take several days for authentication and access.

Account creation will require the Respondent to enter a set of basic information (i.e., first and last name, email address, and phone number). Upon confirmation of a BDR Portal account, the Respondent will login using the prescribed two-factor authentication method. Once login is complete, the Respondent will be prompted to enter information about Respondent’s organization and to input the submission with other project-specific information.

If you experience any issues, please reach out to BDR_Admin_Inbox@hhs.gov. Failure to enter your submission on time for any reason (e.g., due to late registration in BDR Portal) will result in the submission not being received. Respondents will be provided an automated confirmation of successful submission.

DISCLAIMER AND IMPORTANT NOTES

This notice is issued solely for information and planning purposes and does not obligate the US Government to award a contract. No entitlement to payment of direct or indirect costs or charges by the US Government will arise because of the submission of the requested information. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow up information requests. The US Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the US Government to determine the organization’s qualifications to perform the work. Respondents are advised that the US Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov under Contract Opportunities in accordance with FAR part 5. However, responses to this notice will not be considered adequate responses to a solicitation.

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY.

Please note that contractors and collaborators performing advisory and assistance services for BARDA will have access to any submission under this Sources Sought Notice. While the data is treated as confidential and will not be disclosed publicly, please do not include proprietary information in response to this SSN.

HHS BARDA POCs:

Yifan Yang - yifan.yang@hhs.gov Jonathan Gonzalez – jonathan.gonzalez@hhs.gov

Posting Date: 26 Jan 2026