SH Flu 2024 J A Redacted.pdf

Justification for Other than Full and Open Competition In accordance with 10 US 2304 (c)(1)

Source Selection Information - FAR 2.101 and 3.104

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an other than full and open competition basis.

3. The proposed acquisition will result in a one (1) year firm fixed price indefinite quantity contract for the Southern Hemisphere Influenza Vaccine. The sole source for this vaccine is Sanofi Pasteur Inc.

National Stock Number (NSN): 6505-01-710-6760 Quantity: Min 6,000 Packages (PG), 60,000 doses/Max 6,600 Packages (PG), 66,000 doses Estimated Unit Price:

Federal Excise Tax (FET):

Estimated Dollar Value:

Maximum Dollar Value:

The quantity is based on the requirements received from the Services.

4. The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 3204 (c)(1), FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Fluzone® Quadrivalent Southern Hemisphere is a vaccine indicated for active immunization for the prevention of the influenza virus. Fluzone® Quadrivalent Southern Hemisphere is approved for use in persons six (6) months of age and older. For the 2024-2025 flu season, Sanofi Pasteur has United States Food and Drug Administration (FDA) approval to market a quadrivalent flu vaccine, which means it includes four (4) different strains of the flu virus. Multiple strains of influenza virus circulate in the population every year and the immune response is different to each of these strains, so an effective vaccine gives protection against each. The Southern Hemisphere Influenza Vaccine is considered necessary for the sector of the population that is located in the Southern Hemisphere, where the Influenza season runs from April through October.

6. In accordance with FAR 5.2, this requirement will be synopsized on Sam.gov. In addition, this justification will be made available for public inspection, after award, in accordance with

FAR.6.305(a). This procurement is being solicited under a specification with essential characteristics.

7. As the Contracting Officer, I hereby determine that the anticipated cost to the Government will be fair and reasonable based on an analysis of other than cost and pricing data.

8. Market research indicates that Sanofi Pasteur is the only FDA approved manufacturer of the Southern Hemisphere Flu vaccine sold in the US. As part of market research, a Sources Sought Notice (SSN) was posted on www.SAM.gov on June 30, 2023 for thirty-one (31) days, in an attempt to find alternate sources for the vaccine, and also to investigate if alternate sources are currently being developed. The SSN closed on July 31, 2023, with two responses received. One response was received from Sanofi Pasteur on July 27, 2023. Another response was received from FluVaccine.org Inc. on July 26, 2023. However, after the Contracting Officer followed up for clarification, FluVaccine.org Inc. replied that they thought the SSN was for season 2023-2024 and no further information was received from FluVaccine.org Inc.

Furthermore, FluVaccine.org Inc. was offering information on product made by Seqirus, but Seqirus confirmed on July 28, 2023 that they cannot make Southern Hemisphere Flu Vaccine for the US market. DLA Troop Support, in conjunction with The Defense Health Agency Immunization Healthcare Division (DHA-IHD) at Falls Church, VA will continue to perform market research prior to any future acquisitions for the requirement.

9. There are no other facts supporting the use of Other Than Full and Open Competition.

10. The only known source for the supply of Southern Hemisphere Influenza Virus Vaccine in the US is Sanofi Pasteur, Swiftwater, Pennsylvania, which has expressed interest in fulfilling the Government’s requirements for this type of vaccine.

11.

In an effort to foster competition, however, the Government has produced a specification with essential characteristics and will advertise the requirements as stated in paragraph six (6) above. In accordance with FAR 6.302- 1(d)(2), any proposal in response to this notice will be considered.

12. As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of her knowledge and belief.

Date YU CHEN Contracting Officer

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s needs in accordance with applicable specifications and that this justification is accurate and complete to the best of my knowledge and belief.

Date

I have reviewed this justification and recommend approval.

I have reviewed this justification and recommend approval.

CHEN.YU.15

04253569

Digitally signed by

CHEN.YU.1504253569

Date: 2023.08.31 09:24:50 -04'00'

I have reviewed this justification for legal sufficiency.

I have reviewed and hereby approve this justification.