JA SH Influenza Vaccine 2020 Final_Redacted.pdf

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

Southern Hemisphere Influenza Vaccine

“Source Selection Information – See 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 definite quantity contract for the Southern Hemisphere Influenza Vaccine. The sole source for this vaccine is Sanofi Pasteur Inc.

National Stock Number (NSN): 6505 - 016902609 Annual Quantity: 2,500 Packages (PG), 25,000 doses Maximum Quantity: 2,500 PG, 25,000 doses Estimated Unit Price: $152.50 Federal Excise Tax (FET): $7.50 Estimated Dollar Value: $400,000.00 (Inclusive of FET) Maximum Dollar Value: $400,000.00 (Inclusive of FET)

The annual 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. 2304(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 6 months of age and older. For the 2020-2021 flu season, Sanofi Pasteur had 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 that sector of the population that is located in the Southern Hemisphere, where the Influenza season runs from April through September. Sanofi Pasteur, is the only known manufacturer for this type of Influenza Vaccine. The vaccine is patented and marketed under the brand name “Fluzone® Quadrivalent Southern Hemisphere”. It is the only known vaccine for the Southern Hemisphere approved by the

FDA.

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

Southern Hemisphere Influenza Vaccine

“Source Selection Information – See FAR 2.101 and 3.104” 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. The Southern Hemisphere Influenza vaccine is a product that is commercial in nature, as it is marketed in a similar fashion to the Northern Hemisphere Influenza Vaccine. Also, Sanofi Pasteur’s price is currently aligned with the Northern Hemisphere vaccine’s “Federal Ceiling Price” that is negotiated between Sanofi Pasteur and the Department of Veterans Affairs. By this agreement, the price ceiling applies to all Government agencies.

8. Market research indicates that Sanofi Pasteur has been the sole manufacturer of the Southern Hemisphere Flu vaccine and this will be the first year it is manufactured in the United States. As part of market research, a Sources Sought notice was posted on beta.sam.gov on July 15, 2020 for 30 days, in an attempt to find alternate sources for the vaccine, and also to investigate if alternate sources are currently being developed. It closed on August 16, 2020 with only one response received from Sanofi Pasteur. 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 is Sanofi Pasteur, Swiftwater, Pennsylvania, which has expressed interest in fulfilling the Government’s requirements for this type of vaccine.

11. The Sanofi Pasteur Southern Hemisphere Influenza Vaccine is under patent, and any manufacturer must undergo extensive product testing to meet the requirements of FDA licensure, a process that can take years. 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. The undersigned Contracting Officer hereby certifies that the information contained in this justification is accurate and complete to the best of her knowledge and belief.

Date

Jenna Wesolowski Contracting Officer

Southern Hemisphere Influenza Vaccine

“Source Selection Information – See FAR 2.101 and 3.104”

I have reviewed and recommend approval of this Justification.

Date

Andrew Good DLA Counsel - Troop Support

I have reviewed and hereby approve this Justification.

Date

Jenna Wesolowski Contracting Officer