J A_FAR_6.305_contract_SPE2DP15D0003_MedImmune.pdf

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

Intranasal Influenza Vaccine

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

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

3. The acquisition will result in an Indefinite Quantity Contract (IQC) for Intranasal Influenza Vaccine. The sole source for these items is MedImmune Biologics. [redacted]

The estimated quantities are based on current orders placed by all Services for the 2014 flu season. The actual demands (reported in March 2015) may be different, in which case the solicitation will be amended accordingly. The base year will have a guaranteed minimum of 75% of the estimated annual amount. The option year will have a guaranteed minimum of 60% to allow for potential declining demands, which has been the recent experience. The maximum amount of 175,000 is used in the event of unexpected demands and is consistent with the demand levels seen in earlier years.

[redacted] These estimated prices are exclusive of the Federal Excise Tax (FET);

however, the total amount is inclusive of the FET in order to show the total anticipated Government obligation.

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. The Intranasal Influenza Vaccine is intended for active immunization of disease caused by influenza viruses in healthy individuals ages 2 through 49. Unlike traditional flu shots, which are made from killed viruses, the Intranasal Vaccine is designed with weakened live viruses that are modified to grow in the cooler nasal passages but not in the warmer lungs, where flu develops. It helps the recipient develop immunity at the site where the flu virus typically enters the body, the nose. For the 2013-2014 flu season, MedImmune had FDA approval to market a quadrivalent flu vaccine, which means it now includes four 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 Intranasal Vaccine is considered necessary for that sector of the population that is averse to needle injection. Influenza Virus Vaccine is available in the injectable presentation; however the military services require both the intranasal and the injectable presentations, especially in the event of occasional batch failures which may cause vaccine shortages.

MedImmune Biologics, which is a division of AstraZeneca, is the only known manufacturer of the Intranasal Influenza Vaccine. The vaccine is patented and marketed under the brand name “Flumist”. It is the only known intranasal vaccine approved by the

FDA.

6. In accordance with FAR 5.2, this requirement will be synopsized in FedBizOpps. In addition, this justification will be published after award in accordance with FAR 6.305(a).

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 Intranasal Influenza Vaccine is a commercial product with a commercial list price and it is sold in substantial quantities to the general public through wellness clinics and pharmacies. Also, MedImmune’s price is currently subject to a “Federal Ceiling Price” that is negotiated between MedImmune and the Dept. of Veterans Affairs. By this agreement the price ceiling applies to all Government agencies.

8. MedImmune has been the sole manufacturer of an intranasal type vaccine since the introduction of the product in 2003. As part of market research, a Sources Sought notice was posted in FedBizOpps on November 17, 2014 for 30 days, in an attempt to find alternate sources for the intranasal influenza vaccine, and also to investigate if alternate sources are currently being developed. No responses or inquiries were received as a result of this post. No additional market research was conducted.

9. The DLA Troop Support, in coordination with the Defense Health Agency – Immunization Healthcare Branch at Falls Church, Virginia, will continue to perform market research prior to any future acquisitions for the requirement.

10. The only known source for the supply of Intranasal Influenza Vaccine is MedImmune Biologics of Gaithersburg, Maryland, which has continually expressed interest in fulfilling the Government’s requirements for this type of vaccine.

11. The MedImmune Intranasal 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 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 his knowledge and belief.

Date NEIL McAVINUE

Contracting Officer DLA Troop Support