The vaccine shall be shall be a live, attenuated, intranasal, trivalent or quadrivalent vaccine, licensed by the FDA, intended for active immunization for the prevention of influenza. The vaccine shall meet the minimum formula for the influenza vaccine as determined by the FDA's Vaccines and Related Biological Products Advisory Committee. The vaccine shall be a pre-measured 0.2 ML dose, each dose shall be pre-filled in a commercially available nasal syringe unit suitable for nasal administration in healthy individuals aged 2 years through 49 years.
Successful contractor must have FDA approval to market the vaccine.
The vaccine shall be delivered directly to military treatment facilities and DoD activities worldwide. The contractor shall be capable of delivering a minimum 50% of the estimated annual quantity by August 31; 30% by September 30; and the remaining 20% by October 31 in each year of the contract.
If your firm currently markets an intranasal flu vaccine, please provide information with respect to the following:
a) Place of manufacture
b) Estimated annual capacity
c) FDA registration
d) Product name and description including description of any special features
e) Current unit sale price
f) Estimated inventory level and storage requirements
*** NEW PRODUCTS UNDER DEVELOPMENT***
For products under development, describe the current stage of development and whether the product has undergone independent laboratory testing or FDA testing/trials etc.
Firms and organizations that currently develop or manufacture intranasal flu vaccines described in this RFI or that have technologies, pharmaceuticals, or manufacturing capabilities under development are invited to submit information to DLA Troop Support. Data obtained from this RFI will be used by DLA Troop Support in making recommendations and decisions on the development of an appropriate planning and procurement strategy for intranasal flu vaccine. All information submitted will be kept confidential as allowed by relevant Federal law and will be eligible for additional special protections under the conditions of the Protected Critical Infrastructure Information (PCII) Program outlined in the Critical Infrastructure Information Act of 2002.
Your response to this RFI may be submitted electronically in pdf format and emailed to [email protected]