UPDATE 08/05/2025: This update is to post another question and response thereto, and to post an amendment addressing all changes resulting from those questions. See attached Amendment A00001. The closing date for this RFQ is not changed.
Question #4: "Does the FDA require delivery of the vaccines all at once or as the product becomes available with final delivery by 09/30/2025?"
Response: Vaccines are required to be delivered anytime after contract award; however, all vaccines (100%) must arrive to the destination locations no later than by September 30, 2025.
UPDATE 08/01/2025: This posting is updated to reflect a quote due date of August 7, 2025, NOT August 5th, 2025.
This update is also to post Q&As that have been received, along with the Government's responses:
Question #1: "Is the volume requested in units or doses? Noting, each unit of influenza vaccine across all manufacturers represent 10 doses"
Response: "We are seeking doses of Flucelvax and 1,00 doses of FLUAD (or equal)."
Question #2: "Under the Requirement and Background on page 2, it states that the product should be FLUAD and Flucelvax. Is the requirement only to be a single-dose pre-filled syringe formulated for adults 65 years of age and older (similar to FLUAD) and a single-dose pre-filled syringe formulated for adults under 65 years of age (similar to Flucelvax)? Is the US FDA seeking an egg-free presentation."
Response: "We are seeking pre-filled syringes however, not specifically seeking an egg-free presentation."
Question #3: "Is the due date for responses August 5th or August 7th? Solicitation indicates the 7th but SAM says the 5th."
Response: "Quotes are due the 7th of August, as per the solicitation. SAM has been updated to reflect that, too."
ORIGINAL: See attached Solicitation/Request for Quote (RFQ) for Flu Vaccines for the Food and Drug Administration.
