SAM #75F40126Q00257

FDA Solicitation for Seasonal Influenza Vaccines for Employee Immunization Program

This opportunity is a solicitation from the Food and Drug Administration (FDA), under the Department of Health and Human Services, for the procurement of seasonal influenza vaccines for its Occupational Health Services (OHS) employee immunization program. - Government Buyer: - Food and Drug Administration (FDA), Occupational Health Services (OHS) - Contracting Officer: Maeve Xavier - Products Requested: - Total of 2,200 units of FDA-approved, CDC-recommended seasonal influenza vaccines for the 2026–2027 season - 2,000 units for adults under 65 years of age - 200 units for adults 65 years and older - All doses must be in 0.5mL single-dose pre-filled syringes - Vaccines must be delivered to FDA Occupational Health Units at White Oak Campus, MD (2,000 units) and Jefferson Laboratories Campus, AR (200 units) - Packaging must clearly indicate manufacturer, NDC number, lot number, and expiration date - All vaccines must be shipped and handled in compliance with CDC cold chain requirements - Notable Requirements: - Only FDA-approved and CDC-recommended vaccines for the specified season are acceptable - Services such as on-site storage, inventory systems, clinical staffing, logistical planning, and recordkeeping are explicitly excluded - Specific vaccine brands mentioned in attachments include FLUAD TIV and Flucelvax TIV, but the solicitation does not restrict to these brands - No specific OEMs or manufacturers are named in the solicitation, but referenced products suggest likely OEMs - Quantities are clearly defined for each age group and location

Description

The Food and Drug Administration (FDA) is responsible for enforcing the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws that safeguard public health. As part of its commitment to employee health and regulatory compliance, the FDA’s Occupational Health Services (OHS) delivers a comprehensive, work-related medical program. This program includes critical services such as immunizations. The annual influenza vaccination effort supports FDA’s workforce health initiatives and aligns with CDC recommendations for influenza prevention. As a direct result of Contract performance, the FDA expects to purchase and deliver seasonal influenza vaccine doses to FDA Occupational Health Units (OHUs) at the White Oak Campus in Silver Spring, MD, and the Jefferson Laboratories Campus in Jefferson, AR. 

The Contractor Shall: Procure and deliver 2,200 units of seasonal influenza vaccine that meet the following specifications: o Vaccines must be FDA-approved and recommended for the 2026–2027 influenza season. o All doses shall be provided in single-dose pre-filled syringes. o Vaccines shall be shipped, stored, and handled in compliance with CDC cold chain requirements. o Each unit’s packaging shall clearly indicate the manufacturer, National Drug Code (NDC) number, lot number, and expiration date. The total order shall consist of: o 2,000 units formulated for adults under 65 years of age. o 200 units formulated for adults 65 years of age and older. The following services are excluded from this Order: o On-site storage or refrigeration, o Inventory or tracking systems, o Clinical staffing or administrative services, o Logistical planning or coordination, and o Recordkeeping or documentation support.

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