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SITCSection 5
U.S. imports of antisera, blood fractions & vaccines (SITC 54163) totaled $6.7B in April 2026, traded with 59 countries.
Importers of Antisera, Blood Fractions & Vaccines paid $101K in duties in April 2026 — an effective duty rate of 9.4% on $1.1M in dutiable value, based on actual customs collections rather than the published tariff schedule. Antisera, Blood Fractions & Vaccines imports of $6.7B in April 2026 ran 13% above the year-to-date monthly average of $5.9B.
Last updated: April 2026 dataAntisera, immunoglobulins, monoclonal antibodies, and vaccines — whether for human or veterinary use — are among the most tightly regulated biologics in international trade, subject to FDA Center for Biologics Evaluation and Research (CBER) licensing requirements for human biologics and USDA Center for Veterinary Biologics (CVB) oversight for animal vaccines. Each lot of imported human vaccine or blood fraction typically requires FDA lot release before distribution in the US market, a process that can add weeks to the supply timeline. Cold-chain integrity is a non-negotiable compliance element: temperature excursions during transit can render a shipment inadmissible regardless of documentation status.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
FDA lot release is a pre-distribution review process in which CBER evaluates manufacturer-submitted test data for each production lot of certain biologics — including many vaccines and blood-derived products — before the lot may be distributed in the US. Not all biologics require official lot release, but those that do cannot be sold or used until FDA issues a release letter, making advance planning critical for importers.
USDA's Center for Veterinary Biologics (CVB) regulates veterinary vaccines and related biologics, while FDA's Center for Biologics Evaluation and Research (CBER) governs human vaccines, antisera, and blood fractions. Importers must route their regulatory submissions to the correct agency based on the intended species of use.
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| Country | Imports | Exports | Balance |
|---|---|---|---|
| GERMANY | $2.2B | $496.1M | -$1.7B |
| IRELAND | $1.2B | $320.8M | -$868.1M |
| NETHERLANDS | $608.3M | $434.6M | -$173.6M |
| BELGIUM | $476.8M | $459.7M | -$17.1M |
| CHINA | $164.1M | $623.5M | +$459.3M |
Monthly import values over time