HSChapter 30
U.S. imports of vaccines for human medicine (HS 300241) totaled $489.2M in April 2026, traded with 18 countries.
Vaccines for Human Medicine imports of $489.2M in April 2026 ran 27% below the year-to-date monthly average of $673.0M.
Last updated: April 2026 dataHuman vaccines occupy a uniquely regulated corner of pharmaceutical trade: every imported lot must be released by FDA's Center for Biologics Evaluation and Research (CBER) before distribution, a process that includes lot-release testing independent of the manufacturer's own quality control. Belgium and Ireland are the leading US source countries under this heading, reflecting the presence of major multinational vaccine manufacturers in those markets. All imports enter under a single 10-digit line (3002410000), but the regulatory burden — establishment registration, biologics license, cold-chain documentation, and CBER lot release — makes this one of the most documentation-intensive pharmaceutical import categories. Importers should work closely with regulatory counsel and a licensed customs broker to ensure pre-arrival filings are complete.
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CBER lot release is an FDA pre-distribution review in which the agency independently tests or reviews manufacturer data for each production lot of certain biologics, including many vaccines. No lot may be distributed in the US until CBER issues a release letter. Importers must factor this review timeline — which can take several weeks — into their supply-chain planning to avoid distribution delays.
Yes. FDA and CBP expect importers to demonstrate that the cold chain has been maintained from the point of manufacture through port of entry. This typically requires temperature-monitoring records (data loggers), a certificate of analysis, and shipping validation documentation. Breaks in the cold chain can result in FDA detention or refusal of the shipment.
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| Country | Imports | Exports | Balance |
|---|---|---|---|
| BELGIUM | $158.6M | $253.9M | +$95.3M |
| NETHERLANDS | $2K | $99.1M | +$99.1M |
| FRANCE | $91.8M | $3.1M | -$88.7M |
| DENMARK | $64.3M | $3.5M | -$60.8M |
| IRELAND | $62.7M | $312K | -$62.4M |
Monthly import values over time
HS10 import codes under this HS6 parent. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % |
|---|---|---|---|
| 3002410000 | VACCINES FOR HUMAN MEDICINE, NESOI | $489.2M | -- |
VACCINES FOR HUMAN MEDICINE, NESOI
HS10 export codes under this HS6 parent. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3002410000 | VACCINES FOR HUMAN MEDICINE, NESOI | $471.7M |
VACCINES FOR HUMAN MEDICINE, NESOI
180.5K kg
MEDICAMENTS NESOI, MEASURED DOSES, RETAIL PK NESOI
HS 300490
IMMUNOLOGICAL PRODUCTS, IN MEASURED DOESE/RTL SALE
HS 300215
HORMONES ETC. (NO ANTIBIOTICS CONTAINED) DOSAGE FM
HS 300439
ANTISERA AND OTHER BLOOD FRACTIONS
HS 300212
IMMUNOLOGICAL PRODUCTS, MIXED, NOT IN MSRED DOSES
HS 300214
MEDICAMENTS CONT CORTEX HORMONES ETC DOSES
HS 300432
| State | Imports | Exports | Balance |
|---|---|---|---|
| Pennsylvania | $266.4M | $121.6M | -$144.8M |
| Massachusetts | $668K | $267.3M | +$266.7M |
| Wisconsin | $75.1M | $673K | -$74.4M |
| Port | Imports | Exports | Balance |
|---|---|---|---|
| JFK INTERNATIONAL AIRPORT, NY | $20.5M | $287.9M | +$267.4M |
| WASHINGTON, DC | $196.6M | $11.0M | -$185.6M |
| CHICAGO, IL | $151.7M | $37.3M | -$114.4M |