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Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) from Germany

This mRNA-based vaccine is used to immunize against SARS-CoV-2, the virus causing COVID-19. It falls under HTS 3002.41.00.00 as a vaccine for human medicine, specifically designed for prophylactic use against infectious disease.

Duty Rate — Germany → United States

15%

Rate breakdown

9903.04.6215%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter
9903.05.900%Articles of aluminum, of steel or of copper or derivative aluminum or steel articles; passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; parts of passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; medium- and heavy-duty vehicles; parts of medium- and heavy-duty vehicles; wood products; patented pharmaceutical articles; and semiconductor articles, as provided in subdivision (f) of U.S. note 52 to this subchapter

Import Tips

Ensure compliance with FDA import requirements including prior approval via IND or BLA and cold chain validation for mRNA stability

Provide certificates of analysis, batch records, and proof of GMP manufacturing to avoid detention at entry