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Title:

Removing Barriers to Global Pandemic Influenza Vaccination

Authors:

Gigi Kwik Gronvall, Luciana Borio

Date posted:

June 15, 2006

Publication type:

Announcement

Publication:

Biosecur Bioterror 2006;4(2):168-175

Publisher:

Mary Ann Liebert, Inc.

Availability:

Available on publisher's website

See also:

Full article as PDF

Introduction:

This article clarifies the regulatory issues surrounding influenza pandemic vaccine for the larger policy community and describes the need for regulatory harmonization. Vaccination would save lives in an influenza pandemic, but a lack of global manufacturing capacity will leave most of the world without access to vaccine. Capacity can be expanded if governments harmonize their regulatory policies. This article details the regulatory approaches taken by the United States, the European Union, and Japan for pandemic vaccine development, three regions that produce the majority of the world’s seasonal influenza vaccine. They should quickly converge on regulatory requirements, intellectual property considerations, the use of recombinant DNA techniques for vaccine production, and technical issues about the composition of pandemic vaccine.

Full article as PDF