Removing barriers to global pandemic influenza vaccination

Gigi Kwik Gronvall, Luciana L. Borio

Research output: Contribution to journalReview articlepeer-review

9 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)168-175
Number of pages8
JournalBiosecurity and Bioterrorism
Issue number2
StatePublished - 2006
Externally publishedYes

ASJC Scopus subject areas

  • Health(social science)
  • Public Health, Environmental and Occupational Health
  • Management, Monitoring, Policy and Law


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