title: Removing barriers to global pandemic influenza vaccination.
abstract: 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.
authors.affiliation: Center for Biosecurity of the University of Pittsburgh Medical Center, Baltimore, Maryland, USA.
authors.forename: Gigi Kwik
authors.initials: GK
authors.lastname: Gronvall
authors.forename: Luciana L
authors.initials: LL
authors.lastname: Borio
mesh_terms: D005062:European Union; D014943:Global Health; D033161:Government Regulation; D006801:Humans; D017589:Immunization Programs; D007251:Influenza, Human / Q000453:epidemiology / Q000276:immunology*; D018973:Intellectual Property; D007564:Japan; D014481:United States; D014612:Vaccines / Q000235:genetics / Q000600:supply & distribution*
chemical_list: D014612:Vaccines