WHO informal consultation on scientific basis for regulatory evaluation of candidate human vaccines from plants, Geneva, Switzerland, 24-25 January 2005.

2.50
Hdl Handle:
http://hdl.handle.net/10029/6272
Title:
WHO informal consultation on scientific basis for regulatory evaluation of candidate human vaccines from plants, Geneva, Switzerland, 24-25 January 2005.
Authors:
Laan, Jan Willem van der; Minor, Philip; Mahoney, Richard; Arntzen, Charles; Shin, Jinho; Wood, David
Abstract:
In January 2005, WHO convened a meeting of leading experts in plant-derived vaccines and experts from regulatory authorities for an informal discussion on the state-of-the-art and to analyse whether specific guidance might be needed for plant-derived vaccines that is not yet provided by regulatory authorities. After a series of individual presentations, a general discussion was held to obtain a consensus on the need for further guidance. Both the presentations and the conclusions are presented. The meeting concluded that existing guidelines for the development, evaluation, and use of vaccines made by traditional methods can be applied to plant-derived vaccines. For plant-derived vaccines some specific issues will have to be addressed. These include, but are not restricted to, containment of the plants including disposal of waste materials. It was noted that plant-derived vaccines have been produced and clinically tested under US investigational new drug application, and all applicable regulatory and good manufacturing practice requirements are in place for this type of product. An innovator wishing to bring a plant-derived vaccine to market should consult closely with regulatory authorities to ensure that all appropriate studies are undertaken.
Citation:
Vaccine 2006, 24(20):4271-8
Issue Date:
15-May-2006
URI:
http://hdl.handle.net/10029/6272
PubMed ID:
16767805
Type:
Article
Language:
en
ISSN:
0264-410X
Appears in Collections:
Vaccines and Vaccination

Full metadata record

DC FieldValue Language
dc.contributor.authorLaan, Jan Willem van der-
dc.contributor.authorMinor, Philip-
dc.contributor.authorMahoney, Richard-
dc.contributor.authorArntzen, Charles-
dc.contributor.authorShin, Jinho-
dc.contributor.authorWood, David-
dc.date.accessioned2006-11-29T15:30:08Z-
dc.date.available2006-11-29T15:30:08Z-
dc.date.issued2006-05-15-
dc.identifier.citationVaccine 2006, 24(20):4271-8en
dc.identifier.issn0264-410X-
dc.identifier.pmid16767805-
dc.identifier.urihttp://hdl.handle.net/10029/6272-
dc.description.abstractIn January 2005, WHO convened a meeting of leading experts in plant-derived vaccines and experts from regulatory authorities for an informal discussion on the state-of-the-art and to analyse whether specific guidance might be needed for plant-derived vaccines that is not yet provided by regulatory authorities. After a series of individual presentations, a general discussion was held to obtain a consensus on the need for further guidance. Both the presentations and the conclusions are presented. The meeting concluded that existing guidelines for the development, evaluation, and use of vaccines made by traditional methods can be applied to plant-derived vaccines. For plant-derived vaccines some specific issues will have to be addressed. These include, but are not restricted to, containment of the plants including disposal of waste materials. It was noted that plant-derived vaccines have been produced and clinically tested under US investigational new drug application, and all applicable regulatory and good manufacturing practice requirements are in place for this type of product. An innovator wishing to bring a plant-derived vaccine to market should consult closely with regulatory authorities to ensure that all appropriate studies are undertaken.en
dc.format.extent129844 bytes-
dc.format.mimetypeapplication/pdf-
dc.language.isoenen
dc.titleWHO informal consultation on scientific basis for regulatory evaluation of candidate human vaccines from plants, Geneva, Switzerland, 24-25 January 2005.en
dc.typeArticleen
dc.format.digYES-
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