Vaccine provision: Delivering sustained & widespread use.
Identifieur interne : 003F28 ( Ncbi/Checkpoint ); précédent : 003F27; suivant : 003F29Vaccine provision: Delivering sustained & widespread use.
Auteurs : Scott Preiss [Belgique] ; Nathalie Garçon [France] ; Anthony L. Cunningham [Australie] ; Richard Strugnell [Australie] ; Leonard R. Friedland [États-Unis]Source :
- Vaccine [ 1873-2518 ] ; 2016.
Abstract
The administration of a vaccine to a recipient is the final step in a development and production process that may have begun several decades earlier. Here we describe the scale and complexity of the processes that brings a candidate vaccine through clinical development to the recipient. These challenges include ensuring vaccine quality (between 100 and 500 different Quality Control tests are performed during production to continually assess safety, potency and purity); making decisions about optimal vaccine presentation (pre-filled syringes versus multi-dose vials) that affect capacity and supply; and the importance of maintaining the vaccine cold chain (most vaccines have stringent storage temperature requirements necessary to maintain activity and potency). The ultimate aim is to make sure that an immunogenic product matching the required specifications reaches the recipient. The process from concept to licensure takes 10-30years. Vaccine licensure is based on a file submitted to regulatory agencies which contains the comprehensive compilation of chemistry, manufacturing information, assay procedures, preclinical and clinical trial results, and proposals for post-licensure effectiveness and safety data collection. Expedited development and licensure pathways may be sought in emergency settings: e.g., the 2009 H1N1 influenza pandemic, the 2014 West African Ebola outbreak and meningococcal serogroup B meningitis outbreaks in the United States and New Zealand. Vaccines vary in the complexity of their manufacturing process. Influenza vaccines are particularly challenging to produce and delays in manufacturing may occur, leading to vaccine shortages during the influenza season. Shortages can be difficult to resolve due to long manufacturing lead times and stringent, but variable, local regulations. New technologies are driving the development of new vaccines with simplified manufacturing requirements and with quality specifications that can be confirmed with fewer tests. These technologies could have far-reaching effects on supply, cost of goods, and on response timing to a medical need until product availability.
DOI: 10.1016/j.vaccine.2016.10.079
PubMed: 27884478
Affiliations:
- Australie, Belgique, France, États-Unis
- Auvergne-Rhône-Alpes, Pennsylvanie, Rhône-Alpes, Victoria (État)
- Lyon, Melbourne
- Université de Melbourne
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 001498
- to stream PubMed, to step Curation: 001476
- to stream PubMed, to step Checkpoint: 001476
- to stream Ncbi, to step Merge: 003F28
- to stream Ncbi, to step Curation: 003F28
Links to Exploration step
pubmed:27884478Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Vaccine provision: Delivering sustained & widespread use.</title>
<author><name sortKey="Preiss, Scott" sort="Preiss, Scott" uniqKey="Preiss S" first="Scott" last="Preiss">Scott Preiss</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, 20 Avenue Fleming, Parc de la Noire Epine, B-1300 Wavre, Belgium. Electronic address: scott.s.preiss@gsk.com.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, 20 Avenue Fleming, Parc de la Noire Epine, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Garcon, Nathalie" sort="Garcon, Nathalie" uniqKey="Garcon N" first="Nathalie" last="Garçon">Nathalie Garçon</name>
<affiliation wicri:level="1"><nlm:affiliation>BIOASTER, 40 Avenue Tony Garnier, 69007 Lyon, France. Electronic address: nathalie.garcon@bioaster.org.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>BIOASTER, 40 Avenue Tony Garnier, 69007 Lyon</wicri:regionArea>
<wicri:noRegion>69007 Lyon</wicri:noRegion>
<placeName><settlement type="city">Lyon</settlement>
<region type="region" nuts="2">Auvergne-Rhône-Alpes</region>
<region type="old region" nuts="2">Rhône-Alpes</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Cunningham, Anthony L" sort="Cunningham, Anthony L" uniqKey="Cunningham A" first="Anthony L" last="Cunningham">Anthony L. Cunningham</name>
<affiliation wicri:level="1"><nlm:affiliation>Westmead Institute, the Centre for Virus Research, 176 Hawkesbury Road, NSW 2145, Australia. Electronic address: tony.cunningham@sydney.edu.au.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Westmead Institute, the Centre for Virus Research, 176 Hawkesbury Road, NSW 2145</wicri:regionArea>
<wicri:noRegion>NSW 2145</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Strugnell, Richard" sort="Strugnell, Richard" uniqKey="Strugnell R" first="Richard" last="Strugnell">Richard Strugnell</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Microbiology and Immunology, University of Melbourne, Doherty Institute, Parkville, Victoria 3010, Australia. Electronic address: rastru@unimelb.edu.au.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Microbiology and Immunology, University of Melbourne, Doherty Institute, Parkville, Victoria 3010</wicri:regionArea>
<orgName type="university">Université de Melbourne</orgName>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Friedland, Leonard R" sort="Friedland, Leonard R" uniqKey="Friedland L" first="Leonard R" last="Friedland">Leonard R. Friedland</name>
<affiliation wicri:level="2"><nlm:affiliation>GSK Vaccines, 5 Crescent Drive, Philadelphia, PA, United States. Electronic address: leonard.r.friedland@gsk.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GSK Vaccines, 5 Crescent Drive, Philadelphia, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2016">2016</date>
<idno type="RBID">pubmed:27884478</idno>
<idno type="pmid">27884478</idno>
<idno type="doi">10.1016/j.vaccine.2016.10.079</idno>
<idno type="wicri:Area/PubMed/Corpus">001498</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001498</idno>
<idno type="wicri:Area/PubMed/Curation">001476</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001476</idno>
<idno type="wicri:Area/PubMed/Checkpoint">001476</idno>
<idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001476</idno>
<idno type="wicri:Area/Ncbi/Merge">003F28</idno>
<idno type="wicri:Area/Ncbi/Curation">003F28</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">003F28</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en">Vaccine provision: Delivering sustained & widespread use.</title>
<author><name sortKey="Preiss, Scott" sort="Preiss, Scott" uniqKey="Preiss S" first="Scott" last="Preiss">Scott Preiss</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, 20 Avenue Fleming, Parc de la Noire Epine, B-1300 Wavre, Belgium. Electronic address: scott.s.preiss@gsk.com.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, 20 Avenue Fleming, Parc de la Noire Epine, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Garcon, Nathalie" sort="Garcon, Nathalie" uniqKey="Garcon N" first="Nathalie" last="Garçon">Nathalie Garçon</name>
<affiliation wicri:level="1"><nlm:affiliation>BIOASTER, 40 Avenue Tony Garnier, 69007 Lyon, France. Electronic address: nathalie.garcon@bioaster.org.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>BIOASTER, 40 Avenue Tony Garnier, 69007 Lyon</wicri:regionArea>
<wicri:noRegion>69007 Lyon</wicri:noRegion>
<placeName><settlement type="city">Lyon</settlement>
<region type="region" nuts="2">Auvergne-Rhône-Alpes</region>
<region type="old region" nuts="2">Rhône-Alpes</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Cunningham, Anthony L" sort="Cunningham, Anthony L" uniqKey="Cunningham A" first="Anthony L" last="Cunningham">Anthony L. Cunningham</name>
<affiliation wicri:level="1"><nlm:affiliation>Westmead Institute, the Centre for Virus Research, 176 Hawkesbury Road, NSW 2145, Australia. Electronic address: tony.cunningham@sydney.edu.au.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Westmead Institute, the Centre for Virus Research, 176 Hawkesbury Road, NSW 2145</wicri:regionArea>
<wicri:noRegion>NSW 2145</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Strugnell, Richard" sort="Strugnell, Richard" uniqKey="Strugnell R" first="Richard" last="Strugnell">Richard Strugnell</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Microbiology and Immunology, University of Melbourne, Doherty Institute, Parkville, Victoria 3010, Australia. Electronic address: rastru@unimelb.edu.au.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Microbiology and Immunology, University of Melbourne, Doherty Institute, Parkville, Victoria 3010</wicri:regionArea>
<orgName type="university">Université de Melbourne</orgName>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Friedland, Leonard R" sort="Friedland, Leonard R" uniqKey="Friedland L" first="Leonard R" last="Friedland">Leonard R. Friedland</name>
<affiliation wicri:level="2"><nlm:affiliation>GSK Vaccines, 5 Crescent Drive, Philadelphia, PA, United States. Electronic address: leonard.r.friedland@gsk.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GSK Vaccines, 5 Crescent Drive, Philadelphia, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Vaccine</title>
<idno type="eISSN">1873-2518</idno>
<imprint><date when="2016" type="published">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">The administration of a vaccine to a recipient is the final step in a development and production process that may have begun several decades earlier. Here we describe the scale and complexity of the processes that brings a candidate vaccine through clinical development to the recipient. These challenges include ensuring vaccine quality (between 100 and 500 different Quality Control tests are performed during production to continually assess safety, potency and purity); making decisions about optimal vaccine presentation (pre-filled syringes versus multi-dose vials) that affect capacity and supply; and the importance of maintaining the vaccine cold chain (most vaccines have stringent storage temperature requirements necessary to maintain activity and potency). The ultimate aim is to make sure that an immunogenic product matching the required specifications reaches the recipient. The process from concept to licensure takes 10-30years. Vaccine licensure is based on a file submitted to regulatory agencies which contains the comprehensive compilation of chemistry, manufacturing information, assay procedures, preclinical and clinical trial results, and proposals for post-licensure effectiveness and safety data collection. Expedited development and licensure pathways may be sought in emergency settings: e.g., the 2009 H1N1 influenza pandemic, the 2014 West African Ebola outbreak and meningococcal serogroup B meningitis outbreaks in the United States and New Zealand. Vaccines vary in the complexity of their manufacturing process. Influenza vaccines are particularly challenging to produce and delays in manufacturing may occur, leading to vaccine shortages during the influenza season. Shortages can be difficult to resolve due to long manufacturing lead times and stringent, but variable, local regulations. New technologies are driving the development of new vaccines with simplified manufacturing requirements and with quality specifications that can be confirmed with fewer tests. These technologies could have far-reaching effects on supply, cost of goods, and on response timing to a medical need until product availability.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>France</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Pennsylvanie</li>
<li>Rhône-Alpes</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Lyon</li>
<li>Melbourne</li>
</settlement>
<orgName><li>Université de Melbourne</li>
</orgName>
</list>
<tree><country name="Belgique"><noRegion><name sortKey="Preiss, Scott" sort="Preiss, Scott" uniqKey="Preiss S" first="Scott" last="Preiss">Scott Preiss</name>
</noRegion>
</country>
<country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Garcon, Nathalie" sort="Garcon, Nathalie" uniqKey="Garcon N" first="Nathalie" last="Garçon">Nathalie Garçon</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Cunningham, Anthony L" sort="Cunningham, Anthony L" uniqKey="Cunningham A" first="Anthony L" last="Cunningham">Anthony L. Cunningham</name>
</noRegion>
<name sortKey="Strugnell, Richard" sort="Strugnell, Richard" uniqKey="Strugnell R" first="Richard" last="Strugnell">Richard Strugnell</name>
</country>
<country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Friedland, Leonard R" sort="Friedland, Leonard R" uniqKey="Friedland L" first="Leonard R" last="Friedland">Leonard R. Friedland</name>
</region>
</country>
</tree>
</affiliations>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Ncbi/Checkpoint
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 003F28 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Ncbi/Checkpoint/biblio.hfd -nk 003F28 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Asie |area= AustralieFrV1 |flux= Ncbi |étape= Checkpoint |type= RBID |clé= pubmed:27884478 |texte= Vaccine provision: Delivering sustained & widespread use. }}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Ncbi/Checkpoint/RBID.i -Sk "pubmed:27884478" \ | HfdSelect -Kh $EXPLOR_AREA/Data/Ncbi/Checkpoint/biblio.hfd \ | NlmPubMed2Wicri -a AustralieFrV1
This area was generated with Dilib version V0.6.33. |