New challenges in assuring vaccine quality
In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have d...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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The World Health Organization
2000-01-01
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| Series: | Bulletin of the World Health Organization |
| Subjects: | |
| Online Access: | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862000000200002&lng=en&tlng=en |
| _version_ | 1827334051255549952 |
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| author | N. Dellepiane E. Griffiths J.B. Milstien |
| author_facet | N. Dellepiane E. Griffiths J.B. Milstien |
| author_sort | N. Dellepiane |
| collection | DOAJ |
| description | In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. |
| first_indexed | 2024-03-07T17:46:39Z |
| format | Article |
| id | doaj.art-20bf710289864c57bb5c15e0ba5bf13f |
| institution | Directory Open Access Journal |
| issn | 0042-9686 |
| language | English |
| last_indexed | 2024-03-07T17:46:39Z |
| publishDate | 2000-01-01 |
| publisher | The World Health Organization |
| record_format | Article |
| series | Bulletin of the World Health Organization |
| spelling | doaj.art-20bf710289864c57bb5c15e0ba5bf13f2024-03-02T14:48:44ZengThe World Health OrganizationBulletin of the World Health Organization0042-96862000-01-01782155162S0042-96862000000200002New challenges in assuring vaccine qualityN. Dellepiane0E. Griffiths1J.B. Milstien2ScientistCoordinatorActing CoordinatorIn the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence.http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862000000200002&lng=en&tlng=endrug evaluationmethods and trendsdrug monitoringlegislationdrugquality controlvaccinesstandards |
| spellingShingle | N. Dellepiane E. Griffiths J.B. Milstien New challenges in assuring vaccine quality Bulletin of the World Health Organization drug evaluation methods and trends drug monitoring legislation drug quality control vaccines standards |
| title | New challenges in assuring vaccine quality |
| title_full | New challenges in assuring vaccine quality |
| title_fullStr | New challenges in assuring vaccine quality |
| title_full_unstemmed | New challenges in assuring vaccine quality |
| title_short | New challenges in assuring vaccine quality |
| title_sort | new challenges in assuring vaccine quality |
| topic | drug evaluation methods and trends drug monitoring legislation drug quality control vaccines standards |
| url | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862000000200002&lng=en&tlng=en |
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