Authorization of Vaccines in the European Union
The current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pressure. The marketing authorization is a necessary...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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World Scientific Publishing
2021-06-01
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| Series: | Molecular Frontiers Journal |
| Subjects: | |
| Online Access: | https://www.worldscientific.com/doi/10.1142/S2529732521400034 |
| _version_ | 1818285907181043712 |
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| author | Ana Hidalgo-Simon Radu Botgros Emil Cochino |
| author_facet | Ana Hidalgo-Simon Radu Botgros Emil Cochino |
| author_sort | Ana Hidalgo-Simon |
| collection | DOAJ |
| description | The current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pressure. The marketing authorization is a necessary gateway that protects public health and provides healthcare professionals and the general public with reliable and relevant evidence reflected in the product information to allow the safe and effective use of these vaccines. Regulators have the expertise and the duty to evaluate vaccines’ benefits and risks and, importantly, monitor safety during clinical use. This evaluation is more important than ever during a pandemic—and must be allowed to be as thorough as ever. |
| first_indexed | 2024-12-13T01:16:09Z |
| format | Article |
| id | doaj.art-40b39ee395824da9bc85f3cac09b9e0a |
| institution | Directory Open Access Journal |
| issn | 2529-7325 2529-7333 |
| language | English |
| last_indexed | 2024-12-13T01:16:09Z |
| publishDate | 2021-06-01 |
| publisher | World Scientific Publishing |
| record_format | Article |
| series | Molecular Frontiers Journal |
| spelling | doaj.art-40b39ee395824da9bc85f3cac09b9e0a2022-12-22T00:04:20ZengWorld Scientific PublishingMolecular Frontiers Journal2529-73252529-73332021-06-010501n02586510.1142/S2529732521400034Authorization of Vaccines in the European UnionAna Hidalgo-Simon0Radu Botgros1Emil Cochino2Advanced Therapies Office, Human Medicines Division, European Medicines Agency, Amsterdam, The NetherlandsClinical Studies and Manufacturing Task Force-Biological Health Threats and Vaccines Strategy, European Medicines Agency, Amsterdam, The NetherlandsRisk Management Specialist, Office of Vaccines and Therapies for Infectious Diseases, European Medicines Agency, Amsterdam, The NetherlandsThe current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pressure. The marketing authorization is a necessary gateway that protects public health and provides healthcare professionals and the general public with reliable and relevant evidence reflected in the product information to allow the safe and effective use of these vaccines. Regulators have the expertise and the duty to evaluate vaccines’ benefits and risks and, importantly, monitor safety during clinical use. This evaluation is more important than ever during a pandemic—and must be allowed to be as thorough as ever.https://www.worldscientific.com/doi/10.1142/S2529732521400034RegulationVaccinesMarketing AuthorizationEuropean Medicines AgencyEMA |
| spellingShingle | Ana Hidalgo-Simon Radu Botgros Emil Cochino Authorization of Vaccines in the European Union Molecular Frontiers Journal Regulation Vaccines Marketing Authorization European Medicines Agency EMA |
| title | Authorization of Vaccines in the European Union |
| title_full | Authorization of Vaccines in the European Union |
| title_fullStr | Authorization of Vaccines in the European Union |
| title_full_unstemmed | Authorization of Vaccines in the European Union |
| title_short | Authorization of Vaccines in the European Union |
| title_sort | authorization of vaccines in the european union |
| topic | Regulation Vaccines Marketing Authorization European Medicines Agency EMA |
| url | https://www.worldscientific.com/doi/10.1142/S2529732521400034 |
| work_keys_str_mv | AT anahidalgosimon authorizationofvaccinesintheeuropeanunion AT radubotgros authorizationofvaccinesintheeuropeanunion AT emilcochino authorizationofvaccinesintheeuropeanunion |