Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection
The rapid and large-scale roll-out of new COVID-19 vaccines has led to unprecedented challenges in assessing vaccine safety. In 2021, the European Medicines Agency (EMA) processed about 1.7 million safety reports related to COVID-19 vaccines in the EudraVigilance (EV) database and identified more th...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-05-01
|
| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/11/5/954 |
| _version_ | 1827739981309804544 |
|---|---|
| author | Christelle Bizimungu Martine Sabbe Françoise Wuillaume Jamila Hamdani Philippe Koch Jean-Michel Dogné |
| author_facet | Christelle Bizimungu Martine Sabbe Françoise Wuillaume Jamila Hamdani Philippe Koch Jean-Michel Dogné |
| author_sort | Christelle Bizimungu |
| collection | DOAJ |
| description | The rapid and large-scale roll-out of new COVID-19 vaccines has led to unprecedented challenges in assessing vaccine safety. In 2021, the European Medicines Agency (EMA) processed about 1.7 million safety reports related to COVID-19 vaccines in the EudraVigilance (EV) database and identified more than 900 potential signals. Beyond the large amount of information to be processed, the evaluation of safety signals has faced several difficulties and limitations, both in the assessment of case reports and in the investigation of databases. The evaluation of a signal of corneal graft rejection (CGR) with Vaxzevria<sup>®</sup> was no exception to this. In this commentary, we present the challenges encountered in making regulatory decisions in the context of evolving evidence and knowledge. The pandemic crisis emphasised the importance of quick and proactive communication to address the many questions and, above all, to ensure the transparency of safety data. |
| first_indexed | 2024-03-11T03:15:36Z |
| format | Article |
| id | doaj.art-98aad9d32b5b43afa815dff228a87391 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-11T03:15:36Z |
| publishDate | 2023-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-98aad9d32b5b43afa815dff228a873912023-11-18T03:36:15ZengMDPI AGVaccines2076-393X2023-05-0111595410.3390/vaccines11050954Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft RejectionChristelle Bizimungu0Martine Sabbe1Françoise Wuillaume2Jamila Hamdani3Philippe Koch4Jean-Michel Dogné5DG Post Authorisation—Federal Agency for Medicines and Health Products, 1210 Brussels, BelgiumDG Post Authorisation—Federal Agency for Medicines and Health Products, 1210 Brussels, BelgiumDG Post Authorisation—Federal Agency for Medicines and Health Products, 1210 Brussels, BelgiumDG Post Authorisation—Federal Agency for Medicines and Health Products, 1210 Brussels, BelgiumDepartment of Ophthalmology, Hôpitaux Iris Sud—Site Ixelles, Réseau Chorus, Université Libre de Bruxelles (ULB), 1050 Brussels, BelgiumDG Post Authorisation—Federal Agency for Medicines and Health Products, 1210 Brussels, BelgiumThe rapid and large-scale roll-out of new COVID-19 vaccines has led to unprecedented challenges in assessing vaccine safety. In 2021, the European Medicines Agency (EMA) processed about 1.7 million safety reports related to COVID-19 vaccines in the EudraVigilance (EV) database and identified more than 900 potential signals. Beyond the large amount of information to be processed, the evaluation of safety signals has faced several difficulties and limitations, both in the assessment of case reports and in the investigation of databases. The evaluation of a signal of corneal graft rejection (CGR) with Vaxzevria<sup>®</sup> was no exception to this. In this commentary, we present the challenges encountered in making regulatory decisions in the context of evolving evidence and knowledge. The pandemic crisis emphasised the importance of quick and proactive communication to address the many questions and, above all, to ensure the transparency of safety data.https://www.mdpi.com/2076-393X/11/5/954COVID-19vaccinessafetypharmacovigilanceadverse eventcausality |
| spellingShingle | Christelle Bizimungu Martine Sabbe Françoise Wuillaume Jamila Hamdani Philippe Koch Jean-Michel Dogné Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection Vaccines COVID-19 vaccines safety pharmacovigilance adverse event causality |
| title | Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection |
| title_full | Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection |
| title_fullStr | Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection |
| title_full_unstemmed | Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection |
| title_short | Challenges in Assessing COVID-19 Vaccines Safety Signals—The Case of ChAdOx1 nCoV-19 Vaccine and Corneal Graft Rejection |
| title_sort | challenges in assessing covid 19 vaccines safety signals the case of chadox1 ncov 19 vaccine and corneal graft rejection |
| topic | COVID-19 vaccines safety pharmacovigilance adverse event causality |
| url | https://www.mdpi.com/2076-393X/11/5/954 |
| work_keys_str_mv | AT christellebizimungu challengesinassessingcovid19vaccinessafetysignalsthecaseofchadox1ncov19vaccineandcornealgraftrejection AT martinesabbe challengesinassessingcovid19vaccinessafetysignalsthecaseofchadox1ncov19vaccineandcornealgraftrejection AT francoisewuillaume challengesinassessingcovid19vaccinessafetysignalsthecaseofchadox1ncov19vaccineandcornealgraftrejection AT jamilahamdani challengesinassessingcovid19vaccinessafetysignalsthecaseofchadox1ncov19vaccineandcornealgraftrejection AT philippekoch challengesinassessingcovid19vaccinessafetysignalsthecaseofchadox1ncov19vaccineandcornealgraftrejection AT jeanmicheldogne challengesinassessingcovid19vaccinessafetysignalsthecaseofchadox1ncov19vaccineandcornealgraftrejection |