Pharmacovigilance challenges of COVID-19 vaccine safety monitoring during the pandemic - a narrative review
DOI:
https://doi.org/10.56782/pps.739Keywords:
Vaccine, COVID-19, pandemic, pharmacovigillance, adverse drug reactionAbstract
This article explores the challenges related to the immense workload associated with pharmacovigilance during the COVID-19 pandemic as well as strategies and solutions employed by key stakeholders, including regulators, industry, and academia. The rapid development and rollout of COVID-19 vaccines was accompanied by increased public interest in their safety, resulting in the collection and analysis of an unprecedented volume of safety data. Requests from regulators worldwide for the accelerated preparation and submission of aggregate safety reports, as well as ad hoc data requests, presented additional challenges. The academic community voluntarily contributed by summarizing emerging evidence on vaccine safety, conducting research to clarify potential mechanisms underlying adverse events, and examining factors associated with vaccine hesitancy. An effective pharmacovigilance system played a crucial role in gathering and rapidly analyzing large amounts of data to identify signals, refine the safety profile of a new medicinal product, and respond promptly to any emerging concerns to ensure that patients are not exposed to medications with an unfavourable benefit–risk balance.
Downloads
References
1. Amarsanaa, J.; Batsaikhan, O.; Jargalsaikhan, B.; Kubo, T.; Ghotbi, N.; Kayano, R.; Chimed-Ochir, O. Impact of the COVID-19 pandemic on health emergency and disaster risk management systems: a scoping review of mental health support provided to health care workers. J. Occup. Health 2025, 67, Art. No: uiaf020. DOI: 10.1093/joccuh/uiaf020 DOI: https://doi.org/10.1093/joccuh/uiaf020
2. Shah, R.; Hanna, N.M.; Loo, C.E.; David, M.; Mafra, A.; Fink, H.; McFerran, E.; Garcia, M.; Ghodssighassemabadi, R.; Acharya, S.; Niyibaga, J.; Langselius, O.; Frick, C.; Lasebikan, N.; Vignat, J.; Steinberg, J.; Hughes, S.; Kircher, C.E.; Goldie, C.L.; Egger, S.; Sullivan, R.; Ginsburg, O.; Bray, F.; Caruana, M.; Hui, H.; Ilbawi, A.M.; Canfell, K.; Soerjomataram, I. The global impact of the COVID-19 pandemic on delays and disruptions in cancer care services: a systematic review and meta-analysis. Nat. Cancer 2025, 6, 194-204. DOI: 10.1038/s43018-024-00880-4 DOI: https://doi.org/10.1038/s43018-024-00880-4
3. da Silva Chaar Neta, R.; da Silva Batista, C.; Machado Palmerim, É.M.; Costa Dias, H.M.; Costa Nóbrega, K.C.; de Oliveira, C.A.; Visco, D.B. The impact of social isolation due to the COVID-19 pandemic on functional performance, fall risk, and gait in individuals with Parkinson's Disease: a systematic review. Neuroscience 2025, 584, 113-126. DOI: 10.1016/j.neuroscience.2025.08.014 DOI: https://doi.org/10.1016/j.neuroscience.2025.08.014
4. Clemente-Suárez, V.J.; Martínez-González, M.B.; Benitez-Agudelo, J.C.; Navarro-Jiménez, E.; Beltran-Velasco, A.I.; Ruisoto, P.; Diaz Arroyo, E.; Laborde-Cárdenas, C.C.; Tornero-Aguilera, J.F. The impact of the COVID-19 pandemic on mental disorders. A critical review. Int. J. Environ. Res. Public Health 2021, 18, Art. No: 10041. DOI: 10.3390/ijerph181910041 DOI: https://doi.org/10.3390/ijerph181910041
5. Pandey, K.; Thurman, M.; Johnson, S.D.; Acharya, A.; Johnston, M.; Klug, E.A.; Olwenyi, O.A.; Rajaiah, R.; Byrareddy, S.N. Mental health issues during and after COVID-19 vaccine era. Brain Res. Bull. 2021, 176, 161-173. DOI: 10.1016/j.brainresbull.2021.08.012 DOI: https://doi.org/10.1016/j.brainresbull.2021.08.012
6. O'Connor, H.; DiSalvo, M.; Gersten, M.; Boyden, S.; Uchida, M. Effects of the COVID-19 pandemic on early child development: A systematic review and meta-analysis. J. Dev. Behav. Pediatr. 2025, 46, e227-e239. DOI: 10.1097/dbp.0000000000001352 DOI: https://doi.org/10.1097/DBP.0000000000001352
7. Gianfredi, V.; Scarioni, S.; Marchesi, L.; Ticozzi, E.M.; Addo, M.O.; D'errico, V.; Fratantonio, L.; Liguori, L.; Pellai, A.; Castaldi, S. The impact of the COVID-19 pandemic on academic performance among developmental age students: a systematic review with meta-analysis. Ann. Ig. 2025, 37, 49-73. DOI: 10.7416/ai.2024.2647
8. Littlecott, H.; Krishnaratne, S.; Hummel, J.; Orban, E.; Heinsohn, T.; Noel-Storr, A.H.; Strahwald, B.; Jung-Sievers, C.; Ravens-Sieberer, U.; Rehfuess, E. Unintended consequences of measures implemented in the school setting to contain the COVID-19 pandemic: a scoping review. Cochrane Database Syst. Rev. 2024, 12, Art. No: CD015397. DOI: 10.1002/14651858.CD015397.pub2 DOI: https://doi.org/10.1002/14651858.CD015397.pub2
9. Lino, M.M.; Mather, S.; Trani, M.; Chen, Y.; Caubel, P.; De Bernardi, B. Challenges and innovations in pharmacovigilance and signal management during the COVID-19 pandemic: an industry perspective. Vaccines (Basel) 2025, 13, Art. No: 481. DOI: 10.3390/vaccines13050481 DOI: https://doi.org/10.3390/vaccines13050481
10. Rudolph, A.; Mitchell, J.; Barrett, J.; Sköld, H.; Taavola, H.; Erlanson, N.; Melgarejo-González, C.; Yue, Q. Y. Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge. Ther. Adv. Drug Saf. 2022, 13, Art. No: 20420986221118972. DOI: 10.1177/20420986221118972 DOI: https://doi.org/10.1177/20420986221118972
11. Beninger, P.; Caubel, P.; Sharma, L.; Pajovich, G.; Boyd, P. Effects of the COVID-19 pandemic on pharmacovigilance strategy, systems, and processes of large, medium, and small companies: an industry survey. Clin. Ther. 2022, 44, 1225-1236. DOI: 10.1016/j.clinthera.2022.07.007 DOI: https://doi.org/10.1016/j.clinthera.2022.07.007
12. European Medicines Agency. EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines. Available online: https://www.ema.europa.eu/en/news/ema-publishes-safety-monitoring-plan-guidance-risk-management-planning-covid-19-vaccines (accessed on 22 September 2025).
13. Boseley, S.; Oltermann, P. Hopes rise for end of pandemic as Pfizer says vaccine has 90% efficacy. The Guardian. Available online: https://www.theguardian.com/world/2020/nov/09/covid-19-vaccine-candidate-effective-pfizer-biontech (accessed on 4 December 2025).
14. Guarino, B.; Wan, W. First coronavirus vaccine shots given in U.S., starting in New York. The Washington Post. Available online: https://www.washingtonpost.com/nation/2020/12/14/first-covid-vaccines-new-york/ (accessed on 4 December 2025).
15. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency Off. J. Eur. Union 2004, L136, 1–33.
16. European Medicines Agency. COVID-19 vaccines safety update, 8 December 2022. Available online: https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccines-safety-update-8-december-2022_en.pdf (accessed on 3 December 2025).
17. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) – Module VI (Rev 2): Collection, management and submission of reports of suspected adverse reactions to medicinal products. Available online: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports-suspected-adverse-reactions-medicinal-products-rev-2_en.pdf (accessed on 3 December 2025).
18. Kiazand, A.; Luther, R.; Marlind Wurtele, J.; Southall, N.; Domalik, D.; Ysander, M. Pandemic vaccines: a formidable challenge for pharmacovigilance. Nat. Rev. Drug Discov. 2023, 22, 1-2. DOI: 10.1038/d41573-022-00178-z DOI: https://doi.org/10.1038/d41573-022-00178-z
19. Caubel, P. The new post-COVID pharmacovigilance landscape. In Proceedings of the World Drug Safety Congress Europe, Amsterdam, the Netherlands, 4–5 October 2023.
20. Kruk, M. Pharmacovigilance innovations serving the fight against the COVID-19 pandemic. In Proceedings of the World Drug Safety Congress Europe, Amsterdam, the Netherlands, 27-29 September 2022.
21. Kruk, M. Pharmacovigilance of the vaccine against COVID-19. In Proceedings of the XXXIII Nobel Session, Medical University of Warsaw, Warsaw, Poland, 11 December 2023.
22. Carley, S.; Horner, D.; Body, R.; Mackway-Jones, K. Evidence-based medicine and COVID-19: what to believe and when to change. Emerg. Med. J. 2020, 37, 572-575. DOI: 10.1136/emermed-2020-210098 DOI: https://doi.org/10.1136/emermed-2020-210098
23. Snow, E. K.; Miller, J. L.; Kester, L.; Mendham, N. A.; Heydorn, J. D.; Huang, S. C.; Leu, L. L.; Kohoutek, L. M.; Rosanelli, N. C.; Harves, K. M. Creation and maintenance of a table for assessment of evolving evidence for COVID-19-related treatments. Am. J. Health Syst. Pharm. 2021, 78, 154-157. DOI: 10.1093/ajhp/zxaa334 DOI: https://doi.org/10.1093/ajhp/zxaa334
24. National Institute for Health and Care Excellence. Products: A list of all our products on COVID-19. Available online: https://www.nice.org.uk/guidance/conditions-and-diseases/infections/covid19/products?Status=Published (accessed on 1 December 2025).
25. McMaster Health Forum and the Ottawa Hospital Research Institute. COVID-END: COVID-19 Evidence Network to support Decision-making. Available online: https://www.mcmasterforum.org/networks/covid-end (accessed on 1 December 2025).
26. Agency for Health Technology Assessment and Tariff System. COVID-19: Publication Radar. Available online: https://covid19-radar.aotm.gov.pl/#/ (accessed on 20 June 2023).
27. Agency for Health Technology Assessment and Tariff System. Review of International Guidelines in COVID-19. Available online: https://www.aotm.gov.pl/en/review-of-international-guidelines-in-covid-19/ (accessed on 4 December 2025).
28. Agency for Health Technology Assessment and Tariff System. Recommendations Pharmacotherapy COVID-19. Available online: https://www.aotm.gov.pl/en/covid-19-2/recommendations-in-covid/pharmacotherapy/ (accessed on 4 December 2025).
29. World Health Organization. Global Research on Coronavirus Disease (COVID-19). Available online: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/ (accessed on 4 December 2025).
30. Gautret, P.; Lagier, J. C.; Parola, P.; Hoang, V. T.; Meddeb, L.; Mailhe, M.; Doudier, B.; Courjon, J.; Giordanengo, V.; Vieira, V. E.; Tissot Dupont, H.; Honoré, S.; Colson, P.; Chabrière, E.; La Scola, B.; Rolain, J. M.; Brouqui, P.; Raoult, D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int. J. Antimicrob. Agents 2020, 56, Art. No: 105949. DOI: 10.1016/j.ijantimicag.2020.105949 DOI: https://doi.org/10.1016/j.ijantimicag.2020.105949
31. Silva, H.M. Challenges and reflections on pandemic disinformation: the case of hydroxychloroquine and the implications for global public health. Value Health Reg. Issues 2024, 43, Art. No: 101005. DOI: 10.1016/j.vhri.2024.101005 DOI: https://doi.org/10.1016/j.vhri.2024.101005
32. Peter Lamy Center on Drug Therapy and Aging at the University of Maryland School of Pharmacy. Optimizing Medication Management During the COVID-19 Pandemic: Implementation Guide for Post-Acute and Long-Term Care. Available online: https://www.pharmacy.umaryland.edu/centers/lamy/optimizing-medication-management-during-covid19-pandemic/ (accessed on 4 December 2025).
33. Shrotri, M.; Swinnen, T.; Kampmann, B.; Parker, E.P.K. An interactive website tracking COVID-19 vaccine development. Lancet Glob. Health 2021, 9, e590-e592. DOI: 10.1016/S2214-109X(21)00043-7 DOI: https://doi.org/10.1016/S2214-109X(21)00043-7
34. Kim, J.H.; Marks, F.; Clemens, J.D. Looking beyond COVID-19 vaccine phase 3 trials. Nat. Med. 2021, 27, 205-211. DOI: 10.1038/s41591-021-01230-y DOI: https://doi.org/10.1038/s41591-021-01230-y
35. Lamprinou, M.; Sachinidis, A.; Stamoula, E.; Vavilis, T.; Papazisis, G. COVID-19 vaccines adverse events: potential molecular mechanisms. Immunol. Res. 2023, 71, 356-372. DOI: 10.1007/s12026-023-09357-5 DOI: https://doi.org/10.1007/s12026-023-09357-5
36. Fox, S.E.; Akmatbekov, A.; Harbert, J.L.; Li, G.; Quincy Brown, J.; Vander Heide, R.S. Pulmonary and cardiac pathology in African American patients with COVID-19: an autopsy series from New Orleans. Lancet Respir. Med. 2020, 8, 681-686. DOI: 10.1016/S2213-2600(20)30243-5 DOI: https://doi.org/10.1016/S2213-2600(20)30243-5
37. Lax, S. F.; Skok, K.; Zechner, P.; Kessler, H. H.; Kaufmann, N.; Koelblinger, C.; Vander, K.; Bargfrieder, U.; Trauner, M. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: results from a prospective, single-center, clinicopathologic case series. Ann. Intern. Med. 2020, 173, 350-361. DOI: 10.7326/M20-2566 DOI: https://doi.org/10.7326/M20-2566
38. Poor, H.D. Pulmonary thrombosis and thromboembolism in COVID-19. Chest 2021, 160, 1471-1480. DOI: 10.1016/j.chest.2021.06.016 DOI: https://doi.org/10.1016/j.chest.2021.06.016
39. Bilotta, C.; Perrone, G.; Adelfio, V.; Spatola, G. F.; Uzzo, M. L.; Argo, A.; Zerbo, S. COVID-19 vaccine-related thrombosis: a aystematic review and exploratory analysis. Front. Immunol. 2021, 12, Art. No: 729251. DOI: 10.3389/fimmu.2021.729251 DOI: https://doi.org/10.3389/fimmu.2021.729251
40. Gollamudi, J.; Sartain, S. E.; Navaei, A. H.; Aneja, S.; Kaur Dhawan, P.; Tran, D.; Joshi, J.; Gidudu, J.; Gollamudi, J.; Chiappini, E.; Varricchio, F.; Law, B.; Munoz, F. M. Thrombosis and thromboembolism: Brighton collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine 2022, 40, 6431-6444. DOI: 10.1016/j.vaccine.2022.09.001 DOI: https://doi.org/10.1016/j.vaccine.2022.09.001
41. Rahmig, J.; Altarsha, E.; Siepmann, T.; Barlinn, K. Acute ischemic stroke in the context of SARS-CoV-2 vaccination: a systematic review. Neuropsychiatr. Dis. Treat. 2022, 18, 1907-1916. DOI: 10.2147/NDT.S374549 DOI: https://doi.org/10.2147/NDT.S374549
42. Tan, L.J.; Koh, C.P.; Lai, S.K.; Poh, W.C.; Othman, M.S.; Hussin, H. A systemic review and recommendation for an autopsy approach to death followed the COVID 19 vaccination. Forensic Sci. Int. 2022, 340, Art. No: 111469. DOI: 10.1016/j.forsciint.2022.111469. DOI: https://doi.org/10.1016/j.forsciint.2022.111469
43. Kontovazainitis, C.G.; Katsaras, G.N.; Gialamprinou, D.; Mitsiakos, G. Covid-19 vaccination and pregnancy: a systematic review of maternal and neonatal outcomes. J. Perinat. Med. 2023, 51, 823-839. DOI: 10.1515/jpm-2022-0463 DOI: https://doi.org/10.1515/jpm-2022-0463
44. Luxi, N.; Giovanazzi, A.; Capuano, A.; Crisafulli, S.; Cutroneo, P. M.; Fantini, M. P.; Ferrajolo, C.; Moretti, U.; Poluzzi, E.; Raschi, E.; Ravaldi, C.; Reno, C.; Tuccori, M.; Vannacci, A.; Zanoni, G.; Trifirò, G.; Ilmiovaccino COVID19 collaborating group. COVID-19 vaccination in pregnancy, paediatrics, immunocompromised patients, and persons with history of allergy or prior SARS-CoV-2 infection: Overview of current recommendations and pre- and post-marketing evidence for vaccine efficacy and safety. Drug Saf. 2021, 44, 1247-1269. DOI: 10.1007/s40264-021-01131-6 DOI: https://doi.org/10.1007/s40264-021-01131-6
45. Piche-Renaud, P.P.; Morris, S.K.; Top, K.A. A narrative review of vaccine pharmacovigilance during mass vaccination campaigns: Focus on myocarditis and pericarditis after COVID-19 mRNA vaccination. Br. J. Clin. Pharmacol. 2023, 89, 967-981. DOI: 10.1111/bcp.15625 DOI: https://doi.org/10.1111/bcp.15625
46. Sun, H.; Bu, F.; Li, L.; Zhang, X.; Yan, J.; Huang, T. COVID-19 vaccine response and safety in patients with cancer: An overview of systematic reviews. Front. Public Health 2022, 10, Art. No: 1072137. DOI: 10.3389/fpubh.2022.1072137 DOI: https://doi.org/10.3389/fpubh.2022.1072137
47. Baba, C.; Ozcelik, S.; Kaya, E.; Samedzada, U.; Ozdogar, A. T.; Cevik, S.; Dogan, Y.; Ozakbas, S. Three doses of COVID-19 vaccines in multiple sclerosis patients treated with disease-modifying therapies. Mult. Scler. Relat. Disord. 2022, 68, Art. No: 104119. DOI: 10.1016/j.msard.2022.104119 DOI: https://doi.org/10.1016/j.msard.2022.104119
48. Wallach, A.I.; Schiebel, M.; Picone, M.A. Antibody response to SARS-CoV-2 vaccination following typical and three-dose dosing schedules in multiple sclerosis patients treated with disease modifying therapies. Mult. Scler. Relat. Disord. 2022, 63, Art. No: 103856. DOI: 10.1016/j.msard.2022.103856 DOI: https://doi.org/10.1016/j.msard.2022.103856
49. Cook, C. E.; Patel, N. J.; Fu, X.; Wang, X.; Kawano, Y.; Vanni, K. M. M.; Qian, G.; Banasiak, E.; Kowalski, E.; Choi, H. K.; Zhang, Y.; Sparks, J. A.; Wallace, Z. S. Comparative effectiveness of BNT162b2 and mRNA-1273 vaccines against COVID-19 infection among patients with systemic autoimmune rheumatic diseases on immunomodulatory medications. J. Rheumatol. 2023, 50, 697-703. DOI: 10.3899/jrheum.220870 DOI: https://doi.org/10.3899/jrheum.220870
50. La Costa, R. COVID-19 vaccine effectiveness in oncology patients. J. Adv. Pract. Oncol. 2022, 13, 441-447. DOI: 10.6004/jadpro.2022.13.4.6 DOI: https://doi.org/10.6004/jadpro.2022.13.4.6
51. Mekkawi, R.; Elkattan, B.A.; Shablak, A.; Bakr, M.; Yassin, M.A.; Omar, N.E. COVID-19 vaccination in cancer patients: A Review Article. Cancer Control 2022, 29, Art. No: 10732748221106266. DOI: 10.1177/10732748221106266 DOI: https://doi.org/10.1177/10732748221106266
52. Britton, A.; Embi, P. J.; Levy, M. E.; Gaglani, M.; DeSilva, M. B.; Dixon, B. E.; Dascomb, K.; Patel, P.; Schrader, K. E.; Klein, N. P.; Ong, T. C.; Natarajan, K.; Hartmann, E.; Kharbanda, A. B.; Irving, S. A.; Dickerson, M.; Dunne, M. M.; Raiyani, C.; Grannis, S. J.; Stenehjem, E.; Zerbo, O.; Rao, S.; Han, J.; Sloan-Aagard, C.; Griggs, E.P.; Weber, Z.A.; Murthy, K.; Fadel,W.F.; Grisel, N.; McEvoy, C.; Lewis, N.; Barron, M.A.; Nanez, J.; Reese, S.E.; Mamawala, M.; Valvi, N.R.; Arndorfer, J.; Goddard, K.; Yang, D.H.; Fireman, B.; Ball, S.W.; Link-Gelles, R.; Naleway, A.L.; Tenforde, M.W. Effectiveness of COVID-19 mRNA vaccines against COVID-19-associated hospitalizations among immunocompromised adults during SARS-CoV-2 Omicron predominance - VISION Network, 10 States, December 2021-August 2022. MMWR Morb. Mortal. Wkly. Rep. 2021, 71, 1335-1342. DOI: 10.15585/mmwr.mm7142a4 DOI: https://doi.org/10.15585/mmwr.mm7142a4
53. Jatoi, H. N.; Abbas, S.; Abbasi, M. S.; Tauni, M. A.; Ghazanfar, S.; Zafar Malick, M. D.; Umar, M. F.; Tahir, M. J.; Asghar, M. S.; Ahmed, A. BNT162b2 vaccine considerations for immunocompromised individuals: A global perspective. Ann. Med. Surg. (Lond). 2022, 78, Art. No: 103796. DOI: 10.1016/j.amsu.2022.103796 DOI: https://doi.org/10.1016/j.amsu.2022.103796
54. Kreuzberger, N.; Hirsch, C.; Andreas, M.; Böhm, L.; Bröckelmann, P. J.; Di Cristanziano, V.; Golinski, M.; Hausinger, R. I.; Mellinghoff, S.; Lange, B.; Lischetzki, T.; Kappler, V.; Mikolajewska, A.; Monsef, I.; Park, Y. S.; Piechotta, V.; Schmaderer, C.; Stegemann, M.; Vanshylla, K.; Weber, F.; Weibel, S.; Stephani, C.; Skoetz, N. Immunity after COVID-19 vaccination in people with higher risk of compromised immune status: a scoping review. Cochrane Database Syst. Rev. 2022, 8, Art. No: CD015021. DOI: 10.1002/14651858.CD015021 DOI: https://doi.org/10.1002/14651858.CD015021
55. Marinho, A. Vaccination in children with immune-mediated disorders. J. Pediatr. (Rio J.) 2023, 99, Suppl 1(Suppl 1):S62-S69. DOI: 10.1016/j.jped.2022.11.008 DOI: https://doi.org/10.1016/j.jped.2022.11.008
56. American Academy of Neurology. COVID-19 Resource Center. Available online: https://www.aan.com/tools-resources/covid-19-resources (accessed on 4 December 2025).
57. Quinn, G. A.; Connolly, R.; ÓhAiseadha, C.; Hynds, P.; Bagus, P.; Brown, R. B.; Cáceres, C. F.; Craig, C.; Connolly, M.; Domingo, J. L.; Fenton, N.; Frijters, P.; Hatfill, S.; Heymans, R.; Joffe, A. R.; Jones, R.; Lauc, G.; Lawrie, T.; Malone, R. W.; Mordue, A.; Mushet, G.; O'Connor, A.; Orient, J.; Peña-Ramos, J.A.; Risch, H.A.; Rose, J.; Sánchez-Bayón, A.; Savaris R.F.; Schippers M.C.; Simandan, D.; Sikora, K.; Soon, W.; Shir-Raz, Y.; Spandidos, D.A.; Spira, B.; Tsatsakis, A.M.; Walach, H. What lessons can be learned from the management of the COVID-19 pandemic? Int. J. Public Health 2025, 70, Art. No: 1607727. DOI: 10.3389/ijph.2025.1607727 DOI: https://doi.org/10.3389/ijph.2025.1607727
58. Ferreira-da-Silva, R.; Lobo, M.F.; Pereira, A.M.; Morato, M.; Polonia, J.J.; Ribeiro-Vaz, I. Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance. Front. Med. (Lausanne). 2025, 12, Art. No: 1501921. DOI: 10.3389/fmed.2025.1501921 DOI: https://doi.org/10.3389/fmed.2025.1501921
59. National Library of Medicine. PubMed. Search strategy: ((COVID-19[Title/Abstract]) AND (vaccine[Title/Abstract] OR vaccination[Title/Abstract])) AND (hesitancy[Title/Abstract]). Available online: https://pubmed.ncbi.nlm.nih.gov/advanced/ (accessed on 18 February 2023).
60. Capurro, G.; Tustin, J.; Jardine, C.G.; Driedger, S.M. When good messages go wrong: Perspectives on COVID-19 vaccines and vaccine communication from generally vaccine accepting individuals in Canada. Hum. Vaccin. Immunother. 2022, 18, Art. No: 2145822. DOI: 10.1080/21645515.2022.2145822 DOI: https://doi.org/10.1080/21645515.2022.2145822
61. Lodyga, M.; Maciejewska, K.; Rydzewska, G. A prospective questionnaire-based study to evaluate factors affecting the decision to receive COVID-19 vaccination in 267 patients with inflammatory bowel disease in Poland. Med. Sci. Monit. 2022, 28, Art. No: e938665. DOI: 10.12659/MSM.938665 DOI: https://doi.org/10.12659/MSM.938665
62. Conger, K. Stanford Medicine. How misinformation, medical mistrust fuel vaccine hesitancy. Available online: https://med.stanford.edu/news/all-news/2021/09/infodemic-covid-19.html (accessed on 4 December 2025).
63. InterAcademy Partnership. Countering COVID-19 Vaccine Hesitancy: Report of an IAP Webinar With Recommendations for Action. Available online: https://www.interacademies.org/sites/default/files/2022-04/Countering%20COVID-19%20Vaccine%20Hesitancy%20final.pdf (accessed on 4 December 2025).
64. InterAcademy Partnership. World Immunization Week: Check Our New Infographic on COVID-19 Vaccines and Fight Vaccine Hesitancy With IAP. Available online: https://www.interacademies.org/news/world-immunization-week-infographic-covid-19-vaccines (accessed on 4 December 2025).
65. van den Ouweland, F.; Charpentier, N.; Türeci, Ö.; Rizzi, R.; Mensa, F. J.; Lindemann, C.; Pather, S. Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data. Hum. Vaccin. Immunother. 2024, 20, Art. No: 2315659. DOI: 10.1080/21645515.2024.2315659 DOI: https://doi.org/10.1080/21645515.2024.2315659
66. Ip, S.; North, T. L.; Torabi, F.; Li, Y.; Abbasizanjani, H.; Akbari, A.; Horne, E.; Denholm, R.; Keene, S.; Denaxas, S.; Banerjee, A.; Khunti, K.; Sudlow, C.; Whiteley, W. N.; Sterne, J. A. C.; Wood, A. M.; Walker, V.; CVD-COVID-UK/COVID-IMPACT Consortium; Longitudinal Health and Wellbeing COVID-19 National Core Study. Cohort study of cardiovascular safety of different COVID-19 vaccination doses among 46 million adults in England. Nat. Commun. 2024, 15, Art. No: 6085. DOI: 10.1038/s41467-024-49634-x DOI: https://doi.org/10.1038/s41467-024-49634-x
67. Thurin, N.H. Risk assessment of 32 adverse events of special interest following COVID-19 vaccination in the French population. In Abstracts of the 24th ISoP Annual Meeting: Pharmacovigilance: Back to the Future; Cairo, Egypt, 24–27 October 2025; Drug Saf. 2025, 48, 1433–1660. DOI: https://doi.org/10.1007/s40264-025-01605-x
68. European Medicines Agency. COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines. Available online: https://www.ema.europa.eu/en/news/covid-19-ema-sets-infrastructure-real-world-monitoring-treatments-vaccines (accessed on 3 December 2025).
69. Shivji, R.; Conocchia, R.; Korakianiti, E.; Jekerle, V. Considerations for the chemistry, manufacturing and controls (CMC) - quality package for COVID-19 vaccines: interim lessons learnt by the European Medicines Agency (EMA). Vaccine 2022, 40, 5539-5541. DOI: 10.1016/j.vaccine.2022.06.058 DOI: https://doi.org/10.1016/j.vaccine.2022.06.058
70. US Food & Drug Administration. COVID-19 Vaccine Safety Surveillance. Available online: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance (accessed on 3 December 2025).
71. Oosterhuis, I.; Scholl, J.; van Puijenbroek, E.; Kant, A.; van Hunsel, F. Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience. Drug Saf. 2023, 46, 65-75. DOI: 10.1007/s40264-022-01253-5 DOI: https://doi.org/10.1007/s40264-022-01253-5
72. Crommelynck, S.; Thill, P. Pharmacovigilance for COVID-19 vaccines: A 1-year experience in France. Infect. Dis. Now 2022, 52, S16-S18. DOI: 10.1016/j.idnow.2022.09.018 DOI: https://doi.org/10.1016/j.idnow.2022.09.018
73. Italian Medicines Agency. New National Pharmacovigilance Network (RNF) launched. Available online: https://www.aifa.gov.it/en/-/al-via-la-nuova-rnf (accessed on 3 December 2025).
74. Torjesen, I. Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination. BMJ (Clinical research ed.) 2021, 372, Art. No: n149. DOI: 10.1136/bmj.n149 DOI: https://doi.org/10.1136/bmj.n149
75. Republic of Poland, The Ombudsman for Patients' Rights. The Protective Vaccination Compensation Fund has expanded its scope. Available online: https://www.gov.pl/web/rpp/fundusz-kompensacyjny-szczepien-ochronnych-rozszerzyl-swoj-zakres (accessed on 4 December 2025).
76. Fundusz Kompensacyjny – działanie, zmiany w 2023 r. [Compensation Fund – operation, changes in 2023]. Available online: https://www.infor.pl/prawo/prawa-konsumenta/prawa-pacjenta/5625219,fundusz-kompensacyjny-odszkodowanie-nop-zmiany-2023.html (accessed on 4 December 2025).
77. Ministry of Health, Israel. תופעות אשר דווחו על ידי הציבור בסמיכות לקבלת חיסון נגד נגיף הקורונה: דוח מסכם לתקופה 09/12/2021-31/05/2022 [Adverse events reported by the public in proximity to COVID-19 vaccination: Summary report for the period 9 December 2021–31 May 2022]. Ministry of Health: Jerusalem, Israel, 2022.
78. Ministry of Health, Israel. תופעות שהופיעו בסמיכות לקבלת חיסון נגד קורונה [Adverse events occurring in temporal proximity to COVID-19 vaccination]. Ministry of Health: Jerusalem, Israel, 2021.
79. Israel Ministry of Health. Proceedings of the Committee on COVID-19 Vaccine Effectiveness and Safety. Available online: https://www.gov.il/en/pages/vaccine-efficacy-safety-follow-up-committee (accessed on 20 December 2025).
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Dagmara Mirowska-Guzel, Magdalena Niedzielko, Barbara de Bernardi, Antonella Fretta, Marcin Kruk, Weronika Lepionka, Kavita Ramji, Patrick Caubel
This work is licensed under a Creative Commons Attribution 4.0 International License.
For all articles published in Prospects in Pharmaceutical Sciences copyright is retained by the authors. The journal publishes articles in the Open Access policy, within the CC BY 4.0 licence.
This is a human-readable summary of (and not a substitute for) the license. Disclaimer.
You are free to:
Share — copy and redistribute the material in any medium or format
Adapt — remix, transform, and build upon the material for any purpose, even commercially.
The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation.
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
How to Cite
