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An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic

Estella Achick Tembe-Fokunang, Banin Andrew Nyuki, Joseph Fokam, Dobgima John Fonmboh, Kristen Nubia Kaba, Lovet Benyella Fokunang, François-Xavier Mbopi-Keou, Abena, Ondoua Obama Marie Therese, Ralf Duerr, Charles Ntungwen Fokunang

Journal of Advances in Medical and Pharmaceutical Sciences · pp. 24–41 · Published 28 Jul 2022

10.9734/jamps/2022/v24i630308

Abstract

Once a drug is approved in phase III of clinical trials, pharmacovigilance (PV) becomes very important for the surveillance of drug, vaccine or medical devices. PV constitutes part of the phase IV approval, which involves a study for collecting, detecting, and monitoring adverse events in any population that the drug is used. The adverse events that are reported must be assessed to ascertain the causal effects and prevent or avoid unanticipated side effects on the population. With the advent of the coronavirus disease 2019 (COVID-19) pandemic, vaccination has been the motor for the management of the pandemic, and through intensive health sensitization, more people are vaccinated in a short period leading to greater challenges to the PV taskforce and the PV operating centrers. Global partnerships including the international society of pharmacovigilance (ISOP), the French national agency for medicines and health products safety (ANSM), and a multitude of others are working in synergy towards putting in place a continuous collaboration work package with many sensitization, education, capacity building, and research initiatives. This is within the framework of identifying the safety and efficacy of vaccines in order to provide solutions to emerging challenging ethical questions. Through PV, signal detection is in progress for the identification of adverse events. The unanticipated emergence and negative impact of COVID-19, caused by the severe acute respiratory syndrome virus 2 (SARS-CoV-2) has significantly compelled global pharmacists and drug actors to collectively play an important role in the management of COVID-19. This has to be done within the framework of therapeutic strategies and guaranteed safety, efficacy and quality of new and old xenobiotics. In the current treatment COVID-19 has created health-related challenges and a shift in paradigm in drug discovery and development of new chemical entities (NCE), for vaccine or drug repurposing for different levels of treatment interventions. The accelerated interest in dynamic research and innovation have led to different approaches of treatment and this has come with potential side effects, which has led to the call for post marketing surveillance and monitory. PV is therefore a key component for phase IV study for the drugs and vaccines approved for global use. This paper gives an insight into the global PV monitoring and surveillance of new chemical entities (drugs and vaccines) and new technologies targeting the management of COVID-19.

Pharmacovigilance COVID-19 SARS-CoV 2 adverse drug reaction surveillance monitoring vaccine

References (46)

  1. 1 Home visits: a strategy to improve newborn survival - Authors' reply [DOI]
  2. 2 Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia [DOI]
  3. 3 Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial [DOI]
  4. 4 Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial [DOI]
  5. 5 The Medical Dictionary for Regulatory Activities (MedDRA) [DOI]
  6. 6 Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial [DOI]
  7. 7 Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial [DOI]
  8. 8 Immunological considerations for COVID-19 vaccine strategies [DOI]
  9. 9 Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine [DOI]
  10. 10 COVID-19 Vaccine: A comprehensive status report [DOI]
  11. 11 Cutaneous reactions reported after Moderna and Pfizer COVID-19 vaccination: A registry-based study of 414 cases [DOI]
  12. 12 Evolution of the COVID-19 vaccine development landscape [DOI]
  13. 13 Finding the Missing Link for Big Biomedical Data [DOI]
  14. 14 Pharmacoepidemiology and Drug Safety [DOI]
  15. 15 The challenges of COVID-19 for community pharmacists and opportunities for the future [DOI]
  16. 16 COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials [DOI]
  17. 17 On vaccine's adjuvants and autoimmunity: Current evidence and future perspectives [DOI]
  18. 18 Incidence of Adverse Drug Reactions in COVID‐19 Patients in China: An Active Monitoring Study by Hospital Pharmacovigilance System [DOI]
  19. 19 The Impact of the COVID-19 “Infodemic” on Drug-Utilization Behaviors: Implications for Pharmacovigilance [DOI]
  20. 20 Mortality Rate and Characteristics of Deaths Following COVID-19 Vaccination [DOI]
  21. 21 CoViD vaccines and thrombotic events: EMA issued warning to patients and healthcare professionals [DOI]
  22. 22 Covid-19 vaccine- induced thrombosis and thrombocytopenia-a commentary on an important and practical clinical dilemma [DOI]
  23. 23 Safety and efficacy of the Russian COVID-19 vaccine: more information needed – Authors’ reply [DOI]
  24. 24 The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France [DOI]
  25. 25 Immune thrombocytopaenic purpura: an autoimmune cross-link between infections and vaccines [DOI]
  26. 26 Integrating pharmacies into public health program planning for pandemic influenza vaccine response [DOI]
  27. 27 Pharmacovigilance and Biomedical Informatics: A Model for Future Development [DOI]
  28. 28 Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK? [DOI]
  29. 29 Recurrent Immune Thrombocytopenia After Influenza Vaccination: A Case Report [DOI]
  30. 30 Vigilance regarding immune thrombocytopenic purpura after COVID-19 vaccine [DOI]
  31. 31 French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge [DOI]
  32. 32 The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic [DOI]
  33. 33 A Case of Immune Thrombocytopenic Purpura After Influenza Vaccination [DOI]
  34. 34 Time Series Disturbance Detection for Hypothesis-Free Signal Detection in Longitudinal Observational Databases [DOI]
  35. 35 The French pharmacovigilance surveys: A French distinctiveness, a real input [DOI]
  36. 36 Efficacy and Safety of AZD1222, BNT162b2 and mRNA-1273 vaccines against SARS-CoV-2 [DOI]
  37. 37 Pharmacovigilance of COVID-19 vaccines in the context of Nepal: an assessment based on early adverse drug reaction reports [DOI]
  38. 38 Influence of COVID-19 on the Pharmacovigilance Workforce of the Future [DOI]
  39. 39 Need of Vibrant Vaccine Pharmacovigilance During Current Global COVID-19 Pandemic: More Than Ever [DOI]
  40. 40 A review on vaccine pharmacovigilance during covid-19 [DOI]
  41. 41 Pharmacovigilance, and COVID-19 [DOI]
  42. 42 Journal of the Pharmacy and Bioallied Sciences [DOI]
  43. 43 Journal of Pharmaceutical Health Services Research [DOI]
  44. 44 Albanian Journal of Trauma and Emergency Surgery [DOI]
  45. 45 Adverse drug reaction monitoring: Doing it the French way – Act II [DOI]
  46. 46 Pharmacovigilance Analysis on Cerebrovascular Accidents and Coronavirus disease 2019 Vaccines [DOI]

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