An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic
Journal of Advances in Medical and Pharmaceutical Sciences,
Page 24-41
DOI:
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.
Keywords:
- Pharmacovigilance
- COVID-19
- SARS-CoV 2
- adverse drug reaction
- surveillance
- monitoring
- vaccine
How to Cite
Tembe-Fokunang, E. A., Nyuki, B. A., Fokam, J., Fonmboh, D. J., Kaba, K. N., Fokunang, L. B., Mbopi-Keou, F.-X., Therese, A. O. O. M., Duerr, R., & Fokunang, C. N. (2022). An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic. Journal of Advances in Medical and Pharmaceutical Sciences, 24(6), 24-41. https://doi.org/10.9734/jamps/2022/v24i630308
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Lt. Pushkar a. Pharmacovigilance analysis on cerebrovascular accidents and Corona virus disease 2019 vaccines; 2021.
Jha N, Palaian S, Shankar P, Dangal G. Pharmacovigilance of COVID-19 vaccines in the context of Nepal: an assessment based on early adverse drug reaction reports. Journal of Pharmaceutical Health Services Research; 2021.
Logunov DY, Dolzhikova IV, Tukhvatullin AI, Shcheblyakov DV. Safety and efficacy of the Russian COVID-19 vaccine: more information needed–Authors’ reply. The Lancet. 2020 Oct 3;396(10256):e54-5.
Zhu F, Li Y, Guan X, Hou L, Wang W, Li J et al. 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. The Lancet. 2020;395(10240):1845-1854.
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Beninger P. Influence of COVID-19 on the pharmacovigilance workforce of the future. Clinical therapeutics. 2021 Feb 1;43(2):369-71.
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Whalen E, Hauben M, Bate A. Time series disturbance detection for hypothesis-free signal detection in longitudinal observational databases. Drug Saf. 2018;41:565e577.
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Navya JK, Jaka A, Rupavath PN, Vaddadi RR. A review on vaccine pharmacovigilance during COVID-19. Journal of Innovations in Applied Pharmaceutical Science (JIAPS). 2021 Aug 14:15-22.
Beninger P. Influence of COVID-19 on the pharmacovigilance workforce of the future. Clinical therapeutics. 2021 Feb 1;43(2):369-71.
Kaur SP, Gupta V. COVID-19 Vaccine: A comprehensive status report. Virus Res. 2020;288:198114.
Jeyanathan M, Afkhami S, Smaill F, Miller MS, Lichty BD, Xing Z. Immunological considerations for COVID-19 vaccine strategies. Nat. Rev. Immunol. 2020;20:615–632.
Yan ZP, Yang M, Lai CL. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials. Pharmaceuticals. 2021;14:406.
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Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, et al. 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. Lancet. 2021;397:671–681.
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Elbeddini A, Prabaharan T, Almasalkhi S, Tran.Pharmacists and COVID-19.J Pharm Policy Pract, 3. 2020;1-4
Fitzgerald TJ, Kang Y, Bridges CB, Talbert T, Vagi SJ, Lamont B, Graitcer SB. Integrating pharmacies into public health program planning for pandemic influenza vaccine response. Vaccine. 2016 Nov 4;34(46):5643-8.
Available:http://dx.doi.org/10.1016/j.vaccine.2016.09.020 | Medline
Hayden JC, Parkin R. The challenges of COVID-19 for community pharmacists and opportunities for the future. Irish journal of psychological medicine. 2020 Sep;37(3):198-203.
Available:http://dx.doi.org/10.1017/ipm.2020.52
Tuccori M, Convertino I, Ferraro S, Cappello E, Valdiserra G, Focosi D, Blandizzi C. The impact of the COVID-19 “Infodemic” on drug-utilization behaviors: implications for pharmacovigilance. Drug safety. 2020 Aug;43(8):699-709.
Available:http://dx.doi.org/10.1007/s40264-020-00965-w
Sun J, Deng X, Chen X, Huang J, Huang S, Li Y, Feng J, Liu J, He G. Incidence of adverse drug reactions in COVID‐19 patients in China: an active monitoring study by hospital pharmacovigilance system. Clinical Pharmacology & Therapeutics. 2020 Oct;108(4):791-7.
FDA Briefing Document-Moderna COVID-19 Vaccine. Vaccine and related Biological Products advisory committee Metting, Dec 17, 2020. Moderna TC, Inc. pp 54.
Houda F, Youness K, Pharmacovigilance, and COVID-19. The open COVID Journal. 2021(1):20-21,
DOI: 10.2174/2666958702101010020.
Chandler R, McCarthy D, Delumeau J, HarrisonWoolrych M. The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic. Drug Safety. 2020;43(6):511-512.
Le T, Cramer J, Chen R, Mayhew S. Evolution of the COVID-19 vaccine development landscape. Nature Reviews Drug Discovery. 2020;19(10):667-668.
Meher B. Need of vibrant vaccine pharmacovigilance during current global COVID19 pandemic: More than ever. Journal of Pharmacy And Bioallied Sciences. 2021;13(1):1.
Dhanda S, Osborne V, Lynn E, Shakir S. Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?. BMJ EvidenceBased Medicine. 2020;bmjebm-2020-111507.
Olivier P, Montastruc J. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiology and Drug Safety. 2006;15(11):808- 812.
Abou Taam M, Jacquot B, Ferard C, Thery A, Mounier C, Grandvuillemin A et al. The French pharmacovigilance surveys: A French distinctiveness, a real input. Therapies; 2020.
Soeiro T, Lacroix C, Micallef J. Adverse drug reaction monitoring: Doing it the French way – Act II. Therapies; 2020.
Lacroix C, Salvo F, Gras-Champel V, Gautier S, Massy N, Valnet-Rabier M et al. French organization for the pharmacovigilance of COVID19 vaccines: A major challenge. Therapies; 2021.
Agence nationale de sécurité du médicament et des produits de santé. Journal de Pédiatrie et de Puériculture. 2021;26(1):67-72.
Safety and Efficacy of the BNT162b2 mRNA Covid19 Vaccine. New England Journal of Medicine. 2021;384(16):1576-1578.
McMahon D, Amerson E, Rosenbach M, Lipoff J, Moustafa D, Tyagi A et al. Cutaneous reactions reported after Moderna and Pfizer COVID-19 vaccination: A registry-based study of 414 cases. Journal of the American Academy of Dermatology. 2021;85(1):46-55.
Merchant H. CoViD vaccines and thrombotic events: EMA issued warning to patients and healthcare professionals. Journal of Pharmaceutical Policy and Practice. 2021;14(1).
Mantadakis E, Farmaki E, Thomaidis S, Tsalkidis A, Chatzimichael A. A Case of Immune Thrombocytopenic Purpura After Influenza Vaccination. Journal of Pediatric Hematology/Oncology. 2010;32(6):e227-e229.
Hamiel U, Kventsel I, Youngster I. Recurrent Immune Thrombocytopenia After Influenza Vaccination: A Case Report. PEDIATRICS. 2016;138(6):e20160124-e20160124.
Rinaldi M, Perricone C, Ortega-Hernandez OD, Perricone R, Shoenfeld Y. Immune thrombocytopaenic purpura: an autoimmune cross-link between infections and vaccines. Lupus. 2014 May;23(6):554-67.
Pellegrino P, Clementi E, Radice S. On vaccine's adjuvants and autoimmunity: Current evidence and future perspectives. Autoimmunity Reviews. 2015;14(10):880-888.
Wise J. Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots. BMJ. 2021;n699.
Lee E, Cines D, Gernsheimer T, Kessler C, Michel M, Tarantino M et al. Thrombocytopenia following Pfizer and Moderna SARS-CoV -2 vaccination. American Journal of Hematology. 2021;96(5):534537.
Saudagar V, Patil S, Goh S, Pothiawala S. Vigilance regarding immune thrombocytopenic purpura after COVID-19 vaccine. Irish Journal of Medical Science (1971); 2021
Gupta A, Sardar P, Cash M, Milani R, Lavie C. Covid-19 vaccine- induced thrombosis and thrombocytopenia-a commentary on an important and practical clinical dilemma. Progress in Cardiovascular Diseases; 2021.
EMA. European Medicines Agency AstraZeneca's COVID-19 Vaccine Analysis; 2021.
Available:https://www.ema.europa.eu/en/news/astrazenecascovid-19-vaccine-ema-finds-possible-link-very-rarecases-unusual-blood-clots-low-blood 2021.
Logunov D, Dolzhikova I, Shcheblyakov D, Tukhvatulin A, Zubkova O, Dzharullaeva A et al. Safety and efficacy of an rAd26 and rAd5 vectorbased heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. The Lancet. 2021;397(10275):671-681.
Alimehmeti I. Efficacy and Safety of AZD1222, BNT162b2 and mRNA-1273 vaccines against SARSCoV-2. Albanian Journal of Trauma and Emergency Surgery. 2021;5(1):791-796.
Association of Facial Paralysis With mRNA COVID-19 Vaccines: A Disproportionality Analysis Using the World Health Organization Pharmacovigilance Database. American medical association. 2021;.
Lt. Pushkar a. Pharmacovigilance analysis on cerebrovascular accidents and Corona virus disease 2019 vaccines; 2021.
Jha N, Palaian S, Shankar P, Dangal G. Pharmacovigilance of COVID-19 vaccines in the context of Nepal: an assessment based on early adverse drug reaction reports. Journal of Pharmaceutical Health Services Research; 2021.
Logunov DY, Dolzhikova IV, Tukhvatullin AI, Shcheblyakov DV. Safety and efficacy of the Russian COVID-19 vaccine: more information needed–Authors’ reply. The Lancet. 2020 Oct 3;396(10256):e54-5.
Zhu F, Li Y, Guan X, Hou L, Wang W, Li J et al. 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. The Lancet. 2020;395(10240):1845-1854.
Lv G, Yuan J, Xiong X, Li M. Mortality Rate and Characteristics of Deaths Following COVID-19 Vaccination. Frontiers in Medicine. 2021;8.
Beninger P. Influence of COVID-19 on the pharmacovigilance workforce of the future. Clinical therapeutics. 2021 Feb 1;43(2):369-71.
Jyothi K. Navya1*, Jaka Archana , Velpula Padma Sujaya1, Rupavath Pallavi Nayak1, Randeep Raj C Vaddadi2J. A review on vaccine pharmacovigilance during COVID-19.J. innov. appl. pharm. Sci. 2021;6(2):15-22.
Available:www.saap.org.in ISSN:2455-5177.
World Health Organization causality assessment method; 2002.
Available:http://www.who-umc.org/ defs.html2002.
Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Safety. 1999;20(2):109-17.
Li J. Unexpected Opportunities for Innovators in the Post COVID World; 2021.
Available:https://blog.usejournal.com/unexpected-opportunitiesfor-entrepreneurs-in-the-covid-19-world-fd3eac2a441a. Posted May 2, 2020. Accessed January 23, 2021
Royster K. Friedman lab finds unexpected opportunities in COVID adjusted research activities; 2021.
Available:https://as.vanderbilt.edu/news/2020/11/30/friedman-lab-finds-unexpected-opportunities-in-covid-adjusted-research-activities/. Posted November 30, 2020. Accessed January 23, 2021
Roth M. The unexpected side effect of COVID-19: Collaboration. https://www.healthleadersmedia.com/innovation/unexpectedside-effect-covid-19-collaboration. Posted October 12, 2020. Accessed January 23, 2021
Emmons B. U.S population growth slowing to a crawl; 2021.
Available:https://www.stlouisfed.org/on-the-economy/2020/february/us-populationgrowth-slowing-crawl. On the Economy Blog. Posted February 10, 2020. Accessed January 23, 2021
Beninger P, Ibara M. Pharmacovigilance and biomedical informatics: a model of future development. Clin Ther. 2016;38:2514e2525.
Hauben M, Hung E. Global and country level time series analyses of the effect of the COVID-19 pandemic on spontaneous reporting. Clin Ther. 2021;43(2):80e88.
Whalen E, Hauben M, Bate A. Time series disturbance detection for hypothesis-free signal detection in longitudinal observational databases. Drug Saf. 2018;41:565e577.
Weber GM, Mandl K, Kohane IS. Finding the missing link for big biomedical data. N Engl J Med. 2014; 311:2479e2480.
Navya JK, Jaka A, Rupavath PN, Vaddadi RR. A review on vaccine pharmacovigilance during COVID-19. Journal of Innovations in Applied Pharmaceutical Science (JIAPS). 2021 Aug 14:15-22.
Beninger P. Influence of COVID-19 on the pharmacovigilance workforce of the future. Clinical therapeutics. 2021 Feb 1;43(2):369-71.
Kaur SP, Gupta V. COVID-19 Vaccine: A comprehensive status report. Virus Res. 2020;288:198114.
Jeyanathan M, Afkhami S, Smaill F, Miller MS, Lichty BD, Xing Z. Immunological considerations for COVID-19 vaccine strategies. Nat. Rev. Immunol. 2020;20:615–632.
Yan ZP, Yang M, Lai CL. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials. Pharmaceuticals. 2021;14:406.
Polack FP, Thomas S.J, Kitchin N, Absalon J, Gurtman A, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N. Engl. J. Med. 2020;383:2603–2615.
Baden, LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N. Engl. J. Med. 2021;384:403–416.
Ramasamy MN, Minassian AM, Ewer K.J, Flaxman AL, Folegatti PM, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): A single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2021;396:1979–1993.
Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, et al. 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. Lancet. 2021;397:671–681.
Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, et al. Interim Results of a Phase 1-2a Trial of Ad26.COV2. COVID-19 Vaccine. N. Engl. J. Med. 2021;384:1824–1835.
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