A review on vaccine pharmacovigilance during covid-19

Navya, Jyothi K; Jaka, Archana; sujaya, Velpula Padma sujaya Velpula Padma; Rupavath, Pallavi Nayak; Vaddadi, Randeep Raj C

doi:10.37022/jiaps.v6i2.226

Cited by 2 publications

(2 citation statements)

References 16 publications

(13 reference statements)

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“…Pharmacovigilance, too, may well be the beneficiary of unexpected opportunities during these periods. During the past 1 to 2 decades, PV has evolved as it has settled into three core disciplines-case management, signal management, and benefit-risk managementsupported by professionals with distinct and gradually defined knowledge bases and skill sets [33,50]. Furthermore, PV has played increasingly important roles in other domainfacing disciplines of pharmaceutical research and development, including nonclinical and clinical pharmacology, regulatory affairs, manufacturing, and medical affairs [51].…”

Section: Impact Of Covid-19 On the Pharmacovigilance Workforcementioning

confidence: 99%

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

Tembe-Fokunang

Nyuki²,

Fokam³

et al. 2022

JAMPS

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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.

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Section: Impact Of Covid-19 On the Pharmacovigilance Workforcementioning

confidence: 99%

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

Tembe-Fokunang

Nyuki²,

Fokam³

et al. 2022

JAMPS

View full text Add to dashboard Cite

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“…Five incidences of severe hypersensitivity reactions were promptly recorded. The following ADRs are uncommon, although clinical trial evidence [7] shows that lethargy, headache, nausea, fever, and [14]. In the pharmacovigilance database, 150 cases of immune thrombocytopenic purpura were documented after immunisation, according to BMJ [15].…”

Section: Covid-19 Vaccine Vigilancementioning

confidence: 99%

Covid-19 vaccines pharmacovigilance-a rapid review

Arackal¹,

Kalaparambath²,

Kidangeth³

et al. 2022

Asian Jour Hosp Phar

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The rapid process of research and development and lack of follow-up time post-vaccination aroused greater public concern about the safety profile of COVID-19 vaccine candidates. Pharmacovigilance is critical for gathering, recognising, and monitoring adverse events, which is the primary goal. The reported adverse events should be evaluated to determine the causal relationship and avoid unnecessary consequences on the recipient. Many people are getting vaccines in a short period of time, putting a strain on pharmacovigilance facilities. The International Society of Pharmacovigilance (ISOP), the French National Agency for Medicines and Health Products Safety (ANSM), and many others worked together and took many initiatives to determine the safety and efficacy of vaccines, as well as to provide answers to the questions that were raised. Signals were discovered and several adverse occurrences were identified thanks to pharmacovigilance. BioNTech/Pfizer-m-RNA, Moderna-mRNA vaccine, Covishield, Johnson and Johnson, Vaxzervria, Sputnik V, and Convidicea pharmacovigilance is discussed. There were 12,249 ADRs reported with BioNTech/Pfizer-mRNA, 577 ADRs with Moderna-mRNA vaccine, 447 ADRs with Covishield, 653 ADRs with Johnson and Johnson, and 743 ADRs with Vaxzervria. As a result of these immunizations, Immune thrombocytopenic purpura, cerebrovascular events, thrombosis, thrombocytopenia, facial paralysis, fatalities, and a variety of other potentially lethal reactions have all been linked to these immunizations. However, the recorded incidents were minor in comparison to the patients' safety. The Uppsala monitoring centre kept track of all of these events. Uppsala monitoring centre, an initiative of WHO to detect various ADR relating to medications and preventing serious causalities associating with it have a greater role in minimizing the serious cases occurs with medicine dysfunction.

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A review on vaccine pharmacovigilance during covid-19

Cited by 2 publications

References 16 publications

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

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

Covid-19 vaccines pharmacovigilance-a rapid review

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