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On this page you will find links to a wide variety of resources related to safety monitoring and pharmacovigilance with a focus on COVID-19. You will find tools and guidelines, relevant publications and discussion articles, videos, links to external sites and much more.
We are continually updating this page so please check back often! If you have any tools, other resources or items of interest that you believe would be helpful for others and that you would like to share with members, please let us know, either as a blog, in one of the discussion groups, or email a site co-ordinator directly.
Covid-19 Vaccines: Safety Surveillance Manual
The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
For ease of use, the manual is available in a compiled form and in several separate modules that can be consulted individually. For each module, specific training material is also available to facilitate implementation.
Safety of COVID-19 Vaccines - Article
Part of a series of explainers on vaccine development and distribution
Coronavirus disease (COVID-19): Vaccines Safety Q&A
WHO Q&A on COVID-19 Vaccines Safety
COVID-19 Vaccine Safety Poster
Poster advising healthcare workers on how to montior and report COVID-19 vaccine side effects
COVID-19 Vaccine Pharmacovigilance Dashboard
This dashboard aims to support regulatory processes for the introduction and the monitoring of COVID-19 vaccines safety in the Americas, consolidating in a single tool information on the various components of the matter. The dashboard is presented in Spanish and English language, and consists of the following components or sections:
Resources - COVID-19 Information
Webpage dedicated to information on pharmacovigilance of medicinal products used to treat and prevent COVID-19 (coronavirus).
ISoP Vaccine Surveillance Special Interest Group
The overall aim of the Vaccines SIG is to provide a focal point for ISoP members interested in vaccine safety to share and provide information on relevant issues and developments and to support vaccine pharmacovigilance.
The Vaccine SIG has recently conducted a webinar series entitled 'Vigilance of COVID-19 vaccines'.
ISoP Israel Chapter - COVID Vaccine Information Campaign
A series of COVID-19 vaccine safety-related Q&As based on validated references from Vaccine Safety Net, Regulatory agencies, FDA, EMA. MHRA, WHO, Israeli Ministry of Health, and scientific literature.
Medicines safety during COVID-19
Useful information and guidelines for carrying out pharmacovigilance work during COVID-19, including the following:
- How to capture adverse event reports for COVID-19 treatments
Coding guidance for reports concerning COVID-19 treatments
- How to find adverse event reports linked to COVID-19 in VigiLyze
Guidelines to help users in the WHO Programme for International Drug Monitoring find adverse event reports linked to COVID-19 treatments
Video: COVID-19 research at Uppsala Monitoring Centre
Pharmacovigilance scientist Alem Zekarias gives an overview of UMC's research activities related to COVID-19, including a study on sex differences in reported adverse drug reactions to COVID-19 drugs.
Video: Vaccine Safety and Pharmacovigilance Videos
UMC video series on vaccines pharmacovigilance
Monitoring of COVID-19 medicines
The European Medicines Agency (EMA) is making use of real-world data to monitor the safety and effectiveness of authorised COVID-19 treatments and vaccines and other medicines used in patients with COVID-19 in the European Union (EU).
Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines
In view of the public health urgency and the extensive vaccination campaigns foreseen worldwide, the European Medicines Agency (EMA) and the national competent authorities (NCAs) in EU member states have prepared themselves for the expected high data volume by putting in place this pharmacovigilance plan specific for COVID-19 vaccines.
Consideration on Core Requirements for RMPs of COVID-19 Vaccines
Marketing authorisation applicants for COVID-19 vaccines should follow EMA's guidance on preparing risk management plans (RMPs) for COVID-19 vaccines, together with guidance on Risk management plans and Good pharmacovigilance practices, which apply to all medicines. The guidance reflects special safety monitoring measures for COVID-19 vaccines by providing considerations and requirements for several sections of the RMP.
COVID-19 vaccines: development, evaluation, approval and monitoring
Safety updates for authorised COVID-19 vaccines
EMA publishes monthly safety updates for the COVID-19 vaccines authorised in the EU.
Public-health advice during COVID-19 pandemic: Reporting suspected side effects
The European Medicines Agency (EMA) is providing impartial advice to patients and healthcare professionals on the safe use of medicines during the COVID-19 pandemic, in particular in patients with or at risk of COVID-19 infection.
Brighton Collaboration COVID -19 Resources and Tools
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with the Brighton Collaboration (BC), through the Task Force for Global Health (TFGH), to harmonize the safety assessment of CEPI-funded vaccines via its Safety Platform for Emergency vACcines (SPEAC) Project. SPEAC is creating resources and tools to facilitate COVID-19 vaccine safety clinical trials and pharmacovigilance, which includes the following:
- COVID-19 AESI list: Literature Review and Quarterly Updates
- Webinars on COVID-19 Vaccine Safety
- BRAVATO (Benefit-Risk Assessment of VAccines by TechnolOgy) Templates
- AESI Case Definitions
- Glossary of Terms to define terms used in the anaphylaxis and neurologic case definitions.
- AESI Case Definition Companion Guides
Medical Product Quality Reports
These monthly reports aim to collate information and reports in the public domain on the quality of medicinal products that are currently in use, or that are being trialled for COVID-19’s prevention or treatment. They do not aim to include discussion of the multiple fraudulent claims and quackery. They also include reports on key subjects such as access, affordability or off-label use for COVID-19 if they mention concern of the quality of the products. The reports presented are mostly extracted from the Medicines Quality Monitoring Globe (MQM Globe), a system that scrapes online newspapers (referenced in Google News) for early warnings of substandard and falsified medical products. The reports also include scientific literature and policy documents related to COVID-19 medical products quality identified by manual searches in PubMed and Google Scholar.
ISPE Members COVID-19 Work
COVID-19 has emphasized the importance of epidemiologic expertise on many levels, including our work in pharmacoepidemiology. This webpage is dedicated to featuring ISPE members’ work aimed at addressing the pandemic.
COVID-19: Ensuring the Safety of Vaccines
COVID-19: DSRU research and capabilities
Includes information on The UK Consortium for Monitoring the Post-authorisation Safety and Effectiveness of COVID-19 Vaccines and Systematic Benefit-Risk Assessments on drugs used to treat COVID-19.
COVID-19 Drug Interactions Checker
The Liverpool Drug Interactions website team have developed this freely available drug interactions resource to provide information on the likelihood of interactions between the experimental agents used for the treatment of COVID-19 and commonly prescribed co-medications.
COVID-19 vaccine safety monitoring plan
The aim of the COVID-19 Vaccine Safety Monitoring Plan is to strengthen the existing vaccine vigilance system for early detection and investigation of suspected side effects (also known as adverse events) following COVID-19 immunisation.
MHRA guidance on coronavirus (COVID-19)
The MHRA is producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak, including:
- Vaccines and vaccine safety
- Medicines and COVID-19
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