The reported side effects of COVID-19 vaccine such as fever, fatigue, headache, muscle pain, chills, and diarrhoea among others have been mild to moderate in most cases. However, adverse events have emerged, which make monitoring and surveillance of adverse events following immunization (AEFI) crucial for massive immunization exercises underway.
Technological intervention by way of pharmacovigilance at various checkpoints can help in standardized AEFI reporting for assessment and employment of safety measures in the long run. Pharmacovigilance deals with the detection, medical assessments, evaluations, monitoring and, prevention of adverse drug reactions (ADRs)
This paper will explore how technological interventions can help to address the challenges that the pharma companies are facing today. Pharmacovigilance plays a critical role in the following areas:
Patient/ Consumer safety: Creates appropriate reporting structure to assess and monitor drugs both during and post clinical trials.
Regulatory obligations and compliance: Creates appropriate protocols for drug recalls, issuing patient/consumer warnings and assure compliance.
Enhanced process: Creates and provides better assessment and evaluation for the drug companies to ensure long-term viability for the business and improved trust from the patients/consumers.
COVID-19 and the state of vaccination
The COVID-19 pandemic caught everyone unaware. Around the world, the regulatory bodies and governments began talks with pharma players to accelerate the vaccine development process. These efforts to produce a vaccine at a breakneck pace resulted in advancing the process of production by almost a decade.
The first three COVID-19 vaccines were given emergency use authorization2 (EUA) by the end of 2020 in the US, UK, and Europe, in less than a year. At the time of licensing the vaccine, the WHO3 found identification of rare and very rare adverse events insufficient to provide more information on AEFI.
The latest data as of 20 June 2021 revealed that 2.66 billion doses of the COVID-19 vaccine have been administered globally. There have been reports of side effects and a few are severe in different COVID-19 vaccines. There is a need to strike a delicate balance in communicating the rare side effects alongside the dangers of severe COVID-19.
Challenges in AEFI reporting
The chances for immunization errors and AEFI are much higher during large-scale vaccination exercises than routine immunization. Clinical trials may not detect extremely rare side effects, which might occur in less than one case per 1 million vaccinations. Certain reports on adverse effects indicate severe allergic reactions and blood clots, but it is difficult to ascertain which should be actually linked to the vaccine.
Several European countries paused5 the distribution of vaccines made by the University of Oxford and AstraZeneca following the reports of blood clot disorders in mid-March 2021. It was resumed soon after the European Medicines Agency (EMA)6 said that it could not definitively state whether the cases were linked to the AstraZeneca vaccine.
These instances highlight the need for better AEFI reporting. Complete reporting with as much detail as possible at the first point of contact is critical. However, the adherence to AEFI guidelines at ground level becomes challenging due to the following factors:
- Possession of varying levels of knowledge among stakeholders.
- Lack of clarity on their roles and responsibility among stakeholders to carry out their tasks satisfactorily.
- Under reporting or double reporting of the affected cases due to varying reporting standards set by regulatory bodies.
- Misinformation surrounding vaccination among certain population groups leading to vaccine hesitancy.
- Available data on adverse effects of vaccines is unsatisfactory for health bodies to undertake proactive measures.
Multilateral health body WHO had outlined various aspects of AEFI that have an impact on the overall ecosystem in its report. Let us take a closer look:
- A large number of immunization anxiety-related reactions are anticipated due to numerous factors including older age groups, the different vaccinating environments, the novelty of the vaccines and their administration modalities.
- Because of potential comorbidities in vaccines if they are tested and proved, it will be challenging to differentiate true coincidental events from COVID-19 vaccine product related reactions or drug reactions or interactions.
- Coincidental events can occur in healthy individuals without comorbidities especially where a higher frequency is expected based on age, gender, geographic location or ethnic background.
- Knowing the population-based incidence (background rates) of pre-specified adverse events of special interest (AESI) helps to anticipate and respond to such events.
- For new vaccine platforms, the knowledge of potential vaccine quality defects might be insufficient at the time of COVID-19 vaccine licensing, more information will be needed for which AEFI, and AESI surveillance must be strengthened.
- The rapid scaling up of vaccine production poses additional potential risks and identification of the exact substance causing the event is needed.
Many public health bodies are aware of the potential adverse side effects but the overall public good outweighs the few adverse cases reported.
At the regional level, governments have taken steps to educate and inform the public about adverse effects. For instance, the Health Sciences Authority in Singapore actively monitors the safety of COVID-19 vaccines to ensure that the benefits of these vaccines continue to outweigh the risks and that they remain safe for use.
Solution: Timely intervention, prediction, and tracking
During the early period of the COVID-19 pandemic, governments were active in promoting open government data (OGD). In a study, the Organisation for Economic Co-operation and Development (OECD) made following observations on COVID-19 data use:
- There has been a missed opportunity to use OGD to address the pandemic with more sophisticated products during the initial stages.
- The governments were not fully prepared to release relevant, high-quality datasets with the speed and quality necessary.
Wipro’s scalable and sustainable pharmacovigilance operating model brings value to organizations by optimizing human capital, and by enhancing product quality and patient safety. Wipro’s dedicated centres of excellence for pharmacovigilance vertical focuses on:
- Medical Information Contact Center (MICC): Wipro’s MICC is a well-established unit, providing specialized services in managing medical inquiries, product quality complaints and adverse event management.
- Individual Case Safety Report (ICSR) Management: Wipro offers a cost-effective adverse event management system for post marketing and clinical trial cases for global regions.
- Signal and Risk Management: Wipro provides companies with risk management and support services in preparation of communication plan, signal detection, validation, and prioritization and characterization.
- Literature Search: Wipro has extensive capability in performing literature search and analysis in various databases using a specialized search strategy that has been developed to identify relevant safety publications and, at the same time, minimize non-relevant publications.
- Qualified Person for Pharmacovigilance (QPPV) Services: Wipro’s QPPVs are highly qualified and experienced resources, supporting as Point of Contact for EMEA, AFME, LATAM & APAC regions along with National Competent Authorities on a 24/7 basis.
- Medical Writing: Wipro’s medical writing team has extensive industry experience in authoring, reviewing, and submission of high quality documents for regulatory submissions and scientific communications. Our services include authoring, review, finalization, publishing and submission of reports.
Transforming pharmacovigilance with technology
Organizations can utilize data-backed research and digital interventions to revamp their design and execution of clinical trials and minimize risks in the long term.
Standardized reporting and data collection
Standardized tools provide a platform for synchronized efforts and a measurable way to interpret massive amounts of data generated. Wipro has developed a unique PV Automation Service Platform called TaloSafe for achieving a complete, correct, and compliant output through a global delivery model so that pharmacovigilance operations teams can ensure clinical and compliance corrections of cases. The framework lets you track the process, monitor metrics, and extract meaningful reports.
Training and re-skilling
Health workers should be trained to provide factual data and infographics on side effects. Training can help healthcare workers cement their understanding of data and how to build critical skills for real-time decision making. Wipro’s QPPVs services can be used to train healthcare workers and staff to understand AEFI reporting guidelines and perform their tasks effectively.
Risk assessment and audit
Healthcare organizations in the near term should conduct an audit of their data model to identify the risks of errors in critical operational areas. Wipro offers Talosafe as the next-gen, end-to-end completely integrated service for optimized processes across the clinical, regulatory and PV functions around the globe.
Tackle misinformation and respond timely on AEFI
Pharmaceutical companies and public health bodies can leverage social media business intelligence in identifying adverse events and respond in time. Wipro’s 4-step social media model lays bare enhanced measures for ensuring patient safety. The first is to identify the right keywords that your audience is using to search for you. Second, listen to their conversations and feedback. Third, leverage reporting and analytics on the captured data, and fourth, respond creatively and leverage this medium to generate awareness and address their problems.
Establish surveillance for analysis and classification of AEFIs
Blockchain can help address the challenges in pharmacovigilance. Blockchain provides a de-centralized and evenly distributed database in terms of nodes, safeguarding security and transparency of the data.
Toward a secure future
It remains to be seen how the vaccines fare in providing long term protection from COVID-19. As countries cautiously weigh vaccine inoculation for younger populations who are not included in the vaccination program now, wider surveys, research and data analysis will help understand the implications.
Qualitative assessment will reveal differences in experiences and standardization in AEFI reporting. Healthcare centers and medical workers at the forefront will play a pivotal role in collating, interpreting and analyzing the ongoing COVID-19 vaccination programs. The training and re-skilling of medical workers will aid greatly in ascertaining factual accuracy, surveillance and reporting.
Efforts in these areas alongside public awareness campaigns by health bodies will help to break myths surrounding vaccination. People worldwide will embrace the vaccines that passes the safety net with minimal side effects.
If you are interested in learning more about how Wipro is helping our clients achieve a transformed pharmacovigilance system, please connect with our experts.
About the Author
Dr Sakshi Rastogi has over 18 years of life Sciences and pharmaceutical industry experience in areas of pharmacovigilance, medical affairs, operations, program management, presales and solutioning, and analytics (Commercial & Safety). She is a certified physician and previously worked as a clinical practitioner. In Wipro, she is a principal consultant in Medical Devices Pharma and Services for Pharmacovigilance and Medical Affairs. She is passionate about improving business value meter for clients and spearheads transformative solutions across industry verticals.