COVID‑19 Pharmacovigilance Platform
The global distribution and allocation of several COVID‑19 vaccines simultaneously will create multiple challenges in global health — including pharmacovigilance of vaccine and drug safety combinations.
The massive scale of deployment of SARS‑CoV‑2 vaccines to prevent the development of COVID‑19 disease will be unprecedented. This is at a time when societal pessimism and concerns about vaccination are at an all-time high. We need to implement policies and procedures as well as reporting systems that utilize the most sophisticated methods of pharmacovigilance to combat all of these issues. The current phase of development of the candidate vaccines is not as mature and thoroughly studied either on a mechanistic basis or through a staged clinical development process. Therefore, the challenges in the regulatory approval of safe and effective vaccines against coronaviruses is a monumental task.
Multiple vaccines to combat COVID‑19 are going to be approved shortly, some following a novel “rolling review” scheme and while some are based on traditional approaches, including antigens and adjuvants, others have accelerated completely novel technologies and unproven basis with fast-track approval. There exists a significant imbalance between our understanding of the safety and long-term efficacy of these vaccine candidates and their ability to protect against future SARS‑CoV‑2 infection.
The evaluation of vaccine reactions in the presence of other medicinal products is largely underexplored which amplifies the necessity to monitor and evaluate drug-vaccine interactions. In such a broad population health approach there may be a significant number of previously uncharacterized or unknown biological events and clinical outcomes that may put many patients at risk. It is our aim to detect signals that will enhance the prediction of adverse events resulting from vaccination to protect against COVID‑19.
Caparna offers the incorporation of new analytical methodologies, reporting and safety systems which the company believes will propel vaccine safety surveillance into the twenty-first century. At this time, our goal of is to provide tools that may aid in the protection of public health within populations receiving recently developed SARS‑CoV‑2 vaccines while enhancing the ability to evaluate collected evidence of vaccine safety and potential adverse events.