The covid-19 pandemic showed us how difficult it can be to monitor live the safety of vaccines when litterally millions of doses are distributed per day.
The vaccine manufacturer and the regulatory authorities are trying to catch up with the enormous amount of safety information being poured in their system while being under scrutiny by the press, public and the pharmacovigilance (PV) community. The public is looking for high transparency in specific times like pandemic where vaccines were released on the market using a fast track and some waivers. Unfortunately, the PV community does not have access to most of the data and cannot contribute in their area of expertise to analyze data in parallel. Only those belonging to 'right' organization (manufacturer or regulatory) have access to the case details. The rest of the pharmacovigilance community is left on the bench whereas eager to analyze, contribute. For those who can experience side effects on their own or through their medical office, they can submit letters into relevant journals, but the rest of them is left with official publications coming much later after the peer review process and very often without the full case details. Their energy is lost on posts in social media and the PV community does not benefit from their curiosity, expertise and eagerness to contribute.
The field of epidemiology though has benefit from the covid-19 pandemic: new visualizations have been created, exposure data has been centralized, expertise about parameters influencing propagation has been gained, etc.
In pharmacovigilance, the covid-19 didn't change the way to share the data, new methods have been developed but they stay within the walls of the company developing them, etc.
The solution is simple though: create a platform with the data and the evaluations across organizations.
We consequently upgraded VAERS Analytics with signal management functionalities to allow people from different organizations to contribute. And to stay ahead of the next epidemic we loaded VAERS data related to the monkeypox vaccine Jynneos.
Anyone in the PV community can request access and is free to contribute after a demo on how to use the tool. I hope to expand the scope from VAERS to literature. And potentially to other data sources if they are made available to OpenSourcePV (fingers crossed).
For requesting access or for more information, please contact email@example.com