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Balancing Speed, Safety, and Risks in a Global Pandemic

In the age of Covid-19, the cause of a global pandemic, everything has changed over the last year in nearly every aspect of life. The pharmaceutical industry is at the center of this on helping to mitigate. We have seen dramatic adjustments in the way vaccines are developed, tested, and surveilled for safety. Previously, developing a vaccine would take 7-10 years. In 2020, two vaccines were produced in less than a year in response to Covid-19. Despite these changes, it is important that the traditional development steps are preserved as well as safety and pharmacovigilance actions. Let us take a deeper look into how vaccine safety continues to be prioritized and the different elements that are involved.

First, it is important to be efficient and save time. Specifically, it is important to discover areas where time savings can be realized to release new vaccines quickly, without taking shortcuts on vital safety and surveillance requirements. This is critical in reducing administrative time – that is the time between clinical trials, entering and analyzing safety data, and areas where activities can be done in parallel.

In the push to release a COVID-19 vaccine, many steps were running in parallel such as conducting trials while mass production started. While this was a very visible piece in the speed to release, the ability to reduce the resources needed to enter and analyze all the possible adverse event data, allowed safety concerns to be reported, researched, and remediated to meet safety standards. The ability to get through the safety process by increasing efficiency while not skipping critical steps is going to become more common across vaccines and other biopharmaceuticals.

Additionally, a Pharmacovigilance Safety Database Provider that increases efficiency, reduces risks, and keeps vital information at the hands of those who need it, is paramount to allowing hybrid clinical trials, different paths to AE reports, and global teams to simultaneously see and use this data to ensure drug safety. ArisGlobal’s LifeSphere MultiVigilance (LSMV) covers all these bases. Product safety is a key variable in determining how quickly a vaccine can be brought to market and vaccine safety requires a unique approach to pharmacovigilance.

Linical Vaccine Development in Age of Covid

In a recent webinar with Linical Americas and ArisGlobal, the two companies discussed “Vaccine Development and Surveillance in the Age of Covid”. In the session, they revealed that the following makes vaccine production unique:

  • Usually administered to healthy individuals
  • Preventative in nature
  • Administered to a large population with different physical characteristics.
  • Likely provided to children and infants
  • Vaccines are not administered on a continuous basis
  • Generally complex biological products with multiple components
  • Much less than other pharmaceuticals

 For these reasons, the safety system implemented needs to allow teams to find possible safety issues with efficient data intake, best in class signal detection, and automation with the latest AI and ML. A system with these capabilities, aids in discovery of safety issues and concerns, in the noise and growing caseloads that are required in a contracted product release.

Developed in partnership with the world’s best life sciences companies, LifeSphere MultiVigilance is an end-to-end, automated safety system that helps hundreds of pharmacovigilance teams around the world save time and effort, ensure future-proof compliance, and keep global teams aligned.

To learn more about ArisGlobal’s LSMV: LifeSphere MultiVigilance 10 – End-to-End Drug Safety System | ArisGlobal | ArisGlobal

 

 

 

 

 

 

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