{"id":39470,"date":"2021-02-11T11:37:29","date_gmt":"2021-02-11T16:37:29","guid":{"rendered":"https:\/\/arisglobal.com\/?p=39470"},"modified":"2021-02-11T11:37:29","modified_gmt":"2021-02-11T16:37:29","slug":"balancing-speed-safety-and-risks-in-a-global-pandemic","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/balancing-speed-safety-and-risks-in-a-global-pandemic\/","title":{"rendered":"Balancing Speed, Safety, and Risks in a Global Pandemic"},"content":{"rendered":"\n\n

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.<\/span><\/p>\n

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 \u2013 that is the time between clinical trials, entering and analyzing safety data, and areas where activities can be done in parallel.<\/span><\/p>\n

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.<\/span><\/p>\n

Additionally, a Pharmacovigilance Safety Database Provide<\/a>r 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\u2019s 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.<\/span><\/p>

In a recent webinar with Linical Americas and ArisGlobal, the two companies discussed \u201cVaccine Development and Surveillance in the Age of Covid<\/a>\u201d. In the session, they revealed that the following makes vaccine production unique: <\/span><\/p>\n