With global concerns over vaccine safety, DZS works to dispel myths, increase knowledge
By Kathryn E. Vinson, MS, CCRC
Vaccines are without a doubt a subject of much controversy, especially in today’s hyper-connected world. From fears of developmental disorders to questions about safety and testing, there is seemingly no end to the questions and alarms that are raised almost daily on our social media platforms. Here at DZS, we want to take some time to discuss some of these issues, as well as what we in the clinical research industry are doing to ensure safe, reliable vaccines.
As a global leader in clinical research, DZS Clinical Services is proud to partner with sponsors and sites around the world working on vaccines against COVID and many other diseases. With this pandemic in particular, we have seen the power of the research community, both in terms of collaboration and speed. While most people are in awe of the way researchers have come together, many in the public have expressed uneasiness over the speed of development.
This speed of development, while awe inspiring to many, has raised fears over the ability of the research community to adequately review the data. Contrary to the belief of some in the general public, investigational vaccines must go through the same rigorous testing (safety and efficacy trials) as any other investigational new drug. From pre-clinical to Phase I healthy volunteer trials for tolerability and safety, to phase III studies looking at efficacy and safety, investigational new vaccines are scrutinized at every step. With phase III testing often requiring data from thousands of volunteers, the concerns regarding this speed are understandable.
The graphic below, courtesy of our friends at the CDC, explains the journey that vaccines take from the lab to marketing.
As it seems that these vaccines have been developed at lightning speed compared to the timelines we see for other investigational new drugs and devices, some skepticism is understandable; however, we want to address these issues in order to allay the fears of the general public – both in regards to COVID vaccine research, and vaccine trials in general.
No Cutting Corners
As the old saying goes, when we work together, anything is possible – and that is precisely what we are seeing on a global scale in our quest for a safe and effective COVID-19 vaccine. With researchers worldwide fully engaged in the fight to end this pandemic, data and methods are being shared in an unprecedented manner. Massive levels of funding for the development of these immunizations have enabled these collaborations, as well as provided ample moneys needed for both laboratory and clinical trials.
But what about the data from those thousands of research participants? Thankfully, we live in a time with electronic data capture and electronic case report forms that can be uploaded to the project databases in a mere fraction of the time that it would have taken as recently as ten to twenty years ago. By utilizing standardized formatting, such as we discussed in “All Hail the King” with CDISC, quality statistical analyses for safety and efficacy can be completed in record time.
In a similar manner, the call for volunteers has been answered with a resounding “Yes!” From the perspective of research sites running vaccine trials, the recruitment of volunteers is generally not a difficult task. With no shortage of healthy, normal volunteers, vaccine trials usually reach their targets quickly. The public interest in finding a vaccine for the novel coronavirus has also aided in recruitment efforts, as many people are eager to assist their fellow man.
For more on DZS Clinical Services partnerships with researchers globally, be sure to check back in with us next week, when we take an in depth look at vaccine development in Africa.