Clinical Research as Clinical Care When Vaccines are in Short Supply. | Alcanza Clinical Research

Dr. Rica Santiago
Coastal Carolina Research Center

 mRNA advances opened a world of new drug development pathways with the success of COVID vaccines. The first-ever vaccine for RSV shortly followed, and today there are many exciting new opportunities in the biopharmaceutical pipeline to treat and prevent disease. However, the initial excitement has recently turned into widespread frustration, due to a massive vaccine shortage in the updated COVID-19 vaccines and RSV shots for children. 

Dr. Rica Santiago, Principal Investigator at Coastal Carolina Research Center discusses the potential for an expanded role of clinical research to offset vaccine shortages and ensure broader vaccine access across a wide range of communities who may struggle to find them or face challenges in getting their insurance to pay for it. As the demand for vaccines outpaces supply, joining clinical trials emerges as a viable avenue for many to access these life-saving shots. The many benefits of vaccine clinical research participation include: 

Expedited Access to Vaccines 

Participating in vaccine clinical trials often means that study volunteers receive vaccines that are being evaluated as investigational products or FDA-approved vaccines that are considered standard of care. In either scenario, participants receive treatment they may otherwise be hard pressed to find. In situations where there’s a shortage, being part of a trial might provide individuals with earlier access to vaccines than the general public. It’s a win-win – participants have the potential for early access, and researchers gain valuable data. 

Advancing Scientific Knowledge to Build on a Growing Body of Vaccine Evidence 

All clinical trials generate valuable data for the scientific community to build upon – including the clinical trials that fail on treatment efficacy. As mRNA are a relatively new type of vaccines, knowledge building is mission critical to advance and accelerate the promise of mRNA technology across a wide range of therapeutic areas.  More vaccines and more effective booster shots mean better distribution and improved access. By participating, individuals can accelerate this expansion, making vaccines available to more people, faster. It’s also worth noting one of the top motivations for participating in a research trial to help advance science for others. 

Global Reach and Equitable Distribution 

Clinical trials often occur simultaneously in multiple locations worldwide. Participating in these trials can bolster the data needed to approve vaccines in various regions, ensuring a more equitable global distribution. This is particularly crucial for areas experiencing acute shortages. There’s also the growing issue of health equity. Insurance reimbursement is not guaranteed and, in many cases, there’s a lag time before insurers will pay for associated costs. When vaccines aren’t readily accessible to the people who need them, it will ultimately drive up the cost of care. Clinical trial participation is a great way to receive medical care for free. The ongoing medical monitoring that is a standard part of every clinical trial is comprehensive and rigorous. Considering the average vaccine trial spans six months, participants may visit research sites every two to four weeks for early phase studies and every four to six weeks for Phase III trials, the level of personal medical attention and oversight is arguably superior to the medical attention received at a doctor’s office or clinic for a single vaccine. 

Alleviating Pressure on Mainstream Supplies 

With a section of the population receiving vaccines through trial participation, the pressure on mainstream vaccine supplies is reduced.  In practical terms, this means that vaccines from the primary supply chain can reach a broader audience, mitigating the effects of shortages. 

As the world continues to navigate vaccine shortages, clinical trials offer a practical alternative and beacon of hope. They not only pave the way for scientific advancements but also provide a direct avenue for individuals to access vaccines. In the current climate, promoting clinical trial participation is more than just a call for scientific collaboration; it’s a call to action for community resilience and global health.