I know we have all heard by now about a possible vaccine coming soon! So far, it is 47 candidate vaccines undergoing clinical evaluation. But, what does this really mean? Vaccine clinical development will follow the same guidelines that are in place for for medications.
A company who wishes to begin clinical trials must submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND will include:
A description of the vaccine, how it will be manufactured, and the quality control tests that will be used.
A clinical document that will provide details for the study in humans.
Documentation that includes the ability to provide an immune response in animal testing.
Information about the investigator.
Note: Additional information related to the safety of the vaccine will be included as well.
Pre-marketing clinical trials are normally done in 3 phases. Let's take a few minutes to review those below!
Phase I - The purpose is to identify the safety and the immune response in a small number of individuals. These individuals will be closely monitored throughout this phase. In Phase I, it is important to figure out how the vaccine will interact in the human body. Researchers will adjust doses along the way to see how much the body can tolerate and what are some of the severe or sudden side effects that can occur. This phase can take several months and not all studies will move to Phase II.
Phase II - This will consist of several doses and more than 100 individuals will be enrolled in the study. The vaccine will be given to individuals who share the same characteristics of whom the vaccine is intended for.
Phase III - The goal is to enroll thousands of individuals. After Phase III, the study should be able to provide very important documentation that consist of the effectiveness of the vaccine and any additional safety data that is required for licensing. If the data raises any kind of significant concerns, the FDA will request additional information or the study can be put on hold. Once all 3 phases have been completed, the license can be submitted for FDA approval.
Phase IV - Some vaccines will go through Phase IV once it is on the market. Even after a vaccine has been approved, the FDA will continue to monitor the vaccine to ensure that it is still safe. Unfortunately, all potential adverse events will not be identified until the vaccine has been given to the general population. Also, the government will rely on the Vaccine Adverse Event Reporting System (VAERS) to identify any problems after it is on the market.
It is 8 vaccine candidates that are specifically in Phase III. It is 2 candidates that are in Phase II/III. Candidates in II/III will benefit by using a smaller amount of patients to answer research questions. Developing a vaccine in a few months is a very rare thing. But, these Clinical Trials are being monitored closely to help tackle this virus and hopefully provide a potential life-saving vaccine for COVID-19.
Did you know that Pharmacy Technicians work in Clinical Trial studies too? When you get a chance search online for Research Pharmacy Technician or Investigational Drug Pharmacy Technician. 😊
I hope that this post provided a little more insight on the Clinical Trial process and what we will be seeing over the next couple of months with a possible vaccine and/or treatment for COVID-19.
Continue to stay safe!