As our society continues to grow and develop, the role of public health becomes more critical. One of the measures in which public health is pursued is through creating and distributing vaccines however, how do we know a vaccine is safe as well as effective in its use of preventing disease and prolonging life in our community? An effective vaccine starts with thorough research and development before moving into multiple phases of clinical trials, which are used to evaluate the safety of the vaccine before it is ever released to the general public.
The Food and Drug Association writes, “Currently, the United States of America has the safest, most effective vaccine supply in its history” so our country takes great care in ensuring that its vaccines are effective and safe for public use. As a part of the efforts to ensure that America continues to develop and release safe vaccines, we know just how important vaccine trial safety protocols are. Let’s take a closer look at just a few of the many safety measures and protocols that are followed in the United States.
Clinical Trials
Vaccines are developed and tested in laboratories before they ever move on to animal or human testing. Laboratory tests must come back and show potential before the vaccines are tested on animal subjects. From there, the vaccine must prove to be safe on these test subjects and is then moved into a series of clinical trials with human subjects. There are four phases of clinical trials that a vaccine will move through, each designed to test for safety and efficacy. You can read more about each phase of a clinical trial in Aim Trial’s previous blog post.
Rules and Regulatory Bodies
Every component of vaccine research, development, manufacturing, marketing, and distribution is highly regulated by policies and regulatory bodies. The Food and Drug Administration (FDA) ensures a vaccine trial meets scientific and ethical standards and also licenses (approves) vaccines once they’re ready to hit the market. In addition to evaluating the available information and licensing vaccines, the FDA also continues to ensure the safety, effectiveness, and availability of vaccines in the United States. Manufacturing companies must make sure the vaccines they are batching are potent, pure, and sterile, and the FDA confirms their findings and inspects their factories. There are also policies in place that state these manufacturers must obtain a license to ship the vaccine between states or to the country.
Ethical Review Boards
There are regulatory bodies that exist to make sure vaccines are as safe as possible, and there are also ethical review boards (ERBs) who ensure ethical standards are met during clinical vaccine trials. ERBs are made up of community representatives, academic researchers, ethicists, and medical professionals who independently evaluate a clinical trial’s design and its participant procedures. The continued evaluation and approval of an ERB (also called an Institutional Review Board) ensures that research participants and their rights are protected.
Data Monitoring Committees
Once a vaccine is on the market, there are still measures in place to ensure the vaccine remains effective in its purpose and is safe for public use. The U.S. has one of the most advanced systems in the world for tracking and ensuring the safety of its vaccine supply, and this is largely because of its long list of data monitoring committees that all work together to provide a full picture of vaccine safety. Outlined by the U.S. Department of Health and Human Services, a few of the data monitoring committees in the United States include:
- Vaccine Adverse Events Reporting System (VAERS): If patients or healthcare professionals notice a negative side effect after receiving or administering a vaccine, they can use VAERS to report the side effect. This committee tracks the patterns of side effect reporting to determine if there is a potential vaccine safety issue that needs to be evaluated.
- The Vaccines Safety Datalink (VSD): This committee uses databases of medical records (not self-reports) to compare data to determine if side effects are related to a vaccine. They are able to work and do research in large populations.
- Post-licensure Rapid Immunization Safety Monitoring System (PRISM): They focus on monitoring post-licensed vaccines and utilize a database of health insurance claims to identify potential safety issues for these vaccines. They are a part of the FDA’s national system to check in on post-licensed vaccines.
- Clinical Immunization Safety Assessment Project (CISA): CISA was established in 2001 to address unmet vaccine clinical research needs. If a healthcare provider requests it, they will also evaluate complex individual cases.
- Other Data Monitoring Committees: The above are just a few of many organizations working to analyze incoming data in real time. A few more committees that complete ongoing research on vaccines and vaccine safety include the Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), National Institutes of Health (NIH), and the Office of Infectious Disease and HIV/AIDS Policy (OIDP).
Transparency and Communication
In order to protect participants and their rights, participants and patients are prioritized throughout every stage of the trial process. During clinical trials, participants receive detailed information about the purpose of the trial, potential risks, and benefits. Communication is kept transparent and clear, so participants can make informed decisions, further emphasizing ethical standards and respect for autonomy. At Aim Trials, our team is dedicated to fostering an environment of trust and open communication, ensuring our patients feel safe, supported, and informed at all times.
Understanding Vaccine Safety Protocols at Aim Trials
Here at Aim Trials, we are committed to conducting high-quality clinical trials that contribute to the development of safe and effective vaccines.
If you or someone you know is interested in contributing to the advancement of public health efforts, Aim Trials is equipped to facilitate vaccine studies for your company. Aim Trials has successfully partnered on Phase 2 through Phase 4 trials for multiple vaccines, including RSV, influenza, COVID-19, meningococcal, and more.
As a multi-specialty site integrated within a private practice, Aim Trials has extensive experience conducting high-volume vaccine studies. For the RSVpreF trial, we achieved a 98% eCOA compliance rate. With our diverse database of patients, we are also equipped to recruit effectively across hard-to-reach demographics. Our team has exceptional retention and compliance rates.
Contact [email protected] to learn about our vaccine trial capabilities.