What it Takes to Develop a Vaccine for Public Use

Post-Licensure Monitoring And Further Trials You didn’t think that the vaccine was ready for shipping once the FDA approved the application and gave the licensing, did… Trista - April 2, 2020

Just because the FDA approves the vaccine and the licensure doesn’t mean the process is over. Shutterstock.

Post-Licensure Monitoring And Further Trials

You didn’t think that the vaccine was ready for shipping once the FDA approved the application and gave the licensing, did you? There are further monitoring and trials that come after the approval process. While they don’t last as long as the previous three tests, phase IV still takes a bit of time. However, it’s also an optional phase, so when a vaccine is meant to happen quickly, like with the current crisis, it might not happen. But, most scientists continue with phase IV to ensure that everything is safe and continues to run smoothly.

Phase IV trials focus on the drug companies that might want to conduct their tests once they receive the vaccine. When they do these studies, they work with the manufacturer to ensure efficacy and safety. One of the benefits of these studies is that they often lead to other potential uses. Sometimes this phase will also show that the vaccine can become more robust with a couple of changes, which brings the scientists back to the earlier steps and approval. However, this is all part of the job.

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Reporting is a crucial part of the process, even once the vaccine is sent for public use. Shutterstock.

Reporting On The Virus Continues

Once everything is approved, and all phases are complete to the point they have to be, the vaccine is sent to hospitals and clinics so the public can receive it. But, this doesn’t mean that the process is completely over. It means that now the CDC, FDA, and the scientists continue their reporting of the vaccine with the help of hospitals, clinics, and other experts. In 1990, the FDA and the CDC established a system that everyone uses called The Vaccine Adverse Event Reporting System (VAERS).

According to the CDC, this system is used to “detect possible signals of adverse events associated with vaccines.” In general, VAERS receives about 30,000 cases a year, with 10% to 15% described as severe medical cases that needed hospitalization. Other events that happened that are reported include life-threatening illness, death, or disability. It’s important to note that anyone can report to VAERS as its voluntary based, which means teachers and parents can also use it.

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Other than reporting, officials also gather information through a Vaccine Safety Datalink. Shutterstock.

The Vaccine Safety Datalink Is Another After Production Process

In 1990, the CDC established a system known as the Vaccine Safety Datalink. This is a collection of linked databases that contain information from various large medical groups. The information that the datalink shows include what populations are more likely to get the vaccine. It allows the manufacturer, along with any other researchers the information they need to monitor the progress of the vaccine. However, they need to request approval from the CDC before they can access the datalink.

The datalink is still in the early stages, which means many changes continue to happen within it. For instance, it doesn’t have any information for unvaccinated children. It’s also known as data that is difficult to control and evaluate, which leads many scientists to find different ways to monitor the vaccine.

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The work on vaccines is never truly over, but once it’s out to the public, scientists take a more relaxing breath. Shutterstock.

Vaccine Work Is Never Done

For a researcher, the work on any vaccine is never truly over. Even when it’s available for the population, they continue to do their research, monitor, and look at any necessary changes. They are also continuously looking at developing other vaccines that are an arm of their current strain because colds, cases of flu, and other diseases change over time, and this means the vaccine needs to change with them.

Developing and approving vaccines is a long process that usually takes years, so if a vaccine comes out within a matter of months, you need to thank hard-working researchers, experts, and the advancement in technology.

Sources:

“Vaccine Testing and the Approval Process.” Centers For Disease Control and Prevention.

“Vaccine Product Approval Process” U.S. Food and Drug Administration. January 2018.

“How Long Will It Take to Develop a Vaccine for Coronavirus?” Shawn Radcliffe, Healthline. January 2020.

“HOW ARE NEW VACCINES DEVELOPED?.” Gary Finnegan, Vaccines Today. September 2012.

“Vaccine Development, Testing, and Regulation.” History of Vaccines. January 2020.

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