How Is a Vaccine Developed?

Vaccination is an important part of global health, and it has literally allowed our race to survive. Throughout history, we have been faced with all sorts of viruses, and it is only through the development of a vaccine that we no longer experience them as a life-threatening disease.

There is still an on-going debate, confusion, and skepticism regarding the use of a vaccine. Some people believe that it causes diseases and defects to their child. We may not convince them to believe in any vaccine’s effectiveness, but this article may help shine some light on their doubts.

Steps in Vaccine Development

There are plenty of agencies and industries involved in this process. Drug developers like Pion Inc., pharmaceutical distributors like Amerisource, and government units like the FDA, are all part of vaccine development.

To fully comprehend the importance and efficiency of a vaccine, we first understand how they’re developed. We often fear what we don’t know, and gaining some basic knowledge about vaccine development may reduce or completely diminish our fears.


The first step in vaccine development is research. Scientists and medical professionals alike join together to gather data regarding the effects and structure of a virus. As the adage goes, “know your enemy,” and understanding a virus is essential in knowing how to defeat it. More often than not, research in vaccine development takes about two to five years or longer. Still, in some cases, especially when a global pandemic is at hand, emergency funds are funneled into research facilities to speed up the process.

Safety and Efficacy

Once the research is done, the next step is to test its safety and efficacy. Researchers often use candidates with identical body composition as us humans to conduct an initial assessment of the vaccine’s safety and effectiveness. This will help determine whether there are anomalies or areas in the vaccine that need further development. This entire process alone can add another two years to guarantee that adequate data is recorded and analyzed.


Human Safety and Efficacy

Only when the vaccine has reached an acceptable percentage of safety and efficacy can it be tested or used on humans. This needs the United States Food and Drug Administration’s approval to guarantee that it does not pose extreme risks to the receiving party. Phase 1, which often takes two years, includes testing of the vaccine to 100 volunteers. Data is gathered again to determine whether it’s possible to proceed with the next phase.

Phase 2 of human safety and efficacy involves the use of the vaccine to a larger group. Generally, this takes about two to three years as well. Research is conducted on the vaccinated patients to develop the drug further. The last phase is when the vaccine is injected into thousands of people through a randomized, double-blind study.


If further research suggests that the vaccine is safe to use on humans, the next step is to receive licensure. The U.S. FDA would then conduct its own series of tests on the vaccine and monitor its production to guarantee that the quality does not decrease. Safety, purity, and potency are all part of quality testing. It often takes around two more years before licensure is provided to the vaccine and developers.

Scaling Up

Once the developers have acquired licensure for mass production, the next step, scaling up, begins. As you may have noticed, the previous phases in vaccine testing only involved a maximum of a few thousand people. The question now is what happens if the virus becomes a global pandemic? That’s what scaling up aims to solve. Large quantities of the vaccine are produced and distributed to multiple countries that need it the most. However, developers must still adhere to the regulatory requirements needed to meet the vaccine’s standard of quality.

Quality Control

Even when the vaccine is released to the market and is already being used globally, its quality must still be maintained. Various agencies monitor the production and the effects of the vaccine when used on different people. Incidents or discrepancies are recorded to hold those accountable and make sure that necessary steps are taken to prevent it from happening again and keep the vaccine’s development.

There are many misconceptions about vaccines, and a considerable percentage of the population still doubt their efficacy and purpose. However, if we take the time to really understand where it comes from, the process it takes to guarantee that those who use them stay safe, we may have to reconsider our negative predispositions on it.

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