Find Out Fact: Why is Developing a Coronavirus Vaccine Taking so Long?

Amidst the COVID-19 pandemic, all eyes are on the vaccine that could restrain the dreadful virus. Many experts have been discussing the availability of vaccines, some suggesting that it could possibly take 12-18 months or even more, before any effective vaccine could be developed.

“For a new coronavirus vaccine to be available for large populations, I would say it’s a matter of two years minimum” stated Dr. Stanley Plotkin, Emeritus Professor at the University of Pennsylvania.

A notable aspect of the situation is that some scientists who are suggesting that a vaccine could be available by end of 2020 could possibly be only an ‘emergency’ use authorized vaccine and not a ‘fully’ approved one, according to Dr. Seema Yasmin, director of the Stanford Health Communication Initiative.

The vaccine development is segmented into several stages, each of the stages taking a variable amount of time. Since the process of vaccine development involves multiple stages, it can take up to years before the vaccine could be made available to the masses. Generally, it takes 10-15 years to make a vaccine and the fastest known vaccine to be developed was for mumps, which took four years.

Let’s take a deeper look into the stages of vaccine development. The stages are named as ‘exploratory’, ‘pre-clinical’, ‘clinical development’, ‘regulatory review’, ‘manufacturing’ and lastly ‘quality control’.

Exploratory Stage

The initial stage of vaccine development involves research to identify the antigens that could prevent or treat a disease. The stage refers to basic laboratory research and typically takes two to four years. The time required could possibly be reduced with the help of modern technology.

Pre-Clinical Stage

In this phase, researchers test the vaccine candidate in cell cultures and animals to observe if the candidate vaccine produces immunity. If there is no immunity produced or the vaccine proves harmful to cells, researchers go back to the previous exploratory stage. Experts suggest that this stage takes at least a year to successfully complete.

Clinical Development Stage

Provided the previous stage is completed, the experimental vaccine is then used for human trial testing in three phases.

The first phase involves the vaccine being given to a small group of people with the aim of determining if the vaccine is safe and to observe the extent of immune response it provokes.

In the second phase, several hundred people participate in vaccine testing. The goal is to achieve more information about the vaccine’s safety, immunogenicity, dose size and immunization schedule.

Then comes the third phase which includes thousands or tens of thousands of people being tested with the aim to determine vaccine safety in a large group of people. This approach is used to identify certain rare side effects of the vaccine that are not revealed in smaller groups of tested people in the previous phases.

Regulatory Review Stage

After the vaccine has successfully passed the three phases of clinical development, the manufacturer submits an application to obtain a license for the production of vaccine.

Manufacturing Stage

The drug manufacturers provide infrastructure, personnel and equipment that is needed to produce large quantities of vaccine. This process can considerably take a vast amount of time and money.

Quality Control Stage

This final stage involves following procedures that determines whether a vaccine is producing satisfactory results. Many advanced systems are used to monitor the performance and effectiveness of the vaccine. In addition, phase four trials are conducted. The phase four trials include optional studies conducted by drug companies to continue testing the safety and effectiveness of the vaccine after it is released.

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