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What are the Stages of Vaccine Development?

 

Due to the recent worldwide outbreak of coronavirus pandemic, the government of various countries including India has imposed a lockdown on its people. As of writing this blog, there are over 3.8 million people infected with coronavirus across the globe. Medical professionals are working day and night to create a proper vaccination that can help cure the patients infected with the coronavirus. But many of the scientists are saying that it will take approximately 12 to 18 months until a vaccination will reach our doorstep. But why? Well, there are certain stages of vaccine development that takes time. There are 6 stages that are required for vaccine development–

  • Exploratory ​stage

  • Pre-clinical stage

  • Clinical development

  • Regulatory review and approval

  • Manufacturing

  • Quality control

Today we are going to learn about these stages:

1. Exploratory

This is the research phase of the vaccine development process in which scientists identify natural or synthetic antigens that might help treat disease. Antigens might include weakened strains of a virus.

2. Pre-Clinical

In this phase medical professionals use cell-culture or tissue-culture systems and animal testing to determine whether the candidate vaccine will produce immunity. Many vaccines don’t make it to the next stage of the development because they either fail to produce immunity or have harmful side effects.

3. Clinical Development

Now, a sponsor, usually a private company, applies for approval of the vaccine. Only the institution that will host the clinical trial can approve the application. Once the proposal has been approved, the candidate vaccine needs to three trial stages of human testing:

Phase I: A small group of people is injected with this candidate vaccine to determine how safe it is and to learn more about the responses it provokes among test subjects.

Phase II: A group of more than hundreds of human test subjects are injected to determine more information about immunogenicity, safety, dose size, and immunization schedule.

Phase III: In this phase, more than thousands of human test subjects are injected to determine rare side effects which sometimes don’t appear in smaller groups.

4. Regulatory Review And Approval

Once a vaccine passes all the phases, the vaccine developer submits a license application to the regulatory authority.

5. Manufacturing

After the license approval, drug manufacturers provide personnel, infrastructure, and equipment necessary to create mass quantities of vaccines.

6. Quality Control

The approval and distribution are far from the end of the line. Stakeholders must adhere to procedures that allow them to track whether a vaccine is performing as anticipated. A candidate vaccine might go through Phase IV trials that can be conducted following the release of a vaccine and many more. These quality control measures are taken to monitor the safety, performance, and effectiveness of an approved vaccine.

This development process involves loads of skills. Medical professionals are doing their work, and sooner or later vaccine will be made. You should do your work and be a responsible citizen of mother Earth. Maintain social distancing and wash your hand frequently. If you have health insurance, then it is good, but if not then you should buy a coronavirus insurance policy. This insurance will take care of your finances when the vaccine is made.