We welcome you here, we are going to show the complete procedure of the development of vaccines and reaching those vaccines in the clinics. Check the vaccine process below from lab to clinic.
Steps of New vaccine development
The general steps of any vaccine development are given here.
- Research & Discovery
- Proof of Concept
- VaccineTesting
- Manufacturing Process
- Vaccine Approval
- Vaccine Recommendation
- Monitor Vaccine after approval
Let’s discuss these steps in detail.
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Research & Discovery
When there is any decides that needs a cure, universities, and private companies are always in need of breakthroughs to give the world the best and be a reason for the cure. The research is usually conducted at universities where interns perform experiments on rats or others. The complete process of vaccine development can be a process of 10 to 15 years in the lab.
Proof of Concept
When scientists are sure about the vaccine in the laboratory, they are asked to prove the result of the vaccine. Scientists and doctors use animals to prove the results of the vaccines. They take the infected mice, rats, rabbits, etc, and give them a dosage of vaccine to prove their results.
Vaccine Testing
The next step is checking the result of vaccination on humans. This stage is also called as clinical trial round. In this stage, a vaccine now comes into the companies from the lab. The companies now produce the vaccines for clinical trials. The vaccine testing process is divided into four phases.
- Phase 1– In the first phase of the vaccine testing, the companies chose 20 to 100 people only. These people who have the disease are given vacancies and kept under monitoring. The health of the vaccinated people is closely checked. If there are any side effects, they will be noted down.
- Phase 2– The second phase includes 100 to 300 people. These people can be from different age groups. And people from various diversity are chosen for the vaccine testing process. The doctors and labs closely monitor the vaccinated people and check their immune system, how it has affected after the vaccination, and if there are any side effects of the vaccine.
- Phase 3– The next phase choose 1000 to 3000 people for the trial round. The labs monitor these people and check what are the common side effects of the vaccine, like some people get a fever after the vaccination but some do not. The doctors will ensure that there are no severe side effects from the vaccination that can affect a person.
- Phase 4– The fourth phase of vaccine testing includes approval from the FDA author. When a company gets approval from the FDA, the companies start the mass production of the vaccine and they get the license for the vaccines to distribute the medicine across the world for the benefit of the people. FDA can conduct its trial round on the selective people before providing the approval.
Manufacturing Process
The next step of the vaccine development is the production of the vaccine. The company that got the approval from the FDA for the production of the vaccines now has the authority to build the vaccine. The FDA will check the manufacturing company facility to see if there are enough resources that manufacture the vaccine or not.
The manufacturing companies develop the vaccine in lots. Now, the companies check the quality of the vaccine and from each lot, it is the responsibility of the company to verify the vaccine’s quality. FDA may ask the companies to submit the test reports from each lot before the distribution of the vaccines.
Vaccine Approval
The manufacturing company that is developing the vaccine needs to submit the Biological License Application to the FDA. The BLA includes all of the details like clinical data, pre-clinical data, information about the manufacturing company, and details of the manufacturing process. It is the responsibility of the FDA to check the safety of the vaccines. In this phase, the dosage of the vaccines according to age group is also decided.
When a company gets approval from the FDA, the company starts the bulk production of the vaccines. In between the production process, the FDA monitors the production process. In large-scale manufacturing, the FDA becomes more responsible for the quality, potency, purity, and safety of the vaccine.
Vaccine Recommendation
The vaccines that are approved by the FDA got recommendations from the ACIP- Advisory Committee on Immunization Practices. ACIP has its parameters that are considered before recommending the vaccines to the public. The parameters are given below.
- Safety and Effectiveness of the Vaccine– The vaccines should be safe for the people and ACIP will consider the effectiveness of the vaccines whether people get treated by it or not.
- Effects of disease– The effects of the disease will be considered as what a disease can cause in a person. If there are long-term effects of the disease.
- What if no vaccine– The ACIP will consider the factors of the benefits of the vaccines to how many people. If the vaccine is not beneficial for everyone, then ACIP will not recommend it to everyone.
Monitor Vaccine after approval
The monitoring of vaccines is necessary. The people who are vaccinated are kept under observation and called for regular checkups. The govt will check if there are any side effects of the vaccine or how people react after the vaccination. Is the disease curable with the vaccines or not? The govt will build a connection between various clinics to monitor the patients.