00:01
So, the approval process for vaccines involves several stages of rigorous testing and evaluation ok.
00:24
All these studies are conducted to ensure safety, efficacy and quality of the vaccines produced ok.
00:39
So, now the specific process it may vary between countries, but here we will discuss a brief overview of the like typical steps involved ok.
00:50
So, the first is preclinical testing ok.
01:00
So, before a vaccine is you know tested in humans, there is extensive laboratory and animal studies ok.
01:15
These studies are performed to assess the safety, the immune response and the potential effectiveness of the vaccine ok.
01:22
Because from these clinical studies, we get an idea about the you know like vaccines potential and we can also identify if there are any kind of potential risks involved ok.
01:34
The next is the ind application ok.
01:43
Ind stands for investigational new ok.
01:55
So, if the preclinical data is good, then the vaccine developer they submit an ind application ok to the regulatory authority.
02:07
Now this regulatory authority it varies from state to state.
02:11
For example, in the united states it is known as fda of us food and like drug administration.
02:18
So, now this ind application it contains a detailed information ok on the vaccines composition, manufacturing process, the preclinical data and the proposed plans for clinical trial ok.
02:59
After the ind application, the third is the if this ind application gets approved, then they conduct the clinical trials phase 1 ok.
03:12
So, clinical trials phase 1, it consists of a small group of healthy volunteers ok.
03:19
So, the and this you know this step it primarily focuses on assessing the vaccine safety, dosage and if there are any kind of potential side effects.
03:31
And these trials they provide an initial information on this vaccines immunogenicity ok.
03:38
Immunogenicity means the ability of the vaccine to you know provoke an immune response and the dosage range.
03:45
After the clinical trials phase 1, then clinical trials phase 2 are conducted.
03:58
So, in the phase 2, phase 2 you know it involves a larger group of volunteers and these volunteers they are like individuals from a target population ok.
04:22
And this in phase 2 is conducted to further evaluate the vaccine safety and immunogenicity...