What is the vaccine?
Before any vaccines are approved and licensed for public use, they must pass vaccine tests. The vaccine study is a form of clinical evaluation that is carried out to ensure that the drug is safe for use on people and that it creates expected protection against a particular virus such as flu. In order to become a license vaccine, the product must undergo a certain level or testing phases. The whole process often takes several years from start to finish and can cost millions of dollars. These studies are usually conducted by certified research organizations at the command of pharmaceutical companies. These studies may include vaccine testing as part of computer simulation, on cultivated tissue in the laboratory and animals, including mice, rabbits and monkeys. Although not always a useful reflection of how the potential vaccine will be recorded by this study is allied work on humans, it is to help determine the basic safety and effectiveness of the drug.
If the vaccine passes through the foreclinical phase, the drug passes into one of the vaccine. This phase is performed for people who voluntarily participated in informed consent. In the first phase, volunteers are generally composed of the relativity of a small group of healthy individuals. These people are largely selected on the basis of their low risk of exposure to a specific virus. Patients are given a vaccine and then observed and tested to determine a number of results, including the production of antibodies, side effects and different dose levels and plans.
When the first phase is successfully passed, then the vaccine attempt proceeds to the second phase. At this stage, there is a group of healthy volunteers, which is larger and who have different degrees of risk and exposure to the virus. This phase takes longer than the first, often a few years. Like the first phase, this study also measures pharmacokinetics and pharmacodynamics of the vaccine.
The third main phase of the vaccine attempt uses volunteers, in even more, ktThe ears are considered to be a high risk of this disease. Until this time, the safety of the vaccine is quite secured and this experiment focuses mainly on the effectiveness of the drug and fine fine -tuning. This trial phase tends to be the most expensive and takes the biggest time, often three to five years. Several attempts can be made to confirm any results.
In order to successfully go through this phase, clinic doctors must follow very strict protocol and documentation requirements. The court must be carried out in a specific way that is reviewed and audited. Testing methods, including random testing, placebo and double blockund testing, get the most accurate possible results. Once the vaccine has successfully passed all the prerequisites, it can be licensed for use.