HOW DOES THE VACCINE APPROVAL PROCESS WORK?
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In order to make vaccine, a considerable amount of time and money is spent (both by the private and public sectors) to study the pathogen or disease of interest. According to the United States Public Service Act of 1944, vaccines must have a licensed issued by the Federal government before it is approved for distribution. A series of phases (or stages) must be completed to ensure that the vaccine does not unintentionally harm the human body.
Pre-clinical testing
In the preclinical stages, vaccines are either tested on animals such as mice and monkeys or are tested on isolated tissue cells grown in a culture. The goal is to see the kinds of cellular and immune responses the vaccine might induce in the body.
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This also may give researchers the idea about the safe dosage of the vaccine to get the appropriate response. If the vaccine is not safe or it does not induce the needed immune response, then the vaccine cannot be developed further. Many vaccinations do not progress after this stage.
Testing the effectiveness of vaccines in human subjects
After the preclinical stages, the private research company will submit their vaccine proposal to FDA in which it will describe previous lab results; propose future plans for clinical trials (such as location, sample size, etc.) and discuss the final goals of the project. The FDA, which has 30 days to approve the proposal, then allows the vaccine to go through additional periods (or phases) of clinical testing.
Monitoring the approved vaccine
Just because the FDA approves the vaccine, does not mean that they can now be mass-produced. The CDC has an Advisory Committee on Immunization Practices (ACIP) which then sets guidelines for how and on whom the vaccine should be used. After the vaccine has been licensed, the FDA and the CDC will continue to monitor vaccine production and look out for any possible side effects. One of the most effective ways in which the CDC and the FDA keep track is through The Vaccine Adverse Effect Reporting System (that was established in 1990). Individuals can choose to enter their information and symptoms into the system database. If any adverse effects are reported, then those individuals are further tested to confirm if the side effects were due to the vaccine itself or if it was patient specific symptoms.
Sources
http://www.chop.edu/service/vaccine-education-center/vaccine-science/how-are-vaccines-made.html
http://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
http://www.cdc.gov/CDCTV/VSI_Vaccination/index.html
