Produce the Antigen (Pathogen against which the body reacts)
The antigen can include any of the following: virus, bacterium, recombinant protein
Types of Vaccines
Live-attenuated: active, or “live” pathogen, but weakened substantially
Example: MMR vaccine
Inactivated: chemically treated pathogen so that it is “killed”
Example: Hepatitis A vaccine
Subunit: takes a small piece of the antigen, or “epitope”; typically chemically inactivated
Example: Hib vaccine
Toxoid: bacterial toxins inactivated by chemical
Example: DTaP vaccine
Conjugate: body incapable of responding to bacteria due to their protective sugar coating, thus, the bacteria are linked with a carrier protein to create a stronger immune response
Example: Pneumococcal vaccine
DNA: injection of genetically engineered DNA, so that your own genome receives the DNA and begins producing the antigen
Example: In Development
Recombinant Vector: Gene encoding a desired vaccine protein is inserted into another virus or producer cells in culture; so, when the carrier pathogen reproduces, the vaccine protein is also produced
Example: Hepatitis B gene inserted into yeast culture, the yeast then expresses the Hepatitis B protein
Another type of genetic engineering is utilized for the HPV vaccine, in which a single viral protein is isolated, and when expressed, a virus like particle (VLP) is created.
The vaccine antigens, which are grown on various substrates (insect, animal, human, cancerous cell lines) are purified, combined with additives (adjuvants, stabilizers, preservatives) and packaged.
The next step involves pre-clinical (phase 0) studies in which animal “safety” dosing is conducted to determine proper dosing. Vaccines are tested for immunogenicity (immune response) in animals via antibody production.
- Phase 1 clinical trials are safety and immunogenicity studies in a small number of closely monitored individuals.
- Phase 2 clinical trials increase the number of participants to hundreds; again, testing safety and efficacy
- Phase 3 clinical trials enroll thousands of individuals; testing safety and effectiveness
The vaccine is then licensed by the FDA; the vaccine is reviewed by a committe
After approval, the vaccine is on the market; this is called a “phase 4 study”; the Vaccine Adverse Event Reporting System (VAERS) is used to identify problems after marketing begins.
***Important Note: “Safety” and “Effectiveness” are subjective, loosely defined terms. While it may seem from the above that vaccines are tested for “safety” and “effectiveness,” it’s important to understand what those terms really mean. Safety tests are extremely short duration (days to weeks typically), and only look for a certain, small list of adverse events. Real, saline, inert placebos are not used in the tests. This is different than all other pharmaceutical drugs that use gold standard protocols (double blind, randomized, placebo controlled). Further, people that have severe reactions are often removed from data. With efficacy, if a vaccine produces antibodies, it is effective. This does not translate to effectiveness as far as disease prevention.
***Important update (7/15/2018): Lawsuit by Robert Kennedy, Jr., and Del Bigtree against the United States Health and Human Services ends in settlement in which the HHS admits that it has NOT conducted the necessary vaccine safety research over the past 30 years! This admittance – that the HHS has NOT been following one of the stipulations of the 1986 NCVIA – is a MAJOR first step, that now invites the opportunity for further lawsuits against the government for lack of safety research.
The 1986 NCVIA afforded legal immunity to the pharmaceutical industry, and so, the incentive to make vaccines safer was removed. In order to remedy this, Congress stipulated that the HHS should report on their improvements to vaccine safety every 2 years, beginning in 1986.
RFK Jr. and ICAN’s Freedom of Information Act Request, as ordered by the court, show that the HHS has not been doing its job. The only agency tasked with improving and studying vaccine safety has NOT being doing so.
This is an unmitigated failure of vaccine safety oversight on the part of the HHS!
STUDIES ON VACCINE SAFETY AND EFFECTIVENESS
REPUTABLE SOURCES OF INFORMATION ABOUT VACCINES