These days there is soooooo much talk about it.......
....... so I thought that I would explore the inception and composition......
Vaccines work by stimulating your immune system to begin to produce antibodies. Vaccines introduce your immune system to an attenuated form of the pathogen which you are seeking immunity from. Vaccines also can trigger the immune system in several different ways, & once injected, the vaccine will enter the immune system through an inactivated form of a pathogen, through a weakened toxin made by the pathogen or through an inactivated form of a pathogen. Vaccines may contain a live version of the virus (however, this weakened version will not cause illness).
Subunit vaccines use a small percentage of the injected pathogen to initiate a response from the immune system once injected. This is achieved when the protein from a pathogen is presented as an antigen. The Moderna Covid 19 vaccine is an example of a subunit vaccine when created through technology by way of the genetic engineering process. Gene coding for a protein vaccine is interleaved into another virus (producer cells) in culture. Next, the producer cells metabolize and vaccine proteins are created. This is known as the recombinant vaccine. Vaccines can contain various other ingredients such as adjuvants and stabilizers. These other ingredients keep the vaccine working and active after it has been made.
Conjugate vaccines are created using two different elements, including pieces of the bacteria coating. The coatings are connected to a carrier protein thus creating a vaccine, producing a more powerful immune response. This is due to the combined effort of the carrier protein also known as immunity.
Examples of subunit/conjugate vaccines include the Hepatitis B vaccine, HPV, Influenza, Pertussis, Pneumococcal and Meningococcal. Other vaccines types are as follows: Toxoid, which is an inactivated toxin (Diphtheria, tetanus- part of DTaP combined immunization). Inactivated or Killed vaccines such as the Polio and Hepatitis A vaccines. The Rabies, Measles, Mumps, Rubella (MMT combined vaccine, Varicella (chickenpox), Influenza (nasal spray), Rotavirus, Zoster (shingles) and Yellow Hay fever all are examples of the Live, Attenuated Vaccines.
The origin of the smallpox virus can be traced back to the Egyptian civilization around approximately 1000 B.C. In China, a primitive version of vaccination was known as variolation. This method involved grinding up the scabs of smallpox and blowing the pustules onto the skin and nostrils of the person seeking immunity. Variolation quickly spread to Africa, the Middle East and Europe prior to the 1,700’s. In 1721 American people were introduced to this method and in 1798 Europe, vaccination replaced variolation which was opposed by some religious persons and physicians. Britain later banned variolation and replaced the practice with vaccination in the 19th century.
In 1880 a French biochemist named Louis Pasteur developed the world’s first laboratory which developed a vaccine against chicken cholera using attenuated bacteria. The vaccine was accidentally tested as a vivisector on some chickens a month after Pasteur produced the vaccine and surprisingly the chicken did not die from the bacteria! The chicken was only slightly ill but did not die. Pasteur proved that (a months’ old) weakened organisms could produce immunity.
Let’s take a look at the disease Polio:
Polio caused by the disease “poliomyelitis” is a disease caused by variants of the poliovirus. The first polio epidemic occurred in the United States in the late 1800’s. In the early 20th century, more than 27,000 people were paralyzed by poliomyelitis and over 6,000 died from it. The virus causes damage to the neurons that control movement and was first discovered millions of years ago in ancient Egypt. When the neurons are damaged, partial or complete paralysis takes place. A person can become infected by consuming contaminated food or water. In the 1950’s the first effective vaccine was developed by Scientist Jonas Salk by using inactivated polio virus. Many polio cases fell in a course of ten years to less than 200 cases. An oral version of the polio vaccine was created in 1961 by Scientist Albert Sabin which became the standard version used for many children. There was much debate about how polio was eradicated and some say sanitation and clean drinking water and not solely vaccination. See the book entitled, “Anyone Who Tells You Vaccines Are Safe and Effective Is Lying. Here's the Proof” By Dr. Vernon Coleman under Further Reading. I thought this book gave an interesting, acceptable spin on the efficacy of Vaccines, so please draw your own conclusions. Vaccines are not for everyone; therefore I remain neutral in this post.
Vaccines can take many, many years to develop; sometimes a decade or more due to the long process to study the efficacy of the final product. On July 1, 1902, the Biologics Control Act was passed “...to regulate the sale of viruses, serums, toxins and analogous products.” This law was created to protect individuals from “vaccine injury” on the heels of the 1901 antitoxin contamination which involved smallpox and diphtheria. The National Institutes of Health (NIH) formerly known as the Hygienic Laboratory of the United States Public Health Service was created to regulate and oversee the production of biological drugs and vaccines. Therefore the government has oversight & legislation over where and when a vaccine may be created.
Vaccines are created in stages and distributed according to schedules. In the United States, the development and testing of a vaccine must follow a series of standardized steps. The initial stages involve exploratory and research methodology. Along the way, regulation expands are the vaccine(s) are cultivated. The first stage is the exploratory stage which involves laboratory research; this can last 2-4 years. In this stage, scientists research natural and synthetic antigens that can possibly treat a disease.
Next is the pre-clinical stage. In this stage, which can last 1-2 years, researchers use cell & tissue like culture systems and vivisectors to conduct the safety and efficacy of the vaccine and immunogenicity. This is where the cellular response is examined and a “starter or safe” dose of the vaccine is emphasized for the next stage in hopes of a safe procedure to administer the vaccine. Here, animals and mice are vaccinated and infected with the pathogen of the virus. If immunity is not produced, then the vaccine fails.
The next stage is the IND Application. A private company submits an application for a new Investigational Drug or IND to the FDA (Food and Drug Administration). In the IND, the sponsor will: 1. Detail the manufacturing and testing process 2. Summarize lab reports, 3. Describe the proposed study. The protocol above must be approved by an institutional review board, which represents where the trial will be conducted. The application process can take up to 30 days to be approved by the FDA. Once approved, the vaccine must undergo three phases of testing:
Phase I- Vaccine trials or Open label trials- This study involves 20-80 participants. This is the initial attempt to determine the efficacy in humans usually within a small group of adults first (and then children, if applicable). This trial is called open label due to the fact that the participants do not have knowledge whether or not a placebo or vaccine is used. The participants are called none blinded. The safety of the vaccine is gauged as well as the extent of the immune response. The participants are monitored carefully and conditions are scrutinized and controlled. Various control factors are used such as the attenuation level of the vaccine to determine efficacy and usefulness.
Phase II- The gist of this group is study the safety of the vaccine, the immunization schedule, proposed doses and immunogenicity (the ability of a foreign substance such as an antigen to irritate an immune response). This is where a larger group of participants are tested (approx. 80 to 200 participants). The trials in this phase are randomized and controlled; Phase 2 trials may even include a placebo group. Some Phase 2 participants may be considered at risk for the disease the vaccination is being produced to fight against.
Phase III - Individuals in this Phase may number in the thousands and include participants from Phase 2. These trials are randomized and participants are double blinded. Placebos such as saline solution or various other types of vaccines may be used in this phase. Questions such as the following are explored:
Does the candidate vaccine prevent disease?
Does the vaccine prevent infection with the pathogen and does the vaccine lead to the production of antibodies or other types of immune responses related to the pathogen?
Approval and Licensure is the next phase in the vaccine approval process. At this juncture, the developer will submit a Biologics License Application to the Food and Drug Administration. The factory where the vaccine will be produced goes through an inspection and the vaccine approval commences. Finally, the Food and Drug Administration will oversee and monitor the production of the vaccine and inspect the production facilities. Systems such as the Vaccine Adverse Reporting System and Vaccine Safety Datalink monitor the vaccine even after approval.
A final phase- Phase IV is an optional phase that scrutinizes and studies the vaccine after its release to the public. The studies are optional to conclude efficacy and safety. In 1990, the Centers for Disease Control and the Food and Drug Administration established the Vaccine Adverse Event Reporting System (VAERS) to “detect possible signals of adverse events associated with vaccines.” Thousands of events are reported each year for vaccine injury, illness, disability or death. Suspected vaccination injury or related illness can be reported to VAERS and the case will be investigated.
I plan to explore more on the vaccination process as well as commentary and concerns. For more information on the origin of vaccines please visit “The History of Vaccines” https://www.historyofvaccines.org/
3DGirl4DWorld
~Pam
Sources:
College of Physicians of Philadelphia, The. (n.d.). The History of Vaccines The College of Physicians of Philadelphia. Retrieved September 2, 2021, from https://www.historyofvaccines.org/content/articles/history-anti-vaccination-movements.
Cleveland Clinic. (2021, March 4). Vaccine FAQs: How Are Vaccines Developed, and How Do They Work? Retrieved September 12, 2021, from https://health.clevelandclinic.org/vaccine-faqs-how-are-vaccines-developed-and-how-do-they-work/.
For further reading:
Coleman, D. V. (2014). Anyone Who Tells You Vaccines Are Safe And Effective Is Lying. Here's The Proof. Published January 9th 2014 by European medical journal.
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