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Safety of Vaccination
John Sullen 10/04/2019 07:11 AM CST


About the author: John Sullen is a content writer and blogger, currently working with writing company. He delivers papers for all the students who have a lack of time to write their papers on their own.             


Safety of vaccination is the absence of a short-term and/or long-term negative impact of vaccination on the inoculated person’s health. Safety of vaccination, along with the efficiency of vaccination, serves as an instrument of various knavish shenanigans and manipulations on the part of pharmaceutics, apothecaries, developers, manufacturers and purveyors of vaccines. These fraudulent activities are designed to conceal numerous cases of complications, including the impairing and lethal ones, brought about by vaccination. The US vaccine lobby is the most vigorous disseminator of propaganda about safety of vaccination, bar none. That said, this paper makes an arduous attempt to spread a reasonable deal of light upon the process of examining safety of vaccines. It also illuminates possible side effects of vaccination against certain infectious maladies. The overriding goal of this paper is to find out if safety testing for vaccines is rigorous enough and if inoculations have a positive effect on human bodies. It also outlines a roadmap for analyzing safety of vaccination. The author arrives at a decision that despite a plethora of adverse reactions caused by some of the most popular vaccines, their use will continue to be of paramount importance throughout the 21st century.

Four stages of safety testing for vaccines

Vaccines, as well as other drugs, must necessarily undergo extensive clinical testing to ensure maximum safety and efficiency. Initial clinical trials are conducted on animals, followed by several phases of testing on humans. Studies are divided into several phases.

The first phase includes laboratory testing of the candidate vaccines, namely research into toxicity, physical properties and chemical composition of these vaccines. A preclinical test on laboratory animals in its turn consists of five phases: a study of the immunoreactivity, a study of the allergenic effect of the vaccine, research into the autoimmune reactions of the organism to the vaccine, an examination of the quantitative and qualitative changes at a cellular level, and the morphology of the immune system. If the immunological reactivity has been altered, the allergic or autoimmune reactions have been detected or the histological changes in the organs of the vaccinated animals’ immune system have taken place, the conclusion about the possibility of further study of the vaccine in clinical trials should be based on a comparison of the correlation of the vaccine’s effect to its safety.

The second phase stipulates limited trials of candidate vaccines on humans, including research into the immunogenicity and safety of vaccines. Hundreds of volunteers express their willingness and eventually participate in the study. These studies are carried out only after the national agency controlling biomedical medicines has arrived at a positive conclusion. The correct concentration of the antigen, as well as the number of vaccine components, technique of manufacturing, effect of the subsequent doses and major adverse reactions are determined in this phase. On the basis of these studies, the final choice of the type of vaccine for the third phase is being made.

The third phase means large-scale trials of candidate vaccines on healthy patients. On this stage vaccine efficacy and adverse reactions are being scrutinized. The number of volunteers skyrockets to thousands of people. Duration of the observation is determined based on the results obtained during the previous stages of testing and is usually limited to one or two years (but not less than 6 months). Simultaneously the control group, which did not receive the vaccine, must be studied. Also the effectiveness, frequency and types of adverse reactions are measured.

The fourth phase envisages the post-license control of the vaccines’ quality. Since the use of vaccine may be conducive to the development of rare adverse reactions, delayed adverse reactions or peculiar reactions in specific subpopulations, research continues even after a certain vaccine has been licensed. Ongoing study of the frequency and severity of adverse reactions, as well as that of the vaccination’s efficiency do not cease.

Monitoring of the Side Effects of Vaccines

Monitoring of the side effects of vaccines is carried out at all levels of health care. The first registration of the complications necessitates the process of establishing diagnosis of the inoculated person by dint of conducting a very minute survey of his health. Special attention is riveted on those inoculated persons, who apply for medical help. The existing American system of registration and analysis of the post-vaccination complications requires improvement, because it does not allow to identify all cases of the side effects of vaccines. Below is a list of adverse reactions, which is recommended by the WHO for use in the expanded program of immunization.

Evaluation System of the Vaccines’ Safety

In accordance with the recommendations of the WHO, every state (even those that do not produce vaccines) should have a national agency monitoring immuno-inflammatory drugs. The system of the vaccines’ safety evaluation includes 5 levels of control. First of all, it is imperative that new vaccines be tested by the pharmaceutist and national monitoring agency. At this stage, the state supervision provides for the examination of normative documents, as well as the laboratory testing of experimental, experimentally practical and the first practical samples of vaccines. Moreover, the concerted attempts to establish if safety testing for vaccines is rigorous enough must be made. In stark contradistinction to many countries, the US has a system of state-run tests, which are conducted under the direction of the controlling agency with the use of the comparator block, double-blind method and many other principles of controlling safety, which rule out involvement of the developers in this process. Vaccines are tested first on adults and then on children. Scientists in charge of such a test use a principle of the informed consent of those persons who are involved in the testing of vaccines.

At the second level, the production of vaccines is inspected. It envisages a mandatory step-wise safety control of the raw material used in production at various stages of the manufacturing process (input control of raw materials, inspection of the semi-finished and finished products etc.). Certification of the vaccines’ series takes place at the next level. All vaccines used in the territory of the United States of America shall be a subject to the compulsory state certification. By the same token, it should be verified that individual series of a certain vaccine meet the regulatory requirements.

Inspection of pharmaceutical enterprises, which produce vaccines, takes place next. The purpose of this step is to verify compliance with the requirements of GMP that guarantees safety of the commercial produce. At the fifth level, state control of the vaccines’ quality at points of use takes place. This step is the responsibility of the sanitary and epidemiological surveillance centers. They should ensure abidance by the rules of storage, transportation and sale of vaccines.

In this respect, foreign vaccines merit special attention. In accordance with the national requirements and recommendations of the WHO, it is allowed to import and utilize only those vaccines that are registered in the United States. Each imported consignment of vaccines must have a certificate issued by the national monitoring agency, confirming that quality of the vaccines imported matches the regulatory requirements set forth by the US. Package of the vaccine and instructions for its use must have text in English. The registration procedure involves an analysis of the materials on the preclinical and clinical testing of the preparations, documentation on their control, as well as the very controlling process. In some cases, observations of the reactogenicity and specific activity, as well as the certification of production are also required.

Side Effects

It would be an inconceivable folly to regard vaccines as a magic panacea or holy water. This is an immunobiologically active drug that causes certain changes in the body, which under ideal circumstances conduce to the development of the insusceptibility, or rather immunity, to a certain infection. However, the changes can also have a negative character, i.e. they can cause severe adverse reactions. The term side effect is used to denote undesirable reactions to vaccines, which arise from inoculation. Side effects, or adverse reactions, can be divided into local, i.e. those that occur at the injection site (redness, tenderness, induration etc.), and common, i.e. those that affect the entire body as a whole (fever, indisposition, malaise, etc).

In general, adverse reactions are a normal reaction of the organism to the introduction of a foreign antigen. In most cases they reflect the process of developing immunity. For example, the reason for the increase in body temperature that occur after the vaccination is a release of the special "mediators" of the immune response into the blood. If the side effects are not severe in nature, they are thought by scientists as a beneficial process. Their appearance demonstrates convincingly that the immunity is being acquired. For instance, a small seal, which occurs at the site of inoculation against acute viral hepatitis shows the rigor of the immunity acquirement process. A vaccinated person is therefore really protected from infection.

Of course, the increase in body temperature up to 40°C cannot be treated as a favorable sign. Consequently, such reactions are usually referred to as a special type of severe adverse reactions. These reactions, along with complications, are a subject to stringent accountability and thus shall be reported to the agencies monitoring the quality of vaccines. If such reactions to a certain vaccine are not few and far between, this vaccine (or one of its series) is removed from the application and its quality should be reinspected.

Usually, adverse reactions to inoculation with inactivated vaccines (DTaP, DT, hepatitis) occur two days after the inoculation. What is more important, they usually evanesce on their own without any treatment within a couple of days. After inoculation with live vaccines, side effects may occur within the ensuing ten days and fade away without treatment as soon as in the previous case.

Most vaccines have been used for decades, so researchers also take typicality of the reactions into account. For example, vaccination against rubella cannot beget gastritis, but at the same time it can cause a short-term swelling of joints. There is an avalanche of research into the incidence of adverse reactions. It is an open secret that the rubella vaccine, which has been used for more than 30 years, begets nearly 5% of the common reactions, while the vaccine against hepatitis, which has been used for more than 15 years, engenders almost 7% of local reactions.

Aftereffects of Vaccination

In contrast to adverse reactions, complications of vaccination are undesirable and quite serious conditions that occur after vaccination. For instance, a sudden drop in blood pressure (anaphylactic shock) as a manifestation of the immediate allergic reaction to any component of the vaccine is neither normal adverse reaction nor even a severe adverse reaction, as anaphylactic shock and collapse require resuscitation. Other examples of complications include seizures, neurological disorders, allergic reactions of varying severity, etc. For the sake of fairness it should be noted that in juxtaposition to the adverse reactions, post-vaccination complications are very rare. The frequency of complications such as encephalitis caused by measles vaccine is one in a few million doses. Generalized BCG infection caused by the improper administration of BCG happens a little more often, but does not exceed the rate of one case in a million of vaccinations. However, if a person suffering from the infection was not inoculated, the very same complications occur with a frequency greater by orders of magnitude.

Prophylaxis of Aftereffects

None of the currently used vaccines can guarantee the absence of side effects. It is therefore extremely important to try and prevent the post-vaccination complications. The main preventive measures are as follows:

1) Strict implementation of the vaccination technique;

2) Compliance with contraindications;

3) Precise execution of the vaccines’ transportation and storage instructions; and

4) Compliance with the intervals between doses.

Factors predisposing to post-vaccination complications include:

1) Nervous breakdowns such as increased intracranial pressure, hydrocephalic and spasmodic syndromes;

2) Any form of allergic manifestations;

3) Frequency, duration and nature of acute illness;

4) A record of abnormal reactions to the previous vaccinations; etc.

In spite of the myriad side effects, myths and contradictions surrounding the utility, or rather expediency, of vaccination, this practice is an extremely important precondition of each person’s normal physiological development. Some pseudo scientists offer what is allegedly a growing body of evidence to buttress up the idea that children can grow and develop in a healthy and vigorous way without being inoculated. However, such unsubstantiated claims should not even be deferred to due to many reasons. Even if some children can dispense with vaccination, the overwhelming majority of others cannot. What is more important, it is next to impossible to find out who to vaccinate in the first place. Of course, almost every inoculation is fraught with the danger of side effects or complications, but complete ignoring of vaccination may have much more severe repercussions. The vast majority of people who tend to eschew the use of vaccines are guided by the fear of adverse reactions. They ignore the fact that harsh side effects are very sporadic, and therefore act like panic-mongers. The chance of the lethal outcome caused by vaccination is millions times less than that of an unvaccinated person succumbing to the infection itself. Thus, the question that people must ask themselves before making any hasty decisions is whether avoidance of vaccination is worth the risks that this avoidance is fraught with. By and large, the question of whether it is necessary to carry out a mass vaccination of population is not as puzzling as many alarmist scientists attempt to portray. A surprising variety of experts insist that human organism can develop properly without vaccinations, but the successful and hallowed practice of inoculation speaks louder than their allegations.