VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 1

Virginia Minimum Immunization Law & Vaccine Safety Analysis

Sarah Slusher

February 13, 2018

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 2

Abstract/Disclaimer

This paper is written for the express purpose of education regarding child immunizations in the

Commonwealth of Virginia. This paper details the basics of the immune system and how

vaccines work with the immune system to prevent disease. It is also proven that vaccines are not

dangerous, nor are they designed to destroy populations. Also in this paper are the ingredients

found in all vaccines mandatory in Virginia, with a description and analysis of functionality of

these ingredients.
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 3

Virginia Minimum Immunization Law & Vaccine Safety Analysis

All stable, emotionally healthy parents desire the best for their children, especially when

it comes to health. There is nothing a devoted parent will not do to keep their child safe, healthy,

and happy. It is this drive to protect the innocent from disease and death that has helped propel

medical research throughout the years. In the 1790’s English physician and scientist Edward

Jenner, who would later be described as the “father of immunology,” found that introducing a

form of cowpox under the skin would produce an immunity to smallpox through inoculation;

Jenner was initially discouraged by the scientific community but went on to perform his first

successful vaccination using the cowpox serum, made from a cowpox pustule on the hand of a

milkmaid, in 1796 (Dranguet, 2013). Jenner was a revolutionary, assisting tremendously in the

eradication of smallpox. In fact, on May 8th, 1980 the World Health Assembly declared the

world was free of smallpox, with the last documented case being in Somalia in 1979, marking

the first time humankind won the war against a specific deadly disease; this was made possible

through Jenner’s discovery of the antigenically related, non-transmissible cowpox virus that

provided protection against smallpox (Dranguet, 2013). Since Jenner’s days of medical research,

vaccinations have come a long way. However, the advancement of vaccinations coupled with

rare and sometimes serious side effects has made vaccinations a heated topic in America; with

laws mandating certain immunizations and vaccinations, it is important to research vaccine

ingredients and possible side effects in order to defend against potential hazards.

The Basics of the Immune System and Vaccination

Removing opinions and social media coverage and focusing on the body’s immune

system and how vaccinations truly work is the best approach to fully understanding this crucial

topic. The world is filled with bacteria, microorganisms, viruses, and innumerable other
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 4

potentially fatal substances and organisms. With the dangers of the outside world threatening

health every second, the body needs a healthy immune system to protect them. The immune

system can be compared to the military in that its main function is to protect the body from

infection, much like military personnel protecting Americans from harm.

The Basics of Immune System Function

The depths of information regarding the immune system and its function are daunting,

but the major components can be explained rather simply. The main systems related to immune

health are the circulatory and lymphatic systems, both of which involve regulating fluids or

blood within the body; specialized cells that move within the blood and lymph vessels are white

blood cells known collectively as leukocytes, which are comprised of granulocytes, monocytes,

and lymphocytes (Urton, 2013). Leukocytes are the body’s main line of defense against

infection, and their sole purpose in the body is to eradicate foreign materials while also ensuring

immune system function. Granulocytes originate in the bone marrow, have no long lasting

memory to aid immune defense, and include many subclassifications of cells, all of which either

consume foreign material, prevent overreaction by the immune system, release enzymes that kill

foreign materials through bursting, or fight parasitic infections (Urton, 2013). Granulocytes are

like the front line that charges into battle to protect the rest of the men, going back to the military

exemplification. Monocytes are the largest cells found in the blood, and while they are terminal

cells (they cannot divide), they aid in immune health by expanding in size in order to specialize

in phagocytosis; once monocytes are enlarged they are known as macrophages (Urton, 2013). In

broad, basic terms, the monocytes enlarge vigorously to eat foreign materials that find their way

into the body. The most sophisticated white blood cells involved in defense are called

lymphocytes and come in many types, such as B lymphocytes and T lymphocytes which are both
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 5

highly involved in disease prevention (Urton, 2013). The blood and fluids in the body are used as

a type of transit for the immune system to defend against foreign substances. T lymphocytes are

primarily responsible for immunity and can change into helper, killer, and suppressor cells,

meaning these lymphocytes, as well as B lymphocytes, can live freely in the blood, recognize

foreign material precisely, and multiply to remove the foreign material (Urton, 2013). These

leukocytes constantly eradicating foreign material are the main way that infection is prevented

within the body. On the offensive line are antigens, any substance that causes the body to fight,

such as bacteria or viruses; when an antigen enters the body, antibody cells (including

leukocytes) attack the foreign matter to prevent infection, sometimes binding to the bacteria or

virus in order to attract phagocytes that consume and destroy the materials (Urton, 2013). The

cycle is ever-present: antigens enter the body, leukocytes and other antibodies attack the

antigens, and either the antigens overpower the antibodies or the virus/bacteria is contained. The

immune system defends against disease through two types of responses, the humoral (also

known as antibody) immune response and the cellular immune response; although no specific

division seems to exist between these two responses, the antibody response typically deals with

organisms such as bacteria that live outside the cell, and the cellular immune response deals

mainly with microbes that exist inside the cell, like intracellular bacteria or viruses (Alder,

Fallon, & Hessen, 2013). The two reactions that the immune system follows are either to attack

outside of the cell or inside of the cell depending on the type of infection that is attempting to

transpire. The immune system constantly prioritizes its responses, while committing certain

responses to memory, which plays a large part in how immunization works (Urton, 2013). The

immune system and the human body both have memory; they are able to retain information on

certain diseases and approaches that worked efficiently to fight those diseases.
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 6

The Basics of Vaccination

The immune system is a complex interconnection of multiple body systems, organs, and

specialized cells that keep the body safe, but sometimes that is not enough. Certain antigens that

causes dangerous diseases are able to make their way into the body. This is where vaccination

comes into play. There are two ways in which immunity can be achieved. The first way does not

achieve long-range immunity but provides powerful short term protection; this type of immunity

is called passive immunity and is performed by injecting preformed antibodies that are able to

fight certain toxins, which are then stored in the body (Alder, Fallon, & Hessen, 2013). Passive

immunity is the best defense against toxins such as anthrax, and works by storing the preformed

antibodies until they are needed. Once those preformed antibodies are used, though, they cannot

be replaced unless inoculation takes place a second time. The second way of achieving immunity

is known as active immunity and involves stimulating antibody production by introducing an

antigen; this can happen either by natural exposure (such as contracting chickenpox as a child),

or through vaccination when altered, safer forms of the antigen are introduced over a period of

time (Alder, Fallon, & Hessen, 2013). Active immunity is long-lasting, as the body can produce

antibodies to combat the antigen again if necessary. Active immunity is most commonly

achieved through use of attenuated strains of bacteria or viruses, which are mutants that have lost

the ability to cause disease but that retain the antigenic character of the virulent strain so that the

body can learn how to fight it (Alder, Fallon, & Hessen, 2013). The first way to achieve active

immunity is by contracting a virus or bacterial infection so that the body learns how to fight

against it. This way is hit or miss in the most serious fashion, and involves relying solely on the

immune system to combat the deadly antigen. The second way is through vaccination, which at

its root is modified antigens or antigens that have been killed being injected into the body to
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 7

achieve immunity without contracting the actual disease. Bringing back the example from the

introduction, Edward Jenner was the first physician to exploit the fact that inoculating a person

with cowpox produced antibodies that provide active immunity to smallpox (Alder, Fallon, &

Hessen, 2013). Jenner’s cowpox vaccine was a main player in the elimination of smallpox, much

like vaccines today protect against other deadly infections.

Virginia Law on Vaccinations

The list of mandatory vaccinations vary by state and in schedule of vaccination; schools

and daycares have certain minimum vaccination requirements while hospitals and doctors offices

have others. In Virginia, however, the following vaccinations are required for school or daycare

attendance, separated per individual vaccine administration: Diphtheria, Tetanus, & Pertussis

(DTaP, DTP, or Tdap); Haemophilus Influenzae Type b (Hib) Vaccine; Hepatitis B Vaccine;

Measles, Mumps, & Rubella (MMR) Vaccine; Pneumococcal (PCV) Vaccine; Polio Vaccine;

Varicella (Chickenpox) Vaccine; and the optional Human Papillomavirus Vaccine, HPV

(Division of Immunization, n.d.). As noted, certain disease vaccinations are combined into one

dosage, such as the DTaP vaccine which protects against diphtheria, tetanus, and pertussis. The

aforementioned vaccinations are required to be administered either through the harmonized

schedule of the Centers for Disease Control and Prevention, CDC, or the harmonized catch-up

schedule (Division of Immunization, n.d.). Mandating vaccination prevents legal backlash if a

deadly disease begins to circulate, as well as allows schools and daycares to be protected against

these potentially fatal diseases. Virginia does have a way around vaccinations through religious

exemptions. This process involves filling out a form stating immunizing agents are against one’s

beliefs, and that the school in question, in the event of a vaccine preventable disease epidemic,

may remove the child from the school until the outbreak is contained (Form CRE-1 Certificate of
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 8

Religious Exemption, n.d.). This allows the school to prevent unnecessary infections as well as

protect all students involved.

Schedule for Mandatory Vaccinations in Virginia

Every vaccine that is required by Virginia government has to be administered during a

specific schedule in order for the child to become fully immune to certain diseases in the shortest

possible period of time. For the DTaP vaccine, children are required to have at least one dose

administered on or after the fourth birthday, while some children may be medically exempt from

the pertussis aspect of this vaccine and may receive the DT vaccine instead, while adult Td for

diphtheria and tetanus is required for children that have not been vaccinated before the age of

seven (Division of Immune Health, n.d.); the CDC’s harmonized schedule for vaccination

recommends initial administration of the DTaP vaccine at two months old, second and third at

four and six months, a fourth dose between 15 and 18 months, and a final dose at 4 to 6 years old

(Recommended Immunization Schedules for Persons Aged 0 to 18 Years, 2016). According to

the CDC’s schedule released in 2016, children should be fully vaccinated against diphtheria,

pertussis, and tetanus by six years of age, while school mandatory requirements accept one dose

by this age. The haemophilus influenzae type b (Hib) vaccine is only required for children up to

60 months, and unvaccinated children from 15 to 60 months are only required to receive one

dose, according to government regulations (Division of Immune Health, n.d.); .the CDC’s

schedule for the Hib vaccine begins with first dose at two months, second at four months, an

optional third at six months, and a booster between 12 and 15 months; the Hib vaccine is not

recommended for children over five years old, though one dose can be administered in the case

of asplenia or sickle cell anemia (Recommended Immunization Schedules, 2016). This vaccine is

one of the few that only require one dose to be administered for unvaccinated children. For the
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS 9

hepatitis b vaccine, children are required to have a complete series of three doses, while children

between the ages of 11 and 15 are required two doses only when the Merck Brand

(RECOMBIVAX HB) Adult Formulation Hepatitis B Vaccine is used (Division of Immune

Health, n.d.); the CDC’s schedule dictates first dose at birth followed by one dose between one

and two months, and the final between six and 18 months (Recommended Immunization

Schedules, 2016). The human papillomavirus vaccine is optional at the discretion of the parents

or guardian, but the vaccine should be completed by age 12. The MMR vaccine requires a

minimum of two measles, two mumps, and one rubella dose to meet school and daycare law

(Division of Immune Health, n.d.); the CDC notes first combination vaccine at age 12 to 15

months and a second between four and six years old (Recommended Immunization Schedules,

2016). The MMR vaccine is one of the vaccines that is typically administered in combination

vaccinations, single doses consisting of individual measles, mumps, and rubella vaccines. The

pneumococcal, PCV, vaccine is only for children under 60 months, with one dose minimum

(Division of Immune Health, n.d.); the CDC states first dose administered at two months, second

at four, third at six months, and the fourth between 12 and 15 months (Recommended

Immunization Schedules, 2016). The final two mandatory vaccinations are polio and chickenpox.

Polio vaccines are required to have four doses minimum, while chickenpox requires one dose at

12 months or older with a second prior to entering kindergarten (Division of Immune Health,

n.d.); the CDC recommends first and second dosage of polio vaccine at two and four months, a

third between six and 18 months, and a final between 4 and 6 years, while chickenpox is

recommended to begin between 12 and 15 months with a second between 4 and 6 years

(Recommended Immunization Schedules, 2016). Most vaccinations occur before age six, but

some are extended into adolescence.

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
10

Vaccine Ingredients

The main cause for concern in regards to vaccination are the ingredients contained within

them. All vaccines come with either a toxoid or antigen of the virus/bacteria, such as the

diphtheria and tetanus toxoids used in the DT vaccine, and other ingredients that serve to protect

against contamination or act as an adjuvant (Diphtheria, Tetanus, and Pertussis Vaccinations,

2016). Full ingredient lists can be found on the Centers for Disease Control and Prevention

website, as linked later in the paper. For simplicity’s sake, specific dosages and ingredient lists

have been omitted, but can be found on the aforementioned website.

Diphtheria, Pertussis, and Tetanus Vaccines

Diphtheria, pertussis, and tetanus vaccinations come in two types. The first type is

diphtheria and tetanus only vaccination, which come in two forms: the DT vaccine for infants

and children and the Td vaccine for children seven years of age or older (Diphtheria, Tetanus,

and Pertussis Vaccinations, 2016). Pertussis is not included in these first types of vaccinations to

protect children who have medical exemption from the pertussis vaccine. Ingredients for the DT

and Td vaccines vary in dosage and composition but include the following ingredients:

diphtheria toxoid, tetanus toxoid, no more than 0.53 mg of aluminum, and trace amounts of

formaldehyde and thimerosal (mercury) from the manufacturing process (Diphtheria, Tetanus,

and Pertussis Vaccinations, 2016). The second form of vaccine for these diseases is the DTaP

vaccine, which comes in six brands, generic and brand name. The ingredients that can be found

in the DTaP vaccines vary in dosage and composition for each brand but may include: diphtheria

toxoid, tetanus toxoid, acellular pertussis antigens or inactivated PT, filamentous hemagglutinin

(FHA), pertactin, fimbriae types 2 and 3 (FIM), aluminum phosphate or aluminum hydroxide,

sodium chloride, D-antigen units of type 1 poliovirus and hepatitis B virus surface antigens (for
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
11

those vaccine brands that protect against polio and hepatitis B as well), polyribosyl-ribitol-

phosphate, polysorbate 80, 2-phenoxyethanol, sucrose, and residual amounts of formaldehyde,

glutaraldehyde, neomycin, polymyxin B, bovine serum albumin, and 2-phenoxyethanol

(Diphtheria, Tetanus, and Pertussis Vaccinations, 2016). Again, this list of ingredients varies in

dosage and composition depending on the brand of vaccine being used. Neomycin sulfate and

polymyxin B are used in the poliovirus vaccine manufacturing process, and may end up in the

final vaccine (Diphtheria, Tetanus, and Pertussis Vaccinations, 2016). The final type of vaccine

for diphtheria, pertussis, and tetanus is the Tdap vaccine. The Tdap vaccine can only be used in

children seven years of age or older, come in two brands, and may include: diphtheria toxoid,

tetanus toxoid, acellular pertussis antigens or inactivated PT, FHA, pertactin, aluminum

phosphate or aluminum hydroxide, sodium chloride, and residual amounts of formaldehyde,

glutaraldehyde, polysorbate 80, and/or 2-phenoxyethanol (Diphtheria, Tetanus, and Pertussis

Vaccinations, 2016).

Haemophilus Influenzae Type b (Hib) Vaccine

Haemophilus influenzae type b, Hib, is an invasive disease that is a leading cause of

bacterial meningitis; before implementation of vaccines for Hib disease, 20,000 children per year

contracted the disease, 1,000 of which died, but after 2014 fewer than 50 cases of Hib disease

occurred each year, most of which included unvaccinated children or children who have not been

fully vaccinated (About the Hib Vaccine, 2016). This dangerous disease affects mostly children

under five years old, especially children under one year old. There are four Hib vaccine brands,

with one (Pentacel) that is included in the DTaP vaccine; the first Hib vaccine brand is

PedvaxHIB, which includes: Haemophilus b PRP (polyribosylribitol phosphate), Neisseria

meningitidis OMPC (outer membrane protein complex), amorphous aluminum

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
12

hydroxyphosphate, and sodium chloride (About the Hib Vaccine, 2016). The second brand of

Hib vaccine is ActHIB, which is a lyophilized powder to be reconstituted with 0.4% sodium

chloride diluent and consists of: haemophilus influenzae type b capsular polysaccharide

(polyribosyl-ribitol-phosphate, PRP), tetanus toxoid, and below 0.5 micrograms of residual

formaldehyde (About the Hib Vaccine, 2016). The final brand of Hib vaccine is Hiberix, which

is also a lyophilized powder to be reconstituted with 0.9% sodium chloride diluent and consists

of: haemophilus b purified capsular polysaccharide, tetanus toxoid, lactose, and residual

formaldehyde (About the Hib Vaccine, 2016).

Hepatitis B Vaccine

The hepatitis b vaccine can also be found in the DTaP vaccine, but can be administered

through individual hepatitis b vaccines. The vaccine for hepatitis b was first legalized in the

United States in 1981 and has since been reformulated and re-licensed; hepatitis b recombinant

vaccines are produced from two manufacturers, Merck and GlaxoSmithKline Pharmaceuticals,

and include HBsAg protein, yeast derived proteins (no yeast DNA is present in final vaccine),

and aluminum hydroxide or aluminum hydroxyphosphate sulfate, which HBsAg vaccine is

absorbed to (Hepatitis B, 2016).

Measles, Mumps, and Rubella Vaccines

Measles, mumps, and rubella are all potentially dangerous diseases listed as mandatory

for school or daycare attendance. There are two vaccines available for measles, mumps, and

rubella: M-M-R-H-II and ProQuad, which also vaccinates against varicella (chickenpox) (MMR

and MMRV Vaccine Composition and Dosage, 2018). Both vaccines available are combination

vaccines that contained ingredients that protect against measles, mumps, rubella, and/or

chickenpox. M-M-R-H-II contains live attenuated (note that attenuated is defined as an altered
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
13

version of the virus that cannot replicate inside the human body) measles virus, attenuated

mumps virus, attenuated live rubella virus, sorbitol, sodium phosphate, sucrose, sodium chloride,

hydrolyzed gelatin, recombinant human albumin, fetal bovine serum, and neomycin (MMRII,

2016). This vaccine only protects against measles, mumps, and rubella. ProQuad protects against

measles, mumps, rubella, and varicella and contains live attenuated measles, mumps, rubella, and

varicella viruses, sucrose, hydrolyzed gelatin, sodium chloride, sorbitol, monosodium L-

glutamate, sodium phosphate dibasic, human albumin, sodium bicarbonate, potassium phosphate

monobasic, potassium chloride, potassium phosphate dibasic, residual components of MRC-5

cells, neomycin, and bovine calf serum (ProQuad, 2017).

Pneumococcal (PCV) Vaccine

Pneumococcal disease presents itself in a number of forms. Pneumococcal disease is an

infection caused by streptococcus pneumoniae, and there are two types of vaccines approved for

use in the U.S., pneumococcal conjugate vaccine for people under two and over 65 and

pneumococcal polysaccharide vaccine for people between two and 65 (Pneumococcal Vaccines,

2017). Pneumococcal disease infection types will be discussed later. Pneumococcal conjugate

vaccine contains purified capsular polysaccharide of 13 serotypes of Streptococcus pneumoniae

conjugated to a nontoxic variant of diphtheria toxin known as CRM197, polysorbate, aluminum

phosphate as the adjuvant, and succinate buffer; pneumococcal polysaccharide vaccine contains

purified preparations of pneumococcal capsular polysaccharide antigen from 23 types of

pneumococcal bacteria and phenol as a preservative (Pneumococcal Vaccines, 2017).

Polio Vaccine

Polio is a debilitating disease that has been included in vaccines for years. Vaccination

for polio may be included in DTaP vaccines Pentacel, Pediarix, and Kinrix (Polio Vaccine
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
14

Composition, Dosage, and Administration, 2017), or there is one polio vaccine in use in America

today, Ipol, which contains D antigen units of Type 1, Type 2, and Type 3 poliovirus,

phenoxyethanol, formaldehyde, and trace amounts of neomycin, streptomycin, polymyxin, and

calf bovine serum albumin (Ipol, 2017).

Varicella Vaccine

Chickenpox, or varicella, is another vaccine that has been around for many years. It also

only has one approved vaccine, and one combination vaccine, ProQuad, which also protects

against measles, mumps, and rubella (Varicella Vaccine Composition, Dosage, and

Administration, 2017). Some vaccines, like the varicella vaccine, are commonly administered in

the same dose as other vaccines. The approved varicella vaccine in use today is Varivax, which

contains plaque-forming units (PFU) of Oka/Merck varicella virus, sucrose, hydrolyzed gelatin,

sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate

monobasic, potassium chloride, and residual components of MRC-5 cells, neomycin, and bovine

calf serum (Varivax, 2018).

Analysis of Vaccine Ingredients

The main argument on the side of anti-vaccination is the wide array of ingredients found

in these vaccines. Parents are concerned of possible health risks resulting from exposure to

chemicals found in vaccines. Although there are multiple perspectives on the side of opposing

vaccinations, vaccine ingredients have appeared more frequently in social media groups than

other reasoning. Following is an analysis and description of each potentially troubling ingredient

found in vaccinations.

The subject that has gained the most attention in recent years is thimerosal, mercury, that

has since been discontinued in use for all but multi-dose containers of certain vaccines.
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
15

Thimerosal is a compound containing mercury, is now only used in multi-dose vials of the flu

vaccine, and is only used as a preservative to protect against dangerous microbes that can form

when a new needle is entered into the vial (Understanding Thimerosal, Mercury, and Vaccine

Safety, 2013). Multi-dose vials of the flu vaccine are used to prevent epidemics of the flu around

the country, and when each new needle is entered into the vial there is potential for dangerous

microbes to accumulate in the vial, contaminating the vaccine and creating potential for harm.

Thimerosal can also be found in trace amounts in two vaccines (DTaP and DTaPHib) due to

residual thimerosal used in the manufacturing process; the thimerosal is removed before the

vaccine is finished, but tiny amounts can still remain (Understanding Thimerosal, Mercury, and

Vaccine Safety, 2013). Companies that use thimerosal in the manufacturing process of vaccines

are required to disclose this information in the package insert. Thimerosal exposure in vaccines

was studied using infant male rhesus macaques, where they were studied from birth to 21 days; it

was found that days to criterion for the acquisition of neonatal reflexes was similar for animals

regardless of vaccine status, suggesting auditory and motor functioning were not affected (Curtis,

Liberato, Rulien, Morrisroe, Kenney, Yutuc, & Mandell, 2013). This study concludes that, in the

population of rhesus monkeys observed, thimerosal from vaccines had no relation to auditory or

motor functioning. The U.S. Food and Drug Administration notes that all vaccines are available

thimerosal-free, but those that do contain thimerosal have been reported safe in a wide array of

scientific peer-reviewed studies, and the antimicrobial properties of thimerosal make it an

effective way to prevent microbial infestation in multi-dose vials of influenza vaccine; the FDA

also notes that multi-dose vials are facilitates seasonal and pandemic influenza campaigns,

saving lives (Thimerosal and Vaccines, 2018). Multi-dose vials make it possible to package large

amounts of influenza vaccine to deliver to areas in need during seasonal or pandemic influenza,
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
16

and all medical facilities will have single dose vials that are thimerosal-free available. After

entering the body, thimerosal is broken down into ethylmercury and thiosalicylate, but there is

inadquate data on the toxicity of ethylmercury, so levels of methylmercury are used to determine

concentrations (Thimerosal Frequently Asked Questions, n.d.). Scientists have not observed the

effects of ethylmercury enough to determine a toxic amount of the material, leading them to use

methylmercury as a substitute to determine a safe level. Methylmercury can be found in seafood,

and is a known neurotoxin, but ehtylmercury has been proven less toxic than methylmercury

(Thimerosal Frequently Asked Questions, n.d.). Methylmercury is the mercury that is known to

be in cans of tuna. The level of thimerosal in a vaccine per 0.5 mL dose cannot exceed 50

micrograms of thimerosal, 25 micrograms of mercury, the same amount that is in a three ounce

can of tuna (Thimerosal and Vaccines, 2018). Eating a can of tuna does not have any dangerous

potential unless the individual is pregnant, in which case tuna as well as thimerosal-containing

drugs and vaccines should be avoided. Thimerosal may have possible dangers as there is

insufficient data available on the effects of ethylmercury and the body, but is available in

thimerosal-free vaccine substitutions.

Formaldehyde is another hot-button topic in vaccinations. Formaldehyde has a long

history of safe use in viral and bacterial vaccines, and is used to inactivate viruses and detoxify

bacterial toxins (Common Ingredients in U.S. Licensed Vaccines, 2014). Formaldehyde is used

to ensure no virus or bacteria has the ability to do any harm within the body. Without

formaldehyde or a chemical that has the same effect, vaccines would not be nearly as safe.

Formaldehyde is naturally occurring within the body (to produce energy, produce amino acids,

and for many other life processes) as well as in some environmental elements like household

cleaners and laboratories; in fact, the concentration of formaldehyde in a completed vaccine is

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
17

miniscule in comparison to the amount that occurs naturally in the body (Common Ingredients in

U.S. Licensed Vaccines, 2014). The body contains formaldehyde, which helps in the production

of amino acids as well as other materials needed for life processes. Environmental elements like

building products and household cleaners are what a good percentage of the population

associates with formaldehyde. Although ethics of animal testing are questionable, amounts of

formaldehyde more than 600 times more than that in vaccines have been given to animals

without causing harm (Offit, 2016). Formaldehyde in large doses may cause harm, but the small

amount of formaldehyde that is used in vaccines has been proven to be benign. A two month old

child weighing 5 kg has an average blood volume of 85 ml per kg would have 1.1 mg of

formaldehyde occurring naturally in their body; the amount of formaldehyde found in any

vaccine cannot exceed 0.7 mg, an amount 1.5 times higher than the amount that is naturally

occurring in the two month old’s body (Offit, 2016). Although most vaccines contain less than

0.7 mg, that is the limit for safe use. The amount of formaldehyde in the Tenivac diphtheria

combination vaccine is less than or equal to 5 micrograms, or 0.005 mg; Infanrix and Kinrix

DTaP vaccines contain less than or equal to 100 micrograms of residual formaldehyde, or 0.1 mg

(Diphtheria, Tetanus, and Pertussis, 2016). To give further perspective, the amount of

formaldehyde in Infanrix and Kinrix DTaP vaccines is 11 times higher than the amount found in

a baby weighing 5 kg.

Aluminum is another popular issue associated with vaccinations. Aluminum salts are

added to vaccines as an adjuvant; an adjuvant is an ingredient added to vaccines to boost immune

response so that the body’s immune system can more efficiently recognize the antigens or toxoid

present (Common Ingredients Found in U.S. Licensed Vaccines, 2014). The immune system’s

antibodies analyze and store memory on potentially hazardous antigens, waste, or toxins that are
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
18

entered into the body. The use of adjuvants like aluminum hydroxide and aluminum phosphate

cause the immune system to react more strongly to the vaccine, which allows these antibodies a

better look at the antigen in question. Aluminum as an adjuvant has demonstrated over 60 years

of safe use, with only uncommon severe local reactions, and the main source of aluminum

exposure is from food or drink; the only two vaccines to contain a different form of adjuvant are

the human papillomavirus, which contains combination of aluminum hydroxide and

monophosphoryl lipid, and the avian flu vaccine in the national stockpile, which contains an oil-

in-water emulsion (Common Ingredients Found in U.S. Licensed Vaccines, 2014). Severe

reactions have occurred after exposure to aluminum found in vaccines, but they are rare. Vaccine

adjuvants go through rigorous clinical trials before being licensed for use in the U.S., and

aluminum salts are used in hepatitis A, hepatitis B, diphtheria-tetanus-containing vaccines,

Haemophilus influenzae type b, and pneumococcal vaccines, but are not used in live vaccines

such as the MMR vaccine (Offit, 2016). Aluminum is found in most Virginia mandated vaccines,

with the exception of all forms of MMR vaccine and the varicella vaccine. Infants receive about

4.4 mg of aluminum total during the first six months of life from vaccines, but ingest

approximately 1.6 times more than that from their mother’s breast milk, totaling at 7 mg in the

first six months; formula-fed babies ingest approximately 38 mg in their first six months, and

soy-formula-fed babies ingest 117 mg (Offit, 2016). The amount of aluminum in vaccinations is

not only significantly lower than any other source of aluminum, but it is also goes through

rigorous clinical testing before being licensed to use in vaccinations.

Other ingredients that may cause worry in a parent's mind are ingredients that are used in

small quantities. To begin, filamentous hemagglutinin (FHA) and fimbriae types 2 and 3 are

components of the pertussis vaccine that the pertussis antigen adheres to, and FHA is involved in
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
19

the antibody response and protection against pertussis; FHA and fimbriae types 2 and 3 are safe

and have undergone clinical testing before being deemed safe for use in vaccines (Acquaye,

2015). FHA and fimriae types 2 and 3 are only in the pertussis vaccine and are safe for use.

Neomycin is used in several vaccines and is an antibiotic; the amount of neomycin present in

vaccines is 1/500th of the amount found in Neosporin or triple antibiotic ointment (Noorbakhish,

2015). Neomycin protects against bacterial infections and is used a precaution in vaccines.

Sodium chloride, potassium chloride, and phosphate versions of sodium and potassium are

natural electrolytes that the body uses daily, and are added to ensure pH balance as well as safety

in the vaccine (Noorbakhish, 2015). These ingredients may appear intimidating for a person who

does not know their exact function, but most ingredients found in vaccines are also found in

food, water, and the body, but in much greater amounts. Albumin, found in the MMR vaccine

and some other vaccinations, is a protein- the most abundant protein found in blood plasma- and

every day the body produces 40,000 times more albumin that is present in the MMR vaccine

(Noorbakhish, 2015). Like many other ingredients found in vaccines, the amount of albumin

present in vaccines is significantly less than the amount found in the body and other sources.

Monosodium glutamate, also known as MSG, is found in Chinese food, mushrooms, and breast

milk; like albumin, there is more monosodium glutamate found in a fresh tomato than that

present in the MMR vaccine and other vaccines (Noorbakhish, 2015). Chemicals and other

ingredients found in vaccines, like MSG, have multiple uses. The type and amount of MSG

found in Chinese food is in much greater amounts than that found in any vaccine. Sucrose is

table sugar, and the amount found in vaccines is 1/200th of a teaspoon; sorbitol is also used as an

artificial sweetener, and the body makes sorbitol during the sugar breakdown process

(Noorbakhish, 2015). Both sorbitol and sucrose are easily flushed out of the body. Bovine calf
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
20

serum or any variant of this ingredient are used to provide nutrients to grow the virus or bacteria

that will then go into the vaccines, but once the virus or bacteria is grown the entire mixture is

put into a centrifuge, which spins the virus out of the host cells; in reality, there is only the

possibility of trace elements of the bovine calf serum left in the vaccine once it is finished

(Noorbakhish, 2015). In order to make the vaccines that protect against viruses, scientists have to

grow the virus or bacteria in their lab, which is what bovine calf serum or chick embryos are

used for. They have to be listed as ingredients because they were used in the manufacturing

process, but in reality there is only a possibility that trace elements will appear in the vaccine.

Regulations Governing Vaccines

Now that all the vaccine ingredients have been explained, it is important to know what

laws and regulations are applied to vaccines. The FDA regulates what ingredients can be used in

vaccines, and which ones are prohibited or limited, but the World Health Organization also keeps

a keen eye on vaccine ingredients. The World Health Organization uses a consultative approach

to consolidate opinions and issues relating to vaccines, and then reports these findings to the

national authorities in the specific regions (Vaccine Regulation, n.d.). Basically, WHO acts as a

governing authority for all biologic products; they ensure safety and report issues with the

product back to the governing authority for specific areas. WHO is not affiliated with the

government, further ensuring safe use of vaccines. The FDA is the governing authority for

American production of vaccines. Vaccines, under FDA regulation, undergo a rigorous review of

clinical and laboratory data to ensure efficacy, safety, purity, and potency of the ingredients

included in vaccines, before licensure is approved for the product (Vaccines, 2018). The FDA

makes sure that all ingredients used in vaccines go through extreme clinical testing to ensure

safety before being approved for wide spread use. The Center for Biologics Evaluation and
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
21

Research, CBER, regulates vaccines products; the Centers for Disease Control and Prevention

states that vaccines have reduced preventable infectious diseases to an all-time low in America

(Vaccines, 2018). The FDA, WHO, and CBER in addition to the CDC all ensure vaccine safety,

product licensing, and govern manufacturing of these products.

Diseases that Vaccines Prevent

In order to form a well-founded opinion on the use of vaccines, it is important to know

about the diseases that these vaccines prevent. In life, some things come down to a judgment

call; it is dangerous to leave children unvaccinated without knowing the symptoms and signs to

look for. As with any illness, time is of the essence when it comes to surviving deadly diseases.

Certain diseases, like measles, can cause a plethora of health complications that can be fatal if

left untreated.

Diphtheria

Diphtheria is one of the diseases all but eradicated in America because of the use of

vaccines. Diphtheria is characterized as an acute infectious disease commonly found in children

that is associated with toxin production by the bacterium Corynebacterium diphtheriae; the

systems of the body effected by diphtheria are the heart, throat, and nervous system (Alder,

2013). This disease primarily targets children, and has devastating effects on the body.

Symptoms of diphtheria appear after a several day to a week incubation period and include fever,

malaise, sore throat, pseudomembrane formation in the throat, and, when the disease spreads to

the bloodstream, damage to the heart and nervous system (Alder, 2013). The pseudomembrane

that is formed from excretions of toxins from Corynebacterium diphtheriae can become thick

and cause respiratory distress. When left untreated for long enough, the bacterium moves into the

bloodstream, causing damage to the heart and nervous system. A less common form of
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
22

diphtheria infection includes open wound infections in the skin, causing lesions and pain;

diphtheria is treated with penicillin or erythromycin and an antitoxin (Alder, 2013). Due to the

dangers associated with infection by this bacterium, prevention is the safest course of action.

Tetanus

Tetanus is another dangerous bacteria that can be contracted at any age. Tetanus is an

infectious disease of the central nervous system caused by toxins secreted by the bacillus

Clostridium tetani, and without prompt treatment can lead to death (Tetanus, 2017). Tetanus is

also called lockjaw, and the bacillus can be found everywhere, especially in topsoil and rusted

metal. The incubation period for C. tetani is typically eight days, but can vary to two to three

weeks; the first symptoms that appear with this infection are often headache and depression,

followed by stiffening of the jaw, trouble swallowing, and muscle spasms in the face- which

cause a peculiar, sardonic grin (Tetanus, 2017). Like diphtheria, symptoms of tetanus are caused

by secretion of toxins by the bacillus C. tetani, and symptoms usually take eight days to three

weeks to appear. Tetanus infection after initial symptoms can cause respiratory distress, muscle

spasms throughout the body, fractures, high blood pressure, abnormal heart rhythm, and

pneumonia; treatment of tetanus involves removing the bacilli through surgery or antibiotics,

antitoxin administration, and supporting or aiding respiration (Tetanus, 2017). Tetanus is

especially deadly for people over age 60, and for small children. Vaccination against tetanus

diminishes chances of infection dramatically.

Pertussis

Pertussis is included with vaccination against diphtheria and tetanus, and is another

potentially life threatening disease that primarily targets children. Pertussis is also known as

whooping cough and is characterized as a highly contagious respiratory disease- that lasts up to
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
23

10 weeks- that includes uncontrollable coughing that ends in a loud whoop as the patient

attempts to inhale (Alder, 2013). As coughing fits associated with pertussis are uncontrollable,

respiratory distress can easily occur. Bordetella pertussis causes the disease, which affects the

chest, heart, neck, respiratory system, and throat; symptoms of pertussis infection include a dry,

hacking cough that becomes deep and uncontrollable, fever, and excess mucous production

(Alder, 2013). Pertussis is especially dangerous due to the respiratory system damage caused by

Bordetalla pertussis. The average incubation period is seven days, and treatment involves bed

rest, antibiotics, and supportive therapy; infants are hospitalized when infected with pertussis,

and intravenous administration of antibiotics may be needed as well as use of corticosteroids to

suppress cough (Alder, 2013). Pertussis infection in infants is highly dangerous, as respiratory

distress is common.

Haemophilus Influenzae Type b (Hib)

This incredibly hard to pronounce infectious bacteria can cause several different diseases,

including Hib disease. The diseases that this bacteria causes include pneumonia, bacteremia,

meningitis, epiglottitis, cellulitis, and infectious arthritis; pneumonia is a lung infection,

bacteremia is a bloodstream infection, meningitis is a disease of the brain tissue, epiglotittus is

swelling in the throat, cellulitis is a skin infection, and infectious arthritis is inflammation in the

joints (Types of Haemophilus influenzae Infections, 2018). The assortment of diseases that

haemophilus influenzae type b causes make it extremely dangerous. Meningitis, for one, is a

deadly disease of the brain. Meningitis causes swelling in the brain tissues, and is caused by

bacterial infection; symptoms of meningitis in teens and adults include headaches, nausea or

vomiting, and pain or stiffness in the neck possibly preceded by a respiratory infection

(Baldridge, 2013). It is imperative to seek medical treatment if one develops these symptoms of
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
24

meningitis, and newborns and the elderly display a different range of symptoms. Newborns may

display either fever or hypothermia (when body temperatures reach dangerous lows), along with

irritability, disinterest in feeding, lethargy, and abdominal distension, while infants may be found

to have swelling of the fontanellas (swelling of the soft tissues around the skull) ; meningitis in

the elderly may be displayed as disorientation, confusion, or lethargy (Baldridge, 2013). It is

crucial for newborns and the elderly to receive treatment as soon as possible once symptoms

appear. Aseptic meningitis may be caused by viruses, and meningococcal meningitis may present

with a pinpoint rash (Baldridge, 2013). Bacteremia is any kind of blood infection, like the blood

infection that Haemophilus influenzae type b can develop into. Early symptoms may include

alternating chills and fever with prostration (the action of lying stretched out on the ground), and

progressive symptoms include mental confusion, changes in breathing and heart rate, and

reduced urine output, while increased heart rate and low blood pressure appear as the infection

moves closer to sepsis (Culvert, 2014). Aggressive treatment must be administered once a blood

stream infection is suspected. This type of treatment entails intravenous broad spectrum

antibiotics administered preferably within two hours of physical examination (Culvert, 2014).

Epiglottitis is swelling in the throat, which can quickly turn dangerous. Also known as

supraglottitis, epiglottitis present itself with symptoms such as fever and sore throat in children,

which progresses in a few hours or less into inability to eat and drooling, with signs of

respiratory obstruction such as stridor (a high pitched noise when breathing); the epiglottis is the

cartilage flap that closes the airway to enable swallowing (Tirumala, 2013). If the epiglottis

swells to a certain point, breathing will become impossible without aid. Treatment for epiglottitis

requires hospitalization into an intensive care unit, where humidified oxygen is administered and,

in severe cases, tracheal intubation (insertion of a breathing tube in the wind pipe) is used; in
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
25

very severe cases, epiglottitis requires emergency puncture of the wind pipe, but if treatment is

administered soon enough, the prognosis is good (Tirumala, 2013). Cellulitis is a skin infection

also caused by Haemophilus influenzae type b. Cellulitis is an infection of the deep tissues of the

skin, characterized by redness, tightness, and a glossy appearance of the skin; in some cases

fever and chills accompany the painful, red skin, and as a skin rash that has fast onset and

spreads (Edens, 2014). Cellulitis is one of the less severe infections caused by Haemophilus

influenzae type b if the infection is not severe. If the infection is severe and does not respond to

oral antibiotics, further testing and intravenous antibiotic administration typically after being

admitted to the hospital is required (Edens, 2014). Finally, infectious arthritis is an infection of

the joints causing swelling. Infectious arthritis is also known as prosthetic joint infection,

pyogenic arthritis, bacterial arthritis, or septic arthritis, and presents with symptoms such as

immobility of the limb of the infected joint, fever, intense joint pain, joint swelling and redness,

and chills; infants also present with fever, immobility of the limb of the infected joint, joint

swelling and redness, and fever with irritability and intense reaction when the joint is moved

(Kirchheimer, 2014). Treatment includes antibiotics. Administration of antibiotics may be

intravenously administered initially to ensure the infected joint receives medication to kill the

bacteria (Kirchheimer, 2014).

Hepatitis B

Hepatitis b is a disease of the liver that is one of the diseases children are required to be

vaccinated against. The disease involves infection by the hepatitis B virus (HBV), and symptoms

present about 25 to 80 days after initial infection and include yellowing skin and eyes (jaundice),

chronic fatigue, pain in the liver located in the upper right side of the abdomen, loss of appetite,

nausea, vomiting, pain, low-grade fever, dark urine and light colored stool, widespread itching,
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
26

and rash (Kassel & Horn, 2014). Treatment includes an array of medications, and patients who

have uncomplicated cases can expect to recover completely. Patients with more severe cases of

hepatitis b may require medication to keep the bacteria suppressed for a long period; the

medications used to treat hep b include interferon alfa-2b (Intron A) injection, lamivudine

(Epivir-HBV) oral medication, adefovir (Hepsera) oral medication, and entecavir (Baraclude)

oral medication (Kassel & Horn, 2014). Hepatitis b can progress into decreased or ceased liver

function.

Measles, Mumps, Rubella, and Varicella

Measles, mumps, and rubella are also diseases that target children, and are vaccinated

against by the MMR or MMRV vaccine. Measles is a highly contagious viral infection that

affects the ears, lungs, mouth, respiratory system, nervous system, and skin; measles is also

known as morbilli or rubeola (not to be confused with rubella), and appears as a spreading rash,

itching, malaise, fever, and respiratory difficulty (Alder, 2013). The dangerous thing about

measles is that there is no specific treatment available, only symptomatic intervention and

quarantine from persons not previously exposed to the virus either through previous contraction

of the disease or immunization. Mumps is also known as epidemic parotitis and affects the

genitals, glands, nervous system, and pancreas; the disease is typically found in children and

causes fever, swollen salivary glands, headache, upset stomach, loss of appetite, mildly

congested nose, red rash, and occasionally organ or joint infections (Reuman, 2013). Mumps

does not have a specific treatment either. No antiviral is available for mumps (the disease is self

limited, so it does not require antivirals), and the disease is treated using conservative therapy,

with a low-acid diet and ample fluids; in some cases mild pain medications are prescribed for

headaches and salivary gland discomfort, and in rare cases stronger pain medication if testicular
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
27

involvement occurs (Reuman, 2013). Rubella is also included in the MMR and MMRV vaccine,

and primarily targets children. Rubella is also known as German measles and is characterized by

a small spotty rash, low-grade fever, headache, loss of appetite, mildly red eyes, stuffy nose, sore

throat, coughing, and lymph node enlargement in the neck (Reuman, 2013). Like measles, the

only treatment of rubella involve alleviation of symptoms. Finally, varicella is a viral infection

similar to measles, mumps, and rubella, as it is also characterized by an itchy rash. Varicella is

also known as chickenpox, which presents with symptoms such as intense itchy skin rash,

malaise, weakness, fever, and runny nose, and is a weaker version of smallpox; chickenpox can

cause people to develop shingles later in life due to the virus staying dormant in the body (Klose,

2013). It is because of the unpleasant nature of chickenpox and the possibility of developing

shingles later in life is why vaccination is recommended. Shingles develops from the same virus

that causes chickenpox and presents as tingly, burning, or sharp pain accompanied by a blistering

rash (Zawada & Baptista, 2013).

Pneumococcal Infections

The pneumococcal, PCV, vaccine prevents against diseases caused by bacteria that

causes pneumococcal disease. The bacteria streptococcus pneumoniae, or pneumococcus can

cause ear infections, sinus infections, meningitis, and bacteremia (Types of Infection, 2017).

Bacteremia and meningitis are dangerous infections of the brain and bloodstream, as stated

previously. Signs of ear infections are hearing loss, pain, itchiness, inflammation, discharge, and

tinnitus, and treatment includes rinsing the ears, antibiotics, or surgical implantation of tubes if

infection is recurrent (Plitnik, 2013). Ear infections can progress into bloodstream infections on

rare occasions, so treatment is advised as soon as symptoms appear. Sinus infections also range

in severity and come with symptoms such as irritation or swelling of the sinuses, congestion or
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
28

pressure in the nose or face, runny nose with varying colors of secretions, decreased sense of

smell, productive cough, fever, tooth pain, and bad breath (Seymann, 2013). Treatment of sinus

infections include antibiotics and medication to alleviate symptoms.

Polio

Polio is one of the dangerous diseases that has all but disappeared in America due to the

widespread use of vaccines. Polio is a viral disease that produced hysteria and fear among North

Americans fearing its transmission in the 1950s; during this decade hundreds of thousands of

people were paralyzed or killed by the virus, which appeared as a summer flu in its original onset

(Singer, 2013). Polio is a devastating disease that almost always causes paralysis without proper

treatment, and in some cases even with proper treatment. Before the 1950s polio was referred to

as "infantile paralysis," as it always led to paralysis to the point where patients had to live in iron

lungs, or machines that helped patients with paralyzed rib cages breathe; vaccinations created

during this decade virtually eliminated cases of the poliovirus and building the nation's trust in

biomedicine (Singer, 2013). Polio can appear in paralytic and non-paralytic versions, with the

non-paralytic version being the most common. Non-paralytic polio appears with symptoms such

as fever, back and neck pain and/or stiffness, headache, sore throat, vomiting, fatigue, pain or

stiffness in the arms or legs, and muscle weakness or tenderness; paralytic polio includes the

aforementioned symptoms as well as loss of reflexes, severe muscle aches or weakness, and

loose and floppy limbs (flaccid paralysis) (Polio, 2017). The last reported case of polio was over

30 years ago. All forms of polio can lead to post polio syndrome, which involves symptoms such

as muscle atrophy (deteriorating muscles), progressive muscle or joint pain or weakness, fatigue,

breathing or swallowing problems, sleep-related breathing disorders such as sleep apnea, and

decreased tolerance of cold temperatures (Polio, 2017). Polio may have been eliminated, but it is
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
29

still a problem in parts of Asia and Africa, so international travel can bring Americans into

contact with the poliovirus.

Potential Side Effects of Vaccination

The potential side effects of vaccinations are important to know and understand once

knowledge of the ingredients in vaccines is acquired in order to make an informed decision. Side

effects can happen with any medical procedure, including vaccination. Parents who do vaccinate

should understand what side effects are common and benign, and which are signs of allergic

reaction to one or more components of the vaccine.

Diphtheria, Tetanus, and Pertussis Combination Vaccines

The side effects that are possible depend on the type of vaccine administered. DTaP

vaccines come with common side effects such as fever, irritability, feeling tired, soreness or

swelling where the shot was given, loss of appetite, and vomiting; Td vaccines come with

potential side effects such as mild fever and pain, redness, or swelling of the injection site; and

common side effects of Tdap vaccines include pain, redness, or swelling where the shot was

administered, mild fever, headache, feeling tired, and nausea, vomiting, or stomach upset

(Diphtheria, Tetanus, and Pertussis Vaccine Safety, 2015).

Haemophilus Influenzae Type B Vaccine

Haemophilus influenzae type b vaccines do not contain many side effects that are

possible. Common side effects of the Hib vaccine include warmth, redness, and swelling of the

injection site and fever (Haemophilus Influenza Type B (Hib) Vaccine Safety, 2015). The side

effects of the Hib vaccine are fewer and less severe than the diseases it causes, though allergic

reaction is possible.

Hepatitis B Vaccine
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
30

Hepatitis B vaccines are sometimes combined with other vaccinations, but side effects for

strictly the hepatitis b vaccine are few. The two common side effects related to the hepatitis b

vaccine are sore arm on the side the shot was given and fever (Hepatitis B Vaccine Safety,

2015). Again, serious side effects can occur, but are rare and primarily are allergic reactions to

one or more ingredients in the vaccine.

MMR, MMRV, and Varicella Vaccines

Measles, mumps, rubella, and varicella are all viral infections that involve a skin rash.

They are protected against via the MMR, MMRV, and Varicella vaccinations. Side effects

possible for the MMR vaccine include sore arm from the shot, fever, mild rash, and temporary

joint stiffness and pain, mostly in teenage or adult women who do not have immunity to the

rubella component of the vaccine (Measles, Mumps, and Rubella (MMR) Vaccine Safety, 2015).

These side effects are common and go away within a week of vaccination. The MMRV vaccine

comes with potential side effects such as soreness at the injection site, fever, and rash (MMRV

Vaccine Safety Studies, 2015). Finally, the varicella vaccine singularly comes with potential side

effects as well. These include soreness at the injection site, fever, mild rash, and temporary pain

and stiffness in the joints (Chickenpox (Varicella) Vaccine Safety, 2015).

PCV Vaccine

The pneumococcal vaccine prevents against 13 types of pneumococcal bacteria that can

lead to an array of different diseases. Potential side effects of the PCV vaccine include soreness

at the injection site or swelling, feeling drowsy, loss of appetite, fever, and headache

(Pneumococcal Vaccine Safety, 2015).

Polio Vaccine
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
31

Polio has all but been eradicated in America, with prevalence still in parts of Africa and

Asia, begging the necessity for the vaccine. Side effects of the polio vaccine are the same as the

side effects for the DTaP vaccine, as polio is often included in the DTaP vaccine or variants of

the vaccine.

Conclusion

Although vaccination is ultimately the parents' decision, vaccinations are a safe way to

protect against a multitude of diseases. Basic understanding of the immune system as well as

knowledge of vaccines, their ingredients and the evidence supporting their safety can lead a

parent to an informed decision. If the risk of allergy is high based on testing and medical history,

declining vaccination may also be the best way to protect the child. The common ingredients that

cause concern in the minds of parents are aluminum, formaldehyde, and mercury. The types of

aluminum used in vaccinations are added as adjuvants to allow for lesser amounts of toxoid,

virus, or antigen to be used, increasing vaccine safety. Formaldehyde is used in the

manufacturing process to protect against contamination, and only trace amounts are found in the

finished vaccine. Mercury is a component of thimerosal, which is only added to multi-dose vials

of flu vaccine. The thimerosal that is in vaccines breaks down into ethylmercury in the body,

which is then easily expelled from the system. The amounts of formaldehyde, thimerosal, and

aluminum in vaccines are not enough to cause harm, regardless of the route of administration. In

fact, babies take in at least 1.6 times more aluminum in their diet naturally than they do from

vaccinations. The same is with the amount of formaldehyde found naturally in their body versus

the amount from vaccines. Another important aspect of knowledge needed for the vaccination

decision is the symptoms and treatments for the diseases vaccines prevent. In most instances, as

is the case with meningitis, bacteremia, pneumococcal disease, and tetanus, the disease is much
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
32

more dangerous than the potential side effects of the vaccines. Knowledge of potential side

effects of vaccination is also important both for vaccinating and for deciding not to; knowing

what to look for when it comes to severe reactions is crucial for prompt recovery. In the end

there are risks in every option, one just has to choose the risk one's willing to take.
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
33

References:

About the Hib Vaccine. (2016). Centers for Disease Control and Prevention. US Department of

Health and Human Services. Retrieved from

https://www.cdc.gov/vaccines/vpd/hib/public/

Acquaye, E. A. (2015). Biochemical characterization of monoclonal antibodies to the Bordetella

pertussis Filamentous hemagglutinin (FHA) and Pertussis toxin (PTx) : implications for

improved acellular pertussis vaccine design. The University of Texas at Austin.

Retrieved from https://repositories.lib.utexas.edu/handle/2152/61768

Alder, R. P. (2013). Diphtheria. Magill’S Medical Guide (Online Edition).

Alder, R. P. (2013). Measles. Magill’S Medical Guide (Online Edition).

Alder, R. P. (2013). Whooping cough. Magill’S Medical Guide (Online Edition).

Alder, R. P., Fallon, L. P., & Hessen, M. M. (2013). Immunization and vaccination. Magill’S

Medical Guide (Online Edition).

Baldridge, I. C. (2013). Meningitis. Magill’S Medical Guide (Online Edition).

Chickenpox (Varicella) Vaccine Safety. (2015). Centers for Disease Control and Prevention.

Retrieved from https://www.cdc.gov/vaccinesafety/vaccines/varicella-vaccine.html

Common Ingredients to U.S. Licensed Vaccines. (2014). U.S. Food and Drug Administration.

Retrieved from

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187

810.htm

Culvert, L. C. (2014). Bloodstream infections. Salem Press Encyclopedia Of Health.

Curtis, B., Liberato, N., Rulien, M., Morrisroe, K., Kenney, C., Yutuc, V., & ... Mandell, D.

(n.d).
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
34

Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate

Model: Assessments of Neurodevelopment, Learning, and Social Behavior.

Environmental Health Perspectives, 123(6), 579-589.

Diphtheria, Tetanus, and Pertussis Vaccine Safety. (2015). Centers for Disease Control and

Prevention. Retrieved from https://www.cdc.gov/vaccinesafety/vaccines/dtap-tdap-

vaccine.html

Diphtheria, Tetanus, and Pertussis Vaccines. (2016). Centers for Disease Control and Prevention.

US Department of Health and Human Services. Retrieved from

https://www.cdc.gov/vaccines/vpd/dtap-tdap-td/hcp/about-vaccine.html.

Division of Immunization. (n.d.). School and DayCare Minimum Immunization Requirements.

Virginia Department of Health. Retrieved from

http://www.vdh.virginia.gov/immunization/requirements/.

Dranguet, C. J. (2013). Edward Jenner. Salem Press Biographical Encyclopedia.

Edens, P. F. (2014). Cellulitis. Salem Press Encyclopedia Of Health.

Form CRE-1 Certificate of Religious Exemption. (n.d.). Commonwealth of Virginia.

Haemophilus Influenza Type B (Hib) Vaccine Safety. (2015). Centers for Disease Control and

Prevention. Retrieved from https://www.cdc.gov/vaccinesafety/vaccines/hib-vaccine.html

Hepatitis B. (2016). Epidemiology and Prevention of Vaccine-Preventable Diseases. Centers for

Disease Control and Prevention. US Department of Health and Human Services.

Retrieved from https://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html#vaccine.

Hepatitis B Vaccine Safety. (2015). Centers for Disease Control and Prevention. Retrieved from

https://www.cdc.gov/vaccinesafety/vaccines/hepatitis-b-vaccine.html

Ipol. (2017). U.S. Food and Drug Administration. Retrieved from

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
35

https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm180053.h

tm

Kassel, K. M., & Horn, D. F. (2014). Hepatitis B. Salem Press Encyclopedia Of Health.

Kirchheimer, S. M., & Horn, D. F. (2014). Septic arthritis. Salem Press Encyclopedia Of Health.

Klose, R. P. (2013). Chickenpox. Magill’S Medical Guide (Online Edition).

Measles, Mumps, and Rubella (MMR) Vaccine Safety. (2015). Centers for Disease Control and

Prevention. Retrieved from https://www.cdc.gov/vaccinesafety/vaccines/mmr-

vaccine.html

MMR and MMRV Vaccine Composition and Dosage. (2018). Centers for Disease Control and

Prevention. Retrieved from https://www.cdc.gov/vaccines/vpd/mmr/hcp/about.html

MMRV Vaccine Safety Studies. (2015). Centers for Disease Control and Prevention. Retrieved

from https://www.cdc.gov/vaccinesafety/vaccines/mmrv/mmrv-safety-studies.html

MMRII. (2016). U.S. Food and Drug Administration. Silver Spring, MD. Retrieved from

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/U

CM123789.pdf

Noorbakhish, K. (2015). Don’t be scared: Let’s see what’s really in vaccines. Kevinmd. Med

Page Today. Retrieved from https://www.kevinmd.com/blog/2015/03/dont-scared-lets-

see-whats-really-vaccines.html

Offit, P. A. (2016). Vaccine Ingredients- Formaldehyde. Children’s Hospital of Philadelphia.

Retrieved from http://www.chop.edu/centers-programs/vaccine-education-center/vaccine-

ingredients/formaldehyde
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
36

Offit, P. A. (2016). Vaccine Ingredients- Aluminum. Children’s Hospital of Philadelphia.

Retrieved from http://www.chop.edu/centers-programs/vaccine-education-center/vaccine-

ingredients/aluminum

Plitnik, G. P. (2013). Ear infections and disorders. Magill’S Medical Guide (Online Edition).

Pneumococcal Vaccine Safety. (2015). Centers for Disease Control and Prevention. Retrieved

from https://www.cdc.gov/vaccinesafety/vaccines/pneumococcal-vaccine.html

Pneumococcal Vaccines. (2017). Centers for Disease Control and Prevention. Retrieved from

https://www.cdc.gov/vaccines/vpd/pneumo/hcp/about-vaccine.html

Polio. (2017). Mayo Clinic. Retrieved from https://www.mayoclinic.org/diseases-

conditions/polio/symptoms-causes/syc-20376512

Polio Vaccine Composition, Dosage, and Administration. (2017). Centers for Disease Control

and Prevention. Retrieved from

https://www.cdc.gov/vaccines/vpd/polio/hcp/composition-dosage-administration.html

ProQuad. (2017). U.S. Food and Drug Administration. Silver Spring, MD. Retrieved from

https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm188806.h

tm

Recommended Immunization Schedules for Persons Aged 0 to 18 Years. (2016). Centers for

Disease Control and Prevention. US Department of Health and Human Services.

Retrieved from https://www.cdc.gov/vaccines/schedules/past.html.

Reuman, P. M. (2013). Mumps. Magill’S Medical Guide (Online Edition).

Reuman, P. M. (2013). Rubella. Magill’S Medical Guide (Online Edition).

Seymann, G. M. (2013). Sinusitis. Magill’S Medical Guide (Online Edition).

Tetanus. (2017). Funk & Wagnalls New World Encyclopedia, 1p. 1.

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
37

Thimerosal Frequently Asked Questions. (n.d.). U.S. Department of Health. Retrieved from

https://www.doh.wa.gov/Portals/1/Documents/Pubs/ThimerosalFrequentAskedQuestions.

pdf

Thimerosal and Vaccines. (2018). U.S. Food and Drug Administration. Retrieved from

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM09

6228

Tirumala, V. M. (2013). Epiglottitis. Magill’S Medical Guide (Online Edition).

Types of Haemophilus influenzae Infections. (2018). Centers for Disease Control and

Prevention. Retrieved from https://www.cdc.gov/hi-disease/about/types-infection.html

Types of Infection. (2017). Centers for Disease Control and Prevention. Retrieved from

https://www.cdc.gov/pneumococcal/about/infection-types.html

Understanding Thimerosal, Mercury, and Vaccine Safety (2013). Centers for Disease Control

and Prevention. Retrieved from https://www.cdc.gov/vaccines/hcp/patient-

ed/conversations/downloads/vacsafe-thimerosal-color-office.pdf

Urton, M. P. (2013). Immune system. Salem Press Encyclopedia Of Science.

Vaccine Regulation. (n.d.). World Health Organization. Retrieved from

http://www.who.int/immunization_standards/vaccine_regulation/en/

Vaccines. (2018). U.S. Food and Drug Administration. Retrieved from

https://www.fda.gov/BiologicsBloodVaccines/Vaccines/

Varicella Vaccine Composition, Dosage, and Administration. (2017). Centers for Disease

Control and Prevention. Retrieved from

https://www.cdc.gov/vaccines/vpd/varicella/hcp/about-vaccine.html

Varivax. (2018). U.S. Food and Drug Administration. Retrieved from

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
38

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/U

CM142812.pdf

Zawada, W. P., & Baptista, V. M. (2013). Shingles. Magill’S Medical Guide (Online Edition).
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
39

Links to All Vaccine Package Inserts

1. Diphtheria, Tetanus, and Pertussis Vaccinations (Td, DT, DTaP, Tdap)

a. https://www.cdc.gov/vaccines/vpd/dtap-tdap-td/hcp/about-vaccine.html

b. Scroll (almost) to the bottom and the PDF files for the package inserts are linked.

2. Haemophilus Influenzae Type B (Hib) Vaccine

a. https://www.cdc.gov/vaccines/vpd/hib/public/

b. Scroll down to subsection “What Types of Hib Vaccine Are There?”

c. PDF files for package inserts are listed

3. Hepatitis B

a. https://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html#vaccine

b. Vaccine insert not included, but plentiful research and information on hep b

vaccine available

4. Measles, Mumps, and Rubella Vaccines

a. MMRHII

i. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Appro

vedProducts/UCM123789.pdf

b. ProQuad

i. https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProduct

s/ucm188806.htm

5. Pneumococcal (PCV) Vaccine

a. https://www.cdc.gov/vaccines/vpd/pneumo/hcp/about-vaccine.html

b. Scroll down until pdf files of vaccine package inserts are listed.

6. Polio Vaccine
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
40

a. https://www.cdc.gov/vaccines/vpd/polio/hcp/composition-dosage-

administration.html

7. Varicella Vaccine

a. https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm0

94073.htm

Note from Me @ You

If you really read all 32 pages of that, I thank you. I worked incredibly hard researching

every section discussed in this paper. My hope is that having all this information consolidated

into one document will allow parents-to-be, or current parents, the opportunity to make fully

informed decisions. Today, there is so much fear mongering it is difficult to determine what

information to trust. Conspiracies, false information, and misleading and biased "medical"

opinions are rampant. All of the information used in this paper has been researched using

alternative, credible sources, however, government websites such as the FDA and CDC websites

are the most credible, as they are regulated by trained personnel and backed by the federal

government. That is where conspiracy theories come into play. Be on the lookout for fallacies

when deciding whether to believe a theory you read on the internet. The first of these that is

applicable to information about vaccines is the straw man fallacy. The straw man fallacy is when

the author attacks a position that the opponent never intended to defend. This applies to vaccine

research in that if the source attacks the reputation of the vaccine company, or the safe

ingredients found in the vaccine without providing any proof or evidence to support their theory,

they may not be a credible source of information. Another fallacy to look out for is the appeal to

ignorance fallacy, which is when the author uses the reader's ignorance of a topic to validate their

information. Vaccine resources may over exaggerate the quantity or dangers of specific elements
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
41

of the vaccine, again without providing credible evidence to support their theory. The false

dilemma, or either-or fallacy, is one to watch for when making a vaccine decision. The decision

is not black and white, vaccinate or do not vaccinate. A delayed schedule, omission of certain

vaccines, and administering singular vaccines at each visit are all options to consider when

deciding whether to vaccinate. The circular argument fallacy is another I've personally witnessed

in many anti-vaccine articles; this fallacy is when the author or speaker's argument is just

restating their original point without actually proving anything. Vaccine articles that contain this

fallacy will appear to be making several points, but in different wording. Hasty generalization is

another dangerous fallacy that appears in anti-vaccination articles. Hasty generalization is when

the author takes a small piece of information and uses it to prove other points. Vaccine articles

using hasty generalization may take the fact that formaldehyde in large quantities can cause

cancer and use it to try and prove that all vaccines are dangerous because they contain

formaldehyde. The red herring fallacy is another that is used to breed fear of vaccinations. Red

herring means to use a topic that is not necessarily relevant to the discussion as a distraction. I

hate to use this as an example, but the way this fallacy is used in vaccine articles typically uses a

case of allergic reaction as a distraction, which is in no means okay. The poor children who have

these allergies should not under any circumstances be exploited for personal gain or for increased

following of anti-vaccine websites. Another way this fallacy is used is by a broad, unfounded

statement like "this or that vaccine is killing babies." The false cause and post hoc fallacies are

the last two I will discuss. The false cause fallacy is when the arguer or author hastily uses an

unfounded "fact" to prove causation between two things. The post hoc fallacy is the "after this,

therefore because of this" argument. In vaccines, the author may argue that developmental issues
VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
42

are caused by vaccines because they occur after the child has been vaccinated, without proper

evidence supporting the theory.

VA MIN IMMUN LAW & VAX SAFETY ANALYSIS
43