Vaccination of Infectious Disease
By Shoshana Weiner
Introduction: Why do we use vaccination?
Immunization is the ability to “artificially induce the body to resist infection.” The idea that immunity was possible originated in observations that those who survived the course of a disease rarely ever contracted the same disease again: “In 430 B.C., Thucydides recorded that while the plaque was raging in Athens, the sick and dying would have received no attention had it not been for those individuals who had already contracted the disease and recovered and recognized their ‘immune’ status.” [28]
The
use of inoculations to protect the host from disease is thought to have started
in
The term vaccination came from a later approach to smallpox inoculation. In 1796, an English physician named Edward Jenner “observed that milkmaids stricken with a viral disease called cowpox [vaccinia] were rarely victims of a similar disease, smallpox… In an experiment…, Jenner took a few drops of fluid from a pustule of a woman who had cowpox and injected the fluid into a healthy young boy who had never had cowpox or smallpox. Six weeks later, Jenner injected the boy with fluid from a smallpox pustule, but the boy remained free of …smallpox.” [3] The French coined the term vaccination, which specifically refers to the use of cowpox (vaccinia) to immunize humans against smallpox (variola). [27]
The use of
this new vaccine has protected the global community from the morbid
consequences of smallpox epidemics. In
the time of Jenner “…a million people died from smallpox each year in
Many other
diseases have been controlled through the use of vaccination. Within the
What are Vaccinations and how do they Work?
The immune system is designed to combat foreign invaders that enter the body before symptoms arise. The body accomplishes this in part by special immune cells that make proteins called antibodies in response to an infection. Antibodies act as “fingerprints” for a certain invader. That way, if the body encounters the same pathogen in the future, the immune system can quickly recognize the invader, and an expedited immune response will be possible. Vaccines work by providing the body with a set of “fingerprints” before the body is naturally invaded. [1, 2]
Vaccines are made from either a modified microbe or part of a microbe that tricks the body into thinking it is being invaded. Therefore, antibodies against the microbe can be made without the person getting sick. [1]
Vaccines
are not 100% protective. “Most childhood vaccines are effective for 85 percent
to 95 percent of recipients. During a disease outbreak, a number of vaccinated
people will…catch the disease. However, those who were immunized usually have a
less serious illness.” [2] Vaccinated
individuals can obtain a disease because either they fail to make antibodies or
the vaccine may have been stored incorrectly thereby making it
ineffective. In addition, some vaccines
require multiple injections since the immune system may gradually lose
antibodies for a microbe over time. [1]
Below are explanations of the different types of vaccines adapted from The National Institute of Allergy and Infectious Disease. For a complete copy of their explanations, please visit their website [3]:
Different Types of Vaccines
Weakened Microbes. Live microbes are weakened by growing them for many generations in animals or in tissue cultures in the laboratory. These weakened microbes can be inoculated into humans to provide protection from their disease-causing counterparts.
Examples: oral polio vaccine, vaccines for mumps, measles, and rubella
Killed Microbes. A number of vaccines have been developed from whole organisms that have been killed. These inactivated microbes stimulate the immune system without causing disease.
Examples: polio, influenza
Inactivated Toxins (Toxoids). Some bacteria cause disease by producing toxins that invade the bloodstream. Inactivated toxins have been used successfully.
Examples: tetanus, diphtheria
Subunit Vaccines. These vaccines use only part of a bacterium or virus.
Examples: typhoid and hepatitis B, whooping cough
Conjugate Vaccines. Certain bacteria have an outer coat that cannot be recognized by the immature immune systems of young infants and, therefore, vaccines made from these bacteria are not effective in babies. Vaccines are made that link together proteins or inactivated toxins from a second organism to the outer coat of the bacteria. This enables a baby's immune system to respond to the combined vaccine and produce antibodies against the disease-causing bacteria.
Examples: pneumonia and meningitis (Haemophilus influenzae type b)
Additional Constituents of Vaccines [12]
Preservatives (phenol, 2-phenoxyethanol,
Thiomersal): Prevention of bacterial and fungal contamination
Adjuvants (aluminum hydroxide, aluminum phosphate, potassium
aluminum sulfate, also known as
alum): Aluminum salts are added for their role in helping to activate an immune response to the vaccine.
Additives (sugars- sucrose, lactose,
etc.; amino acids- glycine, monosodium salt of glutamic
acid; proteins- gelatin, human serum albumin): Used to stabilize vaccines in the face of freeze-drying
or heat
Manufacturing Residues
Inactivating
Agents (formaldehyde, B-propiolactone,
glutaraldehyde): Used to eliminate the harmful effects of pathogens in vaccines
by preventing harmful effects of bacterial toxins and inhibiting viral
replication.
Antibiotics (neomycin, streptomycin,
polymyxin B, chlortetracycline, amphotericin B): Used to prevent bacterial
contamination during production.
Cellular
Residuals (Proteins) Vaccines are made in “two diploid cell
strains of human origin (MRC-5 and WI-38), simian-derived continuous and
diploid cell lines, chick embryo and chick embryo fibro-blasts” [17], as well
as in baker’s yeast [12]. Some proteins, such as egg
proteins, may be left in the vaccine due to these processes.
Animal and human sera (Serum from cows,
pigs, horses, rabbits or humans) “Animal sera are frequently added to culture
media to provide nutrients for microbial growth. Some media are serum-free or may be of
synthetic, semi-synthetic or yeast origin.” [17]
Vaccination Safety
“Before vaccines can be
used, they must meet strict safety standards established by the Food and Drug
Administration (FDA)… During this time
the vaccine undergoes three phases of clinical trials. Once vaccines are
licensed and put in use, the FDA and the Centers for Disease Control and
Prevention (CDC) continue to monitor their safety. Vaccines are also subject to
ongoing research and review by doctors, researchers and public health
officials.” [4]
However, vaccines do not do their job without some side effects. “Most effects are minor and temporary, such as a sore arm, mild fever or swelling at the injection site.” [4] When When serious side effects occur, they are reported to the Vaccine Adverse Event Report System (VAERS). The Vaccine Adverse Event Report System, created by the FDA and the CDC, can be reached at http://vaers.hhs.gov/
When adverse side-effects do occur, it is possible for the patient to receive compensation through the National Childhood Vaccine Injury Act of 1986 (PL-99-660). For more details, please see the section about Vaccination Law.
Below is a short
discussion about some of the additives commonly found in vaccines.
Adjuvants
Adjuvants have been
observed to cause erythema, subcutaneous nodules, contact hypersensitivity, and
granulomatous inflammation.
Preservatives
After 2001, thimerosal has been removed from most vaccines, or only remains in very small amounts. Thimerosal is an organic compound that is metabolized to ethylmercury and thiosalicylate. The mercury or thiosalicylate components of thiomersal may produce hypersensitivity reactions, with severe reactions occurring rarely. Apart from these reactions,thimerosal has been implicated to have a role in the “claimed link between measles, mumps and rubella (MMR) vaccination and autism.” [17] However, the studies that reported this link have been recognized as flawed, in addition to the actual retraction of data interpretation. [18,19]
A 2004 review examined the literature linking thimerosal to autism. The review looked at “10 epidemiologic studies and 2 pharmacokinetic studies of ethylmercury.” The study concluded that “the design and quality of the studies showed significant variation. The preponderance of epidemiologic evidence does not support an association between thimerosal-containing vaccines and ASD. Epidemiologic studies that support an association are of poor quality and cannot be interpreted. Pharmacokinetic studies suggest that the half-life of ethylmercury is significantly shorter when compared with methylmercury.” [19]
An addition study looked at mercury
concentrations in the blood of full-term infants. The concentrations were found to be “well
below the level thought to be associated with adverse effects.” [17]
Lastly, the half-life of ethylmercury, about 7 days, is much faster than that of methylmercury. Therefore, there is a lower chance of toxic reactions due to the short exposure time [12,17]. However, more research needs to be done, specifically to examine the effects of thimerosal on low birthweight premature infants. [17]
“2-Phenoxyethanol is an alternative to thiomersal. One report describes generalised eczema occurring after vaccination where 2-phenoxyethanol was found to be the sensitizing agent.”
Antibiotics
Antibiotics may contribute to allergic reactions, including
anaphylaxis, and local skin reactions.[17]
It is worth noting that neomycin is the only antibody that can be found in
detectable quantities, and that most antibiotics that are known to be
responsible for immediate-type hypersensitivity reactions are not used in the
production of vaccines. These include
penicillins, cephalosporins and sulfonamides. [12]
Bovine Products
“Use of bovine-derived products in vaccine manufacture, such as gelatin or bovine sera, has prompted concern about whether this poses a risk of BSE. BSE is transmitted by prions, which may lead to Creutzfeldt-Jakob disease (vCJD) in humans.
Despite administration of tens of millions of doses of vaccines manufactured using bovine-derived material, there are no reported cases of BSE transmission via human or animal vaccination.
“Australian,
European and
Bovine material must be sourced from countries where no recorded cases of BSE have occurred and an appropriate system of monitoring and reporting of BSE in animals has been implemented. Alternatively, bovine material may be sourced from specific donor herds where animal health is routinely monitored. Use of manufacturing processes, such as heat sterilization and chemical treatment, reduces or removes BSE infectivity from bovine products.” [17]
In addition, allergic reactions to gelatin are possible.
Formaldehyde
Formaldehyde has been observed to cause DNA damage, which leads to
cancerous changes in cells grown in culture.
However, these in vitro results have not been found to be relevant in
vivo. Formaldehyde has not found to be a
cause of cancer in humans, and animals did not develop cancers upon exposure to
large quantities. [12,17]
Egg Proteins
The amount of egg
protein found in influenza vaccines is enough to induce a severe and possible
fatal hypersensitivity reaction in children that have egg allergies. [12]
This is particularly relevant for children with asthma, general allergies and severe atopic dermatitis [17]. Despite these allergies, “current guidelines and evidence suggest that patients with egg allergies, other than anaphylaxis, may be vaccinated safely.”.[17]
Yeast Proteins
Allergies to baker’s yeast may not cause severe reactions, since antibodies for yeast proteins have not been found in vaccine recipients. However, immediate-type hypersensitivity has been observed in Hepatitis B recipients.[17]
Live vaccines
Vaccines made from weaker forms of live vaccines “carry a risk of organisms reverting to virulent forms that cause infection rather than immunity.” [17]
What Vaccines are Available?
Vaccinations are available for the following infectious diseases listed by the National Network for Immunization Information [6]:
For specific information about vaccine availability, history, side effects, dosage, effectiveness, and recommended recipients, select the vaccine of interest from the vaccination list on the National Network for Immunization Information website.
http://www.immunizationinfo.org/
Anthrax
“Anthrax is caused by Bacillus anthracis and is most common among wild and domestic animals such as cattle, sheep, and goats. It is most common in agricultural regions, and human cases are usually from occupational exposure. It is a potential agent for biological warfare so the Department of Defense vaccinates active military personnel. Anthrax occurs in three forms: cutaneous (skin), inhalation, and gastrointestinal. The spores can survive in the soil or animal hides for years. It can also be acquired by eating undercooked meat from infected animals. Most anthrax cases are the cutaneous form when the bacteria enter a preexisting skin wound. It then forms a characteristic black ulcer. Untreated, this form has a 20% mortality. Inhalation anthrax is similar to a cold, but then progresses to great difficulty breathing resulting in shock and usually death. Intestinal anthrax causes severe gastrointestinal symptoms including vomiting blood, and is fatal in 25-60% of cases. Treatment is with penicillin G. Spread of anthrax from person to person is highly unlikely.” [32]
Diphtheria
“Diphtheria is caused by the bacterium Corynebacterium diphtheriae. It causes upper respiratory infection with nasal discharge, sore throat, fever, and the formation of a whitish membrane on the tonsils, nasal septum, and pharynx. This may progress to hoarseness and cough with obstruction of the airway. Most cases are in children who are not immunized. It is passed through the air, usually by coughing. Treatment includes antitoxin along with antibiotics, usually penicillin and erythromycin. Having disease does not necessarily confer immunity, so patients should be immunized following resolution of the disease. Patients with diphtheria must be isolated while contagious. Contacts of the case must be cultured and boosters given.” [32]
Haemophilus
influenzae type b (Hib)
“In children this bacteria can cause meningitis, pneumonia, periorbital cellulites (infection around the eye), epiglottitis (infection and swelling in the lower throat), and septicemia (infection in the blood). The bacteria are spread through secretions. Treatment involves intravenous antibiotics. Those who are exposed to the bacteria can take rifampin to help prevent spread of the disease.” [32]
Hepatitis A
“Hepatitis A is a virus that causes disease in the liver. Many people do not have any symptoms when infected. Symptomatic people usually have sudden onset of fever, fatigue, nausea, dark urine, and jaundice (yellow skin and eyes). Symptoms persist for weeks to months. Diagnosis is made by an antibody test from the blood. Hep A is transmitted by the fecal-oral route. Treatment is supportive. There is a vaccine available for those at high risk.” [32]
Hepatitis B
“Hepatitis B virus affects the liver. Many cases resolve on their own, but some persist and cause lifelong infection, cirrhosis (scarring of the liver), liver cancer, all of which can lead to liver failure and death. Most people do not have acute disease when infected. Acute infections are similar to hepatitis A (see above). HBV is spread by blood and body fluids. Risk factors include unsafe sexual practices, IV drug abuse, and working with blood products. Diagnosis is made by antibody tests from the blood. There is no cure for hep B. There is a vaccine available that all children and adults at risk should receive. Prevention involves vaccination as well as safe sexual practices and not sharing needles.” [32]
Influenza
“There are 3 influenza viruses: A, B, and C. It is spread through droplets from secretions. Cases can vary from asymptomatic to severe. Usually it causes a respiratory infection with fever/chills, headache, fatigue, and runny nose. Complications include pneumonia, myositis (muscle inflammation) and Reye syndrome (a post-viral encephalopathy). Diagnosis is through detection of viral antigen in the nose or through serological tests from the blood. Treatment is to alleviate symptoms. Aspirin should not be used since it increases the risk of developing Reye syndrome.” [32]
Lyme Disease
“Lyme disease is caused by the bacteria Borrelia
burgdorferi and is transmitted by the black-legged tick, Ixodes
scapularis. Risk factors include
being outdoors, especially in the summer/fall months and in wooded areas. The illness starts as a circular, red rash
around the tick bite that expands in size.
This is accompanied by flu-like symptoms and joint pain and
swelling. If untreated, nerve palsies
and heart problems can occur. Diagnosis
is by antibody tests in the blood or spinal fluid. Treatment is with tetracycline. Prevention includes wearing protective
clothing and insect repellant when outdoors in tall grass or wooded areas. When removing ticks from the body, it is
important to remove the mouthparts attached to the skin. Removed ticks can be checked for lyme disease
by the
Measles
“Measles is a highly contagious viral disease that has been largely controlled through immunization. It is spread through nasal and mouth secretions and occasionally through the air. Symptoms appear in 2 stages: 1) runny nose, cough, and fever, possibly red eyes and photosensitivity, and 2) higher fever and red rash beginning on the face, then spreading over the body. White spots known as Koplik spots may appear inside the mouth. Complications include pneumonia, which is usually the cause of death in fatal cases. There is no specific treatment. Vaccination or having the disease confers permanent immunity.” [32]
Meningococcal Disease
“Meningococcal disease includes meningitis and meningococcemia (disseminated infection in the blood) by the bacteria Neisseria meningitides. Many people carry the bacteria and are asymptomatic. It is passed by droplets. Symptoms of meningitis include altered mental status, stiff neck, photophobia, fever, and possibly seizures. Symptoms of meningococcemia are acute onset of fever/chills, malaise, and rash of pink or purple bumps. It can quickly progress to blood clotting abnormalities, shock, coma, and death. Diagnosis of both illnesses is made by Gram stain of spinal fluid or culture of the blood or spinal fluid. Treatment requires hospitalization and intravenous antibiotics. Patients should be isolated until they have received 24 hours of antibiotics. High risk contacts of cases should receive rifampin. There is a vaccine available but only to control outbreaks. It is not recommended for the general population.” [32]
Mumps
“Mumps is caused by a paramyxovirus passed in oral
secretions. It causes painful swelling
of any of the salivary glands, mainly the parotid, and fever. Other symptoms may occur such as loss of
appetite, abdominal pain, and headache.
Among males, 20% have accompanying orchitis (inflamed testicle). Complications of more severe disease include
pancreatitis, deafness, and meningitis.
Diagnosis is by recovering the virus from saliva, urine, or spinal
fluid. Treatment is supportive. In
Pertussis (Whooping
Cough)
“Whooping cough is caused by the
bacteria Bordatella pertussis. It
has become rare due to the DTP and DTaP vaccines. The disease is airborne and is only found in
humans. Disease course is divided into 3
stages: 1) catarrhal, which resembles the common cold and lasts 1-2 weeks, 2)
paroxysmal, describing the violent coughing paroxysms that end in the
characteristic “whoop” inhalation and sometimes vomiting. This stage lasts 4-6 weeks. 3) convalescent, where the whoop and vomiting
stop and the cough begins to disappear over several weeks. Diagnosis is by isolating the organism or
through DNA tests. Treatment is only
effective if given during the catarrhal stage of the illness. The drug of choice is erythromycin. In
Pneumococcal Disease
“Streptococcus
pneumoniae is a group of “strep”
bacteria also known as pneumococci. Pneumococci live in the nose and throats of
people of all ages. Pneumococci can infect many different sites, some
common—like the middle ear and the sinuses—and some less common but more
serious, including the lungs (pneumonia), central nervous system (meningitis),
and blood stream (bacteremia).” http://www.immunizationinfo.org/vaccineInfo/vaccine_detail.cfv?id=9
Polio
“Polio is caused by poliovirus types 1, 2, and 3. It has been eradicated in the Western hemisphere due to the massive immunization campaign over the past few decades. Humans are the only source. Poliovirus is passed by the fecal-oral route and can be found in contaminated water sources such as swimming pools. Up to 90-95% of infections are asymptomatic, 4-8% of infections are mild and similar to a flu-like illness, 1-2% result in nonparalytic poliomyelitis characterized by aseptic meningitis, and only 0.1-2% of polio cases result in paralytic disease. Paralytic polio manifests as flaccid paralysis of one or more limbs with loss of reflexes but maintained sensation. In most cases, muscle function returns completely, but some cases have residual disability. Diagnosis is confirmed by isolating the virus in spinal fluid, stool, or oral secretions. Serologic tests are also available. There is no specific treatment. Immunization is the most important prevention.” [32]
Rabies
“The rabies virus is transmitted from infected animals and affects the central nervous system. It is fatal once symptoms occur. Transmission is usually from a bite of a rabid animal. Early symptoms are irritability, headache, anxiety, and fever. These progress to paralysis, muscle spasms, seizures, delirium, and death. Patients often have an intense fear of water. Rabies can be prevented by immediate wound cleansing, the administration of rabies immune globulin, and 5 doses of the rabies vaccine. Exposure from a rabid animal does not always result in disease. Prevention on a community scale is accomplished by minimizing the number of stray animals, and avoiding contact with wild animals.” [32]
Rotavirus
“Rotavirus is an intestinal virus that infects virtually all
children by three years of age. It is the most common cause of diarrhea in
children, including hospital-acquired diarrhea, and childcare center outbreaks
are common. The disease usually lasts a week or longer and can cause persistent
infection in immunocompromised people. Most rotavirus infections are mild, but
about 1 in 50 cases develop severe dehydration. Each year in the
http://www.immunizationinfo.org/vaccineInfo/vaccine_detail.cfv?id=17
Rubella
“Rubella virus is an airborne infection that causes German measles. The disease starts with a few days of fever, headache, malaise, conjunctivitis, runny nose, sore throat, cough, and swollen lymph nodes. These symptoms then disappear with the appearance of the characteristic rash. The rash consists of fine, pink bumps starting at the hair line and spreading downward. It lasts only 48 hours. The disease is especially dangerous in pregnant women since it can be devastating for the fetus. Diagnosis depends on antibody tests. There is no specific therapy. Patients should be isolated for 7 days after the onset of rash in order to protect susceptible pregnant women. The MMR vaccine has greatly reduced the incidence of rubella and is the best form of prevention.” [32]
Smallpox
“Smallpox is caused by a virus known as Variola. It was declared eliminated in 1980 due to worldwide
vaccination, although stores of the virus are found in the
Tetanus
“Tetanus is caused by the bacteria Clostridium tetani. Spores of the bacteria are found in the soil. They can then be introduced into a puncture wound. The bacteria do not need oxygen to grow. Symptoms include excitability and generalized muscle spasms particularly of the neck. Symptoms are due to a neurotoxin released by the bacteria. Diagnosis can be made by culture but is usually clinical. Treatment is with tetanus immune globulin or with an equine variety to counter the toxin. Penicillin G or tetracycline is also given to kill the bacteria. Prevention involves getting a booster tetanus shot every 10 years.” [32]
Tuberculosis
“TB is caused by the bacteria Mycobacterium tuberculosis that is spread through the air. Many people are infected with TB, as seen by a positive PPD test on the skin but no bacteria in the sputum, but a far smaller number actually develop disease. Those with weakened immune systems are much more likely to develop active disease. Symptoms are fever, night sweats, weight loss, and cough. Diagnosis is made by seeing the bacteria on sputum smear and by characteristic lesions on chest X-ray. Several drugs are used to treat TB although resistance is developing. The most common drugs are isoniazid, rifampin, ethambutol, and streptomycin. Drugs must be taken for several months. Those with evidence of disease even if it is not active should take several months of isoniazid. Prevention involves using respiratory precautions among infected individuals.” [32]
Typhoid Fever
“Typhoid is caused by the bacteria Salmonella typhi
and occurs only in humans. It is passed
by the fecal-oral route. Some people are
carriers of the bacteria but do not suffer disease. Symptoms include a high fever, loss of
appetite, abdominal pain, and rash. Severe
cases can cause bowel obstruction.
Diagnosis is by stool culture.
Therapy includes ampicillin, trimethoprim-sulfamethoxazole, and
ciprofloxacin. There is a vaccine
available for those traveling to endemic countries. Prevention involves hygienic food
preparation.” [32]
Varicella
(Chickenpox)
“Chicken pox are caused by varicella-zoster virus (VZV). Humans are the only host. Transmission is either airborne or through direct contact. It is usually a disease of children. Symptoms are a skin eruption of vesicles that are quite itchy. Fever and malaise may also be present. Complications include Reye syndrome, pneumonia, arthritis, and aseptic meningitis. Those infected as older children or adults are more likely to develop complications. Diagnosis can be made by isolating the virus from the lesions or by antibody tests. Treatment is symptomatic. Aspirin should not be used. Immunity is conferred after one infection. Cases should be isolated until the 6th day after the rash started or until all the lesions are dry. There is now a vaccine available.” [32]
Yellow Fever
“This disease is caused by a virus transmitted by
mosquitoes. It is only found in Africa
and
Vaccination Law
The Centers for Disease Control update the laws of vaccination on the website [5].
Patients must be informed
“By law, parents, guardians, or patients must be given information in writing
about the risks and benefits of vaccination before a vaccine is administered.” This information typically comes in the form
of Vaccination Information Statements (VIS).
These are one page, doubled-sided, documents prepared by the CDC that
state the risks and benefits of vaccination.
Some of these vaccines are covered by the National Childhood Vaccine Injury Act of 1986
(PL-99-660) [29]:
Tetanus
Measles
Haemophilus influenzae type
B
Pertussis
Mumps
Hepatitis B
Polio
Rubella
Varicella
Rotavirus
Some of the vaccines are not covered by this act, but
have a
Influenza
Hepatitis A
Pneumococcal Polysaccharide
Lyme disease
When combination vaccines are given, all relevant
You can obtain copies of these information sheets by calling the CDC National Immunization Program information hotline at 1-800-232-2522 (English) or 1-800-232-0233 (Spanish), or you can obtain copies online at http://www.cdc.gov/nip/publications/vis/.
For more
general information about
National Childhood Vaccine Injury Act of
1986 (PL-99-660)
“The National Childhood Vaccine Injury Act of 1986 (PL-99-660) is a vaccine safety and compensation system which (1) created a no-fault compensation alternative to suing vaccine manufacturers and providers on behalf of citizens injured or killed by vaccines; (2) helps prevent future vaccine injuries through education and an adverse reaction reporting system; and (3) creates incentives for the production of safer vaccines.” [30]
Below is an explanation of the compensation laws of this act from the National Vaccine Information Center Website [30]:
Compensation is divided into two parts:
1) Injuries or deaths prior to October 1, 1988 (no matter how long ago the injury occurred):
· A citizen may choose to pursue a lawsuit unrestricted.
· A citizen could have filed a claim in the compensation system by January 31, 1991
· If the claim was not filed by 1/31/91, the statute of limitations has run out.
2) Injuries or deaths occurring after October 1, 1988:
· A citizen is required to apply for federal compensation prior to pursuing a lawsuit.
· The system will offer to pay up to $250,000 for a vaccine associated death.
· The system will offer to pay for all past and future unreimbursed medical expenses, custodial and nursing home care; up to $250,000 pain and suffering; and loss of earned income.
· If a citizen rejects the award or is turned down, a lawsuit may be filed.
· Claims must be filed within 24 months of a death and 36 months of an injury.
· Restrictions may apply to lawsuits.
· The system is funded by a surcharge on each dose of vaccine sold.
The
NVIC publication, The Compensation
System and How It Works, is available for a $5 donation and
can be bought at https://www.nvic.org/ResourceCenter/Resource_Center.htm#Booklets
Immigration
immunization laws
“Under new immigration laws passed in 1996 and in effect as of July 1, 1997,
all individuals seeking permanent entry into the
School immunization laws
“Each state has immunization
requirements, sometimes called ‘school laws,’ that must be met before a child
may enter school... In most states, a parent must bring written proof of a child's immunizations from the health
provider or clinic at the time of school registration.” It is possible to obtain exemptions due to
medical contraindications, or religious and philosophical beliefs. “Religious exemptions are allowed in 48
states (
You can find out what the requirements for your state at http://www.immunizationinfo.org/
Select the
state of interest from the list provided at the upper right hand corner of the website.
Adult immunization laws
“There are no legally mandated vaccinations for adults, except for persons
entering military service. Some
employers require certain immunizations for those employees who work with
people who are sick or vulnerable to disease, or those who handle or are
exposed to dangerous substances, such as certain bacteria
or viruses.
Hospitals, for example, may require some staff to have influenza or hepatitis B
vaccine.”
Travel immunization laws
“Immunizations were once required for persons traveling overseas. None are
required at this time, but some vaccinations are recommended.” Some diseases that are not common in the
Current Federal and
State Laws
To find out about current legislature, check out this
National Vaccine Information Center Website: http://www.909shot.com/legs.htm
What Vaccines are Recommended?
Below are the recommended vaccinations from the Centers for Disease Control (CDC). Every year the vaccination schedule is revised. It is important to check with the CDC or with a healthcare provider in order to make sure the proper vaccines are administered in a timely fashion.
Pediatrics
Adults
Pregnant Women
"Risk to a developing fetus from vaccination of the mother during pregnancy is primarily theoretical. No evidence exists for the risk from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids. Benefits of vaccinating pregnant women usually outweigh potential risks when the likelihood of disease exposure is high, when infection would pose a risk to the mother or fetus, and when the vaccine is unlikely to cause harm." Committee on Immunization Practices (ACIP) General Recommendations on Immunization, p. 18. [20]
In general, pregnant women should not be given live-virus vaccines. If a woman is giving a vaccine within four weeks of pregnancy, the woman should be counseled about possible side-effects for the fetus.
Below is a general chart delineating the proper treatment of pregnant woman [20]:
|
Vaccine |
Should be considered if otherwise
indicated |
Contraindicated during pregnancy |
|
|
Routine |
Hepatitis A |
|
|
|
Hepatitis B |
X |
|
|
|
Influenza (Inact.) |
Recommended |
|
|
|
Influenza (LAIV) |
|
X |
|
|
Measles |
|
X |
|
|
Mumps |
|
X |
|
|
Pneumococcal |
|
|
|
|
Polio (IPV) |
|
|
|
|
Rubella |
|
X |
|
|
Tetanus/ |
X |
|
|
|
Varicella |
|
X |
|
|
Travel & Other |
Anthrax |
|
|
|
BCG |
|
X |
|
|
Japanese Encephalitis |
|
|
|
|
Meningococcal (MPSV4) |
X |
|
|
|
Meningococcal (MCV4) |
|
|
|
|
Rabies |
X |
|
|
|
Typhoid (Parenteral & Ty21a) |
|
|
|
|
Vaccinia |
|
|
|
|
Yellow Fever |
|
|
|
Current Technology Development and Research
Currently, there are many clinical trials currently being conducted in order to determine the safety and efficacy of vaccination. In addition, there many projects in search for new vaccines that can tackle diseases, such as AIDS. One way vaccination can be improved, and new vaccines can be created is through the development of new technologies.
New Vaccine Biotechnology
"Recombinant" Vaccines
Scientists are currently working on making vaccines by changing the genetic structure of infectious pathogens. An important gene for organism survival can be removed thereby allowing the host to acquire immunity without acquiring disease. Another method of this technology is to add a gene into an organism that will enode a protein of a pathogen. Injection with this organism will lead to the mass production of this protein that will induce an immune response directed toward the pathogen protein. One more method is to inject a naked fragment of a pathogen’s genetic material. The body’s cells can use this DNA to make proteins. These proteins can induce an immune response in the host. These vaccines, in particular, could result in lifelong immunity. This technology is currently being used to make vaccines for malaria, influenza, and HIV. [3]
Genome Sequencing
Many projects are being condected to determine the genetic sequence of pathogens. These sequences could be used to create new vaccines, such recombinant vaccines. Thus far, a complete sequence has been determined for the malaria parasite Plasmodium falciparum. [3]
Edible Vaccines
“Researchers have found that edible
vaccines can safely and effectively trigger an immune response against the Escherichia
coli bacterium and the
Slow
Release Vaccines
A
consortium of British private companies and a university facility is working on
producing a slow release vaccine The
group is working on nanotechnology that will help count down on the amount of
booster shots needed, and can increase the amount of time for which a vaccine
is effective. “They stabilize the
vaccine by embedding it in tiny microspheres, made of calcium phosphate glass,
which dissolve in the body fluids after injection…Proprietary nanoparticles
within the microsphere ensure the vaccine release will be slower and the
vaccine continues to be released into the body over a longer time period.”[9] In addition, MNLpharma is working to develop
an imino sugar adjuvant for the new vaccines. [9]
Stable Liquid Vaccines
“Cambridge Biostability's stable liquid vaccines can be stored safely without the need for a cold chain and do not require reconstitution or bactericides, which are major causes of vaccine safety and wastage problems.”[9]
New Disease Targets
Current information about new vaccines can be obtained from the Red
Book:
http://aapredbook.aappublications.org/news/vaccstatus.shtml
AIDS
Acquired Immune Deficiency Syndrome (AIDS) is caused by the Human Immunodeficiency Virus (HIV). HIV attacks the CD4 cells of the immune system thereby making it difficult for AIDS patients to fight off infections. Currently there are more than 30 candidate AIDS vaccines. Small trials are being conducted in 19 countries on six continents. [35] For more information about the search for an AIDS vaccine, the International AIDS Vaccine Initiative is a good resource: http://www.iavi.org/
HPV (Human papillomavirus)
There are over 100 different types of Human papillomavirus
(HPV). About 30 of these viruses are sexual
transmitted and infect the genital area of men and women. 10 of these 30 can lead to development of genital
warts and cancer of the cervix, vulva, vagina, anus, or penis. There have been many clinical trials testing
the effectiveness and safety of HPV vaccines.
For example, a phase 3 trial called FUTURE II reported in October 2005
that a vaccine called Gardasil was an effective and safe method for preventing
HPV infection.
The researchers found that 90% of new infections were prevented, and that the
vaccine protected against the number 6, 11, 16 and 18 strains of virus. Future research is needed to design vaccines
against the other strains of virus, to look at which vaccines may be useful for
women who are already infected with HPV, and to know how long the vaccines can
provide protection. Merck is waiting to
hear from the FDA about its application to sell Gardasil, and GlaxoSmithKline
is planning to apply to the FDA for approval of their Cervarix vaccine by the
end of the year. [37] For more information about HPV vaccine research go to http://www.cancerhelp.org.uk/help/default.asp?page=16024#vac
Avian Flu
“Avian influenza is an infection caused by
avian (bird) influenza (flu) viruses. These influenza viruses occur naturally
among birds... There are many different subtypes of type A influenza viruses.
These subtypes differ because of changes in certain proteins on the surface of
the influenza A virus (hemagglutinin [HA] and neuraminidase [NA] proteins).
There are 16 known HA subtypes and 9 known NA subtypes of influenza A viruses… ‘Human influenza virus’ usually refers to
those subtypes that spread widely among humans… Of the known viruses that
affect humans, H5N1 is of the most concern since H5N1 has caused the largest
number of detected cases of severe disease and death in humans. In the current
outbreaks in Asia and
Dangers of Vaccine Exemptions and Non-Compliance:
Vaccine Protection Beyond the
Individual
The ability for individuals to obtain exemption from vaccination is important for the protection of personal freedom and the protection of those with vaccine contraindications. However, exemptions and non-compliance can put a population at risk for spreading disease. There will always be a fraction of the population that is not immune, even if 100% of the population receives a vaccine because no vaccine is 100% effective. Even if individual immunity is not perfect, a critical amount of people need to be immune in order to protect the whole population. This phenomenon is called herd immunity, where “protection is achieved through obtaining a high enough level of immunity to a disease so as to make exposure to the organism that causes the disease extremely unlikely” [13]. The immunity necessary within a population depends on the disease and ranges from 83%-94%. If too many people are exempted, than this percentage may not be reached.
If
vaccinations are ended prematurely, a large population can see the recurrence
of a disease as the people who still contain the pathogen are able to renew the
spread of infection.
In addition to preserving immunity, exemption also raises ethical problems within a society. Those who receive vaccinations share in the risk of obtaining negative side effects, while those that are exempt can benefit from herd immunity without having to share these risks. However, the price of exemption is not completely free. Current research is exploring the consequences, and it had been found that exempted individuals have an increased risk of contracting measles, pertussis and tetanus. [14-16]
Even when a
country has eradicated a disease, recurrence can occur in this case because “the
germs that cause the diseases still exist in other parts of the world.”
[4] When
In order to
maintain herd immunity, it is important to regulate the amount of people
obtaining exemptions. In some states,
gaining an exemption is actually easier than acquiring vaccinations for
children. For example, the state of
Exemptions
can be limited by making the process more difficult. Such provisions that make it harder to obtain
exemption have been implemented in
Although the granting of exemption is an important practice in personal rights, it needs to be monitored in order to maintain communal immunity to life-threatening diseases. It has been observed that the more difficult it is to obtain an exemption, the lower the number of people seeking exemption. [10, 11] More efforts should be made to increase the difficulty for obtaining an exemption and to understand the affects of exemption and compulsory laws on the spread of disease. [10]
Barriers to Disease Eradication:
Polio as an Example
With
over 200 years of vaccination, smallpox is the only disease that has been
successfully eradicated. There are many
factors that make vaccination difficult.
The attempts to eradicate polio exemplify these barriers. The Global Polio Eradication Initiative was
started in 1988. At this time in
history, 125 countries reported cases of polio.
Although the number of cases and affected countries has decreased, eradication
has not been possible. [4] There are many barriers to finishing this
initiative. Besides the economics and logistics
of getting the vaccine to everyone that needs it, there are political, educational,
cultural, and motivational influences, as well as scientific limitations.
Thus far $4 billion has been spent, and more will need to be spent until eradication is complete. [7]. What is the money being spent on? Besides the purchasing of the vaccine, additional costs are needed for storage at cold temperature and vaccine delivery. In addition, vaccination is not a “one shot” deal: “Here and elsewhere, eradicating polio means finding ways to get polio drops into the mouths of every child under 5 — over and over. Because it can take many doses to effectively immunize a child in parts of the world where the disease circulates intensely, eradication requires repeated sweeps.”[7] In order to obtain immunity, it can possibly take up to 10 doses, and these doses need to be delivered months apart [7].
Cultural
requirements need to be worked around in order to provide enough workers to
deliver the vaccinations. According to
Nigerian Muslim custom, only a woman can enter a household if the husband is
not home. In addition, mothers were the
best at convincing other members of the community to accept the vaccines. The combination of these cultural influences
made mothers the best candidates for delivering vaccines. However, many men prohibited their wives from
leaving the household because they wanted the jobs for themselves. [7] This catch 22 decreased the amount of the
most effective workers.
Even if the vaccine reaches the door of every family, the family still needs to accept the vaccine. Due to a lack of confidence in the program and other political set backs, the vaccine cannot always reach its target. There is a general feeling of hostility towards the public health workers. One woman Indian woman shouts “‘We have a lot of other problems, and you don't care about those…All you have is drops. My children get other diseases, and we don't get help.’"[7] A skepticism has developed as public health workers drop by time and again to administer vaccinations without addressing day to day concerns. This prolonged project wears on both the recipients and the workers. The recipients are getting tired of hearing promises of eradication, and the public health workers get anxious as the numbers infected drop without the final goal of total eradication in site: “The closer a disease is to eradication, they say, the harder won the gains. Interest lags as the number of cases falls. Fatigue sets in among volunteers, donors and average people. “[7]
Further
set backs in the polio eradication program were caused by misconceptions about
the vaccine. For example, in 2003, the
northern states of
Limitations
come from the vaccine itself. The polio
vaccine that started the eradication process is a modified live virus. As explained in the safety section, these
types of vaccines have the ability to mutate back into the wild type
virus. This occurs in about one in three
million doses of the polio virus. [8] These
are the vaccines of choice because they are easy to administer and they provide
a strong immunity by protecting against three strains of the virus. However, the vaccine requires many injections
as described above. In order to address
this issue, and to attempt to expedite the eradication process, other
countries, such as India, are starting to use a faster acting vaccine that only
vaccinates for the most common strain of the virus. The use of this vaccine has not been
successful as of now. [8] Even after the
infection is eradicated, vaccination is still required in order to sustain
community-wide immunity. A small number
of people have an immune-system defect that allows them to produce and excrete virus
without getting sick, thereby “creating a reservoir that could, theoretically,
cause a new outbreak“ if the virus comes into contact with unvaccinated
individuals [8]. This concerned was
realized in the
In
addition to the scientific challenges, additional barriers to disease
eradication have also been observed within the
Misinformation
has also led to the inappropriate utilization of vaccination in the
The
Conclusion
The discovery of a vaccination does not necessarily result in the eradication of disease. Public health efforts must be made to provide the public with accurate and balanced information about the benefits and risks of vaccination. Continued research is necessary in order to uncover scientific barriers to eradication in addition to finding improved ways of producing effective and safe immune responses. Finally, the overall health and quality of life of every individual must be considered in order to maintain trust in vaccination programs. Less fortunate members of society can become skeptical of preventative measures when active efforts to improve current health and economic problems are absent. Vaccination cannot be successful if it is viewed only as an effort to free society from infectious disease. Vaccination needs to be part of an overall commitment to improve the health of the global community.
For More
Information:
General Information:
National Immunization Program
Sponsored by the Centers for Disease Control
http://www.cdc.gov/nip/default.htm
http://www.909shot.com/Default.htm
NVIC Store Tab has a list of suggested books and resources
MedlinePlus
Links to Many Sites about Vaccination
http://www.nlm.nih.gov/medlineplus/immunization.html
List of Websites recommended by the World Health Organization for vaccine safety
http://www.who.int/immunization_safety/safety_quality/approved_vaccine_safety _websites/en/
For articles in the news about vaccination
http://www.vaccinationnews.com/
Information about the immune system and a good general overview
http://www.niaid.nih.gov/publications/vaccine/pdf/undvacc.pdf
Vaccine Information Statements: Distribution is required by law when giving a vaccine
http://www.cdc.gov/nip/publications/vis/
New Vaccine
Information:
http://aapredbook.aappublications.org/news/vaccstatus.shtml
Specific Questions:
CDC National Immunization Program information hotline
1-800-232-2522 (English)
1-800-232-0233 (Spanish)
Traveling Information
http://www.cdc.gov/travel/index.htm
To Report Adverse
Reactions:
Vaccine Adverse Event Reporting Service
International
Information:
World Health Organization Sites
http://www.who.int/topics/vaccines/en/
http://www.who.int/topics/immunization/en/
Global Polio Eradication Initiative
http://www.polioeradication.org/
Global
http://www.vaccinealliance.org/
Global Immunizations and Vaccinations from the CDC
http://www.cdc.gov/nip/global/default.htm
Resources
1) State Government
of
“Vaccines Explained.” http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/
pages/Vaccines_explained?OpenDocument
2) Mayo Clinic. August 18, 2005. http://www.mayoclinic.com/health/vaccines/ID00023
3) National Institute of Allergy and Infectious Diseases. November 20, 2003. http://www.niaid.nih.gov/factsheets/evolution_vaccines.htm
4) Mayo Clinic. August 18, 2005. http://www.mayoclinic.com/health/vaccines/CC00013
5) Centers for Disease Control.“Immunization Laws.” March 26, 2006.
http://www.hhs.gov/nvpo/law.htm#Globalization%20and%20international%20law
6) National Network for Immunization Information. http://www.immunizationinfo.org/
7) Dugger, Celia W. and McNeil Jr., Donald G. “Rumor, Fear and Fatigue Hinder Final Push to End Polio.” The New York Times. March 20, 2006.
8) McNeil Jr., Donald G. “When a Disease Loses its most Potent Ally, Fear.” The New York Times. March 26, 2006.
9) Roumeliotis, Gregory. “Researchers give 'one-off vaccines' a shot” March 20, 2006. http://www.in- pharmatechnologist.com/
10) Salmon DA, Teret SP, MacIntyre CR,
11) Salmon DA, Sapsin JW, Teret S, Jacobs RF, Thompson JW, Ryan K, Halsey N. (2005) Public Health and the Politics of School Immunization Requirements. American Journal of Public Health. 95(5): 778-783.
12) Offit PA, Jew RK. (2003) Addressing Parents’ Concerns: Do Vaccines Contain Harmful Preservatives, Adjuvants, Additives, or Residuals? Pediatrics. 112: 1394-1397.
13) May T. (2005) Public Communication, Risk Perception, and the Viability of Preventative Vaccination Against Communicable Diseases Bioethics. 19(4): 407- 421.
14) Salmon DA, Haber M, Gangarosa EJ, Phillips L, Smith NJ, and Chen RT (1999). Health Consequences of Religious and Philosophical Exemptions From Immunization Laws: Individual and Societal Risk of Measles. JAMA 282:47-53
16) Fair E, Murphy TV, Golaz A, Wharton M. (2002) Philosophic Objection to Vaccination as a Risk for Tetanus Among Children Younger Than 15 Years Pediatrics 109(1): e2.
17) Eldred BE, Dean AJ, McGuire TM, Nash AL.
(2006) Vaccine components and constituents:
responding to consumer concerns. The
Medical Journal of
18) Murch SH, Anthony A, Casson DH, et al. (2004) Retraction of an interpretation. Lancet. 363: 750.
19) Parker SK,
Schwartz B, Todd J,
20) Centers for Disease Control. July 2005. Guidelines for Vaccinating Pregnant Women http://www.cdc.gov/nip/publications/preg_guide.htm
21) "Deadly
Immunity" Kennedy Jr., Robert F. Rolling Stone. June 20, 2005. rollingstone.com
22) Kennedy Jr.,
Robert F. "Autism, Mercury, and Politics" The
23) Ropeik, David. "Commentary: Connection Between Vaccines and Autism." National Public Radio, Morning Edition, 6/11/04, npr.org
24) Centers for Disease Control. ”Why Immunize?” July 11, 2003. http://www.cdc.gov/nip/publications/fs/gen/Why.htm
25) Harris, Gardiner. “5 Cases of Polio in Amish Group Raise New Fears.” The NewYork Times. November 8, 2005.
26)
April 20, 2006. http://americanhistory.si.edu/polio/virusvaccine/history.htm
27) Harris, Fraser. “Edward Jenner and Vaccination.” April 20, 2006. http://www.worldwideschool.org/library/books/tech/medicine/EdwardJennerAnd Vaccination/Chap1.html
28) “History of Immunology.” April 20, 2006. http://blue.butler.edu/~jshellha/323/History.html
29) Centers for Disease Control. “What you need to know about Vaccine Information Statements.” April 20, 2006. http://www.immunizeseniors.org/website/downloads/instr00.pdf
30)
31)
32) Stuebing, Beth “Reportable Infectious Diseases in the
http://www.case.edu/med/epidbio/mphp439/Reportable_Diseases.htm
33) Hittt, Miranda. “Mumps Epidemic Hits
http://www.webmd.com/content/article/120/113902.htm
34) Welte, Melanie S. “Mumps epidemic spreading across
Star Tribune. March 31, 2006. http://www.startribune.com/484/story/343474.html
35) International AIDS Vaccine Initiative “Progress toward an AIDS vaccine since 2000” April 21, 2006. http://www.iavi.org/viewpage.cfm?aid=13
36) Cancer Research
http://www.cancerhelp.org.uk/help/default.asp?page=16024#vac
37) Rubin, Rita. “HPV vaccines show progress, but need for
booster in question”
38) Centers for Disease Control “Key Facts About Avian Influenza (Bird Flu) and
Avian Influenza A (H5N1) Virus”
February 7, 2006. http://www.cdc.gov/flu/avian/gen- info/facts.htm