This page is about parent resource on WHY ?? to immunise children and gives complete information on immunisation guidelines, side effects , safety of vaccines and information on vaccine preventable diseases.This page is about kids and parents resource on health and safety and has many useful links related to diseases .It is about diseases of children , parents, teens, women and men and preventive measures against Illnesses .It is also about first aid , cpr and choking management and prevention of accidents at home.This page also give information and links on internet security, internet dangers and safe kids browsing.

General Information About Immunization

Q: Why are baby shots so important?
A: These shots protect your baby from nine diseases: measles, mumps, rubella (German measles), diphtheria, tetanus, pertussis (whooping cough), polio, Haemophilus influenzae type b (Hib) and hepatitis B.
Q: Are these diseases very serious?
A: Today, we might not think of these diseases as being very serious because, thanks to vaccines, we don't see them as often as we used to. But they can still be deadly. Measles used to kill hundreds - sometimes thousands - of people a year. In the 1920's, more than 10,000 people a year died from diphtheria. And in the 1940's and '50's, tens of thousands of children were crippled and killed by polio. Even today, these diseases can lead to pneumonia, choking, brain damage, heart problems and blindness in children who are not protected. And they still kill children every year.
Q: Are shots safe?
A: Yes, very safe. But like any medicine they can occasionally cause reactions. Usually these are mild, like a sore arm or a slight fever. Serious reactions are rare, but they can happen. Your doctor or nurse will discuss these issues with you before giving the shots. The important thing to remember is that children are in much more danger from the diseases than from the shots.
Q: How many shots does my child need, and when?
A: Your child should get his or her first shots at 2 months of age (or in some cases before he leaves the hospital after birth). You will have to go back for more shots four or five times before the child starts school. Your doctor or nurse will tell you when to come back. Remember, each of these visits is important! Your child needs several doses of each vaccine to be completely protected.
Q: Isn't getting all these shots expensive?
A: It doesn't have to be. If you take your child to a public health clinic, you might have to pay a small charge for the nurse to give the shots, but the shots themselves are free. Clinics that are supplied the vaccines from the government are forbidden by law from withholding the vaccinations because you can't pay.
Q: Why should I get my child immunized?
A: By getting your child immunized, you will be fighting disease in two ways. First, you will be protecting your own child. And second, since healthy children don't spread disease, you will be protecting others as well.
Q: How do vaccines work?
A: When you get an infection, your body reacts by producing substances called antibodies. These antibodies fight the disease and help you to get over the illness. They usually stay in your system, even after the disease has gone, and protect you from getting the same disease again. This is called immunity.
Newborn babies are immune to many diseases because they have antibodies they have gotten from their mothers. But this immunity doesn't last. It wears off during the first year of life.
Fortunately, we can keep children immune to many diseases, even after they lose their mothers' antibodies. We do this by vaccinating them against those diseases. The germs that cause disease are made into vaccines. These vaccines can be given to children as shots or as drops to be swallowed. Vaccines fool the body into thinking it is under attack by disease, and the body reacts by producing antibodies. These antibodies stay in the body. Then, if the child is exposed to the actual disease, he or she is protected.
Q: What will happen if my child doesn't get these shots?
A: Three things can happen.
If your child is never exposed to any of these diseases, nothing will happen.
If your child is exposed to any of these diseases, there is a good chance he or she will get the disease. What happens then depends on the child and the disease. At the least, the child could get a mild rash and have to stay inside for a few days. At the worst, the child could die.
If your child gets one of these diseases, he or she could also spread it to other children who are not protected. If there are enough of these children in your community, it could lead to an epidemic, with many children getting sick.
Q: What are the chances of my child being exposed?
A: It's hard to say. Some of these diseases are very rare in the United States today, so the chances of exposure are small. Others are more common.
Q: What if my child didn't get her shots when she was supposed to, or has gotten behind schedule?
A: If you have children who did not begin their immunizations at 2 months of age, or who have had only some of their shots, they can still be fully immunized. It is never too late to start getting immunizations. If your children have had some of shots and then gotten behind schedule, they don't have to start over. The shots already given will count. Just continue the schedule where they left off. If you have children who were not immunized when they were infants, contact your doctor or the health department clinic. They will tell you when to bring the children in for their shots.

Common Myths About Immunizations

"I read that the DTP vaccine can cause Sudden Infant Death Syndrome (SIDS)." There is no scientific evidence that links the DTaP or DTP shot and SIDS. This myth continues because the first dose is given at 2 months of age, when the risk of SIDS is greatest. However, these events are not connected. "I saw on the news that there are "hot lots" of vaccines that are more dangerous than other lots." The federal government set up the national Vaccine Adverse Events Reporting System (VAERS) to receive reports of vaccine reactions. People may think that if a large number of VAERS reports result from a particular batch of vaccine (a "hot lot"), then it must be dangerous. To date, no vaccine lot has ever been found to be unsafe based on VAERS reports. Keep in mind, all vaccines are licensed by the Food and Drug Administration (FDA). Vaccine manufacturing facilities are licensed and regularly inspected. In addition, every vaccine lot is safety-tested by the manufacturer. The fact that a vaccine is still being used means that the FDA considers it safe. "I've heard that it is unsafe to immunize a child who has a cold and fever. Is this true?" A child with a minor illness can safely be immunized. Minor illnesses include the following: low-grade fever ear infection cough runny nose mild diarrhea in an otherwise healthy child "I've heard that some children have serious side effects from vaccines so they must not be very safe." Reactions to vaccines may occur, but they are usually mild. Severe reactions to vaccines are very rare. Symptoms of a more serious reaction include the following: Very high fever Generalized rash Large amount of swelling at the point of injection If any of these symptoms occur, call your pediatrician right away. If your child experiences any side effects after a vaccination, talk to your pediatrician. Together you can decide whether your child should receive another dose of the same vaccine. Children with other health problems may need to avoid certain vaccines or get them later than usual. For example, children with certain types of cancers or problems with their immune systems should not get live virus vaccines like the MMR, varicella, or oral polio vaccines. For children with seizures, the pertussis part of the DTaP vaccine may need to be delayed. Ask your pediatrician when the vaccine can be given. "I've heard that giving a child more than one immunization at a time can be dangerous." Studies and years of experience show that vaccines used for routine childhood immunizations can be safely given together. Side effects when multiple vaccines are given together are no greater than when each vaccine is given on separate occasions. Talk to your pediatrician if you are concerned about the number of vaccines your child is scheduled to receive. "Immunizations hurt." They may hurt a little, and your baby may cry for a few minutes. There may be some temporary swelling where your child was injected. However, protecting your child's long-term health is worth a few tears. If your child is old enough to understand, explain that immunizations help prevent some very serious illnesses. Comfort and play with your child after the immunization. Acetaminophen can be used to help relieve some of the more common side effects, such as irritability and fever, but always check the dosage with your pediatrician.

10 Things you need to know about immunizations

1. "Why should my child be immunized?"
Children need immunizations (shots) to protect them from dangerous childhood diseases. These diseases can have serious complications and even kill children.
2. "What diseases do childhood vaccines prevent?"
Measles
Mumps
Polio
Rubella (German Measles)
Pertussis (Whooping Cough)
Diphtheria
Tetanus (Lockjaw)
Haemophilus influenzae type b (Hib disease - a major cause of bacterial meningitis)
Hepatitis B
Varicella (chickenpox)
Pneumococcal disease (causes bacterial meningitis and blood infections)
3. "How many shots does my child need?"
The following vaccinations are recommended by age two and can be given over five visits to a doctor or clinic:
4 doses of diphtheria, tetanus & pertussis vaccine (DTaP)
4 doses of Hib vaccine
7 doses of polio vaccine
3 doses of hepatitis B vaccine
3 doses of pneumococcal vaccine
1 dose of measles, mumps & rubella vaccine (MMR)
1 dose of varicella vaccine
2 doses of Hepatitis A
4. "Do these vaccines have any side effects?"
Side effects can occur with any medicine, including vaccines. Depending on the vaccine, these can include: slight fever, rash, or soreness at the site of injection. Slight discomfort is normal and should not be a cause for alarm. Your health care provider can give you additional information.
5. "Can they cause serious reactions?"
Yes, but serious reactions to vaccines are extremely rare. The risks of serious disease from not vaccinating are far greater than the risks of serious reaction to a vaccination.
6. "What do I do if my child has a serious reaction?"
If you think your child is experiencing a persistent or severe reaction, call your doctor or get the child to a doctor right away. Write down what happened and the date and time it happened. Ask your doctor, nurse or health department .
7. "Why can't I wait until school to have my child immunized?"
Children under 5 are especially susceptible to disease because their immune systems have not built up the necessary defenses to fight infection. By immunizing on time (by age 2), you can protect your child from disease and also protect others at school or daycare.
8. "Why is a vaccination health record important?"
A vaccination health record helps you and your health care provider keep your child's vaccinations on schedule. If you move or change providers, having an accurate record might prevent your child from repeating vaccinations he or she has already had. A shot record should be started when your child receives his/her first vaccination and updated with each vaccination visit.
9. "Where can I get free vaccines?"
A govt program called Vaccines for Children provides free vaccines to eligible children.It is also provided by private practioners
10. "Where can I get more information?"
From your pediatrician, health worker.

Vaccine-Preventable Childhood Diseases

We have record or near record low levels of vaccine preventable childhood diseases in the United States, but that does not mean these have disappeared. Many of the viruses and bacteria are still circulating in this country or are only a plane ride away. That's why it's important that children, especially infants and young children, receive recommended immunizations on time. In our mobile society, over a million people each day people travel to and from other countries, including countries where many vaccine preventable diseases remain relatively common. Without vaccines, epidemics of many preventable diseases could return, resulting in increased- and unnecessary- illness, disability, and death among children.
The following vaccine-preventable diseases, not long ago, disabled and killed millions of American children. Thanks to our country's high childhood immunization coverage levels, these diseases are now very uncommon.
Diphtheria
Haemophilus influenzae type b (Hib)
Hepatitis A
Hepatitis B
Measles
Mumps
Pertussis (whooping cough)
Polio
Rubella (German measles)
Tetanus (lockjaw)
Varicella (chickenpox)
Typhoid
Tuberculosis
Influenza
Meningitis

Diphtheria
Description A respiratory disease caused by bacteria
Symptoms Gradual onset of a sore throat and low-grade fever
Complications Airway obstruction, coma, and death if not treated
Transmission Spread by coughing and sneezing
Vaccine Diphtheria toxoid (contained in DTP, DTaP, DT or Td vaccines) can prevent this disease.
Haemophilus influenzae type b (Hib)
Description A severe bacterial infection, occurring primarily in infants
Symptoms Skin and throat infections, meningitis, pneumonia, sepsis, and arthritis (Can be serious in children under age 1, but there is little risk of getting the disease after age 5)
Complications Hib meningitis (death in one out of 20 children, and permanent brain damage in 10% - 30% of the survivors)
Transmission Spread by coughing and sneezing
Vaccine Hib vaccine can prevent this disease.
Hepatitis A
Description A disease of the liver caused by hepatitis A virus
Symptoms Potentially none (likelihood of symptoms increases with the person's age) If present: yellow skin or eyes, tiredness, stomach ache, loss of appetite, or nausea
Complications Because young children might not have symptoms, the disease is often not recognized until the child's caregiver becomes ill with hepatitis A.
Transmission Most often: spread by the fecal-oral route (An object contaminated with the stool of a person with hepatitis A is put into another person's mouth.) Less often: spread by swallowing food or water that contains the virus
Vaccine Hepatitis A vaccine will prevent this disease.
Hepatitis B
Description A disease of the liver caused by hepatitis B virus
Symptoms Potentially none when first infected (likelihood of early symptoms increases with the person's age) If present: yellow skin or eyes, tiredness, stomach ache, loss of appetite, nausea, or joint pain
Complications The younger the person, the greater the likelihood of staying infected and having life-long liver problems, such as scarring of the liver and liver cancer
Transmission Spread through contact with the blood of an infected person or by having sex with an infected person
Vaccine Hepatitis B vaccine is will prevent this disease.
Measles
Description A respiratory disease caused by a virus
Symptoms Measles virus causes rash, high fever, cough, runny nose, and red, watery eyes, lasting about a week.
Complications Diarrhea, ear infections, pneumonia, encephalitis, seizures, and death
Transmission Spread by coughing and sneezing (highly contagious)
Vaccine Measles vaccine (contained in MMR, MR and measles vaccines) can prevent this disease.
Mumps
Description A disease of the lymph nodes caused by a virus
Symptoms Fever, headache, muscle ache, and swelling of the lymph nodes close to the jaw
Complications Meningitis, inflammation of the testicles or ovaries, inflammation of the pancreas and deafness (usually permanent)
Transmission Spread by coughing and sneezing
Vaccine Mumps vaccine (contained in MMR) can prevent this disease.
Pertussis (whooping cough)
Description A respiratory disease caused by bacteria
Symptoms Severe spasms of coughing that can interfere with eating, drinking, and breathing
Complications Pneumonia, encephalitis (due to lack of oxygen), and death, especially in infants.
Transmission Spread by coughing and sneezing (highly contagious)
Vaccine Pertussis vaccine (contained in DTP and DTaP) can prevent this disease.
Polio
Description A disease of the lymphatic and nervous systems
Symptoms Fever, sore throat, nausea, headaches, stomach aches, and stiffness in the neck, back, and legs
Complications Paralysis that can lead to permanent disability and death
Transmission Contact with an infected person
Vaccine Polio vaccine (IPV) can prevent this disease.
Rubella (German measles)
Description A respiratory disease caused by a virus
Symptoms Rash and fever for two to three days ( mild disease in children and young adults)
Complications Birth defects if acquired by a pregnant woman: deafness, cataracts, heart defects, mental retardation, and liver and spleen damage (at least a 20% chance of damage to the fetus if a woman is infected early in pregnancy)
Transmission Spread by coughing and sneezing
Vaccine Rubella vaccine (contained in MMR vaccine) can prevent this disease.
Tetanus (lockjaw)
Description A disease of the nervous system caused by a bacteria
Symptoms Early symptoms: lockjaw, stiffness in the neck and abdomen, and difficulty swallowing Later symptoms: fever, elevated blood pressure, and severe muscle spasms
Complications Death in one third of the cases, especially people over age 50
Transmission Enters the body through a break in the skin
Vaccine Tetanus toxoid (contained in DTP, DT, DTaP & Td vaccines) can prevent this disease.
Varicella (chickenpox)
Description A virus of the herpes family
Symptoms A skin rash of blister-like lesions, usually on the face, scalp, or trunk
Complications Bacterial infection of the skin, swelling of the brain, and pneumonia (usually more severe in children 13 or older and adults)
Transmission Spread by coughing and sneezing (highly contagious)
Vaccine Varicella vaccine can prevent this disease.

What would happen if we stopped vaccinations???

At a glance: Vaccines are responsible for the control of many infectious diseases that were once common in this country. Vaccines have reduced, and in some cases, eliminated, many diseases that routinely killed or harmed many infants, children, and adults. However, the viruses and bacteria that cause vaccine-preventable disease and death still exist and can be passed on to people who are not protected by vaccines. Vaccine-preventable diseases have a costly impact, resulting in doctor's visits, hospitalizations, and premature deaths. Sick children can also cause parents to lose time from work.
Polio
Polio virus causes acute paralysis that can lead to permanent physical disability and even death. Before polio vaccine was available, 13,000 to 20,000 cases of paralytic polio were reported each year in the United States. These annual epidemics of polio often left thousands of victims--mostly children--in braces, crutches, wheelchairs, and iron lungs.
Development of polio vaccines and implementation of polio immunization programs have eliminated paralytic polio caused by wild polio viruses in the U.S. and the entire Western hemisphere.
In 1999, as a result of global immunization efforts to eradicate the disease, there were about 5,000 documented cases of polio in the world. In 1994, wild polio virus was imported to Canada from India, but high vaccination levels prevented it from spreading in the population.
Measles
Before measles immunization were available, nearly everyone in the U.S. got measles. There were approximately 3-4 million measles cases each year. An average of 450 measles-associated deaths were reported each year between 1953 and 1963.
In industrialized countries, up to 20% of persons with measles are hospitalized, and 7% to 9% suffer from complications such as pneumonia, diarrhea, or ear infections. Although less common, some persons with measles develop encephalitis, resulting in brain damage. It is estimated that as many as one of every 1,000 persons with measles will die.
Measles is one of the most infectious diseases in the world and is frequently imported into the U.S. In 1998, most cases were associated with international visitors or U.S. residents who were exposed to the measles virus while traveling abroad. More than 90% of people who are not immune will get measles if they are exposed to the virus.
According to the World Health Organization, nearly 900,000 deaths occurred among persons in developing countries in 1998. In populations that are not immune to measles, measles spreads rapidly. If vaccinations were stopped, 2.7 million measles deaths worldwide could be expected.
In the U.S., widespread use of measles vaccine has led to a greater than 99% reduction in measles compared with the pre-vaccine era. If we stopped immunization, measles would increase to pre-vaccine levels.
Haemophilus Influenzae Type b (Hib) Meningitis
Before Hib vaccine became available, Hib was the most common cause of bacterial meningitis in U.S. infants and children. Before the vaccine was developed, there were approximately 20,000 invasive Hib cases annually. Approximately two thirds of the 20,000 cases were meningitis, and one-third were other life-threatening invasive Hib diseases such as bacteria in the blood, pneumonia, or inflamation of the epiglotis. About one of every 200 U.S. children under 5 years of age got an invasive Hib disease. Hib meningitis killed 600 children each year, and left many survivors with deafness, seizures, or mental retardation.
Since introduction of conjugate Hib vaccine in December 1987, the incidence of Hib has declined by 98 percent. From 1994-1998, fewer than 10 fatal cases of invasive Hib disease were reported each year.
This preventable disease was a common, devastating illness as recently as 1990; now, most pediatricians just finishing training have never seen a case. If we were to stop immunization, we would likely soon return to the pre-vaccine numbers of invasive Hib disease cases and deaths.
Pertussis (Whooping Cough)
Since the early 1980s, reported pertussis cases have been increasing, with peaks every 3-4 years; however, the number of reported cases remains much lower than levels seen in the pre-vaccine era.Compared with pertussis cases in other age groups, infants who are 6 months old or younger with pertussis experience the highest rate of hospitalization, pneumonia, seizures, encephalopathy (a degenerative disease of the brain) and death. From 1990 to 1996, 57 persons died from pertussis; 49 of these were aged <6 months.
Before pertussis immunizations were available, nearly all children developed whooping cough. In the U.S., prior to pertussis immunization, between 150,000 and 260,000 cases of pertussis were reported each year, with up to 9,000 pertussis-related deaths.
Pertussis can be a severe illness, resulting in prolonged coughing spells that can last for many weeks. These spells can make it difficult for a child to eat, drink, and breathe. Because vomiting often occurs after a coughing spell, infants may lose weight and become dehydrated. In infants, it can also cause pneumonia and lead to brain damage, seizures, and mental retardation.
The newer pertussis vaccine (acellular or DTaP) that has been available for use in the United States since 1991. These vaccines are effective and associated with fewer mild and moderate adverse reactions when compared with the older (whole-cell DTP) vaccine.
During the 1970s, widespread concerns about the safety of pertussis immunization led to a rapid fall in immunization levels in the United Kingdom. More than 100,000 cases and 36 deaths due to pertussis were reported during an epidemic in the mid 1970s. In Japan, pertussis vaccination coverage fell from 80 percent in 1974 to 20 percent in 1979. An epidemic occurred in 1979, resulted in more than 13,000 cases and 41 deaths.
Pertussis cases occur throughout the world. If we stopped pertussis immunizations in the U.S., we would experience a massive resurgence of pertussis disease. A recent study* found that, in eight countries where immunization coverage was reduced, incidence rates of pertussis surged to 10 to 100 times the rates in countries where vaccination rates were sustained.
*Reference for study: Gangarosa EJ, et al. Impact of anti-vaccine movements on pertussis control: the untold story. Lancet 1998;351:356-61.
Rubella (German Measles)
While rubella is usually mild in children and adults, up to 90 percent of infants born to mothers infected with rubella during the first trimester of pregnancy will develop congenital rubella syndrome (CRS), resulting in heart defects, cataracts, mental retardation, and deafness.
In 1964-1965, before rubella immunization was used routinely in the U.S., there was an epidemic of rubella that resulted in an estimated 20,000 infants born with CRS, with 2,100 neonatal deaths and 11,250 miscarriages. Of the 20,000 infants born with CRS, 11,600 were deaf, 3,580 were blind, and 1,800 were mentally retarded.
Many developing countries do not include rubella in the childhood immunization schedule. Since 1996, greater than 50% of the reported rubella cases have been among adults. Sites of exposure for several outbreaks have included workplaces and communities. In 1998, 12 outbreaks of rubella occurred resulting in 19 pregnant women contracting rubella.
If we stopped rubella immunization, immunity to rubella would decline and rubella would once again return, resulting in pregnant women becoming infected with rubella and then giving birth to infants with CRS. Incidence of CRS declined dramatically with widespread use of rubella vaccine.
Varicella (Chickenpox)
Chickenpox is always present in the community and is highly contagious. Prior to the licensing of chicken pox vaccine in 1995, almost all persons in the U.S. had suffered from chickenpox by adulthood. Chicken pox was responsible for an estimated 4 million cases, 11,000 hospitalizations, and 100 deaths each year.
Chicken pox is usually mild, but may be severe in some infants, adolescents, and adults. Some people who get chicken pox have also suffered from complications such as secondary bacterial infections, loss of fluids (dehydration), pneumonia, and central nervous system involvement. In addition, only persons who have had chicken pox in the past can get shingles, a painful inflammation of the nerves. There are about 300,000 cases of shingles that occur each year when inactivated chicken pox virus is activated in people who have had chicken pox in the past.
From March 1995-August 1999, a total of 18.5 million doses of chicken pox vaccine were distributed in the United States. Vaccine coverage among children 19-35 months was 43% in 1998.
In 1990 in the U.S., the cost of caring for children who contracted chickenpox was estimated as $918 million annually. If we were to stop vaccinating for chicken pox in the U.S., this disease would quickly return to its previous high rate of infection. As a result, almost every child would miss a week of school (and the parent a week of work), 11,000 people--mostly children--would be hospitalized, and 50-100 varicella-related deaths would occur each year, most of them in previously healthy children and adults.
Hepatitis B
More than 2 billion persons worldwide have been infected with the hepatitis B virus at some time in their lives. Of these, 350 million are life-long carriers of the disease and can transmit the virus to others. One million of these people die each year from liver disease and liver cancer.
National studies have shown that five percent of Americans --1.25 million people -- have been infected with hepatitis B virus. In addition, these studies have shown that about 300,000 people have been infected with hepatitis B virus each year for the two decades prior to 1990. Currently, there are about 1.25 million people who have life-long hepatitis B virus infection. Each year about 4,000-5,000 of these people die from related liver disease resulting in over $700 million of medical and work-loss costs.
Infants and children who become infected with hepatitis B virus are at highest risk of developing lifelong infection, which often leads to death from liver disease (cirrhosis) and liver cancer. Approximately 25% of children who become infected with life-long hepatitis B virus would be expected to die of related liver disease as adults.
CDC estimates that one-third of the life-long hepatitis B virus infections in the United States resulted from infections occurring in infants and young children. About 16,000 - 20,000 hepatitis B antigen infected women give birth each year in the United States. It is estimated that 12,000 children born to hepatitis B virus infected mothers were infected each year before implementation of infant immunization programs. In addition, approximately 33,000 children (10 years of age and younger) of mothers who are not infected with hepatitis B virus were infected each year before routine childhood hepatitis B vaccination was recommended.
Diphtheria
Diphtheria is a serious disease caused by poison produced from the bacteria. It frequently causes heart and nerve problems. The death rate is 5%-10%, with higher death rates (up to 20%) in the very young and the elderly.
In the 1920's, diphtheria was a major cause of illness and death for children in the U.S. In 1921, a total of 206,000 cases and 15,520 deaths were reported. With vaccine development in 1923, new cases of diphtheria began to fall in the U.S., until in 1998 only one case was reported.
Although diphtheria is rare in the U.S., it appears that the bacteria continues to get passed among people. In 1996, 10 isolates of the bacteria were obtained from persons in an American Indian community in South Dakota, none of whom had classic diphtheria disease. There has been one death reported in 1999 from clinical diphtheria caused by a related bacteria.
There are high rates of susceptibility among adults. Screening tests conducted since 1977 have shown that 41%-84% of adults 60 and over lack protective levels of circulating antitoxin against diphtheria.
Although diphtheria is rare in the U.S., it is still a threat. Diphtheria is common in other parts of the world and with the increase in international travel, diphtheria and other infectious diseases are only a plane ride away. If we stopped immunization, the U.S. might experience a situation similar to the Newly Independent States of the former Soviet Union. With the breakdown of the public health services in this area, diphtheria epidemics began in 1990, fueled primarily by persons who were not properly vaccinated. From 1990-1998, more than 150,000 cases and 5,000 deaths were reported.
Tetanus (Lock Jaw)
Tetanus is a severe, often fatal disease. The bacteria that cause tetanus are widely distributed in soil and street dust, are found in the waste of many animals, and are very resistant to heat and germ-killing cleaners. From 1922-1926, there were an estimated 1,314 cases of tetanus per year in the U.S. In the late 1940's, the tetanus vaccine was introduced, and tetanus became a disease that was officially counted and tracked by public health officials. In 1998, only 45 cases of tetanus were reported in the U.S.
People who get tetanus suffer from stiffness and spasms of the muscles. The larynx (throat) can close causing breathing and eating difficulties, muscles spasms can cause fractures (breaks) of the spine and long bones. Some people go into a coma, and die. Approximately 30% of reported cases end in death.
Tetanus in the U.S. is primarily a disease of adults. From 1995-1997, 35% of reported cases of tetanus occurred among persons 60 years of age or older, 60% occurred in patients 20-59 years of age. The National Health Interview Survey found that in 1995, only 36% of adults 65 or older had received a tetanus vaccination during the preceding 10 years.
Worldwide, tetanus in newborn infants continues to be a huge problem. Every year tetanus kills 300,000 newborns and 30,000 birth mothers who were not properly vaccinated. Very recently, an increased number of tetanus cases in younger persons has been observed in the U.S. among intravenous drug users, particularly heroin users.
Tetanus is infectious, but not contagious, so unlike other vaccine-preventable diseases, immunization by members of the community will not protect others from the disease. Because tetanus bacteria is widespread in the environment, tetanus can only be prevented by immunization. If vaccination against tetanus were stopped, persons of all ages in the U.S. would be susceptible to this serious disease.
Mumps
Before the mumps vaccine was introduced, mumps was a major cause of deafness in children, occurring in approximately 1 / 20,000 reported cases. Mumps is usually a mild viral disease. However, rare conditions such as swelling of the brain, nerves and spinal cord can lead to serious side effects such as paralysis, seizures, and fluid in the brain.
Serious side effects of mumps are more common among adults than children. Swelling of the testes is the most common side effect in males past the age of puberty, occurring in up to 20-50% of men who contract mumps. An increase in spontaneous abortions has been found among women who develop mumps during the first trimester of pregnancy.
An estimated 212,000 cases of mumps occurred in the U.S. in 1964. After vaccine licensure in 1967, reports of mumps decreased rapidly. In 1986 and 1987, there was a resurgence of mumps with 12,848 cases reported in 1987. Since 1989, the incidence of mumps has declined, with a total of 606 cases in 1998. This recent decrease is probably due to the fact that children have received a second dose of mumps vaccine (part of the two-dose schedule for measles, mumps, rubella or MMR) and the eventual development of immunity in those who did not gain protection after the first mumps vaccination.
If we were to stop vaccination against mumps, we could expect the number of cases to climb back to pre-vaccine levels, since mumps is easily spread among unvaccinated persons.

How FDA Works to Ensure Vaccine Safety

The gasping for breath and desperate hacking of whooping cough. The iron lungs and braces of polio. Birth defects from rubella. For many people today, those signs of terrible diseases are the stuff of history books, thanks to vaccines. But the rare case of vaccine-associated polio or the death of an infant soon after receiving a dose of pertussis vaccine may make people wonder - are vaccines safe enough, or could they be safer?
For the Food and Drug Administration's Center for Biologics Evaluation and Research, vaccine safety, along with effectiveness, is central to regulation of these preparations.
Clinical Trials
The first step to licensing a new vaccine is safety testing in animals. If the laboratory animals immunized with the vaccine don't have serious reactions, FDA consults with the vaccine manufacturer or sponsor on further refining of the manufacturing process.
Because the weakened viruses used for vaccines are grown in animal or human cells, a tremendous amount of time studying the safety of those cells according to CBER'S Office of Vaccine Research and Review.
For example, the manufacturer of the recently licensed Varicella (chickenpox) vaccine had to prove the human cell line used to grow the virus was not contaminated with any other viruses, such as hepatitis.
Only after those studies have been done does testing in people begin.
FDA requires new vaccines to undergo several phases of clinical trials - testing in people - for safety and effectiveness.
Phase 1 trials evaluate basic safety and identify only very serious or very common adverse events. These trials are small - between 20 to 100 patients - and last just several months.
Phase 2 trials include several hundred patients and last anywhere from several months to two years. This allows for more information on safety and preliminary information on effectiveness to be collected.
Unless severe reactions or a lack of effectiveness surfaces during the first two phases, the trials are expanded in Phase 3 to include several hundred to several thousand people. These trials continue to measure effectiveness and safety.
If, towards or at the end of the Phase 3 trials, the manufacturer believes there are adequate data to show that the vaccine is safe and effective for its intended use, the manufacturer applies to FDA for two licenses - one for the vaccine (product license) and one for the manufacturing plant (establishment license).
An internal FDA committee then reviews the clinical data, proposed labeling, and manufacturing protocols that ensure a consistent product, and the results of the agency's own confirmatory tests of the vaccine's components and the final product. The review process includes an inspection of the manufacturing facility.
Advisory Committees
FDA advisory committees are groups of experts outside government that review data and issues associated with products and recommend what action the agency should take.
Advisory committees can be brought in at any stage in the review process. For example, before the Phase 1 trials of some of the first AIDS vaccines, the proposed studies were shown to the Vaccines and Related Biological Products Advisory Committee. Also, as trials move into determining what might be appropriate efficacy studies, advisory committees may be consulted early. Involving the committees throughout the process is a good idea because these expert advisors bring a wealth of scientific background to address vaccine issues confronting FDA.
Through the years, the FDA has had an outstanding advisory group. Members have been willing to serve as consultants for many years after their four-year term, and this provides a continuity on some of the issues that were discussed years ago and are still being studied today.
Committee recommendations are not binding on FDA, but the agency considers them carefully when deciding whether to license a vaccine for marketing.
Green Light
Licensing of a vaccine is only the beginning of FDA's oversight. Manufacturers must submit samples of each vaccine lot and results of their own tests for potency, safety and purity to the agency before release.
Each lot must be tested because vaccines are derived from living organisms that are sensitive to environmental factors and are susceptible to contamination.
Tests that are generally applicable to all products include those for bacterial and fungal sterility, those for general safety, purity, identity and suitability of constituent materials, and those for potency. Sterility testing is performed on both bulk- and final-container material. In addition, cell-culture-derived vaccines must be tested for disease-causing organisms. All ingredients such as diluents, preservatives or adjuvants must also meet generally accepted standards of purity.
The importance of these tests was established years ago. In 1955, the virus-inactivated Salk polio vaccine first went on the market. Unfortunately, virus in some batches of the vaccine produced by one manufacturer was not totally inactivated, and some of the children who got that vaccine developed polio. Inadequate tests of the final vaccine were the reason for this unfortunate occurrence.
The tests manufacturers must perform on each lot are spelled out in the Code of Federal Regulations or in the product license application. When the manufacturer sends the lot samples, along with the results of testing, to FDA, the FDA either tests the lot sample directly or goes with the manufacturer's documentation according to Jerome A. Donlon, M.D., Ph.D., director of CBER's Office of Establishment Licensing and Product Surveillance. With vaccines for diseases that attack the nervous system, such as the live polio vaccine, "we test every lot because of the tremendous potential for harm," he explains.
Over the last 10 years, there have been only three vaccine recalls. One lot was recalled after FDA detected particulates; another was mislabeled. The third lot was recalled because of potential problems after an FDA inspection found violations of good manufacturing practices at the production plant.
Continuing Studies
Although clinical trials are carefully designed to uncover potential adverse reactions before FDA licenses a vaccine, it is difficult to get all the information premarketing according to Susan Ellenberg, Ph.D., director of CBER's Division of Biostatistics and Epidemiology. "You're never going to be able to do studies big enough to detect risks that might happen at a level of one in 100,000 or one in 1 million. We'd never get vaccines on the market. Still, such risks are important to detect because of the large population exposed. So we have to develop postmarketing surveillance programs."
For some vaccines, there are formal Phase 4 studies under way. At FDA's request, the manufacturer of the new chickenpox vaccine, licensed by FDA March 17, 1995, will monitor several thousand vaccinated children for 15 years to determine the long-term effects of the vaccine and possible need for a booster immunization.
For most vaccines, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins.
FDA and the national Centers for Disease Control and Prevention manage VAERS, a system the two agencies developed in response to the National Childhood Vaccine Injury Act of 1986. Anyone - physicians, vaccine manufacturers, patients, or the parents of a patient - can report to VAERS an adverse event that may be associated with any vaccine.
"What we're most interested in with VAERS is identifying any new problem, particularly serious problems, that might be so rare that it wasn't noticed or detected during the clinical trials," says Ellenberg.
However, many events that might be associated with vaccines go unreported.
"We don't have to have 100 percent reporting," says Donlon. Ellenberg agrees. Still, she adds, "We need enough reports to permit detection of rare events and to allow us to make reliable comparisons of reporting rates among vaccine lots. Our ability to do this improves if doctors make more reports and make them more timely."
Donlon points out that the report of an adverse event to VAERS is not documentation that a vaccine caused the event. He says doctors shouldn't make that judgment.
"Just report it," he says, "even if you've never seen it before. Maybe many others around the country are seeing the same thing."
For example, a mother recently called FDA because her child's hair had fallen out each time the child received a dose of the hepatitis B vaccine. The mother said she asked the pediatrician whether the vaccine could have caused the hair loss, but the pediatrician was sure that couldn't be the case. In fact, after the second dose of the vaccine and subsequent hair loss, the doctor was preparing to do a scalp biopsy to determine the cause.
A search of the VAERS database found 45 cases of hair loss after hepatitis B vaccination. Of those, 15 cases were like this one, in which hair loss happened after each of two doses of the vaccine.
"That's called 'positive rechallenge,'" says Ellenberg, "and it gives you a much stronger belief that the event was actually due to the product. Now, hair falling out is not a life-threatening event. But if people are aware it could happen, then they won't be imagining the worst, and invasive, unnecessary tests may not have to be performed."
Besides identifying previously unknown adverse events, VAERS is an important tool for monitoring individual lots of vaccines. "We don't expect there to be problems with vaccine lots," says Ellenberg, "because the regulations are very stringent. But even though we don't expect to find anything, we look [at the reports to VAERS] every week, and if there really was a problem with a lot, we could move very rapidly to get that lot off the market.
"One of the first things we do if we see a lot that has an elevated number of adverse events is look at its 'sister' lots, the other lots that came from the same larger bulk lot. If those lots also have high rates of adverse events, it would raise our level of suspicion that there might be a problem. If, however, the other lots had average or even low rates, we would feel that this is just more likely chance variation."
Another key factor to assess the significance of the number of adverse events is the size of the lot.
"A lot with hundreds of thousands of doses is going to be associated with more events than a lot with tens of thousands of doses," says Ellenberg.
VAERS is designed to detect signals or warnings that there might be a problem rather than to answer questions about what caused the adverse event, according to "Research Strategies for Assessing Adverse Events Associated with Vaccines," a 1994 report by the Institute of Medicine. These signals can lead to hypotheses about causality, which can then be tested by other methods, such as epidemiologic or laboratory studies.
Background Rates Cause Confusion
"The problem with any vaccine that's given to very young children is that there are a lot of background adverse events occurring in the first year of life," says Ellenberg. Thus, a reaction thought to be due to a vaccine may actually have been from something else, such as an ear infection.
Children less than a year old are at greatest risk for high fevers, seizures and sudden infant death syndrome (SIDS). These events are seen both in the presence and absence of vaccination. The SIDS death rate is approximately 1.3 per 1,000 live births during the first year of life, according to Ellenberg. During that same period, babies receive the DPT vaccine three times - at 2, 4 and 6 months old.
"You don't have to be a mathematician to appreciate the fact that, by chance, SIDS will sometimes occur shortly after the vaccine was administered," says Ellenberg. "The calculations that we have been able to do suggest that the numbers of SIDS following vaccination that have been reported to VAERS are not beyond what would be expected by chance. And there have been some well-conducted, focused studies that demonstrate that SIDS is not associated with DPT vaccination. But, on the basis of VAERS data alone, we don't have proof that vaccines are not contributing to these problems and we certainly don't have proof that they are contributing."
Adding to the confusion is the fact that DPT is only one of many infant vaccines. The recommended childhood immunization schedule includes vaccines for hepatitis B, haemophilus b, measles, mumps, rubella, and polio, all during the first 12 months.
At the other end of the age spectrum, deaths are also reported after administration of the influenza vaccine. "Often these vaccines are given to people in nursing homes," explains Ellenberg. Unfortunately, this population has a relatively high death rate anyway, so it's almost impossible to say whether a given death is associated with the vaccine, she says.
As inevitable as some of those deaths, as well as other adverse events, may be, the FDA remains vigilant in its efforts to improve vaccine safety. The agency continues to be aggressive in its efforts, along with manufacturers and other government agencies, to get safer vaccines on the market.