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From?Opposing Viewpoints in Context
The Children’s Hospital of Philadelphia?Vaccine?Education Center seeks to provide information about?vaccines?and the?diseases?they prevent to parents and healthcare professionals.
Although no?vaccine?is completely harmless,?vaccines?do protect people from the real danger of disease. The?vaccines?against hepatitis B, pertussis, pneumococcal disease, and rotavirus all have the possibility of certain side effects, but the harms of disease prevented by the?vaccines?outweigh the risk of any adverse effects. There are systems in place to protect against side effects and?vaccines?are only given to children after a long approval process.
The first definition of the word safe is “harmless.” This definition would imply that any negative consequence of a?vaccine?would make the?vaccine?unsafe. Using this definition, no?vaccine?is 100 percent safe. Almost all?vaccines?can cause pain, redness or tenderness at the site of injection. And some?vaccines?cause more severe side effects. For example, the pertussis (or?whooping cough)?vaccine?can cause persistent, inconsolable crying, high fever or seizures associated with fever. Although none of these severe symptoms result in permanent damage, they can be quite frightening to parents.
But, in truth, few things meet the definition of “harmless.” Even everyday activities contain hidden dangers. For example, every year in the United States, 350 people are killed in bath- or shower-related accidents, 200 people are killed when food lodges in their windpipe, and 100 people are struck and killed by lightning. However, few of us consider eating solid food, taking a bath, or walking outside on a rainy day as unsafe activities. We just figure that the benefits of the activity clearly outweigh the risks.
The second definition of the word safe is “having been preserved from a real danger.” Using this definition, the danger (the disease) must be significantly greater than the means of protecting against the danger (the?vaccine). Or, said another way, a?vaccine’s?benefits must clearly and definitively outweigh its risks.
To better understand the definition of the word?safe?when applied to?vaccines, let’s examine four different?vaccines?and the diseases they prevent:
The Safety of the Hepatitis B Vaccine
The hepatitis B?vaccine?has few side effects. However, one side effect is serious. About one of every 600,000 doses of hepatitis B?vaccine?is complicated by a severe allergic reaction called anaphylaxis. The symptoms of anaphylaxis are hives, difficulty breathing and a drop in blood pressure. Although no one has ever died because of the hepatitis B?vaccine, the symptoms of anaphylaxis caused by the?vaccine?can be quite frightening.
Because the benefits of the hepatitis B?vaccine?clearly and definitively outweigh its risks, the hepatitis B?vaccine?is safe.
On the other hand, every year about 5,000 people die soon after being infected with hepatitis B virus. In addition, about 10,000 people every year suffer severe liver damage (called cirrhosis) or liver cancer caused by hepatitis B virus. People are much more likely to develop these severe and often fatal consequences of hepatitis B virus?infection?if they get infected when they are very young children. For this reason, the hepatitis B?vaccine?is recommended for newborns.
Some parents wonder whether it is necessary to give the hepatitis B virus?vaccine?to newborns. They ask: “How is a baby going to catch hepatitis B?” But, before the hepatitis B virus?vaccine, every year in the

United States about 18,000 children less than 10 years of age caught hepatitis B virus from someone other than their mother. Some children catch it from another family member, and some children catch it from someone outside the home who comes in contact with the baby. About 1 million people in the United States are infected with hepatitis B virus. However, because hepatitis B virus can cause a silent infection (meaning without obvious symptoms), many people who are infected with hepatitis B virus don’t know that they have it! So it can be hard to tell from whom you could catch hepatitis B virus. Worse yet, many people don’t realize that you can catch hepatitis B virus after coming into contact with minute quantities of blood through casual contact with someone who is infected (for example, sharing washcloths or toothbrushes). In fact, a milliliter of blood (about one-fifth of a teaspoon) from someone who is infected can contain as many as one billion infectious viruses, so people can be infected with quantities of infected blood small enough that they are not visible to the naked eye.
Because the benefits of the hepatitis B?vaccine?clearly and definitively outweigh its risks, the hepatitis B?vaccine?is safe.
The Safety of the Pertussis Vaccine
The old pertussis?vaccine?had far more risks than the hepatitis B?vaccine. The old pertussis?vaccine?was called the “whole-cell”?vaccine?and had a high rate of severe side effects. Persistent, inconsolable crying occurred in one of every 100 doses, fever greater than 105 degrees occurred in one of every 330 doses, and seizures with fever occurred in one of every 1,750 doses. Due to negative publicity related to this?vaccine, its use decreased in many areas of the world.
For example, the Japanese Ministry of Health decided to stop using the pertussis?vaccine?in 1975. In the three years before the?vaccine?was discontinued, there were 400 cases of pertussis and 10 deaths from pertussis in Japan. In the three years after the pertussis?vaccine?was discontinued, there were 13,000 cases of pertussis and 113 deaths! It should be noted that although the side effects of the pertussis?vaccine?were high, children didn’t die from pertussis?vaccine; however, they did die from pertussis infection. The Japanese Ministry of Health, realizing how costly their error had been, soon reinstituted the use of pertussis?vaccine.
The children of Japan proved that, despite the side effects, the benefits of the old pertussis?vaccine?clearly outweighed the risks.
Scientific progress eventually led to the creation of another version of the pertussis?vaccine. Known as the “acellular” pertussis?vaccine, it was more purified, so instead of containing about 3,000 immunogenic proteins, it only contained two to five proteins. The (“acellular”) pertussis?vaccine?became available in the United States in 1996. Children who received this?vaccine?had a much lower risk of severe side effects than those who received the old “whole-cell”?vaccine. Therefore, the new pertussis?vaccine?is safer than the old pertussis?vaccine. But because the benefits of the old pertussis?vaccine?outweighed its risks, it too was safe.
The Safety of the Pneumococcal Vaccine
Let’s take a look at the pneumococcal?vaccine. The pneumococcal?vaccine?was licensed in the United States in the year 2000 and was recommended for use in all children less than 5 years of age. Some parents chose to take a “wait-and-see” attitude. They reasoned that because the problems with the rotavirus?vaccine?were not revealed until the?vaccine?was given to 1 million children, why not wait and see what happened after the pneumococcal?vaccine?was given to several million or more children.
The first rotavirus?vaccine?was withdrawn from use because of a problem with safety.
However, the choice not to give the pneumococcal?vaccine?was not a risk-free choice. Before pneumococcal?vaccine?was first given to infants in 2000, every year in the United States about 700 children (less than 5 years old) got meningitis, 17,000 got bloodstream infections, and 71,000 got pneumonia from pneumococcus. So the choice not to give a pneumococcal?vaccine?was a choice to risk the severe, often permanent, and occasionally fatal consequences of pneumococcal infection. Parents should be reassured by two facts. First, the pneumococcal?vaccine?was tested in about 20,000 children before it was licensed for use. Second, the?Haemophilus influenzae?type b (Hib)?vaccine?is made in a

manner almost identical to the pneumococcal?vaccine?and has been given safely to millions of children since 1990.
The Safety of the Rotavirus Vaccine
A new rotavirus?vaccine?was recommended for use in February 2006. This?vaccine?was tested in more than 70,000 infants. About half of the children received?vaccine?and the other half received a salt water solution. This large study showed the?vaccine?to be safe. Children who received the?vaccine?were not more likely to experience vomiting, diarrhea, fever, irritability or poor feeding than children who did not receive the?vaccine.
The first rotavirus?vaccine?was withdrawn from use because of a problem with safety. The?vaccine?was found to cause a rare, but potentially very serious, side effect called intussusception. Intussusception occurs when one section of the small intestine folds into another section of the intestine. When this happens, the intestine can become blocked. Intussusception is a medical emergency, and children can die from the disease. The rotavirus?vaccine?was given to about 1 million children in the United States between 1998 and 1999. About one of every 10,000 children who were given the?vaccine?got intussusception (a total of about 100 children), and one child died because of the?vaccine.
Because of the problem with intussusception in the previous?vaccine, any new rotavirus?vaccine?had to be evaluated for this potential side effect as well. There are currently two rotavirus?vaccines?available in the U.S. Studies have shown that children who receive either of the rotavirus?vaccines?are no more likely to experience intussusception than those who did not receive the?vaccine. Intussusception occurs naturally in about 1 of every 100,000 infants.
Systems in Place to Protect Against Side Effects
The previous rotavirus?vaccine?is an example of how rare side effects can be detected quickly. The rotavirus?vaccine?was tested in about 11,000 children before it was submitted to the FDA [US Food and Drug Administration] for licensure. After the?vaccine?was licensed and recommended for use, the?vaccine?was given to about 1 million children.
A system called the?Vaccines?Adverse Event Reporting System (VAERS) initially found about 15 cases of an intestinal blockage called intussusception soon after administration of the?vaccine. This was worrisome enough to the Centers for Disease Control and Prevention (CDC) to cause them to temporarily suspend use of the rotavirus?vaccine?until it could be determined whether the?vaccine?did, in fact, cause intussusception. Their analysis showed that intussusception occurred in about one of every 10,000 children who received the?vaccine. Because only 11,000 children were tested before the?vaccine?was licensed, it was really not possible to pick up such a rare side effect. The result of the rotavirus?vaccine?experience is that at least 60,000 children had to be tested before the next?vaccine?was licensed.
Several other systems of study to understand the rate of?vaccine?side effects, such as the?Vaccine?Safety Data Link (VSD), are also available. The VSD also allows one to determine the background rate of side effects, meaning the rate of adverse events in children who don’t receive a?vaccine. So, in many ways, systems like the?Vaccine?Safety Data Link are better than VAERS because they allow one to determine whether a particular?vaccine?is the cause of a rare side effect.
Trials can take years, giving companies ample time to provide the FDA with proof of long-term safety and effectiveness.
The Licensure of New Vaccines
Vaccines?are only given to children after a long and careful review by a number of different groups. These different groups either: license, recommend or require?vaccines.
The first of three processes, licensure, involves gaining approval from the Food and Drug Administration (FDA). As a result, it is the longest of these processes. It can take years, even decades, before pharmaceutical companies can actually start providing the?vaccine. For example, the varicella [chicken pox]?vaccine?took about 11 years to be licensed by the FDA.
Vaccines?are usually made by first showing that they are safe and effective in experimental animals. Once this is established, the?vaccine?becomes an Investigational New Drug (IND) and the company is given an IND license to further study the safety and effectiveness of the?vaccine?in adults, and eventually, children. Again, these trials can take years, giving companies ample time to provide the FDA with proof of long-term safety and effectiveness.
The Recommendation Process
The “recommendation” process begins only after a?vaccine?is licensed by the FDA. Doctors don’t just decide to start giving the?vaccine?on their own. They seek the recommendations of the Advisory Committee on?Immunization?Practices (ACIP), which is part of the Centers for Disease Control and Prevention (CDC), the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).
While the FDA licensure process involves determining the risks versus the benefits of a particular?vaccine, the recommendation process considers the costs versus the benefits. Here’s the distinction:
The FDA examines?vaccine?safety by considering whether there are any risks (negative effects) associated with the?vaccine. They ask: “Do these risks outweigh the benefits of the?vaccine?or vice versa?”
In addition to considering the risks and benefits of a?vaccine, the ACIP, AAP and AAFP also examine the costs associated with immunizing all or just a segment of the population. For instance, with the chickenpox (varicella)?vaccine: What is the cost of immunizing children compared with the potential savings in medical and non-medical costs from immunizing them? (An example of non-medical costs would be money lost by parents who miss work taking care of their unvaccinated child.)
Another part of the recommendation process is determining which groups of people within the population would benefit from the?vaccine, and on what schedule the?vaccine?should be given based on data previously presented to the FDA.
Whereas?immunity?from disease often follows a single natural infection, immunity from?vaccines?usually occurs only after several doses.
Just because a?vaccine?is recommended for use doesn’t mean that it is required for use. State legislatures and health departments determine whether a?vaccine?is required. They examine the practicality of requiring it for every child within the state. Factored into this equation is whether a local or state government can afford to pay for the?vaccines?of children whose parents can’t afford it.
The Need for Vaccines

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