Vaccine Concerns

Editor's Note: The following information is reprinted from Chapter 15 "Common Concerns about Vaccines," p. 92-115, from the book Vaccines: What You Should Know, third edition, by Paul A. Offit, MD, and Louis M. Bell, MD, ©2003. It is reprinted with permission of Dr. Offit. Cost of the book is $14.95. To purchase a copy, visit your local bookstore or go to www.wiley.com

It seems that almost every month newspaper articles and television programs depict the horrors of vaccines. The villains of these stories are greedy vaccine manufacturers, disinterested doctors, and burdensome regulatory agencies. The focus of the stories is that children are hurt unnecessarily by vaccines, and the tone is one of intrigue and cover-up.

Perhaps the most dangerous part of these stories (apart from the fact that they may cause many children to miss the vaccines they need) is that the explanations are presented in a manner that seem believable. Below we have listed the most commonly aired stories about vaccines and have tried to separate fact from myth.

CONCERN: Vaccines don't work.

Probably the best example of the impact of vaccines is the vaccine that prevents meningitis caused by the bacterium Haemophilus influenzae type b (Hib). The current Hib vaccine was first introduced to this country in 1990. At that time Hib was the most common cause of bacterial meningitis, accounting for approximately 15,000 cases and 400 to 500 deaths every year. The incidence of cases and deaths per year had been steady for decades. After the current Hib vaccine was introduced, the incidence of Hib meningitis declined to fewer than fifty cases per year! The power of the Hib vaccine is that most pediatricians and family practitioners working today saw its impact. The story of the Hib vaccine is typical of all widely used vaccines. A dramatic reduction in the incidence of diseases such as measles, mumps, German measles, polio, diphtheria, tetanus, and pertussis occurred within several years of the introduction of vaccines against them. Vaccines not only work, but they work phenomenally well.

CONCERN: Vaccines aren't necessary.

In some ways, vaccines are victims of their own success. Most young parents today have never seen a case of measles, mumps, German measles, polio, diphtheria, tetanus, or whooping cough. As a result, some of these parents question the continued need for vaccines.

Vaccines should be given for three reasons:

• Some diseases are so prevalent in this country that a decision not to give a vaccine is a decision to risk that disease (for example, pertussis).
• Some diseases are still present in the environment. These diseases continue to occur, but at fairly low levels (for example, measles, mumps, and German measles). If immunization rates drop, outbreaks of these diseases will again occur and children will die from our lack of vigilance. This is exactly what happened in the late 1980s and early 1990s when immunization rates against measles dropped. The result was 11,000 hospitalizations and more than a hundred deaths caused by measles. Now, due to an increase in measles immunization rates, there are only about a hundred cases of measles and no deaths every year in the United States.
• Some diseases have been virtually eliminated from this country (such as polio and diphtheria). However, these diseases continue to cause outbreaks in other areas of the world. Given the high rate of international travel, these diseases could be easily imported by travelers or immigrants.

CONCERN: Vaccines are not safe.

What does the word safe mean?

The first definition of the word safe is "harmless." This definition would imply that any negative consequences of vaccines 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 be a very rare cause of persistent, inconsolable crying or high fever. Although none of these severe symptoms results 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, each 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 its risks.

The second definition of the word safe is "having been preserved from a real danger." This definition implies that vaccines provide safety. 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.

Is the hepatitis B vaccine safe?

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.

On the other hand, every year thousands of people die soon after being infected with hepatitis B virus. In addition, tens of thousands of people every year suffer severe liver damage (called cirrhosis) or liver cancer caused by hepatitis B virus. Children 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. For this reason, the hepatitis B vaccine is recommended for newborns.

Some parents wonder whether it is necessary to give the hepatitis B 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 thousands of children less than ten years of age caught hepatitis B virus from someone other than their mothers. Some children caught it from another family member, and some children caught it from someone outside the home who came in contact with the baby. About 1 million people in the United States now are infected with hepatitis B virus. However, because hepatitis B virus can cause a silent infection (meaning without obvious symptoms), many people who have hepatitis B virus infection don't even know that they have it! So it can be hard to tell who might be contagious. Worse yet, you can catch hepatitis B virus after casual contact with someone who is infected (for example, sharing hand towels).

Because the benefits of the hepatitis B vaccine clearly and definitively outweigh the risks, the hepatitis B vaccine is safe.

Was the old pertussis vaccine safe?

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°F occurred in one of every 330 doses, and seizures with fever occurred in one of every 1,750 doses. Due to negative publicity about this vaccine, the use of pertussis vaccine decreased in many areas of the world.

For example, Japan simply stopped using the pertussis vaccine in 1975. In the three years before the vaccine was discontinued, there were 400 cases of pertussis and ten deaths from pertussis. 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. What they did die from was pertussis infection. The Japanese Ministry of Health, realizing how costly their error had been, soon reinstituted the use of pertussis vaccine.

What happened to the children of Japan proved that the benefits of the pertussis vaccine clearly outweighed the risks. Today's new "acellular" pertussis vaccine has a much lower risk of severe side effects than the old "whole-cell" vaccine-therefore, it is even safer.

Was the rotavirus vaccine safe?

The rotavirus vaccine was withdrawn for 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.

What happened to children who didn't get the rotavirus vaccine? Of the 1 million children who didn't get the vaccine, about 16,000 were hospitalized with water loss (or dehydration) and about five to ten died from dehydration caused by rotavirus. Many more children were hospitalized and killed by rotavirus infection than were hospitalized and killed by the rotavirus vaccine. So the United States had to choose between the risk of the rotavirus vaccine and the risk of natural infection. The Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics felt that the risk from rotavirus vaccine was simply too great and preferred to wait for a rotavirus vaccine that was safer.

But let us not fool ourselves into thinking that the decision not to use a rotavirus vaccine rendered children free from risk. Because rotavirus disease is common, the choice not to give the rotavirus vaccine was a choice to allow for continued natural infection with rotavirus. This choice meant that children will continue to be at risk of severe and occasionally fatal rotavirus infection.

Is the pneumococcal vaccine safe?

The pneumococcal vaccine was licensed for use in the United States in the year 2000 and was recommended for use in all children less than five years of age. Some parents chose to take a "wait and see" attitude when the vaccine was first licensed. 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 happens after the pneumococcal vaccine is given to at least 1 million or more children?

However, the choice not to give the pneumococcal vaccine was again not a risk-free choice, because every year in the United States thousands of children get meningitis, bloodstream infections, and 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 about the safety of this vaccine because of two facts. First, the pneumococcal vaccine was tested in about 20,000 children before being 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 about 3 million children every year since 1990.

Are systems in place to ensure that vaccines are safe after they are licensed?

The rotavirus vaccine is an example of how rare side effects can be detected. The vaccine was tested in about 11,000 children before it was submitted to the Food and Drug Administration (FDA) 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 Events Reporting System (VAERS) then found about fifteen cases of an intestinal blockage called intussusception soon after administration of the vaccine. This was worrisome enough to the CDC to cause them to temporarily suspend use of the vaccine until it could be determined whether the vaccine did, in fact, cause intussusception. An analysis by the CDC showed that intussusception occurred in about one of every 10,000 children that received the vaccine. Because only 11,000 children had been tested before the vaccine was licensed, it had not been really possible to detect such a rare side effect. The result of the rotavirus vaccine experience is that at least 60,000 children will be tested before the next rotavirus vaccine is licensed.