| Common
Misconceptions About Vaccinations
Diseases had already begun to disappear before vaccines
were introduced, because of better hygiene and sanitation.
Statements like this are very common in anti-vaccine literature,
the intent apparently being to suggest that vaccines are not needed.
Improved socioeconomic conditions have undoubtedly had an indirect
impact on disease. Better nutrition, not to mention the development
of antibiotics and other treatments, have increased survival rates
among the sick; less crowded living conditions have reduced disease
transmission; and lower birth rates have decreased the number of
susceptible household contacts. But looking at the actual incidence
of disease over the years can leave little doubt of the significant
direct impact vaccines have had, even in modern times. Here, for
example, is a graph showing the reported incidence of measles from
1950 to the present.
There were periodic peaks and valleys throughout the years, but
the real, permanent drop coincided with the licensure and wide use
of measles vaccine beginning in 1963. Graphs for other vaccine-preventable
diseases show a roughly similar pattern, with all except hepatitis
B* showing a significant drop in cases corresponding with the advent
of vaccine use. Are we expected to believe that better sanitation
caused incidence of each disease to drop, just at the time a vaccine
for that disease was introduced?
*The incidence rate of hepatitis B has not dropped so dramatically
yet because the infants we began vaccinating in 1991 will not be
at high risk for the disease until they are at least teenagers.
We therefore expect about a 15 year lag between the start of universal
infant vaccination and a significant drop in disease incidence.
Hib vaccine is another good example, because Hib disease was prevalent
until just a few years ago, when conjugate vaccines that can be
used for infants were finally developed. (The polysaccharide vaccine
previously available could not be used for infants, in whom most
of cases of the disease were occurring.) Since sanitation is not
better now than it was in 1990, it is hard to attribute the virtual
disappearance of Hib disease in children in recent years (from an
estimated 20,000 cases a year to 1,419 cases in 1993, and dropping)
to anything other than the vaccine.
Varicella can also be used to illustrate the point, since modern
sanitation has obviously not prevented nearly 4 million cases each
year in the United States. If diseases were disappearing, we should
expect varicella to be disappearing along with the rest of them.
But nearly all children in the United States get the disease today,
just as they did 20 years ago or 80 years ago. Based on experience
with the varicella vaccine in studies before licensure, we can expect
the incidence of varicella to drop significantly now that a vaccine
has been licensed for the United States.
Finally, we can look at the experiences of several developed countries
after they let their immunization levels drop. Three countries -
Great Britain, Sweden, and Japan - cut back the use of pertussis
vaccine because of fear about the vaccine. The effect was dramatic
and immediate. In Great Britain, a drop in pertussis vaccination
in 1974 was followed by an epidemic of more than 100,000 cases of
pertussis and 36 deaths by 1978. In Japan, around the same time,
a drop in vaccination rates from 70% to 20%-40% led to a jump in
pertussis from 393 cases and no deaths in 1974 to 13,000 cases and
41 deaths in 1979. In Sweden, the annual incidence rate of pertussis
per 100,000 children 0-6 years of age increased from 700 cases in
1981 to 3,200 in 1985. It seems clear from these experiences that
not only would diseases not be disappearing without vaccines, but
if we were to stop vaccinating, they would come back.
Of more immediate interest is the major epidemic of diphtheria
now occurring in the former Soviet Union, where low primary immunization
rates for children and the lack of booster vaccinations for adults
have resulted in an increase from 839 cases in 1989 to nearly 50,000
cases and 1,700 deaths in 1994. There have already been at least
20 imported cases in Europe and two cases in U.S. citizens working
in the former Soviet Union.
The majority of people who get disease have been vaccinated.
This is another argument frequently found in anti-vaccine literature
- the implication being that this proves vaccines are not effective.
In fact it is true that in an outbreak those who have been vaccinated
often outnumber those who have not - even with vaccines such as
measles, which we know to be about 98% effective when used as recommended.
This apparent paradox is explained by two factors. First, no vaccine
is 100% effective. To make vaccines safer than the disease, the
bacteria or virus is killed or weakened (attenuated). For reasons
related to the individual, not all vaccinated persons develop immunity.
Most routine childhood vaccines are effective for 85% to 95% of
recipients. Second, in a country such as the United States the people
who have been vaccinated vastly outnumber those who have not. How
these two factors work together to result in outbreaks in which
the majority of cases have been vaccinated can be more easily understood
by looking at a hypothetical example:
In a high school of 1,000 students, none has ever had measles.
All but 5 of the students have had two doses of measles vaccine,
and so are fully immunized. The entire student body is exposed to
measles, and every susceptible student becomes infected. The 5 unvaccinated
students will be infected, of course. But of the 995 who have been
vaccinated, we would expect several not to respond to the vaccine.
The efficacy rate for two doses of measles vaccine can be as high
as >99%. In this class, 7 students do not respond, and they,
too, become infected. Therefore 7 of 12, or about 58%, of the cases
occur in students who have been fully vaccinated.
As you can see, this doesn't prove the vaccine didn't work - only
that most of the children in the class had been vaccinated, so those
who were vaccinated and did not respond outnumbered those who had
not been vaccinated. Looking at it another way, 100% of the children
who had not been vaccinated got measles, compared with less than
1% of those who had been vaccinated. Measles vaccine protected most
of the class; if nobody in the class had been vaccinated, there
would probably have been 1,000 cases of measles.
There are "hot lots" of vaccine that have been
associated with more adverse events and deaths than others. Parents
should find the numbers of these lots and not allow their children
to receive vaccines from them.
This misconception got considerable publicity recently when vaccine
safety was the subject of a television news program. First of all,
the concept of a "hot lot" of vaccine as it is used in
this context is wrong. It is based on the presumption that the more
reports to VAERS** a vaccine lot is associated with, the more dangerous
the vaccine in that lot; and that by consulting a list of the number
of reports per lot, a parent can identify vaccine lots to avoid.
This is misleading for two reasons:
1. A report made to VAERS does not mean that
the vaccine, or other vaccines from the same group or lot caused
the event. VAERS is a national system for reporting health problems
that happen around the same time of the vaccination. Only some
of the reported health conditions are side effects related to
vaccines. A certain number of VAERS reports of serious illnesses
or death do occur by chance alone among persons who have been
recently vaccinated.
VAERS reports have many limitations since they often lack important
information, such as laboratory results, used to establish a true
association with the vaccine. For all serious and other clinically
significant events (life-threatening events, hospitalization,
permanent disability, death), follow-up with the health care provider
and/or the parent or vaccinated individual is conducted in an
attempt to collect supplemental information on the reports. Because
of the limitations of this type of reporting system, causality
is difficult to determine. Regardless of the cause, VAERS is interested
in hearing about any health concerns that happen around the time
of vaccination. In summary, scientists are not able to identify
a problem with a vaccine lot based on VAERS reports alone without
scientific analysis of other factors and data.
2. Vaccine lots are not the same. The sizes
of vaccine lots might vary from several hundred thousand doses
to several million, and some are in distribution much longer than
others. Naturally a larger lot or one that is in distribution
longer will be associated with more adverse events, simply by
chance. Also, more coincidental deaths are associated with vaccines
given in infancy than later in childhood, since the background
death rates for children are highest during the first year of
life. So knowing that lot A has been associated with x number
of adverse events while lot B has been associated with y number
would not necessarily say anything about the relative safety of
the two lots, even if the vaccine did cause the events.
Reviewing published lists of "hot lots" will not help
parents identify the best or worst vaccines for their children.
If the number and type of VAERS reports for a particular vaccine
lot suggested that it was associated with more serious adverse
events or deaths than are expected by chance, the Food and Drug
Administration (FDA) has the legal authority to immediately recall
that lot. To date, no vaccine lot in the modern era has been found
to be unsafe on the basis of VAERS reports.
All vaccine manufacturing facilities and vaccine products are
licensed by the FDA. In addition, every vaccine lot is safety-tested
by the manufacturer. The results of these tests are reviewed by
FDA, who may repeat some of these tests as an additional protective
measure. FDA also inspects vaccine-manufacturing facilities regularly
to ensure adherence to manufacturing procedures and product-testing
regulations, and reviews the weekly VAERS reports for each lot
searching for unusual patterns. FDA would recall a lot of vaccine
at the first sign of problems. There is no benefit to either the
FDA or the manufacturer in allowing unsafe vaccine to remain on
the market. The American public would not tolerate vaccines if
they did not have to conform to the most rigorous safety standards.
The mere fact is that a vaccine lot still in distribution says
that the FDA considers it safe.
Vaccines cause many harmful side effects, illnesses, and
even death - not to mention possible long-term effects we don't
even know about.
Vaccines are actually very safe, despite implications to the contrary
in many anti-vaccine publications (which sometimes contain the number
of reports received by VAERS, and allow the reader to infer that
all of them represent genuine vaccine side-effects). Most vaccine
adverse events are minor and temporary, such as a sore arm or mild
fever. These can often be controlled by taking acetaminophen before
or after vaccination. More serious adverse events occur rarely (on
the order of one per thousands to one per millions of doses), and
some are so rare that risk cannot be accurately assessed. As for
vaccines causing death, again so few deaths can plausibly be attributed
to vaccines that it is hard to assess the risk statistically. Of
all deaths reported to VAERS between 1990 and 1992, only one is
believed to be even possibly associated with a vaccine. Each death
reported to VAERS is thoroughly examined to ensure that it is not
related to a new vaccine-related problem, but little or no evidence
suggests that vaccines have contributed to any of the reported deaths.
The Institute of Medicine in its 1994 report states that the risk
of death from vaccines is "extraordinarily low."
DTP Vaccine and SIDS
One myth that won't seem to go away is that DTP vaccine causes
sudden infant death syndrome (SIDS). This belief came about because
a moderate proportion of children who die of SIDS have recently
been vaccinated with DTP; and on the surface, this seems to point
toward a causal connection. But this logic is faulty; you might
as well say that eating bread causes car crashes, since most drivers
who crash their cars could probably be shown to have eaten bread
within the past 24 hours.
If you consider that most SIDS deaths occur during the age range
when 3 shots of DTP are given, you would expect DTP shots to precede
a fair number of SIDS deaths simply by chance. In fact, when a number
of well-controlled studies were conducted during the 1980's, the
investigators found, nearly unanimously, that the number of SIDS
deaths temporally associated with DTP vaccination was within the
range expected to occur by chance. In other words, the SIDS deaths
would have occurred even if no vaccinations had been given. In fact,
in several of the studies children who had recently gotten a DTP
shot were less likely to get SIDS. The Institute of Medicine reported
that "all controlled studies that have compared immunized versus
nonimmunized children have found either no association . . . or
a decreased risk . . . of SIDS among immunized children" and
concluded that "the evidence does not indicate a causal relation
between [DTP] vaccine and SIDS."
But looking at risk alone is not enough - you must always look
at both risks and benefits. Even one serious adverse effect in a
million doses of vaccine cannot be justified if there is no benefit
from the vaccination. If there were no vaccines, there would be
many more cases of disease, and along with them, more serious side
effects and more deaths. For example, according to an analysis of
the benefit and risk of DTP immunization, if we had no immunization
program in the United States, pertussis cases could increase 71-fold
and deaths due to pertussis could increase 4-fold. Comparing the
risk from disease with the risk from the vaccines can give us an
idea of the benefits we get from vaccinating our children.
Risk from Disease versus Risk from Vaccines
DISEASE
Measles
Pneumonia: 6 in 100
Encephalitis: 1 in 1,000_Death: 2 in 1,000
Rubella
Congenital Rubella Syndrome: 1 in 4 (if woman becomes infected
early in pregnancy)
VACCINES
MMR
Encephalitis or severe allergic reaction: 1 in 1,000,000
DISEASE
Diphtheria
Death: 1 in 20
Tetanus
Death: 2 in 10
Pertussis
Pneumonia: 1 in 8
Encephalitis: 1 in 20
Death: 1 in 200
VACCINES
DTaP
Continuous crying, then full recovery: 1 in 1000
Convulsions or shock, then full recovery: 1 in 14,000
Acute encephalopathy: 0-10.5 in 1,000,000
Death: None proven
The fact is that a child is far more likely to be seriously injured
by one of these diseases than by any vaccine. While any serious
injury or death caused by vaccines is too many, it is also clear
that the benefits of vaccination greatly outweigh the slight risk,
and that many, many more injuries and deaths would occur without
vaccinations. In fact, to have a medical intervention as effective
as vaccination in preventing disease and not use it would be unconscionable.
Research is underway by the U.S. Public Health Service to better
understand which vaccine adverse events are truly caused by vaccines
and how to reduce even further the already low risk of serious vaccine-related
injury.
Vaccine-preventable diseases have been virtually eliminated from
the United States, so there is no need for my child to be vaccinated.
It's true that vaccination has enabled us to reduce most vaccine-preventable
diseases to very low levels in the United States. However, some
of them are still quite prevalent - even epidemic - in other parts
of the world. Travelers can unknowingly bring these diseases into
the United States, and if we were not protected by vaccinations
these diseases could quickly spread throughout the population, causing
epidemics here. At the same time, the relatively few cases we currently
have in the U.S. could very quickly become tens or hundreds of thousands
of cases without the protection we get from vaccines.
We should still be vaccinated, then, for two reasons. The first
is to protect ourselves. Even if we think our chances of getting
any of these diseases are small, the diseases still exist and can
still infect anyone who is not protected. A few years ago in California
a child who had just entered school caught diphtheria and died.
He was the only unvaccinated pupil in his class.
The second reason to get vaccinated is to protect those around
us. There is a small number of people who cannot be vaccinated (because
of severe allergies to vaccine components, for example), and a small
percentage of people don't respond to vaccines. These people are
susceptible to disease, and their only hope of protection is that
people around them are immune and cannot pass disease along to them.
A successful vaccination program, like a successful society, depends
on the cooperation of every individual to ensure the good of all.
We would think it irresponsible of a driver to ignore all traffic
regulations on the presumption that other drivers will watch out
for him or her. In the same way we shouldn't rely on people around
us to stop the spread of disease; we, too, must do what we can.
Giving a child multiple vaccinations for different diseases
at the same time increases the risk of harmful side effects and
can overload the immune system.
Children are exposed to many foreign antigens every day. Eating
food introduces new bacteria into the body, and numerous bacteria
live in the mouth and nose, exposing the immune system to still
more antigens. An upper respiratory viral infection exposes a child
to 4 - 10 antigens, and a case of "strep throat" to 25
- 50. According to Adverse Events Associated with Childhood Vaccines,
a 1994 report from the Institute of Medicine, "In the face
of these normal events, it seems unlikely that the number of separate
antigens contained in childhood vaccines . . . would represent an
appreciable added burden on the immune system that would be immunosuppressive."
And, indeed, available scientific data show that simultaneous vaccination
with multiple vaccines has no adverse effect on the normal childhood
immune system.
A number of studies have been conducted to examine the effects
of giving various combinations of vaccines simultaneously. In fact,
neither the Advisory Committee on Immunization Practices (ACIP)
nor the American Academy of Pediatrics (AAP) would recommend the
simultaneous administration of any vaccines until such studies showed
the combinations to be both safe and effective. These studies have
shown that the recommended vaccines are as effective in combination
as they are individually, and that such combinations carry no greater
risk for adverse side effects. Consequently, both the ACIP and AAP
recommend simultaneous administration of all routine childhood vaccines
when appropriate. Research is under way to find ways to combine
more antigens in a single vaccine injection (for example, MMR and
chickenpox). This will provide all the advantages of the individual
vaccines, but will require fewer shots.
There are two practical factors in favor of giving a child several
vaccinations during the same visit. First, we want to immunize children
as early as possible to give them protection during the vulnerable
early months of their lives. This generally means giving inactivated
vaccines beginning at 2 months and live vaccines at 12 months. The
various vaccine doses thus tend to fall due at the same time. Second,
giving several vaccinations at the same time will mean fewer office
visits for vaccinations, which saves parents both time and money
and may be less traumatic for the child.
Reference:
Vaccines, 4th Edition By Stanley A. Plotkin, MD and Walter A. Orenstein,
MD Approx. 1696 pages, Copyright 2004 http://www.us.elsevierhealth.com/product.jsp?isbn=0721696880
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