| Vaccine Safety |
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| Note:
Information about the safety for specific
vaccines are included in the Ask The Experts
set for that vaccine. |
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| Some parents
are requesting that we space out their
infant's vaccinations because they are
concerned that receiving multiple vaccinations
at a single office visit might overwhelm the
infant's immune system. What do you think
about using alternative schedules? |
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| Vaccine
recommendations are determined after extensive
studies in large clinical trials. They include
studies on how vaccine recipients respond to
multiple vaccines given simultaneously. The
overall aim is to provide early protection for
infants and children against
vaccine-preventable diseases that could
endanger their health and life. |
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| No scientific
evidence exists to support that delaying
vaccinations or separating them into
individual antigens is beneficial for
children. Rather, this practice prolongs
susceptibility to disease, which could result
in a greater likelihood of the child becoming
sick with a serious or life-threatening
disease. There could also be added expense
(e.g., multiple office visits), additional
time off from work for parents, and increased
likelihood that the child will fail to get all
necessary vaccinations. |
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| Some of my
patients are reading The Vaccine Book, in
which the author, Dr. Bob Sears, cites studies
that he interprets as showing that the amount
of aluminum found in certain vaccines might be
unsafe. He thinks it is better to separate
aluminum-containing vaccines, rather than give
them according to the recommended U.S.
immunization schedule. I would love any
information you have about this. |
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| Paul Offit, MD,
and Charlotte Moser, BS, of the Vaccine
Education Center (VEC) at the Children's
Hospital of Philadelphia, published an
article, "The Problem with Dr. Bob's
Alternative Vaccine Schedule," in the January
2009 issue of Pediatrics. It includes a
section about aluminum. You can read it in its
entirety at
pediatrics.aappublications.org/cgi/content/full/123/1/e164. |
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| Here are some
additional sources of related information: |
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| "Aluminum in
Vaccines: What you should know" is available
from VEC at
www.chop.edu/export/download/pdfs/articles/vaccine-education-center/aluminum.pdf. |
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| "Vaccine
Ingredients: What you should know" is
available from VEC at
www.chop.edu/export/download/pdfs/articles/vaccine-education-center/vaccine-ingredients.pdf. |
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| Does the
thimerosal in some vaccines pose a risk? |
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| Thimerosal, a
very effective preservative, has been used to
prevent bacterial contamination in vaccine
vials since the 1930s. It contains a type of
mercury known as ethylmercury, which is
different from the type of mercury found in
fish and seafood (methylmercury). At very high
levels, methylmercury can be toxic to people,
especially to the neurological development of
infants. |
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| In recent years,
several large scientific studies have
determined that thimerosal in vaccines does
not lead to neurologic problems, such as
autism. Nonetheless, because we generally try
to reduce people's exposure to mercury when
possible, vaccine manufacturers have
voluntarily changed their production methods
to produce vaccines that are now free of
thimerosal or have only trace amounts. They
have done this because it is possible to do,
not because there was any evidence that the
thimerosal was harmful. |
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| Comprehensive
information about thimerosal in vaccines is
available from the U.S. Food and Drug
Administration at
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm096228.htm.
The Vaccine Education Center at Children's
Hospital of Philadelphia also has extensive
information about thimerosal and other vaccine
ingredients at
www.chop.edu/centers-programs/vaccine-education-center. |
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| A patient has expressed concern that some vaccines have been produced in fetal tissue. How can I address this concern? |
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| The production of a few vaccines, including those for varicella, rubella, hepatitis A, and one of the COVID-19 vaccines (Janssen, Johnson & Johnson) involves growing the viruses in human cell culture. Two human cell lines provide the cell cultures needed for producing vaccines; these lines were developed from two legally aborted fetuses in the 1960s. These cell lines are maintained to have an indefinite life span. No fetal tissue has been added since the cell lines were originally created. |
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| Some parents are concerned about this issue because of misinformation they have encountered on the Internet. Two such untrue statements are that ongoing abortions are needed to manufacture vaccines and vaccines are contaminated with fetal tissue. |
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| Parents can read the facts and several thought-provoking articles about this issue at www.immunize.org/talking-about-vaccines/religious-concerns.asp and then make an informed decision. |
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| A Catholic Pontifical Academy for Life statement that Catholic parents have no general obligation to refuse permission for these vaccines is summarized at www.immunize.org/talking-about-vaccines/vaticandocument.htm. |
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| Where can I
find more information to help address my
patients' concerns about vaccine safety? |
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| There are many excellent websites that have information about vaccine safety, including the American Academy of Pediatrics, the CDC, Vaccinate Your Family, Immunize.org, the National Academies of Science, Engineering, and Medicine, and the Vaccine Education Center of the Children's Hospital of Philadelphia. |
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| What is
syncope? |
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| Syncope, also
called fainting, is a temporary loss of
consciousness as a result of decreased blood
flow to the brain. The most common form of
fainting is called "vasovagal" fainting. This
type of fainting can be triggered by an event
associated with pain or anxiety. Some people
may experience jerking movements after
fainting which are not seizures. Published
literature reveals that about 3% of men and
3.5% of women report at least one episode of
fainting during their lifetime. |
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| Who is more
likely to experience fainting after
immunization? |
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| Fainting is most
commonly reported in adolescents, according to
the Vaccine Adverse Event Reporting System. One study showed
that 62% of all fainting reports to VAERS were
among adolescents 11 to 18 years old; however,
due to the limitations of VAERS, we cannot use
this system to determine how frequently
fainting occurs after vaccination. |
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| Do specific
vaccines cause fainting? |
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| Not that we know.
Nearly all vaccines have been reported to be
associated with the fainting. Post-vaccination
fainting has been most frequently reported
after three vaccines commonly given to
adolescents (HPV, MenACWY, and Tdap). However,
the association with these vaccines may simply
reflect the fact that adolescents are
generally more likely to experience fainting
in response to pain or anxiety. |
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| Can fainting
and related injury after immunization be
prevented? |
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| Falls that occur
due to fainting after vaccination can be
prevented by assuring that the vaccinated
person is sitting in a chair or lying down and
is observed for 15 minutes following
vaccination. |
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| Is there any
harm in giving an extra dose of MMR to a child
of age seven years whose record is lost and
the mother is not sure about the last dose of
MMR? |
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| No. In general,
although it is not ideal, receiving extra
doses of vaccine poses no medical problem.
Receiving excessive doses of tetanus toxoid
(e.g., DTaP, DT, Tdap, or Td) can increase the
risk of a local adverse reaction, however. For
details, see Extra Doses of Vaccine Antigens
in the ACIP's Best Practice Guidelines for
Immunization at
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html. |
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| Vaccination
providers frequently encounter people who do
not have adequate documentation of
vaccinations. Providers should only accept
written, dated records as evidence of
vaccination. With the exception of influenza
vaccine and pneumococcal polysaccharide
vaccine, self-reported doses of vaccine
without written documentation should not be
accepted. An attempt to locate missing records
should be made whenever possible by contacting
previous healthcare providers, reviewing state
or local immunization information systems, and
searching for a personally held record. |
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| If records cannot
be located or will definitely not be available
anywhere because of the patient's
circumstances, children without adequate
documentation should be considered susceptible
and should receive age-appropriate
vaccination. Serologic testing for immunity is
an alternative to vaccination for certain
antigens (e.g., measles, rubella, hepatitis A,
diphtheria, and tetanus). |
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| What is the
Vaccine Adverse Event Reporting System
(VAERS)? |
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| As the name
implies, VAERS is a nationwide system for
monitoring adverse events following
vaccination. VAERS is operated jointly by the
FDA and the CDC since 1990. |
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| How do I
report an adverse event to VAERS? |
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| Reports can be
submitted online through the VAERS website or
by completing and uploading a writable PDF
VAERS report form. Both options can be
accessed on the VAERS website at
vaers.hhs.gov/reportevent.html. If you
need further assistance with reporting to
VAERS, please email
info@VAERS.org or call 1-800-822-7967. |
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| If a patient
faints following vaccination, should we submit
a report to VAERS? |
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| Yes. Any
occurrence of medical significance warrants a
VAERS report. VAERS looks for trends, so such
information is helpful. You can obtain more
information about VAERS at
vaers.hhs.gov or by calling (800)
822-7967. |
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| How do I
decide whether to report an adverse event to
VAERS? |
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| All significant
health events that may have been related to a
dose of vaccine, particularly those that lead
to hospitalization, disability, or death,
should be reported to VAERS. The healthcare
provider doesn't need to be certain the event
was vaccine related in order to report it. It
is not necessary to report minor adverse
reactions, such as local reactions or
low-grade fever. |
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| Why are zoster (RZV, Shingrix, GSK) and pneumococcal polysaccharide (PPSV23; Pneumovax, Merck) vaccines not covered by the National Vaccine Injury Compensation Program? |
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| The National Vaccine Injury Compensation Program (NVICP) includes payment only for injuries determined to have occurred following vaccination with a vaccine routinely recommended for children or pregnant women in the United States. The recipient can be of any age, but the vaccine must be routinely recommended for children through age 18 years or pregnant women. The vaccine must be subject to an excise tax to be included in the program. Shingrix and PPSV23 vaccines are not routinely recommended for children or pregnant women; Shingrix is only recommended for adults. COVID-19 vaccines will transition from injury compensation coverage under the Countermeasure Injury Compensation Program to NVICP once criteria are met for inclusion in NVICP. More information about the program and the covered vaccines is at www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html. |
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ACIP Recommendations
Vaccine Information Statements 
