by H. Cody Meissner, M.D., FAAP
The United States has the safest and
most effective vaccine program in history. Most vaccine recipients experience no
adverse reactions, and if a reaction does
occur, it almost always is mild and of
short duration. Rarely, a more serious side
effect may occur following vaccination.
The Vaccine Adverse Event Reporting
System and the Vaccine Safety Datalink
detect and analyze the occurrence of adverse events following immunization to
help assess whether the association may
be causal (related to vaccine) or temporal
(unrelated to vaccine).
The National Vaccine Injury Compensation Program (VICP), established
by the National Childhood Vaccine Injury Act of 1986, allows individuals who
experience a serious adverse reaction believed to be caused by a covered vaccine
to file a petition for compensation. The
VICP was created to provide swift compensation to individuals with a well-documented
vaccine-related injury and to ensure that the United
States has a stable supply of vaccine by providing liability protection to vaccine manufacturers. Liability
protection also is provided to those who administer
vaccines. Importantly, lawsuits against industry and
health care providers have decreased since the VICP
program took effect in 1988.
Which two of the following statements are not
a) The VICP covers legal fees regardless of whether
the vaccine was found to be the cause of the
b) The VICP covers all listed vaccines in the im-
munization schedule from birth through 18
years of age.
c) Since the beginning of VICP program in 1988,
approximately $3.4 billion has been paid.
d) A petition can be filed by the vaccinee or the
parent, legal guardian or legal representative
of the vaccinee.
e) The program only covers people vaccinated in
the public sector.
The VICP is a no-fault program designed to compensate people injured by covered vaccines that are
routinely administered to children in both the private and public sectors. “No fault” means that a
person filing a claim is not required to prove negligence on the part of the health care provider or the
To be compensated, it must be demonstrated that
the preponderance of evidence indicates causation
(more likely than not) attributable to a vaccine. It
must be demonstrated that residual effects persist for
more than six months after vaccine administration,
death occurred as a consequence of vaccine admin-
istration, or inpatient hospitalization and surgery
occurred as a result of vaccine administration.
Bruce G. Gellin, M.D., former longtime deputy
assistant secretary for health and director of the Na-
tional Vaccine Program Office at the U.S. Depart-
ment of Health and Human Services, offered the
following comment regarding the VICP:
“The recent emphasis on maternal immunizations
has resulted in a broadening of coverage. The passage
of the 21st Century Cures Act signed into law by
President Obama on Dec. 13, 2016, amended the
legislation that created VICP to include coverage
for vaccines recommended for routine use in preg-
nant women. This will ensure that both a woman
who received a covered vaccine while pregnant and
any child in utero at the time are covered by the
Awards are paid from the VICP Trust Fund that
is funded by an excise tax of 75 cents for each dis-
ease prevented on every dose of covered vaccine (e.g.
measles, mumps and rubella vaccine excise tax is
$2.25). Awards to individuals with an injury deter-
mined to be vaccine related have averaged $824,000.
Attorney’s fees are paid if the claim is based on
“good faith and reasonable basis” regardless of entitlement outcome. Through December 2014, $21.6
million has been paid to attorneys, including payment for dismissed cases.
If a financial award is accepted, the claim cannot
be brought to the tort system. A vaccine manufacturer or vaccine administrator still can be sued if
the VICP rejects the claim or if the vaccine is not
covered under the VICP.
The VICP evaluates injuries that have occurred
following administration of a vaccine routinely
recommended for children from birth through 18
years of age, although the vaccinee can be of any
age. The VICP does not cover vaccines not routinely
recommended for children, including zoster, polysaccharide pneumococcal vaccine (PPSV23) and the
meningococcal B vaccines.
In 2009, the Countermeasure Injury Compensation Program was created to cover medical countermeasures developed and/or used in response to public health emergencies such as in influenza pandemic
or a bioterrorism attack (e.g., smallpox, anthrax or
Dr. Meissner is professor of pediatrics
at Floating Hospital for Children, Tufts
Medical Center. He also is an ex officio
member of the AAP Committee on Infectious Diseases and associate editor of
the AAP Visual Red Book.
Vaccine Injury Compensation Program
reduces lawsuits, prevents shortages
Ans wer: b and e are notcorrect
Vaccines covered by the
Vaccine Injury Compensation Program
Diphtheria, tetanus, pertussis (D TaP, Tdap, D TP, D T, T T)
Haemophilus influenzae type b conjugate
Measles, mumps, rubella
Polio (IPV, OPV)
Any new vaccine recommended by the Centers for Disease Control
and Prevention for routine administration to children
• Guidance on how to obtain and complete a Vaccine
Adverse Event Reporting System form can be obtained
at www.vaers.hhs.gov or by calling 800-822-7967.
• The Vaccine Injury Table showing recognized injuries
and time intervals is available at https://hrsa.gov/