Combining Childhood Vaccines at One Visit Is Not Safe

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Abstract
Although health authorities including the Centers for Disease Control and Prevention (CDC) claim that childhood vaccines are safe and recommend combining multiple vaccines during one visit, a review of data from the Vaccine Adverse Event Reporting System (VAERS) shows a dose-dependent association between the number of vaccines administered simultaneously and the likelihood of hospitalization or death for an adverse reaction. Additionally, younger age at the time of the adverse reaction is associated with a higher risk of hospitalization or death.
47Journal of American Physicians and Surgeons Volume 21 Number 2 Summer 2016
ABSTRACT
Although health authorities including the Centers for Disease
Control and Prevention (CDC) claim that childhood vaccines are
safe and recommend combining multiple vaccines during one
visit, a review of data from the Vaccine Adverse Event Reporting
System (VAERS) shows a dose-dependent association between
the number of vaccines administered simultaneously and the
likelihood of hospitalization or death for an adverse reaction.
Additionally, younger age at the time of the adverse reaction is
associated with a higher risk of hospitalization or death.
Background
In the 1980s vaccine manufacturers were frequently sued
by the parents of children who were permanently disabled or
died following vaccination. After paying out millions of dollars
in these lawsuits, vaccine manufacturers were prepared to stop
producing vaccines unless the federal government provided
them with immunity from jury verdicts.
In response to pharmaceutical manufacturers’ threat to
close their own vaccine factories, in 1986 Congress passed
the National Childhood Vaccine Injury Act (NCVIA), protecting
vaccine manufacturers from most financial liability associated
with their products. Under NCVIA, the National Vaccine
Injury Compensation Program (VICP) was created to provide
cost-effective arbitration for vaccine injury claims. Vaccine
manufacturers can no longer be sued in a state or federal court
for damages arising from a vaccine-related injury or death
unless a petition for compensation under the new program is
filed and denied.
Compensation under the program is paid for by a 75-cent
excise tax on every vaccine purchased. (MMR contains three
vaccines, so the tax is $2.25.) The money goes into a Trust Fund
managed by the U.S. Department of the Treasury. As of Mar 1,
2016, more than $3.2 billion had already been paid out, most of
it to compensate parents whose children were severely disabled
or died after receiving vaccines.1 Today, vaccine manufacturers
not only make millions of dollars annually from their lucrative
business, but they have been disincentivized from producing
safer vaccines, since they are shielded from liability when their
mandatory products harm consumers.
Vaccine Adverse Event Reporting System (VAERS)
The new federal law also required medical workers to
report suspected vaccine reactions to a centralized reporting
system. As a result, the Vaccine Adverse Event Reporting System
(VAERS), jointly operated by CDC and the U.S. Food and Drug
Administration (FDA), was established in 1990. VAERS is a national
vaccine safety surveillance program that collects information
about possible adverse reactions to vaccines. This large database
is accessible to the general public, including independent
researchers who may use it to look for patterns in the data that
might indicate vaccine safety concerns or problems.2
VAERS is a passive surveillance system, which means that
reports about adverse events are not automatically collected.
VAERS relies on doctors and nurses to voluntarily submit reports,
although vaccine recipients and parents may also file reports.
Vaccine manufacturers are required to report all adverse events
of which they become aware. Since 1990, the VAERS database
has received more than 500,000 reports of suspected adverse
reactions to vaccines. Although this represents a large number
of people who may have been hurt by vaccines, under-reporting
is a known limitation of passive surveillance systems. This means
that VAERS only captures a small fraction of actual adverse events.
In fact, shortly after VAERS was established, a large vaccine
manufacturer, Connaught Laboratories, estimated “about a 50-
fold under-reporting of adverse events in the passive reporting
system.3 Perhaps 98% of all adverse reactions to vaccines are not
included in the VAERS database, and up to 25 million U.S. citizens
could have been adversely affected by vaccines in the past 25
years. This well-known disadvantage of a passive reporting
system, as opposed to an active surveillance system in which
medical workers are trained to systematically collect all cases of
suspected adverse vaccine reactions, is rarely acknowledged by
health authorities when vaccine safety is discussed.
Although VAERS collects information about adverse events
that occur after vaccines are administered, it should be noted
that a report is not a confirmation that a vaccine caused the
event. Health authorities like to emphasize this point whenever
VAERS data are used in a study with findings that are critical
of vaccines. The implication is that studies using VAERS are
unreliable and should be disregarded. However, CDC considers
VAERS an important vaccine safety assessment tool and
regularly conducts its own studies using VAERS data, often to
justify maintaining national vaccination campaigns.
CDC Studies Utilizing VAERS
In May 2015, the CDC published a study in Clinical Infectious
Diseases that analyzed the VAERS database for reports of serious
adverse events after MMR vaccination in adults. CDC researchers
found that the vaccine was often administered to pregnant
women, a group in whom the vaccine is contraindicated,
“suggesting the need for continued provider education on vaccine
recommendations and screening. Although 5% of reports were
serious, including several deaths, CDC researchers concluded
that “in our review of VAERS data, we did not detect any new or
unexpected safety concerns for MMR vaccination in adults.4
In November 2014, CDC published a study in the journal
Vaccine that analyzed VAERS reports associated with the
live attenuated influenza vaccine (LAIV3). Although 8.9%
of reports were classified as serious (e.g., cardiovascular
events, neurological debilities, and fatalities) CDC researchers
concluded that “review of VAERS reports are reassuring, the
only unexpected safety concern for LAIV3 identified was a
higher than expected number of Guillain-Barré syndrome
reports in the Department of Defense population, which is
being investigated [sic].5
Combining Childhood Vaccines
at One Visit Is Not Safe
Neil Z. Miller
48 Journal of American Physicians and Surgeons Volume 21 Number 2 Summer 2016
In June 2013, the CDC published a study in the journal
Pediatrics that analyzed the VAERS database to assess
intussusception events in recipients of two rotavirus vaccines,
RotaTeq and Rotarix. (Intussusception is a serious intestinal
condition that may require emergency surgery and can be fatal.)
Although there were hundreds of confirmed intussusception
events after vaccination, and a statistically significant clustering
of intussusception events 3 to 6 days after the first dose of
RotaTeq vaccination, CDC researchers concluded that an
increased risk of intussusception “is outweighed by the benefits
of rotavirus vaccination.6
These studies and others confirm that CDC considers VAERS
an important post-marketing vaccine safety surveillance tool.
Therefore, nobody should be swayed into believing the VAERS
database does not contain immensely valuable raw data to
be used by independent researchers conducting studies that
evaluate the safety of U.S. mandated vaccines. For example, Mark
Geier, M.D., Ph.D., independent researcher and former professional
staff member at the National Institutes of Health (NIH), published
several studies utilizing the VAERS database showing that
vaccines containing thimerosal (mercury) significantly increase
the odds of developing neurological disorders, including
autism.7-9 Independent researchers Lai and Yew utilized the
VAERS database and discovered that patients who received a
Herpes zoster (shingles) vaccine were more than twice as likely to
subsequently develop arthritis or alopecia compared to a non-
vaccinated control group.10 Other independent researchers have
used VAERS to document numerous vaccine safety concerns;
some of their peer-reviewed papers are summarized in Miller’s
Review of Critical Vaccine Studies.11
The Safety of Simultaneous Vaccines
Although CDC recommends polio, hepatitis B, diphtheria,
tetanus, pertussis, rotavirus, Haemophilus influenzae type B,
and pneumococcal vaccines for two-, four-, and six-month-old
infants, this combination of eight vaccines administered during
a single physician visit was never tested for safety in clinical
trials. This is at odds with a CDC report that found that mixed
exposures to chemical substances and other stress factors,
including prescribed pharmaceuticals, may produce “increased
or unexpected deleterious health effects. This CDC report also
noted that “exposures to mixed stressors can produce health
consequences that are additive, synergistic, antagonistic, or can
potentiate the response expected from individual component
exposures.12 Thus, CDC is well aware that mixing several
pharmaceutical products increases the likelihood of synergistic
toxicity and unexpected adverse reactions. Nonetheless,
CDC urges infants to receive multiple vaccines concurrently
without scientific evidence to confirm the safety of this practice.
Administering six, seven, or eight vaccine doses to an infant
during a single physician visit is certainly more convenient for
parents, as opposed to making additional trips to the doctor’s
office, and increases the likelihood that the infant will receive all
the vaccines, but vaccine safety must remain the highest priority.
In 2002, the journal Pediatrics published a paper by Dr. Paul
Offit, director of the Vaccine Education Center at Children’s
Hospital of Philadelphia, in which he claimed that based
upon certain immunological and mathematical assumptions,
“each infant would have the theoretical capacity to respond
to about 10,000 vaccines at any one time.”13 Ten years later, in
2012, G.S. Goldman and I conducted a study that examined this
astonishing claim.14
We started by downloading the complete VAERS database
from 1990 through 2010. There were more than 325,000 VAERS
reports. We then eliminated all case reports that were not
associated with infants (babies aged up to one year). This left us
with 38,801 VAERS reports in which infants had adverse events
after receiving one or more vaccine doses.
Next, we determined how many vaccine doses each infant
received prior to the adverse event. (A computer program was
written to make these calculations.) For example, if an infant
received a hepatitis B vaccine and a rotavirus vaccine prior to
the adverse event, it was recorded as two vaccine doses. DTaP
is administered with one injection but contains three separate
vaccine doses, for diphtheria, tetanus, and acellular pertussis.
Thus, if an infant received a polio vaccine, a pneumococcal
vaccine, and DTaP prior to the adverse event, it was recorded as
five vaccine doses. Some babies received six, seven, or eight doses
prior to an adverse event. This was not unusual because of the
CDC recommendations noted above, plus its recommendation
for two doses of an influenza vaccine during infancy.
Finally, we isolated the “serious” adverse events—
hospitalizations and death—from non-serious events, such
as fever and local reactions. About 13% of all adverse events
reported to VAERS are classified as serious, involving life-
threatening conditions, hospitalization, permanent disability, or
death. We sought to determine whether there were any trends or
patterns associated with the number of vaccine doses an infant
received and the likelihood that the adverse event reported to
VAERS would require hospitalization or result in death.
Vaccine Doses and Hospitalizations
Of the 38,801 VAERS reports that we analyzed, 969 infants
received two vaccine doses prior to the adverse event and 107
of those infants were hospitalized: a hospitalization rate of 11%.
Of 1,959 infants who received three vaccine doses prior to the
adverse event, 243 of them required hospitalization: 12.4%.
For four doses, 561 of 3,909 infants were hospitalized: 14.4%.
Notice the emerging pattern: Infants who had an adverse event
reported to VAERS were more likely to require hospitalization
when they received three vaccine doses instead of two, or four
vaccine doses instead of three.
The pattern continues: Of 10,114 infants who received
five vaccine doses prior to the adverse event, 1,463 of them
required hospitalization: 14.5%. For six doses, 1,365 of 8,454
infants were hospitalized: 16.1%. For seven doses, 1,051 of
5,489 infants were hospitalized: 19.1%. And for eight doses, 661
of 2,817 infants were hospitalized: 23.5%. The hospitalization
rate increased linearly from 11.0% for two doses to 23.5% for
eight doses. Linear regression analysis of hospitalization rates
as a function of the number of reported vaccine doses yielded a
linear relationship, with an R2 of 0.91.
Note: The hospitalization rate of infants who received just
one vaccine dose was disproportionately high (16.3%) due
to the hepatitis B vaccine administered at birth. As such, the
hospitalization rate corresponding to one dose is an outlier and
was excluded from the linear regression analysis.
Vaccine Doses and Mortality
Our study also calculated the case fatality ratio (mortality
rate) among vaccinated infants, stratified by the number of
vaccine doses they received. Of the 38,801 VAERS reports
that we analyzed, 11,927 infants received one, two, three, or
four vaccine doses prior to having an adverse event, and 423
of those infants died: a mortality rate of 3.6%. The remaining
26,874 infants received five, six, seven, or eight vaccine doses
prior to the adverse event and 1,458 of them died: 5.4%. The
49Journal of American Physicians and Surgeons Volume 21 Number 2 Summer 2016
mortality rate for infants who received five to eight vaccine
doses (5.4%) is significantly higher than the mortality rate for
infants who received one to four vaccine doses (3.6%), with
a rate ratio (RR) of 1.5 (95% CI, 1.4-1.7). Of infants reported to
VAERS, those who had received more vaccines had a statistically
significant 50% higher mortality rate compared with those who
had received fewer.
The Age Effect on Hospitalizations and Death
Our study also analyzed whether the age at which an infant
received vaccines had an effect on hospitalizations and death.
Of the 38,801 VAERS reports that we analyzed, 765 concerned
infants six-weeks-old or younger who received one or more
vaccine doses prior to the adverse event, and 154 of those infants
were hospitalized: a hospitalization rate of 20.1%. Of 5,572
infants aged six months at vaccination, 858 were hospitalized:
15.4%. Of 801 infants who were nearly a year old when they were
vaccinated, 86 were hospitalized: 10.7%. The hospitalization rate
decreased linearly from 20.1% for neonates to 10.7% for older
infants. Linear regression analysis of hospitalization rates as a
function of patient age yielded an R2 of 0.95.
In the 38,801 VAERS reports we analyzed, 26,408 infants
were younger than six months. After receiving one or more
vaccine doses, 1,623 of those infants died: a mortality rate of
6.1%. The remaining 12,393 infants were between six months
and one year of age. After receiving one or more vaccine doses,
258 of them died: 2.1%. The mortality rate for vaccinated infants
younger than six months was significantly higher than the
mortality rate for vaccinated infants aged between six months
and one year, with an RR = 3.0 (95% CI, 2.6-3.4). Infants who had
an adverse event reported to VAERS were significantly more
likely to be hospitalized or die if they were younger rather than
older at the time of vaccination.
Summary of Results and Media Response
Our study showed that infants who receive several vaccines
concurrently, as recommended by CDC, are significantly more
likely to be hospitalized or die when compared with infants
who receive fewer vaccines simultaneously. It also showed
that reported adverse effects were more likely to lead to
hospitalization or death in younger infants.
These findings are so troubling that we expected major
media outlets in America to sound an alarm, calling for an
immediate reevaluation of current preventive health care
practices. But 4 years after publication of our study, this has not
happened. Could it be because, according to Robert Kennedy,
Jr., about 70% of advertising revenue on network news comes
from drug companies? In fact, the president of a network news
division admitted that he would fire a host who brought on a
guest that led to loss of a pharmaceutical account. That may
be why the mainstream media won’t give equal time to stories
about problems with vaccine safety.15
Conclusion
The safety of CDC’s childhood vaccination schedule was
never affirmed in clinical studies. Vaccines are administered
to millions of infants every year, yet health authorities have
no scientific data from synergistic toxicity studies on all
combinations of vaccines that infants are likely to receive.
National vaccination campaigns must be supported by scientific
evidence. No child should be subjected to a health policy that
is not based on sound scientific principles and, in fact, has been
shown to be potentially dangerous.
Undesirable outcomes associated with childhood
vaccination can be reduced by requiring national vaccination
policies to be supported by scientific evidence, holding
vaccine manufacturers accountable when their products
harm consumers, and urging major news outlets that rely on
pharmaceutical advertising revenue to change their business
models so that crucial scientific research, regardless of how
controversial it may be, is widely disseminated into the public
domain. Meanwhile, the evidence presented in this study
shows that multiple vaccines administered during one visit,
and vaccinating young infants, significantly increase morbidity
and mortality. Parents and physicians should consider health
options associated with a lower risk of hospitalization or death.
Neil Z. Miller is a medical research journalist. Contact: neilzmiller@gmail.com.
Disclosures: No conflicts of interest were disclosed.
REFERENCES
1. U.S. Department of Health and Human Services. National Vaccine
Injury Compensation Program. Available at: http://www.hrsa.gov/
vaccinecompensation. Accessed Feb 14, 2016.
2. U.S. Department of Health and Human Services. Vaccine Adverse Event
Reporting System (VAERS). Available at: https://vaers.hhs.gov. Accessed
Feb 14, 2016.
3. Institute of Medicine (U.S.) Vaccine Safety Committee. Appendix B: Strategies
for Gathering Information. In: Adverse Events Associated with Childhood
Vaccines: Evidence Bearing on Causality. Stratton KR, Howe CJ, Johnston RB
Jr., eds. Washington, D.C.: National Academies Press (U.S.); 1994. Available
at: http://www.ncbi.nlm.nih.gov/books/NBK236281. Accessed Mar 5, 2016.
4. Sukumaran L, McNeil MM, Moro PL, et al. Adverse events following measles,
mumps, and rubella vaccine in adults reported to the Vaccine Adverse Event
Reporting System (VAERS), 2003-2013. Clin Infect Dis 2015;60(10):e58-65.
5. Haber P, Moro PL, McNeil MM, et al. Post-licensure surveillance of trivalent
live attenuated influenza vaccine in adults, United States, Vaccine
Adverse Event Reporting System (VAERS), July 2005-June 2013. Vaccine
2014;32(48):6499-6504.
6. Haber P, Patel M, Pan Y, et al. Intussusception after rotavirus vaccines
reported to U.S. VAERS, 2006-2012. Pediatrics 2013;131(6):1042-1049.
7. Geier DA, Hooker BS, Kern JK, et al. A two-phase study evaluating the
relationship between thimerosal-containing vaccine administration and
the risk for an autism spectrum disorder diagnosis in the United States.
Transl Neurodegener 2013;2(1):25.
8. Geier DA, Kern JK, King PG, Sykes LK, Geier MR. The risk of
neurodevelopmental disorders following a thimerosal-preserved DTaP
formulation in comparison to its thimerosal-reduced formulation in the
Vaccine Adverse Event Reporting System (VAERS). J Biochem Pharmacol Res
2014;2(2):64-73.
9. Geier DA, Geier MR. An assessment of the impact of thimerosal on childhood
neurodevelopmental disorders. Pediatr Rehabil 2003;6(2):97-102.
10. Lai YC, Yew YW. Severe autoimmune adverse events post Herpes zoster
vaccine: a case-control study of adverse events in a national database. J
Drugs Dermatol 2015;14(7):681-684.
11. Miller NZ. Miller’s Review of Critical Vaccine Studies: 400 Important Scientific
Papers Summarized for Parents and Researchers. Santa Fe, N.M.: New
Atlantean Press; 2016.
12. Castranova V, Graham J, Hearl F, et al. Mixed exposures research agenda:
a report by the NORA Mixed Exposures Team. Department of Health and
Human Services (DHHS), Centers for Disease Control and Prevention (CDC),
National Institute for Occupational Safety and Health (NIOSH). DHHS
(NIOSH) Publication No. 2005-106; December 2004:vi. Available at: http://
www.cdc.gov/niosh/docs/2005-106/pdfs/2005-106.pdf. Accessed Feb 14,
2016.
13. Offit PA, Quarles J, Gerber MA, et al. Addressing parents’ concerns: do
multiple vaccines overwhelm or weaken the infant’s immune system?
Pediatrics 2002;109(1):124-129.
14. Goldman GS, Miller NZ. Relative trends in hospitalizations and mortality
among infants by the number of vaccine doses and age, based on the
Vaccine Adverse Event Reporting System (VAERS), 1990-2010. Hum Exp
Toxicol 2012;31(10):1012-1021. Available at: http://het.sagepub.com/
content/31/10/1012.full. Accessed Feb 14, 2016.
15. Jaxen, J. Kennedy drops bombshell: 70% news ad revenue from pharma.
Before It ’s News, May 22, 2015. Available at: http://beforeitsnews.com/
health/2015/05/kennedy-drops-bombshell-70-news-ad-revenue-from-
pharma-2574590.html. Accessed Feb 14, 2016.
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  • Vaccine Safety Committee Appendix B: Strategies for Gathering Information Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
    • Medicine Institute
    • Kr Stratton
    • Cj Howe
    • Rb Johnston
    • Jr
    • D C Washington
    Institute of Medicine (U.S.) Vaccine Safety Committee. Appendix B: Strategies for Gathering Information. In: Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Stratton KR, Howe CJ, Johnston RB Jr., eds. Washington, D.C.: National Academies Press (U.S.); 1994. Available at: http://www.ncbi.nlm.nih.gov/books/NBK236281. Accessed Mar 5, 2016.
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    The prevalence of autism in the US has risen from 1 in approximately 2500 in the mid-1980s to 1 in approximately 300 children in the mid-1990s. The purpose of this study was to evaluate whether mercury from thimerosal in childhood vaccines contributed to neurodevelopmental disorders. Neurodevelopmental disorder dose-response curves for increasing mercury doses of thimerosal in childhood vaccines were determined based upon examination of the Vaccine Adverse Events Reporting System (VAERS) database and the 2001 US' Department of Education Report. The instantaneous dosage of mercury children received in comparison to the Food and Drug Administration (FDA)'s maximum permissible dose for the oral ingestion of methylmercury was also determined. The dose-response curves showed increases in odds ratios of neurodevelopmental disorders from both the VAERS and US Department of Education data closely linearly correlated with increasing doses of mercury from thimerosal-containing childhood vaccines and that for overall odds ratios statistical significance was achieved. Similar slopes and linear regression coefficients for autism odds ratios in VAERS and the US Department of Education data help to mutually validate each other. Controls employed in the VAERS and US Department of Education data showed minimal biases. The evidence presented here shows that the occurrence of neurodevelopmental disorders following thimerosal-containing childhood vaccines does not appear to be coincidental.