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Best of AofA: The Naked CDC: the Hit and Run Truth about MMR in their Own Words

 


By John Stone

In a CDC study of the adverse effects of MMR:

Above 1 in 17 toddlers in the study developed a temperature of 39.5C (103F) or greater post vaccination, and 1 in 5.6 a raised temperature

Nearly one quarter of toddlers in the study (23%) were routinely vaccinated despite being unwell prior to vaccination with fever (7%), diarrhea (12%) and rash (7%)

It is all too revealing to look at this 2006 study by LeBaron et al ‘Evaluation of Potentially Common Adverse Events Associated With the First and Second Doses of Measles-Mumps-Rubella Vaccine’ which was apparently designed to be reassuring that the effects of a second and third dose of MMR at pre-school and mid-school age are milder than the first in infancy or toddlerhood.

But if so, we might ask, what about the first?  We learn that it is quite routine for an infant to develop a raging fever with unknown long term consequences. Again LeBaron et al are frank about some of the limitations of their study:

‘Our study suffers from a number of limitations. Data on adverse events were based on unverified, family recorded symptom diaries. We had no unvaccinated control group. The baseline period for the study subjects lasted only 1 week and was relatively close to vaccination when the “healthy vaccinee effect”14 may well have been present. A 17% attrition rate occurred, mostly during the baseline diary period. The sample size was inadequate to examine rare adverse events or common adverse events with less than a twofold increase over baseline. The study population was atypical of the overall population of US children, in that they were almost all white, rural, healthy, and received vaccinations at the recommended ages. Other vaccines were administered simultaneously with MMR for >80% children in the 2 younger groups and <1% in the oldest group, making attribution of adverse events and comparison of groups more difficult.’

But their concept of what constitutes a healthy child, is somewhat thrown into doubt by figure 2 which shows that 7% of subjects already had fever, 12% diarrhea, 7% rash (23% one or all of these)  prior to vaccination.  If the target group is adjudged to be healthy by the authors it leaves a disturbing question about the circumstances in which an already unwell child could routinely be vaccinated, and demonstrates that the health and wellbeing of individual children is not what is at stake in the programme: at best it would be the control of the disease at the expense of the sick child.

The gung-ho attitude of this culture is further evidenced by the fact that more than 80% of toddlers received other vaccines at the same time as MMR. Routinely, a temperature of 39.5C or above is an acceptable side effect. Subjects were only monitored for 3.5 weeks after vaccination: the long term health and development of those getting a high fever has probably never been researched, and probably never will be.

 LeBaron et al conclude (rounding their figures down):

‘Nevertheless, we believe our study findings confirm that vaccine-associated adverse events occur in ∼1 of every 6 toddlers receiving the first dose of MMR, with high fever occurring in ∼1 in 20, although very few of these events require medical attention.’

But I wouldn’t take their word for it. If the parents of Hannah Poling hadn’t been a particularly determined doctor and a nurse would we be any the wiser? And why are we treating babies like immunological supermen? Is it because they can't answer back??

It’s the culture, stupid.

(With thanks to Alex Snelgrove).

 John Stone is UK Editor for Age of Autism.

Comments

ATSC

A pdf of the LeBaron paper can be found here:

http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.561.1582&rep=rep1&type=pdf

Linda1

Ottoschnaut,

The investigators: "aDivision of Viral Diseases, National Center for Immunization and Respiratory Diseases, CENTERS FOR DISEASE CONTROL AND PREVENTION, Atlanta, Georgia; bMarshfield Medical Research Foundation, Marshfield, Wisconsin"

"CONCLUSIONS....
The findings and conclusions expressed
are those of the authors and do not
necessarily represent the views of CDC."

A study from the CDC with a disclaimer that it doesn't necessarily represent the CDC's views? What?

cia parker

Taximom5,
Allison McNeill told me several years ago that Dr. Wakefield had said that the manufacturers of the hep-B vaccine had stopped their safety tests at only four days post-vax, although encephalitic reactions like that of my daughter and the many commenters today at Kim's article about Gianna's birthday usually only start four to five days post-vax.

cia parker

Dawn,
What you said about Louisa May Alcott was interesting, I googled it and found that in her case as well, the pharma shills have been at work. They now say that it was clearly not mercury poisoning that caused her dizziness, rash, and other symptoms, but the autoimmune disease lupus. Without mentioning that lupus is caused by mercury poisoning (usually from vaccines these days), as well as MS, Alzheimer's, Parkinson's, and Lou Gehrig's disease.

Vaccine Information

Here are some excellent VSD graphs of febrile seizure and outpatient fever visits following MMR and MMRV.
http://www.scribd.com/doc/120430481/CDC-MMRV-Vaccine-Data-Safety-Link-Slides
Complete presentation
http://www.scribd.com/doc/110263212/13-3-mmrv

Taximom5

"The baseline period for the study subjects lasted only one week."

Everybody catch that? ONE WEEK.

Anybody remember the most likely timeframe for MMR-induced seizure, according to Merck's website? Isn't it 8-14 days?

So they DELIBERATELY set up the studies so that MMR-induced seizures would not be apparent.

Angus Files

Yo Glax

MMR RIP

@Dawn

Very interesting point about Louisa May Alcott considering some of the "science" types like to mention diseases of literary figures. It may be that the "cure" was as much a part of their ill health as the actual disease, especially where mercury is concerned! There could be a whole little post about this that would be educational.

Ottoschnaut

ARTICLE
Evaluation of Potentially Common Adverse Events
Associated With the First and Second Doses of
Measles-Mumps-Rubella Vaccine
Charles W. LeBaron, MDa, Daoling Bi, MSa, Bradley J. Sullivan, PhD, MDb, Carol Beck, BAb, Paul Gargiullo, PhDa
aDivision of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; bMarshfield Medical
Research Foundation, Marshfield, Wisconsin
The authors have indicated they have no financial relationships relevant to this article to disclose.
ABSTRACT
BACKGROUND/OBJECTIVES. In 1989, the American Academy of Pediatrics and the Advisory
Committee on Immunization Practices recommended that school children
receive 2 doses of measles-mumps-rubella vaccine. With measles and rubella
eliminated from the United States, measles-mumps-rubella vaccine adverse events
have come under scrutiny, but no study has compared the reactogenicity of the
first (measles-mumps-rubella vaccine dose 1) and second (measles-mumps-rubella
vaccine dose 2) doses at the most common ages of administration in the United
States.
METHODS. From a health maintenance organization, 3 groups of children were
recruited: (1) toddlers aged 12 to 24 months receiving measles-mumps-rubella
vaccine dose 1; (2) kindergartners aged 4 to 6 years receiving measles-mumpsrubella
vaccine dose 2; and (3) middle schoolers aged 10 to 12 years receiving
measles-mumps-rubella vaccine dose 2. From 2 weeks before measles-mumpsrubella
vaccine administration until 4 weeks afterward, families recorded in diaries
the occurrence of potentially common symptoms. Postvaccination symptom rates
were compared with the prevaccination baseline, with significance assessed by
testing incidence rate ratios estimated by Poisson regression.
RESULTS. Of 2173 children enrolled, 373 (17%) were lost to attrition, producing a
study population of 1800. Compared with the prevaccination baseline, rates of
fever, diarrhea, and rash were significantly elevated postvaccination among 535
toddlers receiving measles-mumps-rubella vaccine dose 1. An estimated net 95
(18%) experienced measles-mumps-rubella vaccine-associated events (median
onset 5–10 days postvaccination, duration 2–5 days), with high fever (temperature
39.5°C) occurring in 33 (6%). None required medical attention. For 633 kindergartners
and 632 middle schoolers, symptom rates were not significantly elevated
after measles-mumps-rubella vaccine dose 2 compared with baseline.
CONCLUSIONS. Vaccination-associated adverse events occur in 1 of every 6 toddlers
receiving measles-mumps-rubella vaccine dose 1, with high fever occurring in 1 of
20. Adverse events are infrequent for measles-mumps-rubella vaccine dose 2
administered to school-aged children.
www.pediatrics.org/cgi/doi/10.1542/
peds.2006-0678
doi:10.1542/peds.2006-0678
The findings and conclusions expressed
are those of the authors and do not
necessarily represent the views of CDC.
Key Words
measles, mumps, and rubella vaccine,
adverse reactions, second dose, dose
schedule
Abbreviations
ACIP—Advisory Committee on
Immunization Practices
AAP—American Academy of Pediatrics
MMR—measles-mumps-rubella vaccine
CDC—Centers for Disease Control and
Prevention
MMR1—first dose of measles-mumpsrubella
vaccine
MMR2—second dose of measles-mumpsrubella
vaccine
Accepted for publication May 24, 2006
Accepted for publication May 24, 2006-
Address correspondence to Charles W.
LeBaron, MD, MS A-47 CDC, Atlanta, GA
30333. E-mail: clebaron@cdc.gov
PEDIATRICS (ISSN Numbers: Print, 0031-4005;
Online, 1098-4275); published in the public
domain by the American Academy of
Pediatrics
1422 LeBARON et al
IN 1989, FACING a nationwide measles epidemic among
vaccinated school children, the Advisory Committee
on Immunization Practices (ACIP) and the American
Academy of Pediatrics (AAP) recommended that schoolaged
children receive a second dose of measles-mumpsrubella
vaccine (MMR) to provide disease protection
among those in whom the first dose had failed to induce
immunity.1,2 Implementation was swift. In 1988, the
year before the recommendation, 6 million MMR
doses had been administered nationally. In 1990, the
year after the recommendation, this rose to 16 million
doses. Since then, the number has never fallen below 12
million annually, enough vaccine to provide 2 doses to
each child in a US birth cohort of 4 million, plus catch-up
doses to 4 million others (Centers for Disease Control
and Prevention [CDC] unpublished data, 2006). The
disease impact was dramatic. The number of school-aged
children with measles fell from 7351 in 1989 to 72 in
1995, and 70 cases have been reported annually since
2000 (CDC unpublished data, 2006). Ongoing measles
virus transmission was declared eliminated from the
United States in 2000,3 followed by rubella in 2004.4
In the early 1990s, based on then-divergent ACIP and
AAP recommendations,1,2 some states passed laws requiring
the second dose of MMR (MMR2) for kindergarten
entry (27 states by 1994), others for middle or junior
high school entry (12 states by 1994). In 1998, ACIP and
AAP agreed on a kindergarten recommendation,5,6 but it
was not until 2005 that all states began to enforce a
kindergarten requirement. Diversity in recommended
ages for MMR2 is seen among different nations in Europe.
7 In developing countries, second doses of measles
vaccine are often administered as part of mass campaigns
that target a wide age range from infancy through teenaged
years.8 The optimal age for a second dose, based on immunogenicity
or reactogenicity, has not been well defined.
In the absence of measles disease in the United States,
public and media attention has increasingly focused on
vaccine-adverse events, raising concern that vaccine uptake
might be reduced to the point where endemic measles
transmission could return.9,10 However, few studies
have examined adverse events of measles-containing
vaccine beyond the first dose.11–15 Although a number of
studies have attempted to evaluate rare and delayed
adverse events putatively associated with MMR (eg, autism
and epilepsy),16,17 none has compared common and
immediate adverse events associated with administration
of the first and second doses of MMR at the ages at
which these doses have usually been administered in the
United States. We report the results of such a study.
METHODS
Primary Objective
The primary purpose of this work was to evaluate rates
and patterns of potentially common adverse events occurring
within a month after receipt of the first and
second doses of MMR vaccine, when administered to
healthy children at the commonly recommended ages
for school entry in the United States in a setting where
wild disease exposure and boosting were unlikely to
have occurred before vaccination.
Secondary Objectives
The secondary purposes of this work were to compare
adverse event rates for: (1) the first (MMR1) and second
(MMR2) doses of vaccine and (2) MMR2 at the 2 ages
when it has been most commonly administered: 4 to 6
years (kindergarten) versus 10 to 12 years (middle
school).
Setting
The study population was drawn from patients of
Marshfield Clinic, a comprehensive health maintenance
organization that is the principal health care provider for
a rural area of central Wisconsin. The clinic has a longitudinally
stable patient population with a low rate of use
of services outside the clinic. The clinic maintains a
central vaccination registry, captures other health events
by computer, and is 1 of 8 health maintenance organizations
participating in the Vaccine Safety Datalink
project.18 The state of Wisconsin had enacted a law in
1991 requiring documentation of MMR2 receipt for kindergarten
and grade 6 entry. The 7 counties surrounding
the clinic, with a total population in 2000 of 364 187,19
reported 41 confirmed cases of measles during 1985–
1994 and no cases thereafter through 2005 (CDC unpublished
data, 2006).
Study Groups and Enrollment
Three age groups of children were enrolled prospectively
over a 2-year period: group 1, 12 to 24 months old
scheduled to receive MMR1 (“toddlers-MMR1”); group
2, 4 to 6 years old scheduled to receive MMR2 to meet
the kindergarten entry requirement (“kindergarteners-
MMR2”); and group 3, 10 to 12 years old scheduled to
receive MMR2 to meet the middle school entry requirement
(“middle schoolers-MMR2”). Vaccine was administered
by study nurses in standard protocol in accord
with school vaccination requirements. No child entering
kindergarten had vaccine deferred until middle school
entry. Candidate study subjects were excluded if they
had: (1) previously had measles, mumps, or rubella disease;
(2) lived in the same household with anyone who
had had these diseases during the subject’s lifetime; (3)
previously received any component of MMR vaccine
other than as specified; (4) received any other vaccinations
within 30 days of study start; (5) had any contraindication
to MMR vaccination as specified in the recommendations
of the ACIP; or (6) had any condition
likely to impair immune response to MMR vaccine, as
specified in ACIP recommendations.5 In addition, chil-
PEDIATRICS Volume 118, Number 4, October 2006 1423
dren scheduled to receive MMR2 were excluded if they
had not received MMR1 previously between the ages of
12 and 24 months. Parents of study subjects were provided
with informed permission materials, and middle
school children were additionally provided with informed
assent materials. The study was approved by the
human subjects protection offices of both the Marshfield
Clinic and CDC.
Study Design and Data Acquisition
Because study vaccinations were required by law for
school attendance, it was not considered possible or
ethical to recruit a separate control group from whom
vaccines were withheld. Instead, within the study population,
a designated period preceding vaccination was
treated as a baseline for rates of specified health events
to which rates in the postvaccination period were compared.
Specifically, 2 weeks before vaccination, the family
of each participant was prospectively provided with a
prevaccination diary on which to record daily by check
mark the occurrence of 13 symptoms identified in the
literature as potentially associated with MMR vaccination:
fever, runny nose, sore throat, cough, red eyes,
nausea, vomiting, diarrhea, jaw swelling, swollen
glands, joint problems, headache, and rash. A space was
provided for recording other symptoms. If no symptoms
were present, the family was instructed to check “none.”
If fever was suspected, the family was instructed to take
a temperature with a supplied thermometer (rectally for
the toddlers and orally for the older children), to record
the temperature, and to continue doing so at least daily
until the child became afebrile. Because most children
aged 12 to 24 months were deemed unable to provide
meaningful information about headache, nausea, and
sore throat, these symptoms were omitted for group 1
(toddler-MMR1). The prevaccination diary, on completion,
was brought to the clinic, where it was reviewed by
the study nurse. Vaccine was administered, and the family
was provided with an identically structured 4-week
postvaccination diary. The postvaccination diary, on
completion, was mailed to the study nurse, who reviewed
it, with telephone consultation with the family
as needed. The study nurse was available to families for
assistance with diary completion or discussion of health
events at any time during the 6-week observation period.
Any visits to the clinic or health interactions with
the clinic personnel were captured by the system of
computerized medical charts. Other data recorded about
study subjects included date of birth, documented dates
of all vaccinations, gender, and parent-declared race/
ethnicity. Children were enrolled throughout the calendar
year as they became age eligible for vaccination,
although a mode occurred in August before school entry.
No unusual levels of community illness were encountered
during the study period.
Statistical Analysis
Diary data were analyzed using SAS 9.1 (SAS Institute,
Cary, NC). Fever was considered present if the recorded
temperature was 38.0°C (100.4°F).20,21 For bivariate
comparisons between groups, the 2 test was used for
categorical variables and the Wilcoxon rank sum test for
continuous variables. For each of the 4 postvaccination
weeks (week 1 through 4), rates of children with
each symptom were compared with a prevaccination
baseline week (week 2). Significance was evaluated by
testing incidence rate ratios, estimated by Poisson regression
with generalized estimating equations, to account
for correlation of repeated measures and controlling for
other vaccinations administered simultaneously. A
symptom was deemed potentially vaccine associated if
its rate in a postvaccination week was significantly elevated
over the prevaccination baseline. To estimate the
net excess rate for such symptoms, the prevaccination
baseline rate was subtracted from the postvaccination
rate. Symptom characteristics of vaccine-associated adverse
events were examined: day of onset after vaccine
administration, duration of symptom, and fever intensity.
Secondary analyses were performed by: (1) removing
other vaccinations from the model and (2) including
gender in the model. The potential influence of seasonality,
particularly for respiratory illness, was examined
by comparing the net symptom rates for different periods
of the year. Depending on the baseline rate of symptoms,
a twofold increase in postvaccination rates over
baseline could be detected by a sample size of 600 subjects
in each group, or 1800 subjects total. Anticipating a
15% to 20% attrition rate, the initial study population
target was 2200 subjects.
RESULTS
Study Population
A total of 2173 children were enrolled, of whom 373
(17%) were lost to attrition over the 6-week observation
period, producing a final study population of 1800 (Fig
1). Failure to complete the prevaccination diary accounted
for 66% (245 of 373) of subject loss and was
most frequent among group 1 (toddlers-MMR1), who
had the highest overall attrition rate (23%), compared
with 14% and 15% for the other groups (P  .001).
Reflecting the rural Midwestern source population, 99%
(1776 of 1800) of the overall study population was non-
Hispanic white, with no significant racial/ethnic differences
among groups (Table 1). However, the 2 younger
groups were significantly (P  .001) more likely than
the older group to receive other vaccinations at the
same time as MMR: 89% of group 1 (toddlers-MMR1)
and 81% of group 2 (kindergarteners-MMR2) vs 1%
of group 3 (middle schoolers-MMR2). For the 535 toddlers,
vaccines containing Haemophilus influenzae type
b were most frequently coadministered (440 [82%]),
1424 LeBARON et al
followed by pertussis (233 [44%]) and polio (95 [18%]).
For the 633 kindergartners, the relative frequency was
polio (495 [78%]), pertussis (485 [77%]), and others
(31 [5%]). Varicella vaccine was not administered to any
study subject.
Symptom Rates
Among the 13 symptoms examined, 3 were found to
be significantly increased in the postvaccination period
compared with the prevaccination baseline, 6 were not
found to be significantly changed, and 4 were found to
be significantly decreased. The findings were not
changed when simultaneous administration of other
vaccines or gender was included in the model. During
the 6-week observation period, no study subject was
known to have had any health event requiring medically
attended treatment.
Significantly Increased
Among toddlers receiving MMR1 (group 1), fever, diarrhea,
and rash were reported significantly more frequently
in each of the 2 weeks immediately after vaccination
than in the prevaccination control period (Fig 2).
The proportion of children with 1 of these symptoms
was 21% (112 of 535) at baseline and rose to 52% (278
of 535) for the 2-week period after vaccination. In contrast,
relatively few (6%) of the older children receiving
MMR2 (groups 2 and 3) reported any of these symptoms
at baseline, and no significant change in rates
occurred postvaccination.
No Significant Change
Baseline and peak rates of conjunctivitis, nausea, vomiting,
lymphadenopathy, joint pain, and swollen jaws
were relatively low for all groups (6%; Fig 3). Postvaccination
increases were observed for some symptoms
among some groups, but numbers were small and did
not attain statistical significance.
Significantly Decreased
Baseline rates of coryza, cough, pharyngitis, and headache
were high (eg, 40% of toddlers had runny noses)
and tended to show small, slow, steady declines over the
observation period, attaining statistical significance by
the third or fourth week postvaccination (Fig 4). These
patterns did not change when children vaccinated April
through September were compared with those vaccinated
October through March.
Vaccine-Associated Adverse Events
Analysis was restricted to the 52% (278 of 535) of toddlers
in group 1 who had fever, diarrhea, or rash during
the 2 post-MMR1 weeks when these symptoms were
significantly elevated over baseline.
FIGURE 1
Study population enrollment, exclusions, and retention.
TABLE 1 Study Population Characteristics, MMR1 and MMR2 Adverse Events Study
Group N Age at MMR, Median
(Range)
Gender Female,
n (%)
Race/Ethnicity
Non-Hispanic White,
n (%)
Other Immunizations
Any,
n (%)
Pertussis-Containing,
n (%)
1 toddler-MMR1 535 15.1 (12.0–19.7) mo 245 (46) 525 (98) 476 (89) 233 (44)
2 kindergarten-MMR2 633 5.2 (4.1–6.7) y 308 (49) 623 (98) 511 (81) 485 (77)
3 middle school-MMR2 632 11.3 (10.0–12.9) y 303 (48) 628 (99) 5 (1) 1 (0.2)
PEDIATRICS Volume 118, Number 4, October 2006 1425
Event Rates
When baseline prevaccination symptom rates were subtracted
from the postvaccination rates, the net excess
rates were much lower than crude rates: of the 278
children with fever, diarrhea, or rash in the 2 weeks
post-MMR1, an estimated 95 (34%) had symptoms associated
with vaccination (Table 2).
Symptom Patterns
During the baseline period, 80% (90 of 113) of toddlers
had fever, diarrhea, or rash singly, whereas 78% (74 of
95) of toddlers with vaccine-associated symptoms had
grouped symptoms (P  .001): fever and diarrhea, 32%;
fever and rash, 25%; fever, diarrhea, and rash, 21%;
fever alone, 18%; and rash alone, 4%. Almost all of the
FIGURE 2
Postvaccination symptom rates significantly elevated
over baseline. X-axis shows weeks relative to date of vaccination.
Y-axis shows percentage of children in each
group with symptom. A, fever; B, diarrhea; C, rash; D,
fever, diarrhea, or rash. Groups are plotted separately:
group 1 (toddlers receiving MMR1, N535)—;group 2
(kindergartners receiving MMR2, N  633), group 3
(middle schoolers receiving MMR2, N632) . . . . a Postvaccination
weeks in which symptom rates were significantly
elevated over prevaccination baseline.
FIGURE 3
Postvaccination symptom rates with no
significant change from baseline. X-axis
shows weeks relative to date of vaccination.
Y-axis shows percentage of children
in each group with symptom. A, conjunctivitis;
B, nausea; C, vomiting; D, lymphadenopathy;
E, joint pain; F, swollen jaw.
Groups are plotted separately: group 1
(Toddlers receiving MMR1, N  535) —,
group 2 (kindergartners receiving MMR2,
N  633) , group 3 (middle schoolers
receiving MMR2, N632) . . . . Data about
nausea was not captured for group 1 toddlers.
1426 LeBARON et al
toddlers (91 of 95 [96%]) with vaccine-associated symptoms
had fever, compared with approximately one third
(41 of 113 [36%]) of toddlers with fever, rash, or diarrhea
during the baseline period (P  .001).
Onset, Duration, and Fever Intensity
Onset of all 3 of the symptoms was bimodal, with an
initial peak on the day of vaccination, followed by a
second peak 8 to 12 days later (Fig 5); however, this
pattern was most marked for fever, less apparent for
rash, and still less so for diarrhea. Median postvaccination
day of onset was day 9 for fever, day 5 for
diarrhea, day 10 for rash, and day 6 for illness involving
any of these symptoms. The majority of toddlers had
symptoms lasting only a few days: median days of duration
were 2 for fever, 5 for diarrhea, 4 for rash, and
5 for illness involving any of these symptoms (Fig 6). Of
those with fever in the 2 weeks after vaccination, the
median maximum temperature was 38.6°C (101.5°F;
Fig 7). The 33 toddlers with high fever (39.5°C
[103.1°F]) constituted 19% of those with fever (173)
and 6% of the total group 1 population (535). Intensity
of fever did not significantly differ when the 173 toddlers
with fever in the 2 weeks postvaccination were com-
FIGURE 4
Postvaccination symptom rates significantly
decreased from baseline. X-axis
shows weeks relative to date of vaccination.
Y-axis shows percentage of children
in each group with symptom. A, coryza;
B, cough; C, pharyngitis; D, headache.
Groups are plotted separately: group 1
(toddlers receiving MMR1, N  535) —,
group 2 (kindergartners receiving MMR2,
N  633) , group 3 (middle schoolers
receiving MMR2, N632) . . . . a Postvaccination
weeks in which symptom rates
were significantly decreased compared
with the prevaccination baseline. Data
about pharyngitis and headache were not
captured for group 1 toddlers.
TABLE 2 Symptoms Significantly Elevated During Postvaccination Period Compared With
Prevaccination Baseline Among Children Aged 12 to 20 Months Who Received MMR1
(N535 children)
Symptom Baseline Period
(Week2)
Postvaccination Period
(Week1 and2)
Children % Crudea Estimated Netb
Children % Children % (95% Confidence Interval)
Fever 41 7.7 173 32.3 91 17.0 (10.9–23.1)
Diarrhea 62 11.6 153 28.6 50 9.3 (2.9–15.8)
Rash 34 6.4 90 16.8 48 9.0 (4.6–13.4)
Fever, diarrhea, or rash 113 21.1 278 52.0 95 17.7 (9.4–26.1)
Weeks are numbered relative to date of MMR1 vaccination.
a “Crude” indicates the total number and percentage of children reported to have symptom during postvaccine weeks when symptom rate was
significantly elevated over baseline.
b “Estimated Net” indicates the net number and percentage of children with postvaccination symptoms in excess of baseline rate. A daily net
incidence rate was obtained by subtracting the daily incidence rate for the baseline period from the daily incidence rate for the postvaccine weeks
when the symptom was significantly elevated. The net number of children with a vaccine-attributable symptom was estimated by multiplying
the daily net incidence rate by the number of postvaccination days that the symptom was significantly elevated.
PEDIATRICS Volume 118, Number 4, October 2006 1427
pared with the 41 toddlers with fever during the baseline
week. The toddlers who received MMR alone (31
[11%]) also had a bimodal pattern of symptom onset;
compared with those who received MMR simultaneously
with other vaccines (247 [89%]), they did not
differ significantly in symptom onset, duration, and
fever intensity.
DISCUSSION
We report a study of adverse events associated with the
first and second doses of MMR administered at the most
common ages for MMR vaccination in the United States.
We found that 18% of children who received MMR1
at 12 to 20 months of age had symptoms of fever, rash,
or diarrhea that were probably vaccine associated, with a
median onset 5 to 10 days after vaccination and a median
symptom duration of 2 to 5 days. However, we also
found that fever, rash, or diarrhea occurred so commonly
among toddlers in the absence of vaccination that
only 34% of all children with such symptoms in the 2
weeks after receipt of MMR1 were likely to have experienced
a vaccine-associated adverse event. Our findings
FIGURE 6
Symptom duration. X-axis shows duration in days of
each symptom, with day of vaccination the first day. Yaxis
shows percentage of children. Only toddlers receiving
MMR1 who had a specified symptom during a postvaccination
week in which the rate for that symptom
was significantly elevated over baseline are included in
each graph. A, Fever (N173); B, diarrhea (N153); C,
rash (N90); D, fever, diarrhea, or rash (N278). Bars,
percentage of these children whose symptoms lasted
the number of days indicated on the X-axis. In each
graph, the bar-and-whisker graphic indicates the minimum,
25th percentile, median, 75th percentile, and
maximum. ƒ, mean.
FIGURE 5
Symptom onset. X-axis shows days after vaccination,
with day of vaccination the first day. Y-axis shows percentage
of children. Only toddlers receiving MMR1 who
had a specified symptom during a postvaccination week
in which the rate for that symptom was significantly elevated
over baseline are included in each graph. A, Fever
(N173); B, diarrhea (N153); C, rash (N90); D,
fever, diarrhea, or rash (N  278). Bars, percentage of
these children who had onset of the symptom for each
postvaccination day indicated on the x-axis. In each
graph, the bar-and-whisker graphic indicates the minimum,
25th percentile, median, 75th percentile, and
maximum. ƒ, mean.
1428 LeBARON et al
confirm and extend those of previous studies and suggest
that MMR1 may be among the more reactogenic
vaccines in the routine schedule.11,14
We were unable to detect any adverse events for
children receiving MMR2 when administered at either 4
to 6 years or 10 to 12 years of age. Thus, our study does
not demonstrate an advantage for either kindergarten or
middle school in the timing of MMR2 administration,
suggesting that issues of disease protection and immunogenicity
may be more important in the choice of an
age for the second dose. Baseline rates of fever, rash, and
diarrhea were low (5%) in both groups of children,
and increases did not generally occur post-MMR2; for
example, the proportion of children with fever was
slightly lower 2 weeks after vaccination than 2 weeks
before. These data suggest that MMR2 reactogenicity
may be quite low, even in a context where the first dose
had been administered as long as 10 years prior, and
wild disease boosting is unlikely to have occurred in the
interval. Because MMR is a live attenuated vaccine, an
immune host is less likely than a nonimmune host to
experience vaccine virus replication, perhaps explaining
the lowered rate of adverse events among recipients of
the second dose compared with the first.
In their prospective placebo-controlled twin study,
Peltola and Heinonen11 and Virtanen et al14 may have
found somewhat lower rates of adverse events for
MMR1 than we did, although their analysis is based on
child days, and direct comparisons to our findings are
difficult. The number and age range of children who
received MMR2 is also not clear in their study, but they
came to a conclusion consistent with ours about “the
virtual nonreactogenicity of the second dose of MMR in
previously immunized children.”
In their retrospective electronic record review, Davis
et al13 found that of 26 548 children enrolled in a health
maintenance organization, 99 made visits for health
events potentially related to MMR2 in the month after
vaccination compared with 95 during a prevaccination
baseline month. These findings are also suggestive of low
MMR2 reactogenicity. However, whereas children aged
4 to 6 and 10 to 12 years had identical postvaccination
visit rates, the older children made fewer visits at baseline,
suggesting to the authors “a greater risk for adverse
clinical events after MMR2 immunization among 10- to
12-year-olds than among 4- to 6-year-olds.”13 We are
unable to confirm this risk, but primary outcomes differed:
our study focused on self-reported symptoms,
theirs on documented medical encounters. The low rate
of visits (0.4%) in their large, retrospective record
review suggests why we may not have detected any
visits in our smaller prospective study. All of the participants
in our study had access to a study nurse for
discussion of health events, probably reducing the likelihood
of a medical encounter, particularly for postvaccination
rashes, which accounted for almost half of all of
the visits in their study.
A significant postvaccination decrease in respiratory
symptoms was observed in our study, which was not
apparently attributable to seasonality. Most of the decline
occurred at the end of the 4-week postvaccination
observation period, raising questions as to whether the
apparent improvement continued thereafter. These
symptoms were quite common at baseline, and progressive
“diary fatigue” may account for some decrease, but
such fatigue was not observed for the recording of other
common symptoms. Reductions in respiratory symptoms
were also found in the Finnish twin study,14 and
the authors concluded that “MMR vaccine might, in fact,
give some transient protection from the common cold.”
Unfortunately for this hypothesis, the trend toward protection
in our study seems to have begun before vaccine
was administered. In addition, children receiving MMR2
in our study experienced the respiratory benefits more
FIGURE 7
Fever intensity. X-axis shows the upper bound of each temperature interval. Y-axis shows
percentage of children. Only the 173 toddlers receiving MMR1 who had fever during a
postvaccination week in which the rate for that symptom was significantly elevated over
baseline are included in each graph. A, maximum temperature; B, average temperature.
Bars, percent of these children who had fever within the intervals indicated on the x-axis.
In each graph, the bar-and-whisker graphic indicates the minimum, 25th percentile,
median, 75th percentile, and maximum. ƒ, mean.
PEDIATRICS Volume 118, Number 4, October 2006 1429
often than those receiving MMR1, making it difficult to
invoke a biological explanation based on the protective
value of vigorous immune response. The clearest feature
of the respiratory symptom reduction in our study is the
problematic nature of inferring causal relationships from
incidental findings.
Our study suffers from a number of limitations. Data
on adverse events were based on unverified, family recorded
symptom diaries. We had no unvaccinated control
group. The baseline period for the study subjects
lasted only 1 week and was relatively close to vaccination
when the “healthy vaccinee effect”14 may well have
been present. A 17% attrition rate occurred, mostly
during the baseline diary period. The sample size was
inadequate to examine rare adverse events or common
adverse events with less than a twofold increase over
baseline. The study population was atypical of the overall
population of US children, in that they were almost
all white, rural, healthy, and received vaccinations at the
recommended ages. Other vaccines were administered
simultaneously with MMR for 80% children in the 2
younger groups and 1% in the oldest group, making
attribution of adverse events and comparison of groups
more difficult.
Nevertheless, we believe our study findings confirm
that vaccine-associated adverse events occur in 1 of
every 6 toddlers receiving the first dose of MMR, with
high fever occurring in 1 in 20, although very few of
these events require medical attention. When the second
dose of MMR is administered to school-aged children,
adverse events are infrequent and difficult to detect.
ACKNOWLEDGMENTS
We thank Lauri Markowitz, MD, for originally conceiving
the study and assuring its realization; Katrin Kohl,
MD, MPH, PhD, and the Brighton Collaboration for
valuable input on uniform guidelines for characterizing
fever; and Jane Seward, MBBS, for sustained scientific
guidance and managerial support. We are also very
grateful to Evelyn Finch, Catherine Okoro, and Eric
Weintraub for their indispensable data management.
REFERENCES
1. Centers for Disease Control and Prevention. Measles prevention.
Recommendations of the immunization practices advisory
committee (ACIP). MMWR Morb Mortal Wkly Rep. 1989;
38(suppl 9):1–18
2. American Academy of Pediatrics, Committee on Infectious Diseases.
Measles: reassessment of the current immunization policy.
Pediatrics. 1989;84:1110–1113
3. Katz SL, Hinman AR. Summary and conclusions: measles elimination
meeting, 16–17 March 2000. J Infect Dis. 2004;
189(suppl 1):S43–S47
4. Centers for Disease Control and Prevention. Achievements in
public health: elimination of rubella and congenital rubella
syndrome—United States, 1969–2004. MMWR Morb Mortal
Wkly Rep. 2005;54:279–282
5. Centers for Disease Control and Prevention. Measles, mumps,
and rubella—vaccine use and strategies for elimination of measles,
rubella, and congenital rubella syndrome and control of
mumps: recommendations of the advisory committee on immunization
practices (ACIP). MMWR Morb Mortal Wkly Rep.
1998;47(RR-8):1–57
6. American Academy of Pediatrics, Committee on Infectious
Diseases. Age for routine administration of the second dose
of measles-mump-rubella vaccine. Pediatrics. 1998;101:
129–133
7. Tulchinsky TH, Ginsberg GM, Abed Y, Angeles MT, Akukwe C,
Bonn J. Measles control in developing and developed
countries: the case for a 2-dose policy. Bull WHO. 1993;71:
93–103
8. de Quadros CA, Izurieta H, Venczel L, Carrasco P. Measles
eradication in the Americas: progress to date. J Infect Dis. 2004;
189(suppl 1):S227–S235
9. Gangarosa EJ, Galazka AM, Wolfe CR, et al. Impact of antivaccine
movements on pertussis control: the untold story.
Lancet. 1998;351:356–361
10. Jansen VAA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds
WJ, Rhodes CJ. Measles outbreaks in a population with declining
vaccine uptake. Science. 2003;301:804
11. Peltola H, Heinonen OP. Frequency of true adverse reactions to
measles,-mumps-rubella vaccine. Lancet. 1986;i:939–942
12. Chen RT, Moses JM, Markowitz LE, Orenstein WA. Adverse
events following measles-mumps-rubella vaccinations in college
students. Vaccine. 1991;9:297–299
13. Davis RL, Marcuse E, Black S, et al. MMR2 immunization at 4
to 5 years of age: a comparison of adverse clinical events after
immunization in the vaccine safety datalink project. Pediatrics.
1997;100:767–771
14. Virtanen M, Peltola H, Paunio M, Heinonen OP. Day-to-day
reactogenicity and the healthy vaccinee effect of measlesmumps-
rubella vaccination. Pediatrics. 2000;106(5). Available
at: www.pediatrics.org/cgi/content/full/106/5/e62
15. Gothfors L, Bergstrom E, Backman M. Immunogenicity and
reactogenicity of a new measles, mumps, and rubella vaccine
when administered as a second dose at 12 y of age. Scand
J Infect Dis. 2001;33:545–549
16. Kaye JA, Meloro-Montes M, Jick H. Mumps, measles, and
rubella vaccine and the incidence of autism recorded by general
practitioners: a time trend analysis. Br Med J. 2001;322:
460–463
17. Vestergaard M, Hviid A, Madsen KM, et al. MMR vaccination
and febrile seizures: evaluation of susceptible subgroups and
long-term prognosis. JAMA. 2004;292:351–357
18. Chen RT, Glasser JW, Rhodes PH, et al. Vaccine safety datalink
project: a new tool for improving vaccine safety monitoring in
the United States. Pediatrics. 1997;99:765–773
19. US Census Bureau. County and City Data Book: 2000, 13th ed.
Washington, DC: US Census Bureau; 2001:64–65
20. Kohl KS, Bonhoeffer J, Chen R, et al. The Brighton
Collaboration: enhancing comparability of vaccine safety data.
Pharmacoepidemiol Drug Saf. 2003;12:1–6
21. Marcy SM, Kohl KS, Dagan R, et al. Fever as an adverse
event following immunization: case definition and guidelines
of data collection, analysis, and presentation. Vaccine. 2004;22:
551–556
1430 LeBARON et al

Dawn

Any time I hear the medical establishment saying, "This is standard treatment", I know to run in the other direction.

Interesting fact: I read a history journal with a daily history quiz, and today's quiz stated that Louisa May Alcott died of...

"Mercury poisoning. While serving as a nurse during the Civil War, Alcott contracted typhoid. STANDARD TREATMENT (emphasis mine) at the time was colomel, a drug filled with mercury. She suffered from mercury poisoning for twenty years, dying at age 56."

So, I guess in another hundred years, people will be shaking their heads at how our society continued to inject our population with poisons, all in the name of "standard treatment".

Glax Britannicus

Angus

As you know there has always been a special relationship between our great nations. Yo Blair...

John Stone

wdf

While not commending the style it turns that the paper is no longer open access and cannot be read, so thank you for pointing this out. This is the link to the abstract (though I note this is available still from the page we did link to):

http://pediatrics.aappublications.org/content/118/4/1422.abstract

Also, I notice that if you look up the article on Pubmed it says there is free access, but this appears not to be any longer the case. Obviously, this is neither my fault nor the other editors of AoA.

Of course, we would greatly value the opinion of such an esteemed contributer, when they have had a chance to view the paper.

Angus Files

One matter that I can never get my head round is, did the Government corruption protecting Pharma start in the US and then spread to the UK or vice versa ?

The corruption can only remain hidden for so long and then all will be revealed..yummy! Just as the Dis United Kingdom, paedophile Members of Parliament are being exposed in the UK .

'Conflict of interest' raised over Butler-Sloss role in child abuse inquiry

http://www.theguardian.com/society/2014/jul/09/butler-sloss-inquiry-role-asked-to-step-down

So there you/we have it. An 80 year old 100% establishment figure - who I suspect will not [be allowed to] rock the paedophile establishment boat one jot - is to leave no stone unturned in ferreting out the unpalatable truth. Yeah sure!
How The Mighty Fall and will fall...


MMR RIP

aspiesmom

The unaccountable criminal culpability of vaccine industry is staggering :(

wud de fuq

I call BS on you. But first, why don't you actually give us the real citation for the LeBaron et al article, Mister Stone?

Benedetta

The name Dr. Claire Frasher is a popular character in a series of fiction books I enjoy. So I paid attention to that name when it showed up in real life in research papters on the human microbiome.

She too, like Dan Olmstead; was interested in what the human microbiome looks like in people that live like all humans did back in the 1800s.

The unvaccinated Amish living and working around cattle - share a microbe with their cattle called prevotella - the good kind - because there are bad types too.

Prevotella eats carbohydrates - something that epiletics are told to reduce. Prevoltella is a fermenter -- thus making lots of B vitamins -- which according to "Nutrient Power, Heal Your Biochemisty and heal Your Brain" -- seems to be about B vitamins.

So what I would like to know if those "Blunt instruments" a description used by Eric Brown, grad student -- that came in the place of Dr. Finlay to speak about vaccines and microbiome - in the 2013 NIH human microbiome project conference have killed out the prevotella -- in those cattle rasing, farm familes that DO VACCINATE?

Unvaccinated cattle workers --- prevotella
Vaccinated cattle workers ---less prevotella
People Not around cattle - vccinated maybe has-- not got a chance!

As the weakened measle virus finds the niches in the human stomach all empty and just moves on in?

Heather White

It is shocking… the study excerpt in the beginning of the article at least is honest about the weight of their data. Most pro-vaccine studies are not. What I find interesting is the adverse event recordings, that are truly parental accounts during the first week post vax are observational ~ subjective ~ and missing true toxicology. Pediatricians rarely pick up a vaccine encephalopathy much less most parents. The product inserts for the HepB and DTaP (for example) only account for adverse drug events for 3-4 days post vax, with parental diary cards. Further, if a parent was to say on day 5 my child had an autistic regression ~ that account would be waved away as anecdotal and observational the very method that is used from days 1-4. Then of course couple that with 50% of the adult and pediatric population diagnosed with at least one chronic disease and you see a very frightening picture (CDC, 2012; Bethell et al., 2011).

References

Bethell et al. (2011). A national and state profile of leading health problems and health care quality for US children: Key insurance disparities and across-state variation. Academic Pediatrics. Retrieved from http://www.sciencedirect.com/science/article/pii/S1876285910002500

CDC. (2012). Chronic disease and health promotion. Centers for Disease Control and Prevention. Retrieved from http://www.cdc.gov/chronicdisease/overview/index.htm#ref2

Mercky Business

But Jenny, how are they going to get all the schedule in, if they stop for simple matters like the child's immediate ill-health. Come on, be practical!!!

Jenny Allan

From above:- "Nearly one quarter of toddlers in the study (23%) were routinely vaccinated despite being unwell prior to vaccination with fever."

20 years ago, my autistic grandson 'routinely' received the MMR vaccine at 12 months. At the time he was recovering from a respiritory infection and was still taking antibiotics for this. He probably still had a fever.

I've always regarded the practice of vaccinating unwell children, particularly those on antibiotics, as SHEER STUPIDITY!! Paediatricians and other health and medical persons should hang their heads in shame for promoting this unsafe vaccination practice.

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