Many people have observed that unvaccinated children have overall better health than vaccinated children when there is otherwise equal opportunity for attaining optimal health.
For more information on the connection
between vaccines and increased incidence of ear infections (AOM, etc) see:
In the Finland trial, it was admitted that Prevnar caused a 33%
increase in non-vaccine serotype AOM while claiming a 57% decrease of
vaccine serotype AOM. ("vaccine efficacy against AOM due to vaccine
serotype, 57 percent; there was an increase with non-vaccine serotypes
with a negative efficacy of 33 percent;") So does this mean that Prevnar
actually prevents more AOM than it causes? First note that this 57% is
measured against another vaccine combination, not against an unvaccinated
group. Secondly, what does it mean that there was less of a certain
serotype AOM? A mucus discharge from the body, whether ear, eye or nose is
the bodies effort to detoxify. Serotypes are identified by
'protein signatures'. Since the Prevnar vaccine contains seven of these
'protein signatures' or serotypes then why is there not more of these
serotypes present in the AOM ear discharges in the Prevnar group rather
than less? I believe the answer lies in Aluminum. Aluminum is a so called
adjuvant, but in reality aluminum 'bonds' (adsorbs) to the vaccine proteins
and decreases the rate these proteins eliminate from the body while
allowing other undesirable protein combinations to be eliminated at a faster
rate. A vaccine may change the toxic content that the body is working to
eliminate, but this will not make for less illness, only a different diagnosis
as to the 'cause'.
It will argued that the reported adverse events of AOM following are too
few for the above to be true. However, if there is a large incidence to
report ratio, as is commonly verified (10-1 to 100-1 according to the
FDA, CDC and a vaccine manufacturers representative.), then it becomes
quite feasible that Prevnar does not cause any reduction in the incidence
Even the Finnish study states that six percent fails,
"to reach statistical significance ..."
It must also be noted that vaccine trials are only conducted on healthy children.
Logically, both the Prevnar and control groups
should have a lower incidence of all diseases than the national average
(for vaccinated children). Yet in the Finland trial, it was stated that,
suggested that because of the close follow-up during the study that subjects actually
sought treatment with ear tubes more often than would ordinarily be the case in Finland,
and these rates actually were higher, I think, tenfold higher, nearly tenfold higher than
common practice in Finland and also much higher than practice in the
Kaiser system." This 10 fold increase in ear-draining tubes is
'explained away' by the fact that during the trial the procedure was provided free.
A valid study would have been able to supply data
showing what part Prevnar played in either increasing or decreasing
the need for ear tubes.
Ideally, a vaccine study requires data from many groups, but perhaps four groups from the
same time and place would be adequate:
a totally unvaccinated group, a group vaccinated only with Prevnar, a group
vaccinated with all routine vaccines, and a fourth group vaccinated with
Prevnar plus all routine vaccines. Close followup of these children would
have provided data for a valid judgement on the effect of Prevnar on AOM.
The method used in both the Finland and California trials each contained
only one of the required groups, thus NO VALID comparisons could be made.
Entirely too much faith is put on the theory of vaccine protection
(antibodies and serotype matches) versus actual measured (clinical) results.
Preconceived conclusions currently make it unnecessary for the vaccine
industry to conduct valid scientific studies before marketing a vaccine.
Even regulatory agencies assume that vaccines give far more benefit than
damage even when results are borderline and
methodology flawed as was the case in these Prevnar trials. Tests using
flawed methodology is the standard in the vaccine industry.
Both researchers and regulatory agencies continually assume that vaccines
give far more benefit than
damage even when methodology is flawed and results are borderline as was
the case in both of the cited Prevnar trials.
Future vaccine trials and hearings need to have unbiased people with
training in modern science to supervise these trials and point out
defects in trial design and conclusions. This may not happen soon enough
due to the fact that a fair implementing of such oversight would spell the
end of vaccines ever reaching the marketplace. However, as more and more
people wake up from the vaccine paradigm, changes in the way studies are
conducted will be inevitable.
Following is the link to the very long transcript of the FDA hearing on
Prevnar/Otitis_Media, LYMErix, etc discussed in this article:
FDA hearing on Prevnar/Otitis_Media, LYMErix, etc
Following is quoted from:
Peter Baratosy, M.B., B.S., Ph.D.
An Australian medical practitioner, he uses alternative medicine in his general practice and combined
with complementary and orthodox medicines for the maximal benefit for his patients.
"I see many children in my practice. Some are immunized and some are not, my own children are not.
I see the difference between the immunized and the non-immunized. They're much healthier and have
less infections, colds, otitis media and tonsillitis. Dr. Michael Odent has written a letter in the JAMA
(1994) where his figures show a five times higher rate of asthma in pertussis immunized children
compared to non-immunized children. He is also quoted in the International Vaccination Newsletter
(Sept. 1994): "Immunized children have more ear infections and spend more days in hospital."
This, I believe is an indication of immune system suppression due to vaccines. One of the flaws in
studies of vaccines is that there are no true placebo groups. The vaccine is tested in one group of
immunized children and is compared to another group of immunized children. My advantage is that I
have a group of children under my care whose parents have decided not to immunize and I can
compare these children with immunized children. The un-immunized are definitely more healthy and
so far none have caught any nasty illnesses. The irritability that children experience after immunization
is a mild form of encephalitis, which can produce a minimal brain damage. The severity of the initial
encephalitis bears no relationship to the eventual damage. This mild damage can cause autism,
learning difficulties and hyperactivity. In one study a large proportion of juvenile offenders were
discovered to be minimally brain damaged. Minimally brain damaged children were more likely to
behave in a violent way."
AOM = Acute Otitis Media
Some Additional Comments
Pneumococcal disease has dropped much faster than vaccine usage has risen.
So the vaccine is more than 100% effective. Way to go!
Wow, Could the reduction be due to anything other than the vaccine?
* Were the pre-vaccine stats 'cooked' (inflated) to start with?
* Or post vaccine disease incidence is simply not being fully reported?
* Or factors other than vaccine is causing a lowering of disease incidence?
About 55% of children in an small area of Finland were
enrolled in the vaccine trial.
No mention was made of the Otitis Media rate in the remaining 45%.
Remember only healthy children were included in the vaccine trial which means
the number of expected AOM or any other disease should have been lower
than the national average.
Even with all the flawed methodology for testing, these two trials for
Prevnar are refered too as, "two randomized, well controlled trials". ...
And as to why they used Hepatitis B for the control substance instead of a Placebo,
"it seemed to be the right thing to do to offer something to the control
group also, something beneficial." SOMETHING BENEFICIAL!
(Didn't anyone tell
them that Hepatitis B vaccine causes more adverse events in this age group than
Hepatitis B disease causes?)
using a vaccine for the 'control' to another vaccine introduces unknowns,
and biases both safety and effectiveness measurements, the exact
opposite of what a 'control' is supposed to do. 'Unknowns' include the
effect of combining multiple vaccines on the incidence total of AOM.
Prevnar plus California routine*,
Prevnar plus Finland routine, Hepatitis B plus routine, and
meningococcal C plus routine* might all have bias
toward different rates of AOM. (*The routine schedule of recommended vaccines
changed during the California trial.) All of the vaccines, and more so all of the
combinations would likely contribute to causes of AOM. One of the causes would likely
be the foreign matter introduced into the body from the vaccines. Another likely
contribution to AOM might be treating the side effects of vaccination with
antibiotics. Even fever reducing procedures may keep the body more
toxic than procedures of allowing the body to fully heal.
Still, none of the discussing group condemned the study as
'flawed methodology'. I think many individuals who have woke to the dangers of
vaccines would agree that adequate scientific testing of vaccines is
badly needed. Hearings such as this
need to have at least one unbiased person who is knowledgeable in
modern science, and who answers only to consumers to supervise the trials and point out defects of trial design and conclusions.
-----Following quotes are 'highlights' from the original---------
UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING
This transcript has not been edited or corrected, but appears as received
from the commercial transcribing service. Accordingly the Food & Drug
Administration makes no representation as to its accuracy.
TUESDAY, MAY 21, 2002
[Following excerps are only a very small part of the original document.]
So, in summary, we've observed a dramatic reduction in basic
pneumococcal disease in childhood within our population. The magnitude of
the reduction in the first year, which was much greater than the vaccine
coverage, and the reduction observed in adults suggests herd immunity
So at the moment, you may be aware that the package insert
makes no mention whatsoever about otitis media with regard to Prevnar
efficacy, and we are here today to propose that otitis media be included in
the package insert and that the indication be that Prevnar is indicated for
active immunization of infants and toddlers against invasive disease and
otitis media caused by Strep. pneumoniae due to the capsular types included
in the vaccine.
And some of the reasons why we believe this is to be
important is that there are now two randomized, well controlled trials that
you'll hear about which show statistically significant decreases in otitis
media outcomes. ...
DR. KILPI: Good morning. I'm going to present the main
efficacy results of the Finnish otitis media vaccine trial that evaluated
the efficacy of two seven-valent pneumococcal conjugate vaccine for
prevention of acute otitis media due to vaccine serotypes in children less
than two years of age.
And this study was conducted in the Tampere area in Finland,
and the clinical phase started in December '95 and ended in March '99, and
during this time, we had almost 2,500 children were enrolled in the study.
This is approximately 55 percent of the birth cohort in the area.
And all of these children were randomized to receive either
one of the two pneumococcal conjugate vaccines used in the study, the
PncCRM vaccine labeled, licensed as Prevenar or the PncOMPC vaccine or the
control vaccine that was Hepatitis B vaccine in our study. ...
And this is a summary of the main efficacy results, AOM,
vaccine efficacy against AOM due to vaccine serotype, 57 percent;
culture confirmed pneumococcal AOM, 34 percent;
against pneumococcal AOM
confirmed by either culture or PCR, analyzing PCR or both, 20 percent.
These are all statistically significant.
Against any AOM, six percent, and
recurrent AOM, 16 percent.
The latter two failed to reach statistical
significance in our study. ...
And so principally, the indications for tympanostomy tube
placement were the same during the vaccine trial and after the trial when
the children had returned to the normal life situation, but access to
treatment became definitely more difficult when the trial follow-up was
over due to the reasons here.
And this makes plain why the incidence of tympanostomy tube
placements in the FinOM children during the vaccine trial follow-up was
considerably higher than what it is in the children of the same age in
Finland in general.
And it also makes plain why this incidence of tympanostomy
tube placement dramatically dropped when they returned to a normal life
situation. So it appears that milder cases of recurrent AOM and otitis
media with effusion were treated with tympanostomy tube placement during
the trial and after it, and this makes plain why the effect of the vaccine
on the incidence of tube placement was different here from what it was
And these are the tympanostomy tube placements in the fully
evaluated children. During the trial follow-up from two months to two
years of age, 20.3 percent of the children in the PncCRM group as compared
to 23.8 percent of the children in the control group had tympanostomy tubes
place, and the incidence rate of events is here. So the difference between the vaccine group and the control
group is 12 percent, and this is not statistically significant. ...
However, when the normal life situation started during the
period from two years to four to five years, only 8.2 percent of the
children in the PncCRM group as compared to 13 percent of the children in
the control group had a tympanostomy tube placement. ...
As shown here, actually the rates of first ear tube
placement, number of subjects with events in this table were quite similar
and no efficacy estimate was provided. It was suggested that because of
the close follow-up during the study that subjects actually sought
treatment with ear tubes more often than would ordinarily be the case in
Finland, and these rates actually were higher, I think, tenfold higher,
nearly tenfold higher than common practice in Finland and also much higher
than practice in the Kaiser system. ...
Only in Finland did we have data on vaccine related serotype
OM and the related serotypes also showed a significant reduction at 51
percent with reasonably narrow confidence interval, and there was an
increase with non-vaccine serotypes with a negative efficacy, as you've
heard, of minus 33 percent.
Nevertheless, that increase was counterbalanced by the
positive effects within that efficacy for the vaccine against all
pneumococci, 33 percent or 34 percent with, again, a reasonably narrow
confidence band. ...
DR. KATZ: I guess I wondered why you picked Hepatitis B as
the control vaccine. What was the motivation for that?
DR. KILPI: Well, it's not included in the routine program in
Finland. It's only recommended for risk groups, and it seemed to be the
right thing to do to offer something to the control group also, something
DR. KILPI: We do. We looked at -- what we have in the
database is the data on penicillin resistance, but the resistance situation
in Finland is very different from that in the U.S. So that almost all of
them were susceptible to penicillin.
However, if they were not susceptible they were usually or I
think they were exclusively vaccine serotypes. ...
In the Finnish study, subjects were randomized equally to one
of three vaccines, Prevnar, PnbcOMP manufactured by Merck, and the
Hepatitis B vaccine control.
However, only data related to Prevnar were provided in the
application and only data related to Prevnar will be discussed today.
The study was double blind, and eligible subjects were in
good health as determined by medical history, exam, and clinical judgment.
Of note, infants born prematurely could be enrolled in the
study if they were judged to be in good health. ...
[following is some stuff I clipped from the package insert info:
Hep B Recombivax HB (Recombinant)(Merck and Co.)
Earache (clinical trials = or < 1% within 5 days)
Tinnitus (post marketing reports)
Hepatitis B Vaccine (Recombinant) (SmithKline Beecham Biologicals)
Additional adverse experiences have been reported with
the commercial use of Engerix-B. Those listed below are
to serve as alerting information to physicians.
Special senses: Conjunctivitis; keratitis; visual disturbances; vertigo; tinnitus; earache.]
From the Prevnar Insert:
Of the 17,066 subjects who received at least one dose of Pneumococcal
7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar®,
in the efficacy trial, there were 24 hospitalizations (for 29 diagnoses)
within 3 days of a dose from October 1995 through April 1998. Diagnoses were as follows: bronchiolitis
(5); congenital anomaly (4); elective procedure, UTI (3 each); acute gastroenteritis, asthma, pneumonia (2
each); aspiration, breath holding, influenza, inguinal hernia repair, otitis media, febrile seizure, viral syn-drome,
well child/reassurance (1 each). There were 162 visits to the emergency room (for 182 diagnoses)
within 3 days of a dose from October 1995 through April 1998. Diagnoses were as follows: febrile illness
(20); acute gastroenteritis (19); trauma, URI (16 each); otitis media (15); well child (13); irritable child,
viral syndrome (10 each); rash (8); croup, pneumonia (6 each); poisoning/ingestion (5); asthma, bronchi-olitis
(4 each); febrile seizure, UTI (3 each); thrush, wheezing, breath holding, choking, conjunctivitis,
inguinal hernia repair, pharyngitis (2 each); colic, colitis, congestive heart failure, elective procedure, hives,
influenza, ingrown toenail, local swelling, roseola, sepsis (1 each).
For a wonderful in depth article:
PREVNAR A Critical Review of a New Childhood Vaccine
© Michael Horwin, MA
Index: Vaccines, Ear Infections & related articles, otitis media
AOM is closely related to viral respiratory infections and it is one of the most common
diseases in childhood. Approximately every fifth upper respiratory tract
infection is complicated
by AOM (5,6).
The incidence of AOM is highest among children under two years
of age and it gradually diminishes with age, the peak incidence being between the ages of
6 to 12 months (5,7-9).
In a prospective cohort study of 498 children in the area of greater
Boston, the annual incidences of at least one episode of AOMin the first, second and third
year were 62 %, 59 % and 40 %, respectively (9).
In a Finnish cohort study of 2512 children, the cumulative incidence of children who experienced at least one episode of AOM
was 42 % during the first year of life and 71 % by the age of two (8).
An even higher fre-quency
of middle ear disease has been reported in a prospective study from the USA,
where 79 % and 91 % of the 2253 children experienced at least one episode of MEE
before the ages of one and two, respectively (10).
Small differences in
these studies may
be partly due to variable numbers of drop outs, differences in diagnostic
criteria or variation
in microbiological aetiology.
The incidence rates of recurrent AOM in various studies
are summarized in table 1.
"The Prevnar pre-licensure clinical trials, which Wyeth Lederle paid Kaiser Permanente to conduct, compared two
experimental vaccines against each other. To compound this basic methodological flaw, Kaiser and Wyeth
Lederle, allowed most of the children in the trial to be given the more reactive DPT vaccine rather than use the
safer, less reactive DTaP vaccine. This placed the children in that five-year experiment in greater danger and
allowed the drug company to write off the seizures that occurred as being caused by DPT and not Prevnar, when
in fact, they didn't know. Even so, the groups of children who got Prevnar suffered more seizures, higher fevers,
more irritability and other reactions than did the children who got the other experimental vaccine. It was a
no-brainer as far as I was concerned: Kaiser and Wyeth Lederle had proved nothing about Prevnar vaccine
safety."--Barbara Loe Fisher