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Jerri Johnson
*OAH_RuleComments.OAH
Immunization Rules docket 0900-30570
Monday, July 15, 2013 9:54:37 PM
How vaccine safety clinical trials are reported.doc
A study on how vaccine clinical safety trials are conducted and how conclusions of
safety are reported.
Jerri Johnson
Public Relations Coordinator
National Health Freedom Coalition'
651 688 6515
[email protected]
A Case Study in Pharmaceutical Company Reporting
On Clinical Safety Trials of a New Vaccine
This article is written to demonstrate that clinical studies of new
vaccines reveal serious adverse effects of the vaccine, and yet the study
authors conclude that there are no adverse effects. Then parents when
given the Vaccine Information Statement are given untruthful
information on the safety of the vaccine.
Attempts to locate the data from the clinical studies of hepatitis A and
hepatitis B vaccines were futile. The only information given out was in
summary form, with lists of symptoms noted in the study. There was no
information on the frequency or seriousness of the symptoms. In addition,
the reports listed adverse effects noted in post-marketing, but stated that
causality was unknown.
Causality of adverse effects can be easily determined by doing double-blind
studies where one group is given an experimental vaccine and the other
group is given a placebo. This is the way that vaccines should be tested for
safety, but this has not been done for these vaccines, or if it was, the
information is not publicly available.
This paper presents actual data from the pneumococcal vaccine, Prevnar,
not one of the vaccines being considered in Minnesota rulemaking
currently. But it illustrates how a vaccine safety study works, and how
serious adverse effect data is translated into an untruthful conclusion that
the vaccine caused absolutely no adverse effects.
Prevnar (Pneumococcal) Vaccine
Serious safety concerns arose during the clinical testing of Prevnar.
In the pre-licensure test, Wyeth Pharmaceuticals gave Prevnar to 17,066 healthy infants.
Children with known underlying chronic or acute disease were screened out. It was only
given to healthy infants (effects on infants with chronic disease are unknown).
Seizures, HHE, asthma
Eleven infants who had never had a seizure before suffered seizures, eight of them within
72 hours of the vaccine. Three suffered hypotonic/hyporesponsive episodes (they lost all
muscle tone, becoming limp and not responding). One child developed congestive heart
failure within 72 hours of the vaccine. Forty infants who had never had asthma before
required outpatient physician care for asthma, wheezing, shortness of breath or breathholding within 72 hours of the vaccine. No long-term followup information is available
on these children, to monitor for possible lifelong effects.
Hospitalizations
Within 72 hours of receiving the vaccine, there were 24 hospitalizations. Within 60 days,
513 infants, or 3%, required hospitalization. The authors stated that none of the 513
hospitalizations were related to the vaccine.
Emergency room visits,
There were 162 visits to the emergency room, almost 1% of the healthy infants, within 72
hours of receiving the vaccine. How many of these episodes can be attributed to the
vaccine? Certainly some were clearly unrelated, such as trauma, hernia repair, or
ingrown toenails. However, the vast majority were the result of immune-related acute
illness, including: 20 for febrile illness, 19 for acute gastroenteritis, 16 for upper
respiratory infection, 15 for ear infections, 10 for viral illness, 8 for rash, 6 for croup, 6
for pneumonia, 4 for asthma attacks, 4 for bronchiolitis, 3 for urinary tract infection, 2 for
wheezing, 2 for pharyngitis, and 1 for congestive heart failure.
There were 1188 visits to the emergency room within 30 days following the vaccine, or
7% of all infants receiving the vaccine. The data shows that for any given 3 day period in
that month, the highest rate of emergency room visits was in the first 3-day period
following the vaccine - 162 visits in the first 3 days. For the rest of the month, the
average number of ER visits was 114 per 3 day period. The authors of the study
concluded that none were related to vaccination.
Deaths
Twelve infants died during the study, including 5 from SIDS, and 7 from "clear
alternative causes." The seven "clear alternative causes" were not explained, and Wyeth
Pharmaceuticals will not release information on the deaths, saying that this is "proprietary
information". Five deaths from SIDS is less than or equal to the number expected from
the Kaiser Vaccine Safety Datalink database. It is unknown whether the total number of
deaths is comparable to the Kaiser database figures. All of these were in previously
healthy infants with no chronic or acute disease known prior to the vaccine.
Adverse effects in control group
How many of these adverse events would have happened without the vaccine? Any valid
scientific study will have a study group receiving the new vaccine and a control group
receiving no vaccine or a placebo. Comparing the two groups gives scientists the answer
to whether the experimental vaccine causes adverse effects or not.
Unfortunately, Wyeth-Lederle did not attempt to use a placebo group. Rather, they
gave the control group a different experimental vaccine, (the meningococcal
vaccine) which had similar rates of hospitalizations and emergency room visits. They did
not compare the Prevnar group to a group of children receiving no vaccine.
The analysis charted rates of adverse reactions for 92 diagnostic categories, comparing
the Prevnar group to the group receiving the other experimental vaccine. They found
incidences to be similar, and so concluded that none of the illnesses in either group were
vaccine-related. Since the Prevnar vaccine recipients didn’t have any more adverse
effects than the meningococcal vaccine recipients, they decided the Prevnar vaccine was
safe.
No long-term follow-up for chronic disease
The study did not do any long-term follow-up of the children to see whether they had
higher rates of asthma, seizure disorders, neurodevelopmental disorders, or autoimmune
disease.
The authors of the study concluded, "This trial included an extensive evaluation of the
safety of both the pneumococcal and meningococcal conjugate vaccines. Safety
monitoring in this cohort of >37,000 children did not reveal any severe adverse
events related to vaccination that resulted in hospitalization, emergency visits or
clinic visits."
Parents are now told on the Vaccine Information Sheet they receive from their
doctor, "So far, no serious reactions have been associated with this vaccine."
Validity of an exemption from a vaccine assumes that parents are given
truthful information about the risks of a vaccine.
Inherent in the value of parents making the decision to give or not give a vaccine, is the
time-honored principle of informed consent. The argument that we can require a vaccine
because parents have the right to an exemption, loses validity when the parents are told
that no serious adverse events have been associated with it, when that is simply not true.
So, as it turns out, one of the vaccines in question in Minnesota right now actually was
involved in this study. The “control group” got an experimental meningococcal vaccine,
which MDH is now proposing to require for all 7th graders. One wonders if in fact this
was also the simultaneous safety study for the meningococcal vaccine. It seems from the
concluding statement that they also decided that the meningococcal vaccine was safe
because it didn’t cause any more harm than the pneumococcal vaccine did. They
compared rates of adverse effects from the two vaccines, found them pretty much the
same, and pronounced them both safe.
"This trial included an extensive evaluation of the safety of both the pneumococcal
and meningococcal conjugate vaccines. Safety monitoring in this cohort of >37,000
children did not reveal any severe adverse events related to vaccination that resulted
in hospitalization, emergency visits or clinic visits."
Scientific inquiry needs to be unbiased, or it is not science. The study should have
included a large control group of children receiving no vaccine at all.
And scientific information needs to be transparent and open to review by independent
scientists. The data found in the Prevnar/Meningoccal study is the kind of data that
should be available for all vaccines.
However, the pharmaceutical companies manufacturing the hepatitis A and hepatitis B
vaccines refuse to make their clinical study data available. Instead they simply list
symptoms experienced, without qualitative or quantitative data. They did not mention a
control group at all, and they only followed the children for five days so there is no
evidence as to long-term effects of the vaccines.
The meningococcal vaccine should not become a required vaccine based on a faulty study
like this. And until access to safety data on the hepatitis A and B vaccines is publicly
available, the state should not require them.
Jerri Johnson
Vaccine Safety Council of MN