Prevenar 13 Pneumococcal Vaccine Damned in Belgian Media Reports
Posted Dec 01 2012 12:00am
This press release about the safety and
efficacy of Pfizer’s pneumococcal vaccine Prevenar 13 - used in US as well as
European vaccine schedules - was extensively reported in the Belgian media on
Saturday. The report is based on leaked documents from the Belgian medicines agency
and includes the reports of 22 deaths over a two year period. It should be
borne in mind when reading this data that it relates to a country with a
population of only 10.5 million (3% of the US, 15% of the UK) and it provides
powerful evidence that the risks of this vaccine now substantially outweigh any
benefits. It follows a recent press release from Initiative Citoyenne regarding
fatalities from GSK’s hexavalent vaccine Infrarix Hexa . Initiative Citoyenne also carry an
interesting report of a French doctor fined $4000 for failing to inform a patient about the
risks of a Hepatitis B vaccine . With more evidence about the risks of vaccines coming to public light this
is likely to put substantial pressure on the medical profession if there are further cases of this kind.
On the 8th of December, articles in the
press reported on the contents of a substantial 1,271-page confidential GSK
leaked to us by contacts at the Belgian Medicines Agency. This shocking document on the pharmacovigilance
of the Infanrix Hexa vaccine revealed serious safety problems evidenced by a
whole range of serious complications, including 36 deaths (over a 2-year
We have now
received more confidential documents on the safety of another paediatric
vaccine very commonly used on infants and administered alongside the Infanrix
Hexa hexavalent vaccine: the Prevenar
13, a pneumococcal vaccine manufactured by Wyeth/Pfizer.
This is an injection targetting13 different strains of
the bacterium and reputed to be an improved version of the old Prevenar
(targeting only 7 strains). It was in
fact rushed to market in 2010 to replace the older vaccine, presumably an
attempt to cover up the fiasco of its predecessor: the original Prevenar had
disappointingly resulted in an i in serious infections making it
OK, so the vaccine is not as effective as they tell us
but is it at least safe for such tiny babies?
It would appear, according to recent confidential
Wyeth (Pfizer) documents and to a reply from the European Medicines Agency
(EMA) that both the manufacturer and the
agency are aware of a significantly higher number of adverse neurologic effects
On the 4th of January this year, at the end
of the required 6-week period, two Pfizer group Regulatory Affairs Directors,
Mary Allin and Helen Edwards, sent a response to Dr. S. Spinosa of the European
Medicine Agency on the topic of “higher
number of neurologic events reported in Italy following the co-administration
of Prevenar 13 and hexavalent vaccines”.
The two directors specified at the end of this letter that based on data
supplied, they did not feel there was any need to modify the vaccine’s
reference safety information (RSI), in other words its package insert.
At the same time, another confidential document,
nothing more than correspondence
between a division of the European Medicines Agency (Committee for Medicinal
Products for Human Use or CHMP) and Pfizer (MAH),
specifies that “the risk/benefit profile
of the Prevenar 13 remains positive but the following potential safety concerns
requiredfurther investigation/discussion by the MAH:
1) . There were 22 fatal cases during the reporting period
which represents 2.6% of thetotal number of
cases. This proportion has increased from 0.3% during the previous reportingperiod. Additionally, in a large majority of these
cases, the time interval between receipt of13vPnC and death
(or onset of symptomatology leading to death) is narrow. The casepresentations of the fatal cases is considered
2) . There were 51 cases
reported for lack of efficacy. The MAH notes that itcurrently uses
only 3 MedDRA preferred terms (vaccination failure, therapeutic producteffective, and drug ineffective) to capture these
reports. There is a concern that cases ofreported events
of pneumococcal disease, without concomitant coding of one of these threeterms are “missed”: at least 10 case numbers were
identified by this Assessor from theInfections and
infestations SOC which exemplified this concern. Additionally, the largemajority of reports relating to “lack of efficacy”
appear to report only 3 serotypes: 19A, 3 and7. The MAH is request to comment upon this.
4) . Following a inquiry at the October Pharmacovigilance
Working Party regarding apotential
increase in the incidence of neurological reactions with coadminstered vaccinesnoted in a national vaccination program in IT, the MAH
is requested to provide a cumulativereview of
neurological reactions in those cases who were reported to have received
Prevenar13 concomitantly with hexavalent vaccine
We then have the response of the producer which had
delved into a Pfizer database covering the 2-year period from the 10th
of July 2009 to the 9th of July 2011.
The manufacturer informs us that over this period,
Pfizer received 1,691 reports of
adverse events and 18% of these cases,
i.e. 312 events, were neurological.
An important fact is that Pfizer assessed the respective frequency of neurologic
accidents in three different groups of children: those who had all received
the Prevenar 13 on the same day, those who had received the
Prevenar 13 other vaccines on the same day and those who had
received the Prevenar 13 a hexavalent vaccine on the
Of the 934 children who had only received the Prevenar
13 and experienced adverse effects, 87 displayed neurologic events (87/934 = 9%).
Of the 287 children who had received the Prevenar 13
plus other vaccines on the same day, and experienced adverse effects, 62 had
had neurologic episodes (62/287 = 21%).
Of the 470 children who received the Prevenar 13 plus
a hexavalent vaccine, on the same day, and reported adverse effects, 163 had
experienced neurologic reactions (163/470 = 34%!!).
It is therefore clear that the ! This is precisely
what we have been saying for years regarding the dangerous over-vaccination of
Whether persistant crying, convulsions,
hypotonic-hyporesponsive episodes, tremors, loss of consciousness, epilepsy, infantile spasms or absence of
response to stimuli, these effects were always more frequent when the Prevenar
13 was administered alongside the Infanrix Hexa. So how many parents were aware of this and
who told them? Did the Belgian Office
for Childbirth and Childhood (ONE) tell them?
The ONE has always claimed in all its literature that
the co-administration of several vaccines was totally safe, that any adverse
effects were in general similar to those experienced with the administration of
these vaccines separately
and even that concomitant administration of these vaccines reduced the
‘discomfort for the child’. Their
overall commitment to vaccines has never waned!
We also notice that both (most of which took place within 24 hours of
the vaccination or shortly thereafter).
Lastly, a third very important confidential document
on the Prevenar 13 provides condemning clinical trial data. This document states that on the 2nd
of December 2008, the manufacturer requested authorization to register and
market its Prevenar 13 vaccine across Europe and authorization was granted on
the 9th of December 2009. These data
were then used to authorize the vaccine for use in both Japan and Canada as
well. When however it comes to product
tolerance, the information is quite shocking.
First of all, the most incredible is the methodology and the number of children
monitored to assess the “safety’ of the Prevenar 13: instead of comparing a
large sample of vaccinated children with another group of totally vaccinated
children, the manufacturer compared his Prevenar 13 (i.e. the new version) with
its predecessor (Prevenar 7)!!
And when it comes to the number of children assessed,
it is ridiculously low: 796 babies + 569 young children = a total of 1,365
children, spread over two studies and four groups (Prevenar 13/Prevenar 7 given
to babies or young children depending on the study) while 10,000 children is
sometimes still considered insufficient to assess the rare serious adverse
effects! The adverse effects were
monitored for six months in only 580 cases.
Several children were even ‘conveniently’ withdrawn from these data
because the manufacturer decided, arbitrarily, that their adverse effects were
in no way linked to the vaccine being assessed!
We also learn that first of all the frequency of both local and systemic adverse effects is significantly
higher when the injection is intramuscular compared with sub-cutaneous (in
spite of this, the package insert still advises intramuscular injection!).
To grasp the proportions here, it is important to know
that sensitivity at the site of injection is 13 to 20% in those vaccinated
sub-cutaneously compared with 72 to 79% in those who receive an intramuscular
The figures are even more revealing when it comes to
the systemic effects:
Less than 8.1% of children receiving a sub-cutaneous jab had to take
fever-reducing medication after the vaccination compared with between 78 and 84% of those who were given an
intramuscular injection! Loss of appetite occurred in less than
19% of those receiving a sub-cutaneous inoculation compared with over 54% in
those for whom the jab was intramuscular.
Irritability arose in less than 37% of the former while it was over 88%
in the latter, drowsiness in less than 41% of the former compared with over 70%
in the latter and disturbed sleep in less than 24% of the former while it was
over 45% in the latter.
surprisingly, these data reveal clearly that a deeper injection of the toxic
substances in a vaccine (including neurotoxic aluminium) into the tissues of
the body presents much greater risk.
According to the research team at the Henri Mondor University Hospital in Créteil, France, the aluminium
administered by intramuscular rather than sub-cutaneous injection is without a
shadow of a doubt a major contributing factor in the emergence of cases of
macrophagic myofasciitis (MMF).
This confidential document on clinical trials
specifies however that regardless of the method of administration
(sub-cutaneous or intramuscular), 83 to
92% of the recipients spontaneously reported adverse effects, a bit of a
shock when assessing products designed for healthy people!
As for SERIOUS adverse effects and their incidence in
the clinical trials, the manufacturer informs us that in one study, no fewer
than 30 serious reactions were observed in 22 individuals which is an 11.4% rate of adverse events!! Most of these reactions were infections and
conditions requiring hospitalisation.
The manufacturer was however quick to point out that according to the
rapporteur, NONE of these serious reactions was deemed to be linked to the
What is more, this rate was considerably higher in
babies than in slightly older children, confirming that the immaturity of a
baby’s immune system is not at all compatible with the vaccination drive now
recommended by experts blinded by conflicts of interest.
A total of 42
out of the 1,365 individuals assessed displayed serious adverse effects, i.e.
To grasp the extent
of the problem, just remember that the Belgian annual birth rate is
approximately 128,000, a very large majority of whom receive BOTH the Prevenar
and the Infanrix Hexa. A simple
calculation reveals therefore that the annual number of serious adverse
effects, taking ONLY this vaccine into account, could be 3% x 128,000 births = 3,840 children!!!!!
these data are not very reassuring and it is clear that the health authorities are hiding far too much
information which could be extremely USEFUL to parents who are expected to
act in the interest of their children.
Serious adverse effects are much more frequent than they claim and the health of our children is being
DIRECTLY jeopardised first by this commitment to ideology but also by the rigid
vaccination schedule recommendations which push a maximum of concomitant doses,
to obtain parental compliance: yes, but above all to protect the commercial
interests at stake!
Citoyenne is therefore issuing a bold call to arms against the
blind and unbridled pursuit of these death-dealing policies so detrimental to
public health. We call upon all honest and willing members of the
public to demand an end to this ‘Code of Silence’, this taboo, but also to the
blind ideology which reigns over the current vaccination drive.
Our infants and children are literally overpowered by
the current number of vaccines they are given but what can they do? They are simply SPEECHLESS.