... I am a veteran of the vaccine war in the US, and today I feel compelled to speak about what I saw in that war. Legislators were forced to change their votes to revoke vaccine exemptions and rescind the historic right to consent to medical procedures. The vaccine war is a dirty war, in which platitudes about protecting the most vulnerable are invoked by the same pharmaceutical companies that paid $2.7 billion in criminal penalties in the US between 2012 and 2015. The vaccine industry generates enormous profits (estimated 10-40%), benefits from a government-guaranteed market, and receives almost total liability protection. No other industry can rival these benefits. And this industry's rapacious desire to grow and guarantee its Canadian market is the reason we are here today.
Let me add context to this discussion by noting
that in 2014, the NY Times said it
cost $2200 to fully vaccinate one child.
At that price, it cost $163 billion dollars to fully vaccinate every US
child.
May I apologize at the outset for using mostly
US data? I provide Canadian and New
Brunswick information when available.
1.
Pharma's Pilgrimage to New Brunswick
Since
March 2019, representatives
of the three largest vaccine manufacturers in North America: GSK, Merck and Sanofi, have made their way to
New Brunswick to meet with ministers, public servants and lawmakers. This is not coincidental.
Pharmaceutical companies are colluding to expand on legislative victories
gained in the US. Using a media storm over measles, censorship
of numerous vaccine-related websites, new support for mandates from professional
organizations that have benefitted from industry largesse, and deals with
Democratic party leaders, the right to religious and philosophic vaccine
exemptions has been voted away by legislatures in California, New York and
Maine. In the recent case of New York, the Speaker
of the NY Assembly was caught on videotape directing a committee member to
change his vote in order for the mandate legislation to move forward.
This was
not an idle pilgrimage to one of Canada's smallest provinces. For Pharma it is the
gateway to all of Canada.
The
vaccine industry in 2019 is at a crossroads.
On the one
hand, the vaccine business is booming.
Several vaccines have been newly licensed, a robust
industry-FDA revolving door has been established, and the children of North
America are receiving more vaccines than ever before. Merck,
for example, reported increased sales in the second quarter of 2019 for Gardasil HPV vaccine of 46% (to over $3
billion US annually) compared to last year, and increased sales of 58% for its MMRV (measles, mumps, rubella and
varicella) vaccine. These are Merck's 3d and 4th biggest sellers. This year's US measles outbreak (about 1200
cases) and media-driven fears
of contagion contributed to vaccine uptake.
On the
other hand, the industry does not want to shoulder the considerable expense of
developing, testing and licensing new vaccines--over 100 of which are in
development--without a government guarantee that they will be purchased.
Vaccine mandates guarantee a
vaccine market, now and in the future. Mandates put in place today will enforce
the uptake of vaccines on the currently required list, plus other vaccines yet
to be added.
Industry
Challenges
In 2019,
the vaccine industry faces threatening legal challenges:
a) An expert witness for the US Department of
Justice (DOJ) in the 2007 omnibus vaccine autism case (affecting the outcome
for thousands of cases of alleged vaccine injury leading to autism), neurology
professor Andrew Zimmerman, MD recently filed an affidavit stating that his expert
testimony was altered by DOJ lawyers--that he told them that in certain cases,
autism can be a consequence of vaccination. The case for which Prof. Zimmerman's testimony was allegedly changed resulted in a denial of benefits for thousands of families with autistic children. It also led to a negative conclusion in the US Vaccine Court, for all future cases, that autism might be a consequence of vaccination. Potentially thousands of denied cases will need to be re-litigated.
b)
Gardasil, a
Merck vaccine used to prevent HPV infections and putatively cancer, is facing lawsuits
around the world for neurologic injuries and deaths. The Japanese government rescinded its recommendation
for Gardasil due to the
widespread side effects reported. Recall
that Merck, the manufacturer of Gardasil,
MMR, varicella and other vaccines, hid the lethal side effects of Vioxx for nearly five years, paying
out $4.85 billion US dollars to settle 27,000 injury claims. FDA scientist
David Graham, MD estimated
that 39,000 to 61,000 excess deaths occurred due to Vioxx.
c) Danish physician and anthropologist Peter
Aaby, and the group he leads, have been studying vaccines in Africa for 40
years. After completing hundreds of
vaccine studies, they have concluded that the DPT vaccine increases infant mortality, by 100% or more, in African infants. His group notes, "All studies
of the introduction of DTP have found increased overall mortality." You may be interested in his eye-opening talk at a recent Symposium on Scientific Freedom
in Copenhagen.
The Best Defense is a Good Offense
Facing these challenges, in 2019 the vaccine industry seized its opportunity from a prolonged US measles outbreak. A flawless PR campaign conducted for the industry helped ram through legislation for enforced vaccine mandates in the US, and now the industry is repeating the strategy in Canada.
Facing these challenges, in 2019 the vaccine industry seized its opportunity from a prolonged US measles outbreak. A flawless PR campaign conducted for the industry helped ram through legislation for enforced vaccine mandates in the US, and now the industry is repeating the strategy in Canada.
In the wake of the 2015 Disneyland measles epidemic, coupled
with millions of dollars in lobbying fees and direct donations to legislators,
California's legislators voted to end non-medical vaccine exemptions. And this
month, they passed a bill that restricted the granting of medical exemptions.
One of the unforeseen consequences of California's vaccine
mandate was the wholesale withdrawal of children from public schools. California's
Department of Public Health reported that the number of homeschooled,
unvaccinated kindergartners soared from 2,000 to nearly 7,000 between 2016 and
2018, following California's vaccine mandate.
Is New Brunswick, Canada prepared for a
significant reduction in the number of children who attend public school?
2. You have been assured that "Vaccines are
safe and effective."
It has a reassuring ring, but conveys nothing. In fact, each vaccine is very different from
every other. Generally, we know something
(but not enough)
about the benefit, but only a little about the harms of different vaccines. According to the Institute of Medicine,
"The process of anticipating,
detecting, and quantifying the risks of rare adverse events following
immunization presents an enormous challenge." Like drugs, each is appropriately used when
the benefit outweighs the risk. Because vaccines are given to healthy people to
prevent disease, they should be even safer than drugs.
The initial effectiveness of the different childhood
vaccines ranges from about 40% to 93%.
Immunity then wanes over time.
There is a big problem
at the heart of vaccine safety assessment: adverse event information is cloaked in
secrecy, withheld from physicians and the public by public health agencies. Undesirable results are massaged or falsified
until they appear acceptable. Because
this is hard to believe, I will give you 3 important examples of CDC's data
manipulation.
1. Thomas Verstraeten was a young physician on a CDC fellowship who in 1999 studied
the statistical relationship between cumulative amounts of thimerosal (mercury)
infants received from vaccines and neurological illnesses. His results--including
that children exposed to the highest levels of mercury from vaccines after
birth had 7 times the level of autism as children not exposed--were so
disturbing that CDC convened a private meeting of vaccine experts to discuss
and manage them. No reporters or members
of the public were permitted, but a copy
of the meeting transcript was leaked.
(I have provided you with an unpublished abstract obtained by FOIA showing
some of Verstraeten's data before it was massaged to remove the effect of
mercury. His published 2003 paper
says, "No consistent significant
associations were found between thimerosal (mercury) containing vaccines and
neurodevelopmental outcomes." I also gave you a letter
from physician Congressman Bill Weldon to Dr. Julie Gerberding, director of
the CDC about this data manipulation. The
issue is unresolved. Merck
was later found to have misled the public about when it removed thimerosal from
infant vaccines.
2. Dr. William Thompson admitted that his group of CDC scientists was directed to destroy data in their study that linked early MMR vaccination in black males to increased rates of autism. The group met in a conference room, and put all data showing this effect into a garbage can. Thompson secretly retained a copy, and made it available to Congressman Bill Posey. The published paper denied any autism connection. Congressman Posey has called for an investigation, but none has occurred. The movie Vaxxed is about this matter.
3. Poul Thorson was a physician, CDC employee and later CDC contractor who both manipulated Danish data to remove the adverse effects of thimerosal (50% mercury), and stole funds from the CDC. Thorson is currently on the Department of Health and Human Services' list of fugitives from justice.
2. Dr. William Thompson admitted that his group of CDC scientists was directed to destroy data in their study that linked early MMR vaccination in black males to increased rates of autism. The group met in a conference room, and put all data showing this effect into a garbage can. Thompson secretly retained a copy, and made it available to Congressman Bill Posey. The published paper denied any autism connection. Congressman Posey has called for an investigation, but none has occurred. The movie Vaxxed is about this matter.
3. Poul Thorson was a physician, CDC employee and later CDC contractor who both manipulated Danish data to remove the adverse effects of thimerosal (50% mercury), and stole funds from the CDC. Thorson is currently on the Department of Health and Human Services' list of fugitives from justice.
Despite strong evidence
of scientific misconduct in these 3 CDC cases, the papers published in top
medical journals with these manipulated data have never been retracted from the
medical literature. Instead, they
provide foundational support for the safety of the MMR vaccine and for the safety of mercury
in vaccines. The fraudulent papers
pollute the medical literature, making it impossible to discern the true
adverse effects of vaccines.
Since 1995, when
Congress chartered the CDC Foundation, over $800 million
dollars has been donated to CDC through this Foundation vehicle. Health Canada, Merck, Pfizer,
Novartis and other vaccine companies donate to the CDC Foundation,
sometimes to sponsor
programs that increase sales. Former
CDC Director Gerberding became the President of Merck Vaccines after
leaving CDC. Financial
conflicts of interest at CDC with respect to vaccine safety have long been documented.
Vaccine safety science
It is very difficult
to link an adverse reaction to a vaccination unless it occurs soon afterward. In general, late adverse reactions are only
identified as caused by vaccines if they occur many times more often than
expected.
The National Academy
of Sciences was chartered by Congress in 1863 to provide expert advice to
government. Congress requested the National
Academy of Sciences' Institute of Medicine to conduct a series of vaccine
safety studies to inform vaccine policy.
In 2011, the US
National Academy of Sciences' Institute of Medicine examined
the evidence for vaccine causality for 8 vaccines and 158 possible adverse
effect-vaccine combinations. In
the vast majority (85%) of cases, in the language used by the Academy, "the
evidence was inadequate to accept or reject a causal relationship." The science remains unsettled.
President Harvey Fineberg of
the Institute of Medicine/National Academy of Medicine wrote, in the US National
Vaccine Plan 2013 Annual Report: (pages 44-45)
"While few health problems are
clearly associated with vaccines and some putative associations can be rejected
based on evidence, in the majority of cases evidence was inadequate to accept
or to reject a causal relationship... Confidence in vaccine safety
requires more than surveillance and reporting in real time. In light of the
paucity of strong conclusions about possible vaccine side effects, continued and
selective investment in epidemiologic and other investigations into the risks
of immunization will be necessary... About the best one can do is to estimate,
based on the evidence, the probability that the frequency of an adverse event
is less than a specified, low level. This may be enough for the physician who
weighs the public health and personal health benefit against a very low risk,
but not enough to satisfy a wary parent.
Continued, candid, and open
communication is also an essential ingredient to a successful vaccine safety
regime. This means more than the experts explaining the benefits and risks to
parents and families. It means listening carefully to the anxieties and doubts,
staying true to the strength of evidence
without exaggeration or misrepresentation, and reporting fully and fairly on
scientifically sound investigations into possible adverse events."
By 2019 the winds had changed at the Academy of
Medicine. A new President, Victor Dzau, himself and some of his
advisory panelists tainted with undisclosed financial conflicts of interest, dismissed
the concerns of his predecessor about lack of vaccine safety evidence, signing
a brief whitewash: "Our
work has validated that the science is clear--vaccines are extremely
safe."
We now know that the National Academies of Sciences' Institute
of Medicine/National Academy of Medicine has received millions of dollars from
drug companies that have interest in its work. Merckhas given between $5 and $10 million dollars; AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Johnson and Johnson, Eli Lilly, Novartis, Pfizer, Sanofi-Aventis, and United Therapeutics have each given between $1 and $5 million.
Understanding of the adverse effects due to single vaccines,
combinations of vaccines, or the number of vaccines remains murky.
Canadian physicians
examined the health of babies after their 12 and 18 month vaccinations. They found an excess emergency room visit for
one in every 168 babies vaccinated at 12 months with the MMR vaccine, occurring
between one and two weeks later. They
concluded, "There are significantly
elevated risks of primarily emergency room visits approximately one to two
weeks following 12 and 18 month vaccination. Future studies should examine
whether these events could be predicted or prevented."
1300
cases of narcolepsy were caused by the 2009 swine flu Pandemrix vaccine. This particular side effect was able to be
linked to the vaccine because millions of people were vaccinated
simultaneously, the narcolepsy that developed was severe and required intense
medical attention, the rate of narcolepsy was 10-16 times higher than expected,
and vaccine oversight had been increased to evaluate new pandemic vaccines. Canadians received a virtually identical
vaccine (Arepanrix) but it was manufactured
in a different facility, and by chance alone the
Canadian version did not cause narcolepsy.
3. Is New Brunswick undergoing a crisis of
vaccine-preventable disease?
The answer is no. And
if there was a crisis, Bill 39 would not wait to go into effect until 2021.
Measles. As of August 3, Canada
had 84 cases of measles in 2019, and no
measles deaths since 2014. Surprisingly, given the media hoopla over
measles, only three
Americans have died from measles in the last 20 years. The last US child death occurred in 2003, in
a 14 year old after a bone marrow transplant.
In a 2011 measles epidemic in Quebec, where over 95% of the population
was vaccinated, 50% of those developing measles had received 2 doses of measles
vaccine. After the Disneyland
measles epidemic, it was found that 73 cases of measles (38% of those
typed by CDC) were due to viruses from the measles vaccine.
Pertussis. Canada
averages one death from whooping cough per year. There are many cases, most
going undiagnosed and unreported. Some
estimate a million US cases of whooping cough yearly. This is because vaccine protection wanes
rapidly. More
than 80% of whooping cough cases occurred in fully vaccinated children in a
recent study.
Diphtheria. There is one case of diphtheria
every two years in the US.
Mumps. Canada reported 180
mumps cases yearly from 2011-2013. Mumps
outbreaks are a result of waning of vaccine-induced immunity. "Data
from outbreak studies showed that the odds of developing mumps increased by 10
to 27% with each year post-vaccination."
Rubella. All recent US rubella cases were infected in other countries.
Polio. There is no polio in Canada. The last wild
(natural) polio case in Canada occurred in 1977. There have been 3 reported cases in the US
since 2005, all from vaccine strains of polio.
Worldwide, there are more new polio cases due to vaccine strains that
became virulent than there are due to wild polio viruses. Last
year, vaccine-derived viruses paralyzed 105 children worldwide; the wild virus
just 33.
Vaccines
containing live viruses, such as the MMR, Varicella, and oral polio can infect,
harm and very rarely kill the recipient, especially if the child has an unknown
immune deficiency. There are
extensive warnings on the MMR vaccine
information sheet which I have provided you, about who should not
receive the vaccine.
UPDATE: On August 15, 2019 CDC changed most of its Vaccine Information Statements (which must be provided to parents before vaccines are given, according to the 1986 National Childhood Vaccine Injury Act) eliminating many of the warnings associated with each vaccine. The MMR Vaccine Information Statement no longer says, "Some People Should Not Get this Vaccine." The purpose for the changes appears to be to restrict the indications for medical exemptions, and create a federal standard to be applied by states that pass legislation like California's.
UPDATE: On August 15, 2019 CDC changed most of its Vaccine Information Statements (which must be provided to parents before vaccines are given, according to the 1986 National Childhood Vaccine Injury Act) eliminating many of the warnings associated with each vaccine. The MMR Vaccine Information Statement no longer says, "Some People Should Not Get this Vaccine." The purpose for the changes appears to be to restrict the indications for medical exemptions, and create a federal standard to be applied by states that pass legislation like California's.
Although it is not usually acknowledged, vaccination is not
a one-size-fits-all procedure. According
to the Mayo Clinic, "Human
antibody response to measles vaccine is highly variable in the
population." Females have more adverse
reactions than males. Gender and race
influence the response. As does heredity.
Families that have experienced a serious vaccine reaction are right to be concerned about additional vaccinations and the safety of sibling vaccination, for their family is probably at higher than average risk of a reaction. What goes unreported is that many unvaccinated children are themselves a vulnerable group, and should not be vaccinated. However, there are no existing standards for doctors to use to determine the risk of vaccination to most children. So medical exemptions have been improvised, and are generally hard to come by.
Families that have experienced a serious vaccine reaction are right to be concerned about additional vaccinations and the safety of sibling vaccination, for their family is probably at higher than average risk of a reaction. What goes unreported is that many unvaccinated children are themselves a vulnerable group, and should not be vaccinated. However, there are no existing standards for doctors to use to determine the risk of vaccination to most children. So medical exemptions have been improvised, and are generally hard to come by.
4. Herd Immunity is undermined by high rates of vaccine
failures
The Quebec measles epidemic I mentioned demonstrates that even
a vaccination rate over 95% didn't prevent a large measles outbreak. Herd
immunity rates are based on statistical modelling, and are only
projections. The reason that 50% of
measles cases occurred in vaccinated children is primary or secondary vaccine
failure. Primary vaccine failure means
the vaccine never produced immunity, while secondary failure means the immunity
was lost over time.
For most vaccines, primary and secondary failures go unnoticed,
because children are not being exposed to most of these infections. The infections children do get exposed to are
pertussis and influenza, and then vaccine failure is obvious--because most
cases of pertussis and many of influenza occur in fully vaccinated children.
5. Do unvaccinated children put
immunocompromised children at risk?
The fact is that immunocompromised children are not dying
from vaccine preventable diseases, and few are getting them, with the
exceptions of influenza, pertussis and varicella--because vaccines for these 3
infections provide limited immunity.
Fewer than one American dies yearly from measles, mumps,
rubella, polio, or diphtheria. On average, one Canadian dies from whooping
cough (pertussis). Ten Canadian children
die from influenza. One American child
dies yearly from varicella (chickenpox).
You are looking at 11 child deaths per year in Canada. Would vaccinating every child fully against
whooping cough, varicella and influenza prevent these deaths? Remember, most
whooping cough and varicella patients are fully vaccinated. And while the immunity generated in young
children from flu shots varies yearly, it is usually less than 50%.
Herd immunity cannot be achieved for whooping cough or
influenza because neither vaccine is adequate. Pertussis vaccine immunity wanes so quickly
that little protection is left after 3-4 years.
Transmission to others can occur before you realize you have influenza or pertussis.
Even if 100% of Canadians were vaccinated, these diseases
would continue to circulate within the vaccinated and the unvaccinated
population.
Varicella cannot be eradicated both because the vaccine is
not optimal (85%
efficacy), waning
occurs, and because the virus stays in your body permanently after
vaccination or infection. Most
immunocompromised children who develop varicella infections do so from virus
already resident in their bodies. The
claim that vaccine exemptions put immunocompromised children at risk was
invented by PR firms, with no evidence behind it. In
fact, immunocompromised children are at
more risk from the shedding of live viruses in vaccines by other children who were recently vaccinated.
6. Sufficient population immunity appears to
exist
While vaccination rates reported in New Brunswick are low,
non-medical exemption rates are also low: 2%. The
likeliest explanation for lack of epidemics despite low recorded vaccination
rates is inadequate recordkeeping.
In Maine, with similar demographics, vaccination rates for
each of the required vaccines is about 95%. Exemption rates vary by
vaccine. Only 1% of US children receive
no vaccines. Up to 25% receive some, but
not every available vaccine.
7.
Should we be concerned about vaccine quality and origin?
Vaccines
are biologics. According to the FDA,
"Most biologics are complex mixtures that are not easily identified or
characterized."
Translation: vaccines contain
unknown substances, unknown even to the FDA and Public Health Agency of Canada.
This makes them challenging to
regulate. The FDA relies on vaccine manufacturers
to provide accurate data about each step in the manufacturing process. When a problem occurs during manufacturing,
the FDA expects to be told and expects the manufacturer to recall affected lots
of vaccine when necessary. I have provided
you information on 5 vaccine recalls or other issues in Canada since 2012.
The
quality of manufactured drugs has been diminishing. Over
80% of the drugs sold in the US are manufactured overseas, mostly in India and China.
The FDA
usually redacts information about the locations where vaccine ingredients are
manufactured. I am under the impression that at present, US vaccine products
are made in Europe and North America.
However,
the World Health Organization has a system for approving (or "prequalifying")
vaccines made
in underdeveloped countries for sale internationally--generally to other
underdeveloped countries.
Large
multinational pharmaceutical companies, such as Sanofi, which has vaccine
manufacturing facilities in
both India and China,
are manufacturing vaccines in underdeveloped nations. China and India each have over 20 vaccine
manufacturers. It is probably only a
matter of time before vaccines manufactured in countries known for inadequate
government monitoring of pharmaceuticals are being used in Canada and the US.
China
experienced vaccine scandals
in 2016 and in
2018:
"In
July, China experienced its “worst public health crisis in years” as stated by
South China Morning Post. Chinese vaccine maker Changsheng Biotechnology was
found to have fabricated production and inspection records and to have
arbitrarily changed process parameters and equipment during its production of
freeze-dried human rabies vaccines. Furthermore, substandard diphtheria,
pertussis, and tetanus (DPT) vaccines produced by Changsheng Biotechnology were
administered to 215,184 Chinese children; and 400,520 substandard DPT vaccines
produced by Wuhan Institute of Biological Products were sold in Hebei and
Chongqing. On July 25, China's drug regulator launched an investigation into
all vaccine producers across the country. Fifteen people from Changsheng Biotechnology,
including the chairman, have been detained by Chinese authorities.
This
latest vaccine scandal follows on from a series of fake and substandard food
and drugs issues in China. As a result, many parents have lost faith in the
vaccine system."
8.
Influenza, and the Fluad
vaccine
Influenza
is a disease that affects from 3-20% of the population yearly. There were 6515
reported influenza deaths in the US in 2017, during the decade's worst
outbreak. CDC uses mathematical models
to estimate
influenza deaths, and the estimates include deaths from other heart and
lung conditions, in people who had influenza. These estimates usually range
from 30-50,000 deaths yearly, related to influenza. Ninety percent of
influenza deaths occur in those over age 65. While most people over 65 receive annual flu
vaccines in the US, this age group is less likely to develop immunity from the
vaccine, compared to younger people.
Overall, flu vaccine effectiveness
averages about 40%, according to the CDC.
Each year,
influenza vaccines are newly made to contain the dominant strains predicted for
that season. Because of the need to make
different products each year, and make them rapidly available for each flu
season, they are not tested to the same extent as other vaccines. Clinical trials to
test for safety are not required for yearly changes to flu vaccines. Effectiveness trials are impossible to do prior to
mass use. Yearly flu vaccines are
"grandfathered in," although they are checked for manufacturing
defects.
In 2009, a
GSK vaccine for pandemic flu caused 1300 cases of narcolepsy in Europe,
mainly in adolescents and young adults. The European Medicines Agency
failed to warn the public of this problem in a timely manner, leading to
extended use of the problematic vaccine.
Possible
reasons this occurred include the revolving door between vaccine manufacturers
and regulators, the abbreviated safety testing of flu vaccines, and the
liability protection given to manufacturers by governments. The
episode provides a warning that regulators' first priority may not always be
the public's welfare.
The response
of elders to flu vaccines is particularly poor. Two strategies are being tried to enhance
vaccine immunity in this age group. The
first involves using higher concentrations of antigens in the vaccines. The second involves using novel adjuvants,
which are substances that provide increased stimulation to the immune
system. Potentially this can improve
immunity, but it might increase inflammation and autoimmune illnesses.
The Fluad vaccine is the only influenza
vaccine in Canada and the US to contain a novel, immune-boosting adjuvant. The adjuvant is called MF59 C1. Originally produced by an Italian company,
the adjuvant-containing flu vaccine was licensed for elders only, in Italy, in
1997. It was not licensed in the US
until 2015, for elders only, presumably because they were less likely to
experience complications from the vaccine's additional immune stimulation. I have been unable to find unbiased literature
on the MF59 adjuvant or the Fluad
vaccine, as all the research has been sponsored by its manufacturers (Sclavo, then Chiron, then Novartis, and now Sequirus).
Fluad was
licensed for elders in Canada in 2011. The
government
of Ontario's fact sheet on the vaccine makes clear that by 2016 it was
still not known whether the excess immune stimulation it provides actually improved
protection against the flu:
"How well does the Fluad® vaccine protect against
influenza? Influenza vaccines may
decrease hospitalizations and deaths among elderly individuals. According to
the product monograph, Fluad®
produces a higher immune response in elderly individuals when compared to other
influenza vaccines without an adjuvant. The
higher immune response may indicate that Fluad®
works better than unadjuvanted vaccines, although this is not known for
certain."
Nor is it known how safe the adjuvanted vaccine is. It causes about 15% more local reactions than
nonadjuvanted flu vaccines, but we don't know if it causes more serious, or
later onset, adverse reactions.
FluWatch
reports that 10 Canadian children died from flu last season, 8 aged 2-4 years old. Nine
children died the prior season. Canada
and the US recommend yearly flu vaccines for all eligible children aged over 6
months, while most of Europe does not recommend flu vaccine for healthy
children. Very young children generate a
poor immune response to current influenza vaccines. But few die from the disease.
Canada's
National Advisory Committee on Immunizations reviewed the literature on the use
of the Fluad, MF59-adjuvanted
vaccines in infants and young children in 2015. From their report's Executive Summary:
"Severe
reactions are rare, but several of the reviewed studies were too small to
detect clinically significant but rare adverse events. In particular, the
safety information is limited for ATIV (adjuvanted trivalent influenza
vaccines) in children with immunodeficiencies and other chronic illnesses...
There are insufficient data
to assess whether ATIV (adjuvanted flu vaccine) is more effective than UTIV (unadjuvanted
flu vaccine) or LAIV (live attenuated flu vaccine) in practice or to make an
informed risk-benefit analysis."
The reviewers also noted that the European Medicines Agency
(EMA) failed to license the vaccine for European children in 2012. The EMA
report found a number of problems with the single pivotal clinical trial of
Fluad in children. Furthermore, the EMA
report states, "The current application, although related to a product
developed more than 15 years ago and authorized for use in the elderly, includes
only one study addressing clinical vaccine efficacy." The report
concludes, "The overall
benefit-risk balance of Fluad Paediatric
is negative."
Despite
a) the lack of evidence of benefit, b) limited and c) unreliable safety
information, d) rejection in Europe, and e) no evidence of any other country
using it for children, f) let alone use in infants--in 2015 the Public Health
Agency of Canada (PHAC) licensed Fluad
pediatric for use in infants and babies aged 6 months to 2 years.
It seems that Canada's youngest children have been selected
to serve as the unwitting guinea pigs in a massive immune stimulation
experiment of this novel-adjuvanted vaccine.
What was the PHAC thinking?
Will Canadian children serve as experimental subjects, without their
parents' knowledge, for additional vaccines selected for them by their public
health agency?
If vaccine exemptions are removed, how can they be protected
from public health officials whose
primary allegiance may not be to the public?
Public
health officials use the mass media, medical professionals and the levers of
government to encourage, exhort and cajole vaccinations. Their
conduct with the Fluad pediatric
vaccine has shown they must not be given the power to compel.
