The replacement effect
Concern over a vaccine that causes unintended increase in related infections
| By John Dudley Miller
Prevnar, a vaccine that is dramatically decreasing the number of American
babies' infections from a common but serious bacterium, also increases the
number of other infections the babies get, according to an Israeli
researcher. No other vaccine in history has shown this unintended effect,
said Ron Dagan, director of the Pediatric Infectious Disease Unit at Soroka
University Medical Center in Beer-Sheva, Israel. "[Its importance] is not
minor," he said, "but for the moment, we cannot estimate totally the
clinical effect because we still do not have enough vaccinated people."
Hypothetically, Prevnar's disease-enabling ability might someday become as
powerful as its disease-preventing capacity, rendering it effectively
useless, said Dagan, and necessitating a new vaccine design. Future vaccines
utilizing the same approach of targeting specific strains in a larger
microbial family might also create this effect, according to other
Prevnar, a 7-valent pneumococcal conjugate vaccine marketed by Wyeth, helps
prevent routine fevers, headaches, and earaches in young children as well as
rarer, invasive infections with bacterial pneumonia or meningitis caused by
the seven most widespread varieties of 90 types of pneumococcus bacteria.
Kids and adults routinely carry all 90 strains in their noses and throats,
even when they are not sick.
Prevnar vaccinations have been recommended for all American babies since
mid-2000. Between 1999 and 2001, "invasive" pneumococcal infections, the
most serious category, dropped 68% in babies under age 2, according to a
national study conducted by the US Centers for Disease Control and
Prevnar also lowered pneumococcal infection rates in older people who had
never received the vaccine. Over the same 2 years, invasive pneumococcal
infections in the United States dropped 29% in adults aged 20 to 39 and 17%
in people over 65. Dagan attributes those decreases to the fact that
vaccinated babies no longer carry the seven most prominent strains in their
noses and throats, so they can't infect parents or grandparents.
Even so, Prevnar is already becoming somewhat less effective against
infections of the middle ear, according to the CDC's Cynthia Whitney. "It's
a big headache for us… the numbers just aren't as good as one would like,"
she said. Between 1999 and 2001, another study in the Pittsburgh area (C.
McEllistrem et al., unpublished data, 2003) found the percentage of
pneumococcal middle ear infections caused by strains that Prevnar doesn't
protect against more than doubled, from 16 to 37%.
This shift in prevalence from one kind of infection to another is not yet
much of a problem with invasive infections, although Dagan said cases are
increasing. Dagan and others call the effect "replacement" because Prevnar
effectively replaces infections by the seven targeted strains of pneumococci
with similar infections by the other 83 strains. Prevnar vaccination also
enables a slight increase in middle ear infections caused by two unrelated
bacteria. These infections spread more easily because the vaccine wipes out
their seven former competitors.
Dagan said the reason previous vaccines have not caused replacement is that
healthy people don't harbor the bugs those vaccines protect against. With
Prevnar, once it eliminates the seven selected strains, all the others
proliferate inside babies' noses and throats, waiting for an opportunity to
start an infection or to spread to someone else.
Steve Pelton, a pediatrician and pediatrics professor at the Boston
University School of Medicine, points to an additional cause in the
unexpected diversity of the 90 strains of pneumococci. Researchers had hoped
that targeting the seven most common strains would provide more protection
against the other 83, he explained. But if a replacement vaccine is
eventually necessary, Pelton suggests a different approach: If you target
something that's in all pneumococci, then you won't have this problem, he
Links for this article
J.D. Miller, "Unblocking the vaccine pipeline," The Scientist, May 13, 2003.
C.G. Whitney et al., "Decline in invasive pneumococcal disease after the
introduction of protein-polysaccharide conjugate vaccine," New England
Journal of Medicine, 348:1737-1746, May 1, 2003. [PubMed Abstract]
J. Eskola et al., "Efficacy of a pneumococcal conjugate vaccine against
acute otitis media," New England Journal of Medicine, 344:403-409, February
Testimony by Jerri Johnson
Health and Human Services Policy Committee
January 27, 2003
Costs to the State of Adding Vaccine Requirements
Immunization requirements are enforced by child care providers, state
licensers of child care providers, and the public schools. This enforcement
costs money for staff to do record-keeping and follow-up. Much of this cost
is borne by the state. A study in 1998 estimated that enforcing the
immunization requirements cost the state at that time around $5 million per
year. Will adding new vaccines to the list increase costs to schools? It
will, because many more follow-up contacts will be needed for these
Currently, 35% of parents are not vaccinating their children for chickenpox.
Minneapolis Public Schools estimated that each parent follow-up contact cost
$18 in staff time.
Minneapolis Public Schools wrote to the Department of Health asking that no
immunization requirements be added until funding is in place to enforce
them. In addition to the state costs of enforcing vaccine requirements,
these vaccines cost money in health care dollars.
I have included a handout in your package with medical cost analyses of
pneumococcal and chickenpox vaccines. Chickenpox and pneumococcal vaccine
programs actually cost more money than they save from preventing disease.
The pneumococcal vaccine, for example costs
around $60 per dose, or $240 per child for the four-dose series. The
chickenpox vaccine also does not recover costs when looking at the cost of
the vaccine compared to the cost of the disease. Only by factoring in
indirect costs, such as lost wages for a parent to stay home with a child
sick with chickenpox, is this vaccine deemed to be cost-effective.
But these assessments of indirect costs did not include the cost of caring
for vaccine-injured children. Hospitalization and medical costs for these
children are extremely high. During school years, they require special
education services, costs borne by the state. These children may later be
cared for in group homes the rest of their lives, incurring huge costs to
the state. Twelve per cent of our children now have chronic disease of some
sort, and many medical experts believe that the rapid increase in diseases
such as autism, ADD, juvenile diabetes, and asthma is partially attributable
to the increase in required vaccines.
A parent who stays home for 5 days when her child has chickenpox may use
vacation days or may lose some income. But parents of children disabled by
vaccines often must quit work permanently to stay home with their child,
losing years of income, and the vaccine-injured child may never grow up to
earn a productive income.
But ultimately, the question before us is not about dollars and cents. When
we are preventing communicable disease, and when we are preventing vaccine
injuries, the real issue is the value in human life that can't be
quantified. You can't put a price on the joy of having a healthy baby, and
you can't quantify the grief of a parent who loses a baby, no matter what
And so the Minnesota Natural Health Coalition is calling for the following:
1. Safer vaccines. Pharmaceutical companies need to be held accountable to
produce vaccines that have fewer serious side effects.
2. The State of Minnesota should not require new vaccines if we do not know
whether they are safe for our children. In the case of the pneumococcal
vaccine, during the pre-licensure study, where 17,000 healthy infants with
no acute or underlying chronic disease were given Prevnar, 162 infants
required emergency room care and 24 were hospitalized within 72 hours of
receiving the vaccine, 8 infants who had never had seizures before had
seizures within 72 hours. 40 infants who had never had asthma before
required doctor's care for asthma, wheezing, shortness of breath or
breath-holding within 72 hours of the vaccine. One previously healthy child
developed congestive heart failure within 72 hours of the vaccine. Three
children developed hypotonic/hyporesponsive episodes. Were these serious
situations caused by the vaccine? There is no way to determine this without
following the time-honored scientific process of comparing the test group
with a control group that did not receive a vaccine. This was not done. One
variable, the test vaccine, was compared with another variable, another
Yet the physicians who conducted the study concluded at the end, this test
"did not reveal any severe adverse events related to vaccination that
resulted in hospitalization, emergency room visits, or clinic visits." This
is the Vaccine Information Sheet on Prevnar given to parents at their
clinics. It says, "So far, no serious reactions have been associated with
this vaccine." Given the structure of the clinical study, it is not
scientifically possible to say that these reactions were caused by the
vaccine, nor is it possible to say that they were not.
3. If it is inherently impossible to produce a vaccine without a significant
risk of serious adverse effects or death, then we need to be clear about
that. If the pneumococcal vaccine effectively reduces pneumococcal disease,
but at the price of death or disability to a few babies, we need to know
those numbers. Our research needs to be science-based, with control groups,
and parents need to know the risks so they can make an informed decision.
We are having a good debate in this country on the smallpox vaccine. This
could be a great model for our infant vaccination programs. Public health
officials are doing a good job of articulating the risks of smallpox and the
risks of the vaccine. 1 or 2 deaths per million from the vaccine is being
taken very seriously. Adults are weighing the risks and benefits.
We should afford the same courtesy to infants and their parents in the
routine vaccine program.
4. Parents should be educated that if their child is ill, vaccination should
be postponed. They should be told that if their child suffered a seizure or
bad reaction to a previous vaccine, she is at risk for an even greater
reaction to the next one. .If parents have a family history of a severe
vaccine reaction, they should know that their child may be at risk. The CDC
already has guidelines on this, and they are printed on the sheets given to
parents when the child receives a vaccine. If parents knew this before
making their appointments with the doctor, perhaps many vaccine injuries
could be avoided. Again, the smallpox discussion is a good model on this -
people are being informed that if you have eczema, you are at risk from the
vaccine. . If you are on corticosteroids, you are at risk. Similarly,
parents of infants could be advised on this at an early date.
5. If new vaccines being produced can not be safer, then perhaps we need to
rethink the model which vaccinates the entire population for a disease. This
model was developed in response to overwhelming epidemics like polio.
However, in the case of invasive pneumococcal disease, which affects
only 0.2% of Minnesota children, this may not be an appropriate model.
6. Finally, parents who believe that their child was harmed or killed by a
vaccine need to be heard and taken seriously. They should not be brushed off
by being told it was not related to the vaccine. Their experience should be
studied for clues to how we can have safer vaccine programs.
Wyeth Halts Shipments of Prevnar Vaccine
NEW YORK (Reuters) - Wyeth on Thursday said it has temporarily delayed
shipping its blockbuster Prevnar vaccine against childhood pneumococcal
infections because of the need to upgrade company quality-control processes.
(What this really means is the plant is filthy and we had to clean it up)
Wyeth spokesman Doug Petkus declined to give further details, but said the
company decided on its own to upgrade its quality-control systems for
Prevnar and had not been asked to do so by the U.S. Food and Drug
Otitis Media Pathogens Skewed by 7-Valent Pneumococcal
By David Douglas
NEW YORK (Reuters Health) Dec 22 - Certain strains of bacteria are more
prevalent in children with acute otitis media who have been inoculated with
the pneumococcal 7-valent protein conjugate (PNC7) vaccine, researchers
report, with strains not included in the vaccine being favored.
As lead investigator Dr. M. Catherine McEllistrem told Reuters Health, "the
proportion of cases of pneumococcal acute otitis media due to non-vaccine
serogroup strains rapidly increased from 1999 to 2001 in children who
received at least two doses of PNC7 vaccine."
Before licensure of this vaccine, about 85% of middle-ear isolates from
children with the disease were of vaccine serotypes or cross-reacting
However, Dr. McEllistrem of the University of Pittsburgh School of Medicine
and colleagues found that from 1999 to 2001, the proportion of non-vaccine
serogroups increased from 14.8% to 36.5%.
Furthermore, they report in the December 1st issue of the Journal of
Infectious Diseases, among children who received at least two doses of PNC7
vaccine, 46.7% of the isolates had non-vaccine serotypes compared with 20.8%
in children who did not receive the vaccine.
Although this phenomenon is occurring among children who have acute otitis
media due to Streptococcus pneumoniae, "significant serotype replacement has
not been detected among children with pneumococcal invasive disease since
introduction of the PNC7 vaccine," Dr. McEllistrem pointed out.
"These data," she concluded, "underscore the importance of the monitoring
the epidemiology of pneumococcal infections in the PNC7 vaccine era."
J Infect Dis 2003;188:1679-1684.
3 September 2006
Report links 'super dose' to thousands of adverse reactions in US children
Fears new 7-in-1 meningitis jab endangers lives
By Lucy Johnston
Babies given a "super dose" vaccine due to be launched tomorrow risk serious
side effects and even death, a report claims. Prevenar, will be added to the
childhood immunisation programme containing vaccines against seven strains
The drug is designed to combat bacteria that cause diseases such as
pneumonia and blood poisoning as well as meningitis. It provokes the body's
immune response to the bacteria without causing the diseases. But a report,
The Next Storm, reveals that the jab, combined with other childhood
inoculations, has been linked to breathing problems, brain damage,
convulsions, extreme allergic shock and death.
A similar combination of vaccines has been given to babies in the US for
more than five years. The report's author, Dr Edward Yazbak, is an
American child vaccination specialist who has analysed reports of
side-effects received by the American Vaccine Adverse Events Reporting
He discovered thousands of reactions linked with Prevenar.
Since March 2000 there has been 11,611 adverse reports following the jab
including 362 deaths and 1,347 hospitalisations, although Dr Yazbak pointed
out that a report does not prove the jab caused the reaction. He said: "Such
a combination of jabs has been linked with serious reactions and death in
this country. The authorities in Britain should be very alert to what
happens when all these vaccines are given together."
His study has led to calls for an overhaul of the UK vaccination programme,
which will see babies receiving 25 inoculations by the time, they are 13
months old. Doctors and health expert say there have been no long-term
studies into the dangers. Liberal Democrat health spokeswoman Sandra
Gidley said: "We shouldn't be doing this until we know more about what
happens long term." Dr Peter Mansfield, who won a case against the
doctor's governing body, the General Medical Council, for refusing to give
the measles, mumps and rubella jab to infants, said: "We're vaccinating
babies when their immune systems are not ready. We're breaking the rules of
nature and we really don't know what the result will be."
Jackie Fletcher from Jabs, a support group for parents who believe their
children have been damaged by vaccines, wrote to the Chief Medical Officer,
Professor Liam Donaldson, asking for evidence that the new schedule has been
properly tested. She has received no reply. She said: "Doctors have
raised serious concerns about the old schedule. Surely we need to ensure
this is safe before introducing new ones?"
"Single jabs have been phased out without any consultation. Families should
be given a range of options." In a statement to the Sunday Express, Sir Liam
said the new jab had been introduced, "on the best available scientific and
medical evidence." He added: "This will save many babies' lives a year as
well as preventing hundreds more cases of serious illness and disability."
The new schedule :
At 2 months babies will be given the five-in-one - diphtheria, tetanus,
whooping cough, hib meningitis and polio - and Prevenar.
At 3 months they will get a repeat of the five-in-one and a dose of
At 4 months they will receive a third shot of the five-in-one with Prevenar
and meningitis C.
At 12 months hib meningitis and meningitis C.
At 13 months they will get the MMR together with Prevenar, making a total of
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