[NVIC] Combo Vaccine Study Proves Nothing

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Combo Vaccine Study Proves Nothing

by Barbara Loe Fisher

A study funded by British vaccine maker, GlaxoKline, and conducted by

University of Rochester vaccine developers claims to have proven that

simultaneously injecting infants with 7 vaccines in separate shots is no

more reactive or less effective than simultaneously injecting infants with

7 vaccines contained in combination shots.

http://www.medicalnewstoday.com/articles/8460 6.php

Specifically, GSK conducted the study in an effort to " prove " that the 5

vaccines in 1 shot, Pediarix, can be given simultaneously with other

vaccines without causing more reactions or compromising the effectiveness

of the pertussis (whooping cough) portion of the shot as pre-licensure

studies indicated.

http://www.fda.gov/ohrms/dockets/ac/01/transcrip ts/3733t1.htm

What do GSK officials and University of Rochester doctors running the study

for GSK think that they have proven about Pediarix safety and

effectiveness? Do they really believe the educated public will be reassured

by a study that only included 575 two month old healthy babies divided into

three groups - all of whom got seven vaccines whether given separately or

in combination?

To accurately answer outstanding questions about Pediarix safety and

effectiveness - as well as the safety and effectiveness of repeatedly

injecting babies with seven vaccines simultaneously at two, four, and six

months - GSK would have had to prospectively enroll at least 3,000 - 5,000

infants aged two months to five years and followed them up for at least

five years. The study should also have included an unvaccinated group of

children with a five year follow-up period to compare the brain and immune

system function of unvaccinated children to those who were injected with

Pediatrix in combination with other vaccines. By age five, the symptoms of

ADHD, learning disabilities, autism, asthma, severe allergies and other

neuroimmune dysfunction become apparent and, if autism occurs in about 10

per 1,000 children, a study of 3,000 to 5,000 children would yield between

30 and 50 autistic children by age five in all groups if there are no

health outcome differences between vaccinated and unvaccinated children.

Even without an unvaccinated control group, it is ludicrous to conclude

that studying 575 healthy newborns and following them up for 7 months

generates enough useful data to conclude much of anything about giving

infants so many vaccines on one day, whether the vaccines are given

separately or in combination. This study by GSK to promote purchase and use

of Pediarix does nothing to reassure parents and doctors that there are no

adverse long term health consequences from repeatedly using this vaccine in

combination with other pediatric vaccines in the first year of life.

" Only more immunizations will enter the schedule, " said Pichichero,

M.D., professor of Microbiology/Immunology, Pediatrics and Medicine at the

University of Rochester and the study's lead author. " Coupling or tripling

of these vaccines is increasingly important, as this streamlining helps to

promote parent compliance, timely vaccination and fewer administration

errors. " .....The earlier studies found that when the vaccines were

co-administered, a suboptimal immune response was produced against whooping

cough, and more uncomfortable reactions, such as swelling at the injection

site, could be expected.... " Vaccine opponents may liken the process of the

body processing simultaneous vaccines to a computer running too many

applications; the machine grows slow, and the programs, one by one, begin

to terminate, " Pichichero said. " But those fears are unfounded; we have

found no evidence that a child's body is at any point approaching a maximum

threshold as far as learning to produce immune responses. " .... " If

pediatricians were holding out on making the switch to a combined vaccine

for fear that its protection might be inferior, they no longer need be

concerned, " Pichichero said. " It seems the clinical relevance of any

previously observed differences with regard to whooping cough immunity have

been dispelled. " - Medical World News Today (October 3, 2007)

Study Checks The Safety Of Combination Vaccines

Medical News Today

October 4, 2007

www.medicalnewstoday.com/articles/84606.php

A University of Rochester study brings relief to new parents who, while

navigating a jam-packed childhood vaccine schedule, can expect to soothe

their newborn through as many as 15 " pokes " by his or her six-month checkup.

The study, recently published in The Journal of Pediatrics, shows that no

efficacy or safety is compromised when clinicians administer a new

combination vaccine that streamlines the process -- in effect, tripling up

three of the recommended shots to reduce the " poke " total from five to

three, at each of three bimonthly, well-child checkups.

" Only more immunizations will enter the schedule, " said Pichichero,

M.D., professor of Microbiology/Immunology, Pediatrics and Medicine at the

University of Rochester and the study's lead author. " Coupling or tripling

of these vaccines is increasingly important, as this streamlining helps to

promote parent compliance, timely vaccination and fewer administration

errors. "

The study overturns findings (and fears) from a previous study that

suggested problems when two specific vaccines were given at the same time

-- Pediarix, a combination of vaccines that guard against diphtheria,

tetanus, whooping cough, hepatitis B and poliovirus, and Prevnar, which

protects against 7 strains of Streptococcus pneumonia. The earlier studies

found that when the vaccines were co- administered, a suboptimal immune

response was produced against whooping cough, and more uncomfortable

reactions, such as swelling at the injection site, could be expected.

Both Pediarix and Prevnar are recommended for administration at 2-, 4- and

6-month checkups; Prevnar was approved in 2000, shortly before the

licensure of Pediarix.

" This newest study unseated both early reservations, showing that the

combination vaccine was in fact just as safe and as immunogenic as separate

shots, even in the midst of other vaccines in the schedule, " Pichichero said.

Study Details

A total of 575 healthy 2-month-olds were enrolled at 22 sites nationwide.

Each infant was randomly assigned to one of three trial groups:

1. Combination Vaccine Group, which received three vaccines -- the

combination vaccine (DTaP-HepB- IPV, or brand name Pediarix), a second

vaccine to protect against HiB, and a third, PCV-7 (or brand name Prevnar).

2. Separate Vaccine Group, which received five independent vaccines: DTaP,

(for diphtheria, tetanus and whooping cough), HepB (for hepatitis , IPV

(for poliovirus), HiB, and PVC-7.

3. Staggered Vaccine Group that was identical to the Combination Group,

save that PCV-7 vaccines were delayed by two weeks at every appointment,

thereby demanding a total of six pediatric office visits, instead of three.

Blood samples were collected before the study began, and again when infants

were 7 months, to test for a robust immune response to each disease-trigger.

Parents were provided a diary and asked to record temperatures, general

symptoms such as fussiness, irritability or loss of appetite, and local

injection site symptoms such as pain or swelling.

Results

Minor symptoms were more common in the Combination Vaccine Group; however

higher fevers and more severe shot site reactions were not significantly

more likely to occur in infants in any of the three groups.

For example, swelling and pain were significantly higher at the injection

site of the combination vaccine, but Pichichero said that is to be

expected, given that there are more ingredients in that single shot

(vaccines are made from killed or modified forms of bacteria or viruses, or

only pieces or products of the germs). But, he added, it was noteworthy

that at no time did any local symptoms (swelling, redness, pain) lead to an

infant obtaining a medical attention visit.

" Vaccine opponents may liken the process of the body processing

simultaneous vaccines to a computer running too many applications; the

machine grows slow, and the programs, one by one, begin to terminate, "

Pichichero said. " But those fears are unfounded; we have found no evidence

that a child's body is at any point approaching a maximum threshold as far

as learning to produce immune responses. "

When you administer more vaccines, you expect more symptoms, more fevers,

he said. Fever, swelling, redness are all indicators that the vaccine is

working, that the body is busy creating the right immunity to prevent disease.

" So long as they are mild, they pale in comparison to benefits of

convenience to the parent, the fewer number of pokes to the infant, and of

course, the severity of the diseases we are preventing, " he said.

Perhaps most importantly, the study showed the Combination Vaccine Group

enjoyed at least as good immunogenicity as the Separate and Staggered

Groups, for all criteria -- including the criterion for protecting against

whooping cough, for which previous, smaller-scale studies had yielded

inconsistent results.

" If pediatricians were holding out on making the switch to a combined

vaccine for fear that its protection might be inferior, they no longer need

be concerned, " Pichichero said. " It seems the clinical relevance of any

previously observed differences with regard to whooping cough immunity have

been dispelled. "

----------------------------

Article adapted by Medical News Today from original press release.

----------------------------

Childhood immune schedules are established at the federal level by the

Center for Disease Control's Advisory Committee on Immunization Practices,

which works jointly with the American Academy of Pediatrics and the

American Academy of Family Physicians. They currently endorse, but do not

mandate, the use of combination vaccines.

The study was funded by a grant from GlaxoKline Biologicals, makers of

Pediarix.

Source: Becky

University of Rochester Medical Center

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