Combo Vaccine Study Proves Nothing

Combo Vaccine Study Proves Nothing

by Barbara Loe Fisher

A study funded by British vaccine maker, GlaxoSmithKline, 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/84606.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/transcripts/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.

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Medical World News Today, October 4, 2007
Study Checks the Safety of Combination Vaccines

"Only more immunizations will enter the schedule," said Michael 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)