Pediarix's FDA approval criticized

Pediarix vaccine - Shorts

Townsend Letter for Doctors and Patients , Oct, 2003 by Jule Klotter

In December 2002, the FDA approved a new combination vaccine for use in children under 6 months of age. GlaxoSmithKline's Pediarix is for diphtheria, tetanus, whooping cough, hepatitis B, and polio. Marketers boast that Pediarix cuts down on an infant's pain (and tears) because it requires only 3 injections instead of 9 to get the same amount of protection. Dr. Mark M. Blatter of Primary Physicians Research in Pittsburgh, one of the Glaxo-funded study sites, said that "Scientists are working to create vaccines against more and more diseases, and without combining shots there simply won't be room on babies' tiny thighs for more inoculations." An Associated Press article said that side effects were similar in babies who got Pediarix and those who got separate shots, although the Pediarix group had a higher incidence of low fever.

Dr. Sherri Tenpenny, DO, a nationally renowned and respected vaccine expect, criticized the studies that led to Pediarix's FDA approval. Instead of comparing a new vaccine to a known inert substance, such as sterile water or saline, vaccine researchers now compare the new vaccine to a vaccine with a 'known side effect profile.' In the case of Pediarix, researchers, coordinated by the UCLA Center for Vaccine Research, divided 400 children into 4 groups. One group received 3 doses of Pediatrix with HiB (flu). The second group got two doses of the same combination plus another Glaxo investigational combination (DTaP and HepB) plus oral polio. The third also received the DTaP--HepB combination and vaccines for polio and flu. The fourth group received individual doses of DTaP, HepB, HiB and oral polio. All of the children produced antibodies so the combinations were deemed effective.

The study also claimed that "there were no vaccine-related serious adverse events to any group after any vaccine dose," but serious adverse events did occur. Quoting the study, Dr. Tenpenny writes: "Two subjects withdrew from the study because of serious adverse events that were determined by the safety monitor to be unrelated to vaccination. One subject in Group A was diagnosed with a seizure disorder 14 days after the first immunization. Another subject in Group B had a neuroblastoma detected 6 weeks after the first immunization. Six other reported serious adverse events involved hospitalizations for brochiolitis/pneumonia (4), meningitis (1) and apnea (1) and were also determined to be unrelated to vaccination. "Why is it," she asks, "that whenever an adverse event occurs during the course of a vaccine clinical trial, that 'event' is never related to vaccination?"

Dr. Tenpenny urges consumers to read the package inserts for vaccines with care, especially the one for Pediarix. Pediarix contains a troubling list of additives, adjuvants and contaminants including formaldehyde, glutaraldehyde, 2-Phenoxyethanol (antifreeze), Thimerosal (12.5 nanograms), VERO (monkey) cells, neomycin, polymyxin B, polysorbate 80, and yeast protein.

Neergaard, Lauran. New vaccine to cut 6 of 20 shots for babies. The Herald-Sun, 17 December 2002.

Tenpenny, Sherri, DO. Commentary on Pediarix. January 25, 2003 www.mercola.com.