Rotavirus vaccine

Emerging Scandal in Vaccine Mandates

In its initial trial, the rotavirus vaccine appeared to cause intussusception at 30 times the average rate, but the government pretended that those injuries were insignificant. Instead of testing further, the CDC and the vaccine manufacturer subjected babies to more than a million doses of this unnecessary, expensive, and inadequately tested vaccine.

While the risk of intussusception may have been mentioned on the package insert, it was not on the vaccine information statement given to parents. The arbitrariness of government vaccine mandates is shown by the fact that, for the previous year, CDC was demanding that the vaccine be given to all infants, and now suddenly a CDC spokesman is saying, "No one should now be giving rotavirus vaccine to anyone."

Burton Critical of Vaccine Approval Process

The report focuses on the advisory committees' review of the controversial rotavirus vaccine in 1997 and 1998.  Despite concerns about potentially serious side effects of the drug, it won unanimous votes of support in both committees.  Within one year, the vaccine, made by Wyeth Lederle had to be pulled from the market because it was causing severe bowel obstructions in infants that required surgery to correct.  One baby died.

The Committee found that three out of the five full-time FDA advisory committee members who voted for the vaccine had financial ties to Wyeth Lederle or tow companies developing rival rotavirus vaccines...Merck and SmithKline Beecham.  Four out of eight CDC advisory committee members who supported the vaccine had conflicts with the same companies.  The staff report concludes that the committees demonstrated a "lack of vigilance" in their review of the rotavirus vaccine known as "Rotashield", with the CDC's committee rushing to approve guidelines for the vaccine even before the FDA had licensed it.

One physician who voted to recommend the rotavirus vaccine on the FDA's advisory committee received $255,000.00 per year in research funds from the maker of the vaccine, Wyeth Lederle.  She received a waiver from the FDA to vote on the issue because her research for Wyeth focused on other vaccines.  

One member of the CDC's advisory committee who was not allowed to vote on the rotavirus vaccine because of a conflict was allowed to participate in closed-door working group meetings that drafted the committee's recommendations for the vaccine.  He was also allowed to make an impassioned plea for approval of the vaccine at the full committee hearing. 

Another member of the CDC's advisory committee held a lucrative patent on a rival rotavirus vaccine under development by Merck.  Despite this conflict, the doctor voted three times on recommendations regarding Wyeth's vaccine.  It was not until the committee voted to rescind its recommendation of the rotashield that he recused himself because of a "perception of conflict".