FDA Panel Approves Rotarix Safety 11-1

FDA Panel Approves Rotarix Safety 11-1
Consumer Member Vicky Debold Votes "NO" on Proof of Safety by GSK

by Barbara Loe Fisher

NVIC's Director of Patient Safety, Vicky Debold, Ph.D, RN, who is the consumer voting member on the FDA Vaccines and Related Biological Products Advisory Committee, cast the sole dissenting "NO" vote when the Committee was asked whether GlaxoSmithKline's pre-licensure clinical trials had proved that rotavirus vaccine (Rotarix) is safe to give to infants. The FDA Panel voted unanimously that GSK had proven effectiveness but voted 11-1 on the safety question.

Debold noted that there were more deaths among the healthy infants who received Rotarix compared to those who received a placebo. She pointed out that the clinical trials did not inlude premature, sick and otherwise biologically compromised infants and asked "What is going to happen when this vaccine is given to children in the real world?" An FDA staff report analyzing GSK data revealed a statistically significant increase in deaths related to pneumonia among infants who got Rotarix versus the placebo.

Rotarix vaccine will directly compete with Merck's Rotateq vaccine for market share. Rotateq, a genetically engineered hybrid live virus vaccine containing human and bovine strains, has been associated with bowel blockage (intussusception). Bowel blockage does not appear to be a problem for live virus Rotarix, which contains genetically engineered human rotavirus strains, although serious adverse events associated with the new vaccine have included not only pneumonia and death but also bronchitis and convulsions.

"GlaxoSmithKline Plc's infant vaccine to prevent diarrhea caused by the rotavirus appears safe and effective, based on available data, U.S. advisers said on Wednesday.........In a briefing prepared for the meeting, FDA staff had noted a statistically significant increase in deaths related to pneumonia compared with placebo in Glaxo's largest trial. The panel was unanimous the vaccine appeared effective and voted 11-1 that it appeared safe.....Vicky Debold, patient safety director at the National Vaccine Information Center, was the sole panel member to vote that the data does not support the vaccine's safety. She noted the infants studied were all healthy and asked: "What happens when this vaccine is given to children in the real world?" - Kim Dixon, Reuters, (February 20, 2008)

"Steven Rosenthal, an FDA medical officer who presented the agency's review of the vaccine, said there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies. The overall death rate from any cause, however, was similar between infants given the vaccine and those in placebo groups. In total there were 118 deaths among all infants in the studies with 19 pneumonia related-deaths among those receiving the vaccine and 10 among those not receiving it. He said if Rotarix is approved in the U.S., Glaxo would conduct a post-marketing study of the vaccine to monitor for potential side effects such as pneumonia, convulsions and intussusceptions. In briefing documents prepared for Wednesday's meeting, an FDA staff review said it wasn't clear what role, if any, the vaccine played in the risk, while Glaxo officials said there didn't appear to be any link to the vaccine. Clare Kahn, Glaxo's North American vice president of regulatory affairs, said, "The risk-benefit ratio is favorable for the intended population." One panel member voted against the vaccine on safety grounds. Vicky Debold, a nurse and the panel's consumer representative, said she was concerned about not just the pneumonia-related deaths but the overall death rate." - Jennifer Corbbett Dooren, Wall Street Journal, (February 20, 2008)


Anonymous said...

What we are not told about the vaccine and drug pushers are when a new vaccine or drug is tested, they look for targeted reactions to whatever is being studied.

When they give their toxic chemicals to the subjects they look past the adverse side effects or deaths and see if the chemicals caused something in the subjects that can be keyed in on and tout that this new drug/chemical/vaccine will help this ailment.

By all their "studies or trials" they ignore the side effects and run with what happened to a targeted result, claiming it was succeful. Then they skew the data or studies around the "tests" and say the side effects are not related to the product(s) that they push, that it was agenetic defect in the sublect.

Give me a break, literally.

I choose not believe in the FDA or mainstream medicine and that they are there in my best interest or for the actual GOOD health of the people, they are there to control the people and every life.


Cathy said...

Are most vaccines genetically altered and in what way?

Has the nature of vaccines (not just their overuse) changed in the past 20 years?

What bothers me most is not the approval with caution, but the lack of dissenting voices among the medical community (including the FDA). Without an educated debate, how can one make an informed decision? When I take my child into the doctor - I get only warnings about the diseases the vaccines are supposed to prevent.


Archana said...

Information on both rotarix and rotateq is not clear. For example: statistically rotavirus affects almost all kids under the age of 5, at least once. Therefore the risk factor from ages 0-5 yrs is 100% if kids are not vaccinated.

However the vaccine claims to provide safety in children who are below 2 years of age.

I would like to know two things:
1. What is the risk factor of getting rotavirus infection below the age of two?
2. If the vaccine does not protect children between ages of 3 and 5 why take it?

Anonymous said...

I have three children. My first child did not receive the Rotarix immunisation, but the second and third have as it has since become compulsary (ie, they won't be allowed into a kinda/childcare centre without it). My first child has no food allergies/ intolerances, but the other two both have intolerances to dairy and the third who is only six months old already seems to have problems with apple and carrot. I have spoken to a number of mums who's children have had the immunisation who have had similar experiences. I believe there is a correlation with the immunisation and food intolerances, perhaps as the virus damages the gut. Has anyone else had these experiences?? I have found no literature that backs this up or even talks about it.