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)

Flu Vaccine Misses Flu Strains.....Again

by Barbara Loe Fisher

Every year, officials at the World Health Organization (WHO) and the U.S. Department of Health and Human Services (DHHS) look into a crystal ball and try to figure out which strains of Type A and Type B influenza will be prevalent in the U.S.. Sometimes they guess right and sometimes they guess wrong. This year, they guessed wrong as more than half of the influenza virus strains circulating in the U.S. right now are Type A and B strains that are not covered in this year's influenza vaccine.

In a typical flu season, only 20 percent of all flu-like illness is actually influenza. In 2003-2004 a mini-epidemic of a more severe type of influzenza caused by the A/Fujian strain occurred around the world, including the U.S. In spring of 2003, federal health agencies and the pharmaceutical industry knew the genetically mutated type A flu was emerging out of Asia and causing significant complications, including death, but chose not to include it in the 2003/2004 flu vaccine formula after the WHO voted to stay with strains that had been included in the previous year's formulation (A/Panama, A/Caledonia and B/Hong Kong). Without informing the public that the flu vaccine did not contain the strain of flu causing severe flu that season, the CDC heavily publicized child flu deaths in the fall of 2003 and Americans stood in long lines that fall and winter to get flu vaccine, which caused a vaccine shortage and subsequent CDC-recommended rationing of flu vaccine supplies. (http://www.nvic.org/History/Newsletters/%203770Reaction.pdf). The FDA stated that "between October 2003 and early January 2004, the deaths of 93 children younger than 18 had been reported to the CDC, according to preliminary data" and eventually the CDC would state that 152 flu related deaths occurred in children younger than 18 that year.

This year, the CDC is wisely admitting that this year's influenza vaccine does not match the circulating strains and is advising common sense strategies for prevention and management of flu, such as hand-washing.
Those who are suffering with an especially nasty bout with the flu this year can take comfort in the fact that natural experience with type A or type B influenza will produce immunological memory that will help minimize the risk of a severe case of that same strain of influenza when it circulates in the future. In fact, pandemic flu planners are counting on the superior, longer lasting cell mediated immunity of those Americans, who have actually recovered from influenza infection in the past, because drug companies won't be able to produce pandemic flu vaccine fast enough to provide doses for everyone for up to a year after the pandemic begins.

Many Americans are taking steps to deal with influenza or flu-like illnesses by enhancing the functioning of the immune system through diet, exercise and other positive lifestyle and health care changes. And if they do get the flu, they are taking a common sense approach. To prevent and treat influenza or flu-like illness that does not involve a fever over 103 F, pneumonia or serious complications which may require special medical intervention, here are a few non-toxic suggestions:

1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamins A and D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.

"Vaccines & Infant Death (SBS)

“Vaccines & Infant Death (SBS): Pediatrician Speaks Out on NVIC’s The Doctor’s Corner

by Barbara Loe Fisher

The Doctor’s Corner, sponsored by the National Vaccine Information Center, is a new internet forum at www.NVIC.org for pediatricians to publish referenced articles and analyses evaluating vaccine risks. Today, F. Edward Yazbak, M.D., FAAP, has published an analysis, “Multiple Vaccinations and Shaken Baby Syndrome,” that reviews the relationship between administration of multiple vaccines to infants who die and parents are subsequently charged with “Shaken Baby Syndrome (SBS).

Dr. Yazbak provides a review of death reports of infants 6 months of age or younger to the federal Vaccine Adverse Events Reporting System (VAERS). He describes individual case histories and the history of vaccine deaths which are misdiagnosed as Sudden Infant Death Syndrome (SIDS) and discusses vaccine deaths which may be misdiagnosed as Shaken Baby Syndrome (SBS).

When an infant dies after vaccination, often pediatricians are reluctant to consider the possibility that the vaccine(s) recently given to keep the child well have killed the child. In 1985, Dr. Coulter and I described the misdiagnosis as SIDS of infant deaths, which have occurred within 24 to 72 hours after DPT vaccination, in our book, A Shot in the Dark. The fact that coroners often misdiagnose vaccine deaths as SIDS is further evidenced by compensation awards made in the U.S. Court of Claims to parents whose babies died within hours of DPT vaccination but the coroner initially diagnosed the death as “SIDS.”

Dr. Yazbak’s article about the misdiagnosis of vaccine deaths as “Shaken Baby Syndrome” and the subsequent persecution and imprisonment of parents, whose babies died after vaccination, is an important one. No parent, who commits the crime of shaking a baby to death should be held unaccountable.

However, it is well known that vaccines can cause brain inflammation and catastrophic brain damage in some children. Until all of the biological mechanisms for vaccine injury and death are fully understood and described in the scientific literature, parents should be given the benefit of the doubt when babies die after vaccination.

To read Dr. Yazbak's article, click here.