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Studies Fail to Demonstrate Safety or Effectiveness of Influenza Vaccine in Children and Adults

Written by Pathways Magazine   
Friday, 01 December 2006 00:00
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Studies Fail to Demonstrate Safety or Effectiveness of Influenza Vaccine in Children and Adults
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National Vaccine Information Center (NVIC) Calls for Influenza Vaccine Policy Change

An independent analysis by the internationally renowned Cochrane Collaboration of worldwide influenza vaccine studies, published in the British Medical Journal on October 28, 2006, concluded there is little scientific proof that inactivated influenza vaccine is safe and effective for children and adults. Citing the Cochrane Collaboration finding as well as methodological flaws in a child influenza vaccine study published October 25 in the Journal of the American Medical Association (JAMA), the National Vaccine Information Center is calling on the Centers for Disease Control and Prevention (CDC) to stop recommending annual flu shots for all infants and children until methodologically sound studies are conducted.

Studies Fail to Demonstrate Safety“There is a big gap between policies promoting annual influenza vaccinations for most children and adults and supporting scientific evidence,” said epidemiologist Tom Jefferson, Cochrane Vaccines Field, Rome, Italy, who coordinated the comprehensive analysis for the prestigious Cochrane Collaboration. “Given the significant resources involved in annual mass influenza campaigns, there is urgent need for re-evaluation of these strategies.”

The Cochrane Collaboration analysis found that the majority of published influenza vaccine studies were methodologically flawed with selection biases, confounders and heavy reliance on nonrandomized studies. The report points out that potential confusion between respiratory infections caused by influenza viruses and those caused by non-influenza viruses can result in misdiagnosis and gross overestimation of the true impact of influenza on death and illness in a given influenza season. The report concluded that too few clinical trials have been conducted to prove vaccine safety and current evidence indicates that use of inactivated influenza vaccine has only a modest or no effect on preventing influenza in the children and the elderly.

Studies Fail to Demonstrate Safety“The CDC has pushed mass use of influenza vaccine in all children without scientific evidence the policy is either necessary or safe,” said NVIC President Barbara Loe Fisher. “Where is the good science to back up the policy? If the recently published CDC-funded influenza vaccine study in JAMA is the kind of flawed science public health officials are using to convince the public the vaccine is safe, it is no wonder that many parents don’t trust what public health officials say about vaccination. The CDC should stop recommending annual influenza vaccination of all young children when there is insufficient scientific justification for it.”

The JAMA study, which was conducted by Kaiser Permanente doctors with CDC funding, was a non-randomized retrospective analysis of the medical records of children 6 to 23 months old who were given influenza vaccine as well as other vaccines between 1991 and 2003. Vaccines were not randomly administered and unvaccinated controls were not used. Children’s case histories were included in the study only if an HMO doctor had seen them within 14 days of influenza vaccination. Dozens of convulsions and other adverse events, including brain injury experienced by children after vaccination, were excluded from the study if the children had not been seen by a doctor within 14 days of the adverse event or were sick in the weeks before and after vaccination.