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There is no proof that flu shots work well in children under 2, concludes a study released Friday --- the second in as many weeks to seriously challenge the Centers for Disease Control and Prevention's flu shot policies.
The Atlanta-based CDC countered that plenty of data support its recommendation that children ages 6 to 23 months get the shots. The advice, adopted in 2003, was put into effect before the current flu season started.
"Immunization of very young children is not lent support by our findings," wrote the researchers, led by Dr. Tom Jefferson of the Cochrane Vaccines Field in Rome. "We recorded no convincing evidence that vaccines can reduce mortality, admissions, serious complications and community transmission of influenza."
U.S. health officials said ongoing studies could bolster the CDC's recommendation, while also pointing out that scientists are trying to improve the vaccine. Nonetheless, pediatricians urged parents to continue immunizing young children.
"We are looking toward newer and better [flu] vaccines," said Dr. Janet Gilsdorf, director of pediatric infectious diseases at the University of Michigan, who is on the CDC's vaccine advisory board.
"But we have what we have, and we should use it," Gilsdorf said. "I would certainly not be dissuaded from using this vaccine in young children."
Yet advocacy groups concerned about side effects said the new report further calls into the question whether the risks --- which health officials say are minimal --- are worth it. Some of the worry stems from the mercury-containing preservative thimerosal found in some children's flu shots.
Critics of thimerosal say it may cause autism, though nearly all research has refuted such a link. Still, adding flu shots to the many other vaccines recommended for infants potentially increases the risk of any side effects, some say.
"Vaccines are treated in a cavalier way by the CDC; there's almost an assumption of safety and effectiveness before rigorous study," said Barbara Loe Fisher, president of the National Vaccine Information Center. "We're performing a national experiment on 6-month-old babies." Flu season peaking
Meanwhile, this winter's relatively mild flu season appears to be peaking. Thirty-three states, including Georgia, said Friday they have widespread disease. Georgia reported its first confirmed childhood flu death this year --- a 17-year-old from Wilkinson County, east of Macon, who died Feb. 8. It is one of nine deaths among children under 18 reported nationally this year.
During last year's early and heavy flu season, 153 childhood deaths were reported, roughly a third among children under 2.
The new study, published Friday in the British journal The Lancet, is an analysis of 25 previous studies, with researchers concluding that no evidence exists that flu shots reduce flu-related deaths or complications in children under 2. The analysis was conducted by researchers in Italy and England who are part of the international Cochrane Collaboration, which evaluates medical research.
Last week, scientists from the National Institutes of Health --- CDC's sister agency in the U.S. Department of Health and Human Services --- said flu shots don't reduce deaths by half in people age 65 and older as the CDC claims. The CDC argued that the NIH study, published in the Archives of Internal Medicine, was flawed.
The elderly and children ages 6 to 23 months --- considered the most vulnerable to the flu --- are the two groups the CDC targets most in flu shot campaigns, though the agency also recommends the shots for adults with chronic diseases, pregnant women, caregivers of children under 6 months, nursing home residents and health care workers. The elderly account for 90 percent of the estimated 36,000 flu-related deaths each year, and children under 2 are hospitalized for flu at a rate second only to the elderly, the CDC says.
While the new report found no proof that the vaccine benefits the youngest children, the researchers did not conclude that the shots do not work. Very few studies have seriously looked at the issue, they said, and those that have done so have showed little effectiveness. Still, they suggested that health officials are prematurely pushing vaccination in children under 2.
In children overall, the shots prevent flu two-thirds of the time, the analysis found.
Another type of flu vaccine --- such as FluMist, a nasal spray that uses a live but weakened virus --- is 79 percent effective, the researchers said. FluMist is licensed in the United States for people ages 5 to 49. CDC defends benefit
Dr. Carolyn Bridges, a medical epidemiologist with the CDC's National Immunization Program, said the European researchers did not consider a few studies showing that flu shots work well in children under 2.
One, in children 6 to 24 months, said the vaccine stopped two-thirds of infections, Bridges said. Another said the shots were 77 percent to 91 percent effective against flu-related respiratory illness in children ages 1 to 15. A third, conducted during last year's flu season, found the shots to be 49 percent effective in children under 2.
Other studies could also show benefit, Bridges said. Research showing that young children given the vaccine produce antibodies to flu, along with reports on the toll of flu hospitalizations, persuaded the CDC's Advisory Committee on Immunization Practices to recommend the shots for children under 2.
"We would have preferred more randomized, placebo-controlled trials to make the decision, but those were not available," she said. "But the evidence was appropriate enough to go forward."
Copyright 2005 The Atlanta Journal-Constitution
