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FDA Approval Backed for Pneumococcal Disease Child Vaccine

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Nov. 5, 1999 (Bethesda, Md.) -- An expert advisory panel to the FDA today recommended the approval of a new children's vaccine against Streptococcus pneumoniae, a very common bacteria that causes pneumonia, meningitis, and ear infections. The agency's Vaccines and Related Biological Products Advisory Committee endorsed the safety and effectiveness of Wyeth-Lederle's Prevenar vaccine.

In children under 5, the bacteria causes 71,000 cases of pneumonia, 16,000 cases of blood infections, and 1,400 cases of meningitis each year. It is also the No. 1 cause of ear infections, with over 5 million cases in the U.S. each year in this age group.

The vaccine could soon be part of the standard regimen for children. Last month, the CDC's vaccine advisory committee recommended routine use of the vaccine for all children up to the age of 5. Typically, the vaccine would be taken three times during an infant's first year, with a booster shot at 15 months.

Panel chairman Harry Greenberg, MD, tells WebMD, "It's an important disease, and the vaccine looked incredibly effective." He called the vaccine "an extremely exciting breakthrough for a disease that has a devastating effect." Committee member Robert Daum, MD, called the vaccine "a giant step forward for the health of children."

In a trial conducted by Kaiser Permanente, the vaccine was tested in a diverse population of 38,000 infants, with about 21,000 children completing all four doses at an average age of 14 months. Against all types of the pneumococcal bacteria, it demonstrated over 90% effectiveness against pneumonia and meningitis.

Lesser, but significant, results were seen against ear infections. In a follow-up study to the Kaiser trial, the vaccine brought a 7% reduction in the incidence of ear infections. Higher effectiveness (almost 23%) was seen for those children with frequent (six times per year) ear infections.

A pneumococcal disease vaccine is already available, but it is not effective for children under the age of 2 and against ear infections. Invasive pneumococcal diseases have traditionally been treated with antibiotics, but the dramatic rise of resistant bacteria has increased the pressure on vaccines.

Although the panel unanimously backed the vaccine's efficacy, it was slightly less enthusiastic on safety issues, supporting its profile in an 11-1 vote.

The vaccine appeared safe, with only limited adverse events such as seizures and other moderate reactions. Greenberg tells WebMD, "For all vaccines, monitoring long-term effects is something we need to do a better job of. I don't think there's anything specific about this one that makes it more a concern."

Growing grassroots concern about alleged vaccine safety problems prompted congressional hearings earlier this year. This summer, Wyeth-Lederle pulled its rotavirus vaccine from the market after a series of unanticipated adverse events with children.

Citing the rotavirus issue, panel member Barbara Loe Fisher, president of the National Vaccine Information Center, said there was insufficient data to assess the new vaccine's possible long-term association with diabetes and other autoimmune disorders. "We have not been presented enough safety data," Fisher tells WebMD.

The issue also arose of the vaccine's compatibility with other routine vaccines. Some data suggested, for example, that it might prompt a lower response to the polio vaccine. Committee members called for postmarketing studies to continue monitoring the question.

Fisher tells WebMD, "What is going to happen in the real world? How is a parent or a doctor going to know what health problem, following vaccination in combination with others, is due to the pneumococcal vaccine."

FDA often follows the lead of its advisory committees, but is not officially bound by their recommendations.


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