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FDA Approves First Infant Vaccine

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Feb. 17, 2000 (Washington) -- Parents of infants and toddlers got some eagerly awaited news Thursday when the FDA approved the first vaccine to prevent invasive pneumococcal disease in infants and toddlers.

Each year, it is estimated that the pneumococcus organism results in about 60,000 cases of childhood pneumonia, 16,000 cases of bloodstream infections, and 1,400 cases of meningitis, a potentially deadly infection of the brain lining and/or spinal cord. The American Home Products' vaccine, which will be marketed by its Wyeth-Ayerst division under the name Prevnar, is indicated for the prevention of the disease caused by seven strains of that organism. Those strains are thought to be responsible for approximately 80% of all invasive disease in infants and toddlers.

Prior to the FDA approval, the only existing option was treatment "after the fact," a FDA spokesperson tells WebMD. "This new vaccine is great news for parents and their children because now, for the first time, we have a highly effective way to prevent a major cause of meningitis and serious blood infections in the most susceptible children," says FDA Commissioner Jane Henney, MD.

But the most important issue deals with the fact "that we are now going to prevent a lot of pain and suffering in children," Harold Marder, MD, tells WebMD. Marder, who is senior vice president for medical affairs at Wyeth-Ayerst, says Prevnar will be available to parents within two weeks. But the American Home Products division already is seeking approval for additional uses, including the treatment of ear infections.

The present FDA approval is based on a study of about 38,000 children in which the vaccine was 90% effective in preventing all invasive pneumococcal disease. But at the time, data for the prevention of additional indications such as ear infections simply was not available, Marder tells WebMD.

In a sign of the times, though, a CDC advisory committee is recommending that the vaccine be used in children between ages 2 to 5 only if they are at risk of contracting illnesses such as meningitis. The CDC recommendation is based upon concerns about the overall cost, of which about half would be paid by the federal government. At about $58 per shot, or about $232 for children between 2 to 7 months of age, $174 for children between 7 to 11 months, $116 for children between 2 to 5 years, and $58 for children over 5, that could get expensive. But epidemiological studies show that after 2 years of age, native Americans, Eskimos, and children with sickle cell anemia, HIV, or other immunodeficient diseases are the only groups truly at risk, the CDC committee said.

There is also another vaccine that these children must take to prevent meningitis caused by another bacterium called Hemophilus influenza B, or Hib. It was once also the leading cause of bacterial meningitis but lost that distinction after the FDA approved an infant Hib vaccine in 1990. This distinction now belongs to streptococcus pneumonia, which exactly is what makes Thursday's action so significant, the FDA spokesperson tells WebMD.

Other than the cost, the downside does seem minimal. Side effects in the company's study were generally mild and limited to the effects seen in relation to the administration of most vaccines. Approximately 21% of the children taking the vaccine had fevers over 100.3?F compared with 14% of the group receiving a placebo. But the majority of side effects, which occurred with a frequency of between 12% and 20%, were local reactions to the shot itself, such as redness, swelling, or tenderness.


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