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FDA approves new vaccine for childhood ear infections


February 17, 2000
Web posted at: 2:01 p.m. EST (1901 GMT)

ROCKVILLE, Maryland (CNN) -- A new vaccine that fights middle ear infections and other serious conditions caused by pneumococcal disease was approved Thursday by the U.S. Food and Drug Administration.

The vaccine, called Prevnar, protects children from a type of bacteria that leads to pneumococcal disease, which is the most common cause of ear infections in children.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Policy recommended the vaccine be given to all infants and children up to age 2 as part of routine vaccinations. In infancy, the vaccine is given by injection at 2, 4 and 6 months of age with a booster between 12 and 15 months.

The committee also recommended the vaccine be given now for high risk children between the ages of 2 and 5, which include those with a chronic illness such as AIDS or sickle cell disease, those who attend day care, the socially disadvantaged. It also recommended that doctors consider using the vaccine for children with a history of chronic ear infections.

The committee had voted on recommendations in October that Prevnar be used in all children under the age of 5. Wednesday's vote narrowed that field to all children under age two after cost implications were addressed.

Childhood ear infections are responsible for 27 million doctors' visits each year and cost society an estimated $5 billion in medical care, antibiotics and parent time off from work.

Studies show children who receive the vaccine are 23 percent less likely to have frequent bouts of ear infections. They are also 20 percent less likely to need ear tube surgery.

The pneumococcal bacteria is also a major cause of meningitis, pneumonia, sinusitis and bacteremia, a severe bloodstream infection. Some of these conditions can be deadly.

The new vaccine is 100 percent effective against pneumococcal meningitis and bacteremia. There are an estimated 3,000 cases of bacterial meningitis, 50,000 cases of bacteremia and 500,000 cases of pneumonia each year in the United states.

But the new vaccine does have limitations. There are over 80 types of pneumoccocus, and the vaccine protects against seven. Those seven are responsible for about 85 percent of severe diseases and 65 percent of middle ear infections.

It appears this vaccine will be more costly than other childhood vaccinations. The four-shot series will cost about $230, which is the same as all other childhood vaccinations combined. Children over age 2 will need only one dose, which costs $58.

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September 30, 1998
Experimental vaccine may protect against ear infections
August 17, 1998

Food and Drug Administration
Centers for Disease Control and Prevention
Johns Hopkins Infectious Diseases
American Academy of Pediatrics

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