Worried about the high price of a vaccine that fights ear infections, pneumonia and meningitis, a government advisory committee changed its initial recommendation and voted February 16 to require that fewer children get the shots. Food and Drug Administration approval of the vaccine took place on February 17, and its manufacturer, American Home Products, will begin marketing it this spring.

The Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices said the vaccine Prevenar should be administered to all children under 2, and to those ages 2 to 5 who are at high risk of contracting the diseases. It was only the second time the committee has ever debated the potential economic impact of a vaccine, marking a potential shift in what medical experts consider before making a recommendation.

In October, the committee had voted to recommend Prevenar, which costs $232 per four-dose series, for all children under 5. Prevenar fights the bacterium streptococcus pneumoniae ? the leading cause of pneumonia, meningitis and the millions of ear infections that lead to crammed pediatrician waiting rooms every year.

According to a study, the vaccine reduced ear infections by 9 percent. Doctor visits by those who were diagnosed as having chronic ear infections and took the vaccine were down 20 percent, and there was a 20 percent reduction in the number of children who needed tube implants to fight the infections.

Paul Paradiso, vice president for scientific affairs for the division of American Home Products that makes the vaccine, said that the sweeping scope of the first set of guidelines was not expected and that the company is pleased with the new recommendation.

?But the membership of the ACIP needs to understand that cost is a factor and needs to be taken into consideration along with safety and effectiveness,? France said. ?We need to make it part of the discussion before the initial recommendations are made.?

The Food and Drug Administration (FDA) approved the vaccine to prevent meningitis caused by Streptococcus pneumoniae and bacteremia, spread of the bacteria in the bloodstream. It was approved for infants in a series of four shots given at ages 2, 4, 6 and 12-15 months.

In Wyeth's trial, conducted at Kaiser Permanente of Northern California, Prevnar was 100% effective in preventing pneumococcal disease caused by the seven S. pneumoniae strains included in the vaccine. It was 90% effective in blocking disease caused by all S. pneumoniae strains.

The FDA and Wyeth estimate there are 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis in the US each year. Children under age 2 are at highest risk, which means the vaccine, if given to all those children, might wipe out most pneumococcal disease.According to Wyeth Lederle spokesman Doug Petkus, the vaccine will list for $58 per dose.

The CDC advisers said only high-risk 2 to 5 year olds -- those who have sickle cell anemia, HIV, or other immunodeficiencies -- should receive Prevnar. African American, Native American, and Native Alaskan 2 to 5 year olds should also get it, the advisers said, noting higher infection rates in these ethnic groups. The advisers did urge vaccination of all children under age 2.

COMMENT: Yet another vaccine to install havoc and distress on the immune systems of our infants. Fortunately this one was restricted from being required for all children and is merely recommended for at risk groups from 2 to 5. Interesting to note that this four dose vaccine will cost parents over $200 to administer, yet improving the coffers even higher of the drug company that sells it. I doubt that my lifetime will see the change of this well entrenched vaccine philosophy which thoroughly discounts improving the child's immune system with supportive measures like optimized diet rather than assaulting them with vaccines which frequently overwhelm their already challenged immune system.

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