New Vaccine May Help Prevent Ear Infections

WASHINGTON —  The Food and Drug Administration on Thursday approved the first vaccine that will prevent a life-threatening form of bacterial meningitis in young children but also may have the more far-reaching effect of preventing one of the most persistent banes of childhood, the common ear infection.

The vaccine also protects against a serious bloodstream infection known as pneumococcus bacteremia. The less common infections, caused by seven strains of pneumococcus, can lead to brain damage or even death.

But the vaccine’s broader value ultimately could prove to be in preventing many of the nearly 8 million annual cases of ear infections among young children--one of the most persistent banes of childhood--since the same bacterium is also responsible for the majority of these illnesses.

Infants are especially vulnerable to the two more serious infections, and there has been no effective protection until now against them. They account for 16,000 cases of serious bloodstream infections known as pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis annually. About 10% of children with meningitis die.

But, said Dr. Jesse Goodman, deputy director of the FDA’s center for biologics, “I think everybody is very eager to look at the ability of this vaccine to prevent more common but less lethal diseases, including ear infections. Biologically, it’s reasonable to think it will have an impact.”

The vaccine is expected to be given to all young children as part of their regular vaccination schedules. In fact, an advisory committee to the federal Centers for Disease Control and Prevention, which issues guidelines on what vaccines to give children and when, earlier this week recommended that this vaccine be added, even before the FDA made its announcement.

On any given day, nearly one-third of the nation’s children are suffering from ear infections, an affliction that parents find both costly and disruptive. Some estimates put the total cost of such infections at as much as $5 billion annually.

Frequent ear infections result in countless trips to the pediatrician, interrupted parental work schedules, antibiotic treatments of up to two weeks, and--more important--can cause temporary hearing loss and delayed language development. Most children outgrow them by the age of 6.

While ear infections are not life-threatening, they account for about one-fourth of all prescriptions for antibiotics. Moreover, indiscriminate use of antibiotics is regarded as a major factor in the development of antibiotic resistant bacteria, a growing public health threat.

The vaccine acts against the seven strains of pneumococcus that cause 80% of all serious pneumococcal diseases in children younger than 6. These strains are also among the most resistant to the antibiotics traditionally used to treat them.

The organism is responsible for about two-thirds of all ear infections, with the remainder caused by other bacteria or viruses, Goodman said.

Thus, if the vaccine is shown to work against ear infections, “not all will be cured, but it might be a very important tool” in preventing many of them, he said.

The vaccine, Prevnar, will be marketed by Wyeth Lederle Vaccines, a unit of Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corp. It will be available within several weeks and will cost physicians $58 per dose.

Four doses are recommended, given at 2, 4 and 6 months old and finally between 12 and 15 months old.

The dosing schedule will vary for older children beyond the age of the routine infant inoculation schedule at the pediatrician’s discretion. The more serious infections caused by the organism are not as dangerous in older children, the FDA’s Goodman said.

The FDA approval was limited only to preventing the two more serious infections, meningitis and bacteremia. But studies already have shown that it has an impact against ear infections, and company officials said that they intend to seek FDA approval for this additional use.

A study currently underway in Finland, which is looking into whether the vaccine can prevent ear infections caused by this specific bacterium, has shown a 60% reduction in ear infections among children who received it, according to Dr. Peter Paradiso, Wyeth’s vice president for scientific affairs and research strategy.

Also, clinical trials of the vaccine that included a large multi-center study conducted at Northern California Kaiser Permanente in Oakland showed a 9% decrease in pediatric visits for ear infections resulting from all causes and a 25% reduction in the need for ear tubes among children who suffered frequent ear infections, Paradiso said.

Ear tubes are often recommended for persistent sufferers, and require surgical insertion under general anesthesia of tubes that drain infection-prone fluid from the middle ear.

The Kaiser trial enrolled 38,000 children, about half of whom received the vaccine, which proved 100% effective against the seven strains and 90% effective against illnesses caused by all pneumococcal sub-types.

“This new vaccine is great news for parents and their children,” said FDA Commissioner Jane Henney.

The vaccine appears to be safe, causing only the typical side effects of inoculations, such as redness at the site and fever.

All medical products, however, run the risk of producing rare and more serious side effects once they are in widespread public use.

For example, just a year after the government approved it, the FDA pulled a vaccine off the market that was effective against the leading cause of childhood diarrhea, after about 20 infants developed dangerous bowel obstructions. RotaShield, a vaccine also marketed by Wyeth, had been licensed to prevent rotavirus infection.