FDA Approves Vaccine to Protect Babies from Infections

Source

Wyeth-Ayerst Laboratories

Forums

Related Articles

Babies will soon start getting a new vaccine that will give them long-term protection from bacterial meningitis and bloodstream infections, while also cutting their chances of getting pneumonia, ear infections and sinusitis.

The federal Food and Drug Administration yesterday gave approval to Wyeth-Ayerst Laboratories in St. Davids to market the vaccine, which is aimed at stopping infection by pneumococcus bacterium, a big cause of childhood sickness and death.

``This vaccine is a major public health breakthrough for young children,'' said Dr. Steven Black, codirector of the Kaiser Permanente Vaccine Study Center, which did large-scale testing of the pneumococcal vaccine in California. ``This bacteria is a bad actor in all categories.''

In the United States it is estimated that pneumococcal disease is responsible for 40,000 deaths a year among all ages and accounts for an estimated 3,000 cases of bacterial meningitis, 50,000 cases of bloodstream infections, 500,000 cases of pneumonia, and 7 million cases of ear infections -- at a cost of $1.5 billion to the health-care system, not to mention missed days of school and work.

Worldwide -- where access to medical care is not always good and children may be especially vulnerable to disease because of poor living conditions -- an estimated 1.2 million children die every year from pneumococcal disease.

Black and other health experts say the new vaccine is arriving at an especially opportune time because strains of pneumococcal bacteria are increasingly becoming resistant to antibiotics.

Tests of the vaccine in about 38,000 California children found that it reduced by 97 percent the incidence of bloodstream infections and meningitis, a life-threatening inflammation of the lining of the brain and spinal cord, which can lead to blindness, deafness, paralysis and learning problems, Black said.

The vaccine also prompted a 31 percent reduction in the number of children getting pneumonia and about a 9 percent reduction in the number of children going to the doctor because of an ear infection.

The vaccine worked better at reducing the incidence of recurring ear infections -- reducing by about 23 percent the number of children having frequent bouts of infection. It also prompted a 20 percent reduction in those who needed ear tubes to treat chronic infections, Black said.

The vaccine, administered in four doses, should be available in doctors' offices within several weeks, Wyeth-Ayerst officials said yesterday.

An advisory committee to the federal Centers for Disease Control and Prevention on Wednesday recommended that the vaccine be adopted into the routine immunization schedule. The pneumococcus bacterium, known as Streptococcus pneumoniae, is ``probably the most important bacteria of children, the most destructive bacteria of childhood,'' said Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia and a member of the CDC committee.

``There are thousands of children who are permanently harmed or killed by that bacterium each year'' in this country, he said. Infants and young children, as well as the elderly, are at greatest risk for pneumococcal infections. There already is a vaccine available to protect against pneumococcus bacterium in older people, but it does not work in children under 2. The new vaccine, marketed under the name Prevnar, is expected to provide long-term protection against seven strains of pneumococcal bacteria.

In testing, the only notable side effect of the vaccine was swelling and discomfort at the injection sight, Offit said.

Gary Emmett, director of general pediatrics at Thomas Jefferson University and president of the Philadelphia Pediatrics Society, said the only downside to the new vaccine was that it would mean giving more shots to babies.

``What I don't like about it is we're going to be giving four shots, four needles,'' at some of the checkups early in infancy, he said, referring to other shots given in infancy for diseases such as hepatitis B, polio, diphtheria and tetanus, among others.

The CDC advisory recommended that the new vaccine be administered to all children under 2, and children 2 to 5 who are considered to be at heightened risk for pneumococcal disease. The shots will be given at 2 months, 4 months, 6 months, and 12 to 15 months. For older children, the recommendation calls for three doses for babies 7 to 11 months and two doses from children 12 to 23 months old. Only one dose is required for children 2 or older.

The vaccine committee last fall had voted to recommend the vaccine for all children under 5 but pared back the recommendation to include only children under 2 because of the high cost of the vaccine, Offit said. The vaccine will be sold to doctors at $58 a dose, which makes it $232 for the four-dose series.

Insurance companies, as well as government-funded insurance plans, are expected to pay for the vaccine for children under 2. Offit said parents with children older than 2 may want to pay for the vaccine themselves if their health plan does not.

``It's a definite benefit,'' Offit said. ``A single dose, it's money well spent.''

While Black said it would be misleading to think of the new vaccine as an ``ear-infection vaccine,'' it should make a sizable dent in the problem because pneumococcal bacteria are a leading cause of ear infections in children.

Ear infections are a big reason for children missing school. Chronic infections can cause hearing impairment when fluid builds up in the middle ear. That in turn can lead to learning difficulties.

Children with persistent ear infections often go from one antibiotic prescription to the next, adding to what experts say is an alarming overuse of antibiotics.