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New protections for children against infectious diseases are coming soon to a doctor's office or clinic near you.
A vaccine for one serious illness, meningococcal disease, already has been recommended by the Centers for Disease Control and Prevention, and at least five other new vaccines or variations of existing vaccines are well on their way to commercial availability in the U.S. They're intended to protect against diseases ranging from rotavirus, a common cause of diarrhea, to human papilloma virus, which can cause cervical cancer.
"This is more [in development] than I remember. ... I think we're beginning to realize the potential of modern understanding of the immune system and new technology to prevent diseases," said Dr. Ed Marcuse, associate medical director of Children's Hospital & Regional Medical Center and a member of the national committee that advises the CDC on vaccines.
Meningococcal disease
The illness may start like the flu, but with a stiff neck, too. It may come on in hours or one to two days. And in the worst of cases, it progresses to kill or cause lifelong damage.
Most "invasive" cases of this bacterial disease cause meningitis (inflammation of the membranes surrounding the brain and spinal cord) or massive blood infection, killing as many as 12 percent of patients. Among the survivors, as many as 15 percent suffer hearing loss, limb amputation or brain damage.
Immunization data
The CDC reported last month that childhood immunization rates nationwide are at record levels, with about 81 percent of U.S. children ages 19 months to 35 months receiving the recommended shots. About 78 percent of Washington state children this age are current on their shots, ranking the state 42nd in the nation.
That's why the CDC this summer recommended the new vaccine MCV4, or Menactra, to join two others that protect against other bacteria that cause meningitis and pneumonia: Haemophilus influenzae type b and Streptococcus pneumoniae.
Young people ages 14 through 24 comprise about one-fifth of the more than 3,000 annual U.S. cases of meningococcal disease. Thus, the CDC says, youths should routinely receive the new meningococcal immunization against the bacteria Neisseria meningitidis at age 11 or 12.
The new meningitis vaccine joins nine others recommended for some time by the CDC for childhood immunization:
• Hepatitis B
• Tetanus-diphtheria-pertussis
• Haemophilus influenzae type B, which also causes meningitis
• Polio
• Measles-mumps-rubella
• Varicella (chickenpox)
• Pneumococcal bacteria, which also causes meningitis
• Influenza
• Hepatitis A
The vaccines are all recommended for specific times in a child's life. And recently, drug manufacturers have developed additional doses of the varicella and tetanus-diphtheria-pertussis (Tdap) vaccines to be given later in childhood.
Meningococcal disease vaccine A new vaccine: MCV4, or Menactra, is now recommended by the Centers for Disease Control and Prevention to protect against meningococcal disease, which can cause meningitis, blood infection or pneumonia.
Ages it should be given: The agency recommends the shot at age 11 or 12, or before entering high school at about age 15, or for college freshmen who will be living in a dormitory.
What it prevents: The new vaccine covers four types of the bacterium Neisseria meningitidis, but not type B, which causes more than half the cases in children younger than 3.
How the disease spreads: The bacteria are spread through respiratory or throat secretions — typically through coughing or kissing.
Vaccine effectiveness: The vaccine is 85-100 percent effective.
Supply: Because of heavy demand, Menactra is temporarily in short supply. Public Health — Seattle & King County clinics are temporarily limiting the shots to college-bound freshmen living in dormitories, to travelers to countries where meningococcal disease is present, to persons with medical conditions that put them at high risk for the disease and to certain laboratory workers.
Newly recommended
Whooping cough (pertussis): On June 30, the Advisory Committee on Immunization Practices to the CDC recommended that the recently licensed Tdap vaccine (made by two companies) be given to adolescents at age 11 or 12 in place of the booster that contains only tetanus-diphtheria vaccines (Td), previously recommended to be given at that time.
The committee said immunization to pertussis from childhood Tdap shots wanes over five to 10 years. More than 19,000 cases of pertussis, a 40-year high, were reported in the U.S. in 2004. And pertussis-related deaths in infants have increased from about 10 a year to 20 a year over the past decade. Marcuse said the CDC will soon follow the committee's advice. The new Tdap booster is estimated to be nearly 100 percent effective for tetanus and diphtheria and about 89 percent effective for pertussis. Health officials say it should be available in the Seattle area this fall.
Newly available
Chickenpox (varicella): The second dose of varicella vaccine, licensed by the Food and Drug Administration in April, is available for children ages 12 months through 12 years. It was developed because some children who have had the first shot still may contract a mild case of chickenpox if exposed to the disease. They might then spread it to unimmunized adults, who are more seriously affected by the disease than children are. A second dose of the vaccine increases effectiveness from about 94 percent to 98 percent, one study found. (The CDC has long recommended that unimmunized people ages 13 and older receive two doses because the disease may be more severe for them.)
Marcuse said the CDC advisory committee has not recommended the shot for now, in part because of concerns about its cost of more than $50 a dose; but it is considering it further.
Meanwhile, a new vaccine under development would combine varicella with measles, mumps and rubella protection, and would be given at 12 to 15 months and again at 4 to 6 years. If licensed, it likely would be available within two years, Marcuse said.
Vaccines in the pipeline
Other vaccines under development, but still not licensed by the FDA, are designed to protect against rotavirus and human papilloma virus. The CDC advisory committee considers whether to recommend a vaccine only after a license is issued.
Rotavirus: Most children have been infected by this diarrhea-causing virus by the time they are 2. It is the most common cause of severe diarrhea and dehydration among children, with more than 55,000 children hospitalized in the U.S. each year and more than 600,000 worldwide dying.
The FDA licensed an oral vaccine in 1998, but the CDC later withdrew its recommendation of it, because a tiny percentage of children (about one in 10,000 to 32,000) developed bowel obstruction within two weeks of vaccination.
Tests in 70,000 infants of another recently developed rotavirus vaccine, developed by a different company, showed there is no increased risk of the bowel obstruction. Another study of the new vaccine found it 74 percent effective against rotavirus diarrhea in general and 98 percent effective against severe dehydration. Marcuse said he expects the CDC to recommend the vaccine once it is licensed, and it could be available within a year. It is given to infants 6 to 12 weeks old.
Human papilloma virus (HPV): Two new vaccines are being tested for their ability to protect against the two sexually transmitted viruses that cause 70 percent of cervical cancers. One of the vaccines also prevents genital warts.
The vaccines, made by two different companies, have proved 90 to 100 percent effective in early trials and are undergoing additional tests with thousands of people. Merck, which makes one of the vaccines, says it plans to file for an FDA license by the end of this year; and, if the vaccine is licensed, it will be available by the end of 2006.
For now, manufacturers are targeting preadolescent girls for the vaccines. But some experts wonder whether boys, who can spread the viruses to the unimmunized, shouldn't also receive the shot.