AAP Statement on Smallpox Vaccine

Isolating persons infected with smallpox and immunizing those who had contact with them is the best strategy for containing a potential outbreak of the disease, according to a new policy statement by the American Academy of Pediatrics (AAP). The statement appears in the October 2002 issue of Pediatrics.

This strategy, also called ring vaccination, is the same method recommended by the Centers for Disease Control and Prevention. It is based on the knowledge that vaccination can prevent or ameliorate the severity of the disease if given within three to four days of exposure and can decrease symptoms if given within the first week of exposure.

Since the attacks on September 11, 2001, fears have increased that smallpox virus stocks may be in the hands of bioterrorists. Because most of the U.S. population is considered unprotected against the disease, there is debate over whether smallpox vaccination should resume.

Before smallpox immunization was discontinued in the United States in 1972, children were immunized beginning at age one. The concentration of neutralizing antibodies declines significantly over a five- to 10-year period, and people who were immunized as infants or children before 1972 are unlikely to still be fully protected against the disease.

Although there is speculation that cidofovir (Vistide) may offer some benefit, no known antiviral agent to treat smallpox is available. Infected patients should receive supportive care, including hydration and treatment of secondary bacterial infections, when appropriate.

Approximately 15 million doses of smallpox vaccine are available in the United States, and a previously unaccounted-for 85 million doses held by Aventis Pasteur are still biologically active. Recent studies suggest that the vaccine can be diluted as much as 1:10 and still be effective. The government has contracted for an additional 200 million doses of tissue culture-derived vaccine, which are currently in production and still must be approved by the U.S. Food and Drug Administration.

In the event of a known bioterror-ist release of the smallpox virus, vaccine would be administered to people exposed to the virus. If vaccine is given within three to four days of exposure, immunity can develop before the disease occurs. Postexposure immunization is recommended for people who had face-to-face, household contact with, or who had been in proximity to, a person with active smallpox lesions, a person who has cared for such a patient, or a person exposed to laboratory specimens or bedding from an infected patient. This type of ring vaccination program would most effectively use available stocks of the vaccine while exposing a minimal number of people to the risks of immunization.

Other recommendations in the AAP statement include:

• Ongoing reassessment of the risk of smallpox as a bioterrorism agent and sharing any change in that assessment with public health authorities.

• Continued attempts to develop a safer and more effective smallpox vaccine.

• Educating health care professionals about the identification of smallpox.

• A plan by public health authorities to respond immediately to a suspected or confirmed case of smallpox.

• Educating the public about the ring vaccination plan and the possible serious adverse side effects of smallpox immunization.

The American Academy of Family Physicians issued a position statement on smallpox vaccination in June 2002, and it is available atwww.aafp.org/x10636.xml.

Surgeon General's Report on Health Trends

The U.S. Surgeon General's office has issued its annual statistical report on trends in fighting illness, chronic diseases, and mortality. The 430-page report, “Health, United States 2002,” is available on the Centers for Disease Control and Prevention's Web site atwww.cdc.gov/nchs.

Key findings in the report include:

• Death rates among children and adults up to 24 years of age have been halved since 1950. Mortality among adults aged 25 to 64 decreased nearly as much and dropped by one third among adults older than 65 years.

• Life expectancy is the longest ever—almost 77 years in 2000 (74 years for men; 80 years for women).

• Infant mortality rates have decreased 75 percent since 1950. In 2000, the rate was a record low 6.9 deaths per 1,000 live births.

• The gap in life expectancy between blacks and whites narrowed during the 1990s. The life expectancy for white infants was about six years longer than for black infants in 2000.

• Homicide rates among black and Hispanic men aged 15 to 24 years were nearly halved in the 1990s. However, homicide remains the leading cause of death for young black men and the second-leading cause of death for young Hispanic men.

• In 2000, 23 percent of adults were smokers, compared with more than 40 percent in 1965. Adults without a high school education were three times as likely to smoke as were college graduates.

• Infectious disease rates have declined. The 2000 syphilis rate of 2.2 cases per 100,000 people was the lowest since national reporting began in 1941.

Medicare Regulation Changes for Influenza Vaccination

The Centers for Medicare and Medi-caid Services (CMS), the federal agency responsible for the Medicare and Medicaid programs, has changed its regulations allowing appropriate nonphysician personnel to provide influenza and pneumococcal vaccines without an individualized physician order. The regulation changes are available online atwww.cms.gov/providerupdate/regsum.asp#3160FC.

Where allowed by state law, the regulation change can help health care professionals deliver timely vaccinations, increase adult vaccination coverage rates, and decrease illness and mortality from influenza and pneumonia.

CMS changed its regulations to further facilitate safe and effective vaccine delivery and to reduce the administration burden on health care facilities and physicians. The rule change is expected to increase immunization rates of older Americans and to reduce high morbidity and mortality rates because of occurrences of influenza and pneumonia. The change affects about 12.7 million people now admitted to hospitals and 1.5 million in long-term care facilities. Last year, 4 million people in home health care received influenza vaccinations. Ninety percent of the 20,000 to 40,000 deaths related to influenza and pneumonia occurred among persons aged 65 or older, making it the fifth leading cause of death in this age group.

Preventive vaccines are a covered benefit of the Medicare program, but immunization rates are low. According to a telephone survey by the Centers for Disease Control and Prevention, only 67.4 percent of persons in this age group received an influenza shot during the year of the survey, and only 54.9 had ever received a pneumonia shot.

The new rule makes it possible for more hospital, home health, and nursing home patients to receive their influenza and pneumonia vaccinations when a standing order program is in place, relieving the burden from physicians so that they do not have to sign for each individual patient.

Report on Technology-Intensive Childbirth

Technology-intensive childbirth is now the norm, according to a survey of new mothers by the Maternity Center Association. The survey, “Listening to Mothers,” is available online atwww.maternitywise.org/listeningtomothers.

Of the nearly 1,600 women surveyed, 93 percent had electronic fetal monitoring, and 86 percent had an intravenous drip. More than one half of the women said that their amniotic membranes had been artificially ruptured (55 percent) and that they had received artificial oxytocin to strengthen contractions (53 percent). More than two in five women (44 percent) had received a drug or procedure to start labor, and almost one fourth of respondents had undergone a cesarean delivery (about one half of which were planned).

Epidural analgesia was the most common pain-relief method, used by 63 percent of the women. Non-drug methods that were rated “very helpful” or “somewhat helpful” included application of hot or cold objects, hands-on techniques, position changes, and changes in the environment. Breathing techniques were widely used but received mixed support (70 percent of the women who used them found them at least “somewhat helpful,” but 30 percent found them “not very helpful” or “not at all helpful”).

Overall, women gave high ratings to the care they received during labor and delivery. The leading concern that arose was feeling rushed by their physician, midwife, or the nursing staff.

A significant proportion of respondents reported having negative feelings during the weeks after giving birth, including feeling “unsure” (39 percent), “isolated” (35 percent), and “confused” (25 percent). Nearly one fifth of the women surveyed were likely to have experienced some degree of depression, according to their scores on the Edinburgh Post-natal Depression Scale. Most of these women had not seen a health care professional for concerns about their mental health since giving birth.

FDA Approval

• Essure System. The U.S. Food and Drug Administration (FDA) has approved the Essure System, a small metallic implant that is placed into the fallopian tubes of women who wish to be permanently sterilized. Placement of the device does not require an incision or general anesthesia.

During the implantation procedure, the physician inserts one of the devices into each of the two fallopian tubes with a minimally invasive trans-cervical tubal access catheter inserted through the vagina into the uterus and into a fallopian tube. The device works by inducing scar tissue to form over the implant, blocking the fallop-ian tube and preventing fertilization of the egg by sperm.

During the first three months, women cannot rely on Essure implants and must use another form of contraception. After three months, women must undergo a final radiograph procedure in which dye is placed in the uterus and a radiograph is taken to confirm proper placement of the device. Once placement is confirmed, additional contraception use can be discontinued. No serious adverse events were reported during clinical studies.

Women who choose this device for sterilization should be aware that the procedure is irreversible, and they should carefully evaluate such issues as their age and the possibility that they could wish to become pregnant in the future. On the other hand, women also should know that pregnancies following sterilization can occur, even many years after the procedure, and that such pregnancies are at increased risk to be ectopic—a potentially life-threatening condition.