US Civilian Smallpox Preparedness and Response Program, 2003.

Variola virus, the cause of smallpox disease, has been deemed a possible bioterrorism agent. Since November 2001, federal, state, and local public health partners implemented activities to prepare for a possible smallpox outbreak. The Centers for Disease Control and Prevention (CDC) produced and delivered training and educational materials for smallpox preparedness in many formats, developed detailed smallpox vaccine information statements about vaccine contraindications and vaccination site care, and established mechanisms to monitor and respond to adverse events after smallpox vaccination. The last included enhancements to the Vaccine Adverse Event Reporting System, a pregnancy registry for inadvertently vaccinated pregnant women, and a Clinician Telephone Information Line to collect reports about adverse events. The civilian responder vaccination program was conducted with rigorous safety procedures, and few historically recognized adverse events were observed. However, myocarditis and/or pericarditis was newly recognized as an adverse event caused by the New York City Board of Health vaccinia vaccine strain. This smallpox preparedness program put into place a number of measures to advance the United States' readiness for a smallpox outbreak that have assisted in preparedness for other threats.

Evaluation of human-to-human transmission of monkeypox from infected patients to health care workers.

BACKGROUND: In 2003, human monkeypox was first identified in the United States. The outbreak was associated with exposure to infected prairie dogs, but the potential for person-to-person transmission was a concern. This study examines health care worker (HCW) exposure to 3 patients with confirmed monkeypox. METHODS: Exposed HCWs, defined as HCWs who entered a 2-m radius surrounding case patients with confirmed monkeypox, were identified by infection-control practitioners. A self-administered questionnaire and analysis of paired serum specimens determined exposure status, immune response, and postexposure signs and symptoms of monkeypox. RESULTS: Of 81 exposed HCWs, 57 (70%) participated in the study. Among 57 participants, 40 (70%) had > or =1 unprotected exposure; none reported signs or symptoms consistent with monkeypox illness. One exposed HCW (2%), who had been vaccinated for smallpox within the past year, had serological evidence of recent orthopoxvirus infection; acute- and convalescent-phase serum specimens tested positive for anti-orthopoxvirus IgM. No exposed HCWs had signs and symptoms consistent with monkeypox. CONCLUSION: More than three-quarters of exposed HCWs reported at least 1 unprotected encounter with a patient who had monkeypox. One asymptomatic HCW showed laboratory evidence of recent orthopoxvirus infection, which was possibly attributable to either recent infection or smallpox vaccination. Transmission of monkeypox likely is a rare event in the health care setting.

The role of the obstetrician-gynecologist in emerging infectious diseases: monkeypox and pregnancy.

Early in June 2003, the Centers for Disease Control and Prevention (CDC) announced yet another unique infectious disease outbreak, the first evidence of community-acquired monkeypox in the United States. By July 8, 2003, a total of 71 cases had been reported to CDC from 6 states. When emerging infectious diseases are reported in the United States, particularly when these reports receive widespread media attention, obstetrician-gynecologists may be called upon to rapidly respond to queries from their patients and to address certain infectious disease risks within their clinical practices. In addition, obstetrician-gynecologists may have specific concerns about the implications for an infectious disease outbreak, such as monkeypox, for pregnant women. Therefore, it is important that obstetrician-gynecologists know how to gather up-to-date and accurate information about infectious disease outbreaks and that they be familiar with the public health response system for responding to such outbreaks.

The validity of chief complaint and discharge diagnosis in emergency department-based syndromic surveillance.

OBJECTIVE: Emergency department (ED)-based syndromic surveillance systems are being used by public health departments to monitor for outbreaks of infectious diseases, including bioterrorism; however, few systems have been validated. The authors evaluated a "drop-in" syndromic surveillance system by comparing syndrome categorization in the ED with chief complaints and ED discharge diagnoses from medical record review. METHODS: A surveillance form was completed for each ED visit at 15 participating Arizona hospitals between October 27 and November 18, 2001. Each patient visit was assigned one of ten clinical syndromes or "none." For six of 15 EDs, kappa statistics were used to compare syndrome agreement between surveillance forms and syndrome categorization with chief complaint and ED discharge diagnosis from medical record review. RESULTS: Overall, agreement between surveillance forms and ED discharge diagnoses (kappa = 0.55; 95% confidence interval [CI] = 0.52 to 0.59) was significantly higher than between surveillance forms and chief complaints (kappa = 0.48; 95% CI = 0.44 to 0.52). Agreement between chief complaints and ED discharge diagnoses was poor for respiratory tract infection with fever (kappa = 0.33; 95% CI = 0.27 to 0.39). Furthermore, pediatric chief complaints showed lower agreement for respiratory tract infection with fever when compared with adults (kappa = 0.34 [95% CI = 0.20 to 0.47] vs. kappa = 0.44 [95% CI = 0.28 to 0.59], respectively). CONCLUSIONS: In general, this syndromic surveillance system classified patients into appropriate syndrome categories with fair to good agreement compared with chief complaints and discharge diagnoses. The present findings suggest that use of ED discharge diagnoses, in addition to or instead of chief complaints, may increase surveillance validity for both automated and drop-in syndromic surveillance systems.

Vaccine policy changes and epidemiology of poliomyelitis in the United States.

CONTEXT: The last case of poliomyelitis in the United States due to indigenously acquired wild poliovirus occurred in 1979; however, as a consequence of oral poliovirus vaccine (OPV) use that began in 1961, an average of 9 cases of vaccine-associated paralytic poliomyelitis (VAPP) were confirmed each year from 1961 through 1989. To reduce the VAPP burden, national vaccination policy changed in 1997 from reliance on OPV to options for a sequential schedule of inactivated poliovirus vaccine (IPV) followed by OPV. In 2000, an exclusive IPV schedule was adopted. OBJECTIVE: To review the epidemiology of paralytic poliomyelitis and document the association between the vaccine schedule changes and VAPP in the United States. DESIGN AND SETTING: Review of national surveillance data from 1990 through 2003 for cases of confirmed paralytic poliomyelitis. MAIN OUTCOME MEASURES: Number of confirmed paralytic poliomyelitis cases, including VAPP, and ratio of VAPP cases to number of doses of OPV distributed that occurred before, during, and after implementation of policy changes. RESULTS: From 1990 through 1999, 61 cases of paralytic poliomyelitis were reported; 59 (97%) of these were VAPP (1 case per 2.9 million OPV doses distributed), 1 case was imported, and 1 case was indeterminate. Thirteen cases occurred during the 1997-1999 transitional policy period and were associated with the all-OPV schedule; none occurred with the IPV-OPV schedule. No cases occurred after the United States implemented the all-IPV policy in 2000. The last imported poliomyelitis case occurred in 1993 and the last case of VAPP occurred in 1999. CONCLUSION: The change in polio vaccination policy from OPV to exclusive use of IPV was successfully implemented; this change led to the elimination of VAPP in the United States.

Prophylaxis and treatment of pregnant women for emerging infections and bioterrorism emergencies.

Emerging infectious disease outbreaks and bioterrorism attacks warrant urgent public health and medical responses. Response plans for these events may include use of medications and vaccines for which the effects on pregnant women and fetuses are unknown. Healthcare providers must be able to discuss the benefits and risks of these interventions with their pregnant patients. Recent experiences with outbreaks of severe acute respiratory syndrome, monkeypox, and anthrax, as well as response planning for bioterrorism and pandemic influenza, illustrate the challenges of making recommendations about treatment and prophylaxis for pregnant women. Understanding the physiology of pregnancy, the factors that influence the teratogenic potential of medications and vaccines, and the infection control measures that may stop an outbreak will aid planners in making recommendations for care of pregnant women during large-scale infectious disease emergencies.

Smallpox vaccination and adverse reactions. Guidance for clinicians.

The guidance in this report is for evaluation and treatment of patients with complications from smallpox vaccination in the preoutbreak setting. Information is also included related to reporting adverse events and seeking specialized consultation and therapies for these events. The frequencies of smallpox vaccine-associated adverse events were identified in studies of the 1960s. Because of the unknown prevalence of risk factors among today's population, precise predictions of adverse reaction rates after smallpox vaccination are unavailable. The majority of adverse events are minor, but the less-frequent serious adverse reactions require immediate evaluation for diagnosis and treatment. Agents for treatment of certain vaccine-associated severe adverse reactions are vaccinia immune globulin (VIG), the first-line therapy, and cidofovir, the second-line therapy. These agents will be available under Investigational New Drug (IND) protocols from CDC and the U.S. Department of Defense (DoD). Smallpox vaccination in the preoutbreak setting is contraindicated for persons who have the following conditions or have a close contact with the following conditions: 1) a history of atopic dermatitis (commonly referred to as eczema), irrespective of disease severity or activity; 2) active acute, chronic, or exfoliative skin conditions that disrupt the epidermis; 3) pregnant women or women who desire to become pregnant in the 28 days after vaccination; and 4) persons who are immunocompromised as a result of human immunodeficiency virus or acquired immunodeficiency syndrome, autoimmune conditions, cancer, radiation treatment, immunosuppressive medications, or other immunodeficiencies. Additional contraindications that apply only to vaccination candidates but do not include their close contacts are persons with smallpox vaccine-component allergies, women who are breastfeeding, those taking topical ocular steroid medications, those with moderate-to-severe intercurrent illness, and persons aged < 18 years. In addition, history of Darier disease is a contraindication in a potential vaccinee and a contraindication if a household contact has active disease. In the event of a smallpox outbreak, outbreak-specific guidance will be disseminated by CDC regarding populations to be vaccinated and specific contraindications to vaccination. Vaccinia can be transmitted from a vaccinee's unhealed vaccination site to other persons by close contact and can lead to the same adverse events as in the vaccinee. To avoid transmission of vaccinia virus (found in the smallpox vaccine) from vaccinees to their close contacts, vaccinees should wash their hands with warm soapy water or hand rubs containing > or = 60% alcohol immediately after they touch their vaccination site or change their vaccination site bandages. Used bandages should be placed in sealed plastic bags and can be disposed of in household trash. Smallpox vaccine adverse reactions are diagnosed on the basis of clinical examination and history, and certain reactions can be managed by observation and supportive care. Adverse reactions that are usually self-limited include fever, headache, fatigue, myalgia, chills, local skin reactions, nonspecific rashes, erythema multiforme, lymphadenopathy, and pain at the vaccination site. Other reactions are most often diagnosed through a complete history and physical and might require additional therapies (e.g., VIG, a first-line therapy and cidofovir, a second-line therapy). Adverse reactions that might require further evaluation or therapy include inadvertent inoculation, generalized vaccinia (GV), eczema vaccinatum (EV), progressive vaccinia (PV), postvaccinial central nervous system disease, and fetal vaccinia. Inadvertent inoculation occurs when vaccinia virus is transferred from a vaccination site to a second location on the vaccinee or to a close contact. Usually, this condition is self-limited and no additional care is needed. Inoculations of the eye and eyelid require evaluation by an ophthalmologist and might require therapy with topical antiviral or antibacterial medications, VIG, or topical steroids. GV is characterized by a disseminated maculopapular or vesicular rash, frequently on an erythematous base, which usually occurs 6-9 days after first-time vaccination. This condition is usually self-limited and benign, although treatment with VIG might be required when the patient is systemically ill or found to have an underlying immunocompromising condition. Infection-control precautions should be used to prevent secondary transmission and nosocomial infection. EV occurs among persons with a history of atopic dermatitis (eczema), irrespective of disease severity or activity, and is a localized or generalized papular, vesicular, or pustular rash, which can occur anywhere on the body, with a predilection for areas of previous atopic dermatitis lesions. Patients with EV are often systemically ill and usually require VIG. Infection-control precautions should be used to prevent secondary transmission and nosocomial infection. PV is a rare, severe, and often fatal complication among persons with immunodeficiencies, characterized by painless progressive necrosis at the vaccination site with or without metastases to distant sites (e.g., skin, bones, and other viscera). This disease carries a high mortality rate, and management of PV should include aggressive therapy with VIG, intensive monitoring, and tertiary-level supportive care. Anecdotal experience suggests that, despite treatment with VIG, persons with cell-mediated immune deficits have a poorer prognosis than those with humoral deficits. Infection-control precautions should be used to prevent secondary transmission and nosocomial infection. Central nervous system disease, which includes postvaccinial encephalopathy (PVE) and postvaccinial encephalomyelitis (or encephalitis) (PVEM), occur after smallpox vaccination. PVE is most common among infants aged < 12 months. Clinical symptoms of central nervous system disease indicate cerebral or cerebellar dysfunction with headache, fever, vomiting, altered mental status, lethargy, seizures, and coma. PVE and PVEM are not believed to be a result of replicating vaccinia virus and are diagnoses of exclusion. Although no specific therapy exists for PVE or PVEM, supportive care, anticonvulsants, and intensive care might be required. Fetal vaccinia, resulting from vaccinial transmission from mother to fetus, is a rare, but serious, complication of smallpox vaccination during pregnancy or shortly before conception. It is manifested by skin lesions and organ involvement, and often results in fetal or neonatal death. No known reliable intrauterine diagnostic test is available to confirm fetal infection. Given the rarity of congenital vaccinia among live-born infants, vaccination during pregnancy should not ordinarily be a reason to consider termination of pregnancy. No known indication exists for routine, prophylactic use of VIG in an unintentionally vaccinated pregnant woman; however, VIG should not be withheld if a pregnant woman develops a condition where VIG is needed. Other less-common adverse events after smallpox vaccination have been reported to occur in temporal association with smallpox vaccination, but causality has not been established. Prophylactic treatment with VIG is not recommended for persons or close contacts with contraindications to smallpox vaccination who are inadvertently inoculated or exposed. These persons should be followed closely for early recognition of adverse reactions that might develop, and clinicians are encouraged to enroll these persons in the CDC registry by calling the Clinician Information Line at 877-554-4625. To request clinical consultation and IND therapies for vaccinia-related adverse reactions for civilians, contact your state health department or CDC's Clinician Information Line (877-554-4625). Clinical evaluation tools are available at http.//www.bt.cdc.gov/agent/smallpox/vaccination/clineval. Clinical specimen-collection guidance is available at http://www.bt.cdc.gov/agent/smallpox/vaccination/vaccinia-specimen-collection.asp. Physicians at military medical facilities can request VIG or cidofovir by calling the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at 301-619-2257 or 888-USA-RIID.