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Recommendations for using smallpox vaccine in a pre-event vaccination program. Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC).

This report supplements the 2001 statement by the Advisory Committee on Immunization Practices (ACIP) (CDC. Vaccinia [smallpox] vaccine: recommendations of the Advisory Committee on Immunization Practices [ACIP], 2001. MMWR 2001;50[No. RR-10]:1-25). This supplemental report provides recommendations for using smallpox vaccine in the pre-event vaccination program in the United States. To facilitate preparedness and response, smallpox vaccination is recommended for persons designated by public health authorities to conduct investigation and follow-up of initial smallpox cases that might necessitate direct patient contact. ACIP recommends that each state and territory establish and maintain > or = 1 smallpox response team. ACIP and the Healthcare Infection Control Practices Advisory Committee (HICPAC) recommend that each acute-care hospital identify health-care workers who can be vaccinated and trained to provide direct medical care for the first smallpox patients requiring hospital admission and to evaluate and manage patients who are suspected as having smallpox. When feasible, the first-stage vaccination program should include previously vaccinated health-care personnel to decrease the potential for adverse events. Additionally persons administering smallpox vaccine in this pre-event vaccination program should be vaccinated. Smallpox vaccine is administered by using the multiple-puncture technique with a bifurcated needle, packaged with the vaccine and diluent. According to the product labeling, 2-3 punctures are recommended for primary vaccination and 15 punctures for revaccination. A trace of blood should appear at the vaccination site after 15-20 seconds; if no trace of blood is visible, an additional 3 insertions should be made by using the same bifurcated needle without reinserting the needle into the vaccine vial. If no evidence of vaccine take is apparent after 7 days, the person can be vaccinated again. Optimal infection-control practices and appropriate site care should prevent transmission of vaccinia virus from vaccinated health-care workers to patients. Health-care personnel providing direct patient care should keep their vaccination sites covered with gauze in combination with a semipermeable membrane dressing to absorb exudates and to provide a barrier for containment of vaccinia virus to minimize the risk of transmission; the dressing should also be covered by a layer of clothing. Dressings used to cover the site should be changed frequently to prevent accumulation of exudates and consequent maceration. The most critical measure in preventing contact transmission is consistent hand hygiene. Hospitals should designate staff to assess dressings for all vaccinated health-care workers. When feasible, staff responsible for dressing changes for smallpox health-care teams should be vaccinated, all persons handling dressings should observe contact precautions. Administrative leave is not required routinely for newly vaccinated health-care personnel unless they are physically unable to work as a result of systemic signs and symptoms of illness; have extensive skin lesions that cannot be adequately covered or if they are unable to adhere to the recommended infection-control precautions. Persons outside the patient-care setting can keep their vaccination sites covered with a porous dressing hand hygiene remains key to preventing inadvertent inoculation. FDA has recommended that recipients of smallpox vaccine be deferred from donating blood for 21 days or until the scab has separated. Contacts of vaccinees, who have inadvertently contracted vaccinia, also should be deferred from donating blood for 14 days after complete resolution of their complication. In the pre-event vaccination program, smallpox vaccination is contraindicated for persons with a history or presence of eczema or atopic dermatitis; who have other acute, chronic, or exfoliative skin conditions; who have conditions associated with immunosuppression; are aged < 1 year; who have a serious allergy to any component of the vaccine; or who are pregnant or breastfeeding. ACIP does not recommend smallpox vaccination for children and adolescents aged < 18 years during the pre-event vaccination program. Pre-event vaccination also is contraindicated among persons with household contacts who have a history or presence of eczema or atopic dermatitis; who have other acute, chronic, or exfoliative skin conditions; who have conditions associated with immunosuppression; or who are pregnant. For purposes of screening for contraindications for pre-event vaccination, household contacts include persons with prolonged intimate contact (e.g., sexual contacts) with the potential vaccinee and others who might have direct contact with the vaccination site. Persons with inflammatory eye disease might be at increased risk for inadvertent inoculation as a result of touching or rubbing the eye. Therefore, deferring vaccination is prudent for persons with inflammatory eye diseases requiring steroid treatment until the condition resolves and the course of therapy is complete. Eczema vaccinatum, a serious form of disseminated vaccinia infection, can occur among persons with atopic dermatitis and other dermatologic conditions. Potential vaccinees should be queried regarding the diagnosis of atopic dermatitis or eczema in themselves or any member of their household, or regarding the presence of chronic or recurrent rashes consistent with these diagnoses. Persons reporting such a rash in themselves or household members should not be vaccinated, unless a health-care provider determines that the rash is not eczema or atopic dermatitis. Before vaccination, women of childbearing age should be asked if they are pregnant or intend to become pregnant during the next 4 weeks; women who respond positively should not be vaccinated. Any woman who thinks she might be pregnant or who wants additional assurance that she is not pregnant should perform a urine pregnancy test on the day scheduled for vaccination. If a pregnant woman is inadvertently vaccinated or if she becomes pregnant within 4 weeks after smallpox vaccination, she should be counseled regarding concerns for the fetus. Vaccination during pregnancy should not ordinarily be a reason to terminate pregnancy. CDC has established a pregnancy registry to prospectively follow the outcome of such pregnancies and facilitate the investigation of any adverse pregnancy outcome among pregnant women who were inadvertently vaccinated. For enrollment in the registry, contact CDC at 404-639-8253. Smallpox vaccine should not be administered to persons with human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) as part of a pre-event program because of their increased risk for progressive vaccinia. HIV testing is recommended for persons who have any history of a risk factor for HIV infection or for anyone who is concerned that he or she might have HIV infection. HIV testing should be available in a confidential or anonymous setting, in accordance with local laws and regulations, with results communicated to the potential vaccinee before the planned date of vaccination. Smallpox vaccine can be administered simultaneously with any inactivated vaccine. With the exception of varicella vaccine, smallpox vaccine can be administered simultaneously with other live-virus vaccines. To avoid confusion in ascertaining which vaccine might have caused postvaccination skin lesions or other adverse events, varicella vaccine and smallpox vaccine should be administered >4 weeks apart. Health-care workers scheduled to receive an annual purified protein derivative (PPD) skin test for tuberculosis screening should not receive the skin test until >1 month after smallpox vaccination. Persons with progressive vaccinia, eczema vaccinatum, and severe generalized vaccinia or inadvertent inoculation might benefit from therapy with VIG or cidofovir, although the latter has not been approved by FDA for this indication. Suspected cases of these illnesses or other severe adverse events after smallpox vaccination should be reported immediately to state health departments. VIG and cidofovir are available from CDC under Investigational New Drug protocols. Clinically severe adverse events after smallpox vaccination should be reported to the Vaccine Adverse Event Reporting System. Reports can be made online at https://secure.vaers.org/VaersDataEntryintro.htm, or by postage-paid form, which is available by calling 800-822-7967 (toll-free). ACIP will review these recommendations periodically as new information becomes available related to smallpox disease, smallpox vaccines, the risk of smallpox attack, smallpox vaccine adverse events, and the experience gained as recent recommendations are implemented. Revised recommendations will be developed as needed.

Bioterrorism↗

Immunization of health-care workers: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC).

This report summarizes recommendations of the Advisory Committee on Immunization Practices (ACIP) concerning the use of certain immunizing agents in health-care workers (HCWs) in the United States. It was prepared in consultation with the Hospital Infection Control Practices Advisory Committee (HICPAC) and is consistent with current HICPAC guidelines for infection control in health-care personnel. These recommendations can assist hospital administrators, infection control practitioners, employee health physicians, and HCWs in optimizing infection prevention and control programs. Background information for each vaccine-preventable disease and specific recommendations for use of each vaccine are presented. The diseases are grouped into three categories: a) those for which active immunization is strongly recommended because of special risks for HCWs; b) those for which immunoprophylaxis is or may be indicated in certain circumstances; and c) those for which protection of all adults is recommended. This report reflects current ACIP recommendations at the time of publication. ACIP statements on individual vaccines and disease updates in MMWR should be consulted for more details regarding the epidemiology of the diseases, immunization schedules, vaccine doses, and the safety and efficacy of the vaccines.

Adult↗

Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel.

On June 10, 2005, a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) formulated for use in adults and adolescents was licensed in the United States for persons aged 11-64 years (ADACEL, manufactured by sanofi pasteur, Toronto, Ontario, Canada). Prelicensure studies demonstrated safety and efficacy, inferred through immunogenicity, against tetanus, diphtheria, and pertussis when Tdap was administered as a single booster dose to adults. To reduce pertussis morbidity among adults and maintain the standard of care for tetanus and diphtheria prevention and to reduce the transmission of pertussis to infants and in health-care settings, the Advisory Committee on Immunization Practices (ACIP) recommends that: 1) adults aged 19-64 years should receive a single dose of Tdap to replace tetanus and diphtheria toxoids vaccine (Td) for booster immunization against tetanus, diphtheria, and pertussis if they received their last dose of Td >or=10 years earlier and they have not previously received Tdap; 2) intervals shorter than 10 years since the last Td may be used for booster protection against pertussis; 3) adults who have or who anticipate having close contact with an infant aged <12 months (e.g., parents, grandparents aged <65 years, child-care providers, and health-care personnel) should receive a single dose of Tdap to reduce the risk for transmitting pertussis. An interval as short as 2 years from the last Td is suggested; shorter intervals can be used. When possible, women should receive Tdap before becoming pregnant. Women who have not previously received Tdap should receive a dose of Tdap in the immediate postpartum period; 4) health-care personnel who work in hospitals or ambulatory care settings and have direct patient contact should receive a single dose of Tdap as soon as feasible if they have not previously received Tdap. An interval as short as 2 years from the last dose of Td is recommended; shorter intervals may be used. These recommendations for use of Tdap in health-care personnel are supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC). This statement 1) reviews pertussis, tetanus and diphtheria vaccination policy in the United States; 2) describes the clinical features and epidemiology of pertussis among adults; 3) summarizes the immunogenicity, efficacy, and safety data of Tdap; and 4) presents recommendations for the use of Tdap among adults aged 19-64 years.

Adult↗