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At least 19 recordsLinked to original sources

Women with smallpox vaccine exposure during pregnancy reported to the National Smallpox Vaccine in Pregnancy Registry--United States, 2003.

In the absence of circulating smallpox, pregnant women should not be exposed to live vaccinia virus contained in the smallpox vaccine. The smallpox vaccine should not be administered to women who are pregnant or might become pregnant within 4 weeks after vaccination because of the risk for fetal vaccinia, a rare but serious infection of the fetus. In addition, persons who have close contact (e.g., household contact or sexual contact) with pregnant women are advised to forego vaccination. To prevent inadvertent exposure of pregnant women to vaccinia virus, screening for pregnancy is a component of pre-event smallpox vaccination programs. To monitor outcomes of pregnancy in women exposed to smallpox vaccines, CDC, in collaboration with the Department of Defense (DoD) and the Food and Drug Administration (FDA), has established the National Smallpox Vaccine in Pregnancy Registry. This report summarizes data from the registry about these exposures. CDC and the Advisory Committee on Immunization Practices (ACIP) recommendations to screen for pregnancy as a contraindication to smallpox vaccination appear to be effective at preventing inadvertent exposures.

Adult↗

[Localization of specific antigen in the organs of newborn animals vaccinated with liver smallpox vaccine].

Of 20 suckling rabbits, 4-5-days old, inoculated with live smallpox vaccine intradermally 6 displayed symptoms of generalized pox virus and neuroparalysis complications. Intensive accumulation of specific antigen in the brain, lungs, spleen, and the lymph glands was revealed by immunofluorescent method. The smallpox vaccine virus was isolated from these organs. Prolonged persistance of the attenuated smallpox virus was observed in the brain, spinal cord, lungs, spleen, and the lymph glands of 14 suckling rabbits showing no signs of any disease; specific antigen was revealed by immunofluorescent test. Vascular disturbances and slight cell changes were observed in the brain tissue of the inoculated animals. These changes were more severe in the sick animals.

Animals↗

Smallpox Vaccine Adverse Events Monitoring and Response System for the first stage of the smallpox vaccination program.

Smallpox vaccination of civilian volunteer health-care workers began on January 24, 2003. As of February 4, a total of 37 states and counties have received shipments of smallpox vaccine, and 18 states and counties have begun smallpox vaccination; no serious adverse events have been reported. To monitor the occurrence of adverse events associated with vaccination, both those expected on the basis of previous experience and possible new unexpected adverse events, CDC and state health departments have established the Smallpox Vaccine Adverse Events Monitoring and Response System. The system also will be used to monitor the effectiveness of contraindication screening, identify new contraindications, and coordinate the distribution of vaccinia immune globulin (VIG) and cidofovir to the civilian population. This notice describes the components of the system, delineates roles and responsibilities, and explains how data from the system will be compiled and communicated.

Adverse Drug Reaction Reporting Systems↗

Duration of immunity after smallpox vaccination: a study on vaccination policy against smallpox bioterrorism in Japan.

The success of global smallpox eradication in 1980 led all the nations of the world to discontinue smallpox vaccination. To date, however, the threat of deliberate release of smallpox virus has led health authorities to reconsider smallpox vaccination and at the same time, to urge to evaluate duration of the immunity of the population vaccinated before 1980. Although available data is scarce and incomplete, the study suggests that protective immunity lasts longer in a good percentage of vaccinees, although the real percentage and duration are not known. Accordingly, how to establish a national vaccination policy for preparedness in Japan and elsewhere was discussed. The study is intended to cause interest and debate among the medical and public health community.

Bioterrorism↗

Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table. Interim final rule.

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), Public Law 108-20, 117 Stat. 638, authorized the Secretary of Health and Human Services (the Secretary), through the establishment of the Smallpox Vaccine Injury Compensation Program (the Program), to provide benefits and/or compensation to certain persons who have sustained injuries as a result of the administration of smallpox covered countermeasures (including the smallpox vaccine) or as a result of vaccinia contracted through accidental vaccinia inoculations. The SEPPA directed the Secretary to establish, by interim final rule, a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of or exposure to the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. As mandated by law, the Secretary is establishing such a Smallpox (Vaccinia) Vaccine Injury Table (the Table) through this interim final rule. The Secretary is also establishing a set of Table Definitions and Requirements, which define the terms and conditions included on the Table and are to be read in conjunction with the Table. The Secretary is seeking public comment on the Table established through this interim final rule. At a later date, the Secretary will publish a companion final rule setting forth the administrative implementation of the Program. The public will then be afforded an additional opportunity to comment on the procedures set forth therein.

Compensation and Redress↗

A study of the effect of simultaneous vaccination with BCG and smallpox vaccine in newborn infants.

In order to determine whether the BCG and smallpox vaccinations of newborn infants could be combined, thus saving staff, time and money, particularly in the developing countries, 696 newborn infants in Taiwan were divided into three groups and vaccinated by one of the following three methods: simultaneous vaccination with BCG and smallpox vaccine, vaccination with BCG only, and vaccination with smallpox vaccine only. On follow-up, no difference was observed between the "simultaneous" group and the "smallpox only" group in respect of either no-take rate and frequency distribution by size of vaccination lesions or reactions to smallpox revaccination at 12 weeks. Tuberculin tests at 12 weeks revealed a normal distribution in the size of tuberculin reactions with a mean of 11.94 mm and 12.19 mm respectively in the "simultaneous" group and the "BCG only" group; in the "smallpox only" group all the reactions were below 9 mm, the great majority being 0-3 mm. The author concludes that there is no interaction between primary BCG and smallpox vaccination when both vaccines are administered simultaneously, and that, despite the reported complications, simultaneous administration of BCG and smallpox vaccine in newborn infants is a safe procedure.

BCG Vaccine↗

Smallpox vaccination by intradermal jet injection. 3. Evaluation in a well-vaccinated population.

Smallpox vaccinations were performed in a well-vaccinated prison population by multiple-pressure technique and by intradermal jet injection using serial dilutions of vaccine. A total of 140 subjects were divided into groups, and each group was vaccinated by the multiple-pressure technique or by jet injection using 1 of 3 vaccine dilutions with the following calculated titres: ID-Jet 1 = 10(7.0) TCID(50)/ml, ID-Jet 1a = 10(6.3) TCID(50)/ml, ID-Jet 2 = 10(6.0) TCID(50)/ml. Clinical observations were made at intervals during the first week after vaccination. Prevaccination and post-vaccination serum samples were obtained immediately before and 30 days after the vaccination. Results based on clinical and serological evaluations indicated that smallpox vaccination by jet injection with the ID-Jet 1 vaccine was at least as efficacious as vaccination by the standard multiple-pressure technique.

Adult↗