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PubMed2003

Public mistrust: the unrecognized risk of the CDC Smallpox Vaccination Program.

Phase 1 of the CDC's Smallpox Vaccination Program has foundered because of a lack of volunteers. However, despite the enrollment of fewer than 10% of the projected number of hospital employees in Phase 1, and recent recommendations of two advisory groups, CDC and DHHS officials recently announced plans to expand this vaccination program. During Phase 2 of the Smallpox Vaccination Program, an additional 10 million health care and emergency workers are scheduled to receive vaccination. This paper reviews reasons why state health departments and hospitals rejected participation in Phase 1. It urges the federal government to take account of these problems before proceeding to Phase 2 and argues that the flaws in this program not only threaten bioterrorism preparedness efforts but, more importantly, might endanger trust in public health initiatives.

Bioterrorism↗
PubMedDate not supplied

Validity of self-assessment of skin reaction after smallpox vaccination.

OBJECTIVE: Smallpox vaccinees should be evaluated for the presence of a major skin reaction ("take") one week after vaccination, but this could prove to be logistically infeasible in the context of an emergency mass-vaccination campaign. We validated a tool for self-evaluation of the vaccination site for presence of take. METHODS: We conducted a prospective, double-blinded, paired-measurement validation study of 174 non-naive adult vaccinees and their physician evaluators. Subjects provided paired, blinded, independent assessments of take 7-9 days after vaccination. RESULTS: Overall, vaccinees and evaluators agreed on 157 of 174 (90.2%) take assessments. Sensitivity of the tool was 99.1%, and specificity was 75%. The positive predictive value of self-assessment was 87.2% and the negative predictive value was 98%. Specificity of the tool and measures of agreement were significantly modified by age, education, and occupation. When adjusted for the expected take rate among a population including naive vaccinees, positive predictive value and overall agreement increased significantly. CONCLUSIONS: Self-assessment may be a feasible option for evaluation of take in the event of mass smallpox vaccination. The predictive values and overall agreement of the tool are satisfactory, and can be expected to increase when used in a largely naive population.

Adult↗
PubMed2006

Genomic sequence and analysis of a vaccinia virus isolate from a patient with a smallpox vaccine-related complication.

BACKGROUND: Vaccinia virus (VACV)-DUKE was isolated from a lesion on a 54 year old female who presented to a doctor at the Duke University Medical Center. She was diagnosed with progressive vaccinia and treated with vaccinia immune globulin. The availability of the VACV-DUKE genome sequence permits a first time genomic comparison of a VACV isolate associated with a smallpox vaccine complication with the sequence of culture-derived clonal isolates of the Dryvax vaccine. RESULTS: This study showed that VACV-DUKE is most similar to VACV-ACAM2000 and CLONE3, two VACV clones isolated from the Dryvax vaccine stock confirming VACV-DUKE as an isolate from Dryvax. However, VACV-DUKE is unique because it is, to date, the only Dryvax clone isolated from a patient experiencing a vaccine-associated complication. The 199,960 bp VACV-DUKE genome encodes 225 open reading frames, including 178 intact genes and 47 gene fragments. Between VACV-DUKE and the other Dryvax isolates, the major genomic differences are in fragmentation of the ankyrin-like, and kelch-like genes, presence of a full-length Interferon-alpha/beta receptor gene, and the absence of a duplication of 12 ORFs in the inverted terminal repeat. Excluding this region, the DNA sequence of VACV-DUKE differs from the other two Dryvax isolates by less than 0.4%. DNA sequencing also indicated that there was little heterogeneity in the sample, supporting the hypothesis that virus from an individual lesion is clonal in origin despite the fact that the vaccine is a mixed population. CONCLUSION: Virus in lesions that result from progressive vaccinia following vaccination with Dryvax are likely clonal in origin. The genomic sequence of VACV-DUKE is overall very similar to that of Dryvax cell culture-derived clonal isolates. Furthermore, with the sequences of multiple clones from Dryvax we can begin to appreciate the diversity of the viral population in the smallpox vaccine.

Female↗
PubMed2004

The pitfalls of bioterrorism preparedness: the anthrax and smallpox experiences.

Bioterrorism preparedness programs have contributed to death, illness, and waste of public health resources without evidence of benefit. Several deaths and many serious illnesses have resulted from the smallpox vaccination program; yet there is no clear evidence that a threat of smallpox exposure ever existed. The anthrax spores released in 2001 have been linked to secret US military laboratories-the resultant illnesses and deaths might not have occurred if those laboratories were not in operation. The present expansion of bioterrorism preparedness programs will continue to squander health resources, increase the dangers of accidental or purposeful release of dangerous pathogens, and further undermine efforts to enforce international treaties to ban biological and chemical weapons. The public health community should acknowledge the substantial harm that bioterrorism preparedness has already caused and develop mechanisms to increase our public health resources and to allocate them to address the world's real health needs.

Anthrax↗
PubMedDate not supplied

The threat of bioterrorism: a reason to learn more about anthrax and smallpox.

Threats of domestic terrorism and international news about germ warfare research have forced us to recognize the potential menace of biological weapons. Both smallpox and anthrax could be used as biological weapons. It is important for physicians to reacquaint themselves with these diseases, because if a domestic attack were to occur, it might first be recognized when patients with unusual symptoms began presenting to hospitals and primary care physicians. In this article, we discuss symptoms and treatments for smallpox and anthrax, and suggest resources for physicians who wish to learn more about the subject.

Anthrax↗
PubMed2005

Differential regulation of granzyme and perforin in effector and memory T cells following smallpox immunization.

Primary immunization of healthy adults with vaccinia virus induces a local vesicle or "take" in the majority of vaccinees that previously has been shown to correlate with protection against smallpox. However, the immunologic mechanisms underlying this protective response in humans are not well characterized. We have studied human CD8+ T cells for the expression patterns of phenotypic markers and cytolytic effector molecules before and after primary smallpox immunization using nine-color polychromatic flow cytometry. One month after immunization, vaccinees developed vaccinia virus-specific CD8+ T cells with an effector cell phenotype containing both granzyme A and granzyme B. One year after immunization, we found a significant decrease in granzyme B containing cells and an increased memory cell phenotype in virus-specific CD8+ T cells. Perforin was rarely expressed directly ex vivo, but was highly expressed after Ag-specific activation in vitro. Together, these data suggest an important role for effector CD8+ T cells in controlling poxvirus infection, and have implications for our understanding of human CD8+ T cell differentiation.

Adult↗
PubMed2004

Stevens-Johnson syndrome after immunization with smallpox, anthrax, and tetanus vaccines.

A 19-year-old male military recruit developed erythema multiforme 20 days after receiving a triad of vaccinations: smallpox (vaccinia virus), anthrax, and tetanus. Over the course of a few days, the erythema multiforme evolved into Stevens-Johnson syndrome, associated with widespread bullae, stomatitis, conjunctivitis, and fever. After 7 days of conservative management, the patient's signs and symptoms improved. This case serves as a timely reminder of a severe and potentially life-threatening complication of smallpox vaccination.

Adult↗
PubMed1999

[Two hundred years ago: the first smallpox vaccinations in Vienna].

The first successful smallpox vaccination with cowpox lymph outside of England was carried out in Vienna--only ten months after the publication of Edward Jenner's book "An Inquiry into the Causes and Effects of the Variolae Vaccinae, a Disease ... known by the Name of the Cow Pox", and only a little more than three months after the first vaccinations in London: Two hundred years ago, on 30 April 1799, the medical service chief of Lower Austria, Dr. Paskal Joseph Ferro, born in Bonn, vaccinated his three children with vaccine which had come in a letter from London. Subsequently the vaccination was introduced in Austria. Before 1800 effective prophylactic immunizations against smallpox were carried out, apart from England, only in Vienna and environs. The first efficient vaccine to reach India also came from Vienna.

Austria↗
PubMed2000

Adverse reactions to smallpox vaccine: the Israel Defense Force experience, 1991 to 1996. A comparison with previous surveys.

The aim of the present study was to assess the post-smallpox vaccination complication rate in a cohort of Israel Defense Force recruits enlisted in the calendar years 1991 to 1996 and to compare it with rates reported, in similar age groups, in large surveys during the 1960s. The overall complication rate was 0.4 per 10,000 vaccinees, and the rate of severe complications was very low, similar to previously published data. We conclude that among young healthy adults, vaccination with smallpox vaccine is relatively safe and is associated with a low rate of complications. Severe complications were very rare in this age group in our study. However, the complication rate is increasing with the increased percentage of primary vaccinees.

Adult↗
PubMed1975

Clinical observations on smallpox: a study of 1233 patients admitted to the Infectious Diseases Hospital, Calcutta, during 1973.

The paper presents clinical observations on 1 233 persons with smallpox who were admitted to the Infectious Diseases Hospital, Calcutta, in 1973. The disease was of the modified type in 53 patients (4.3%), the ordinary type in 717 (58.2%), the flat type in 249 (20.2%), and the haemorrhagic type in 214 (17.3%). The fatality of these types of smallpox was found to be 5.7%, 26.8%, 88.4%, and 98.1%, respectively, and the overall case fatality was 50.7%. The haemorrhagic type was found mainly among older patients and affected males more often than females. The vaccination status of 1 218 patients was known. Of these, 901 (73.9%) were unvaccinated and had a fatality rate of 53.4%, whereas the 317 (26.1%) vaccinated patients had a fatality rate of 36.5%. Among the 201 haemorrhagic cases, 145 patients were unvaccinated (16.09% of the total number unvaccinated) and 56 (17.67%) had been vaccinated. Of 34 patients vaccinated during the incubation period, 19 (41.1%) died, whereas of 18 patients who had been vaccinated after the onset of fever, but before the appearance of rash, 9 (50%) died.

Adolescent↗
PubMed1994

[The last outbreak of smallpox in Sweden].

On April 6 1963 a fairly well vaccinated seaman, newly arrived to Sweden from the Far East, developed a mild smallpox. He caused an outbreak of smallpox involving 26 further cases. This article describes how the illness was spread in Stockholm.

Disease Outbreaks↗
PubMedDate not supplied

[200 years of the smallpox vaccine].

The expression "inoculation of smallpox" was first employed by Emanuele Timone, native of Chios island and graduated from the Universities of Padua and Oxford. He learned about this procedure in Constantinople. This method was introduced in North America, during the great epidemic outbreak of 1721, by two Bostonian citizens: Cotton Mather and Zabdiel Boylston. The French physician Henri Etienne Morel introduced the procedure into New Spain during the smallpox epidemic of 1779. Nevertheless only in 1798 the English physician Edward Jenner published the results of his observations and experience concerning the "vaccination" in his book "Inquiry into the cause and effects of the variolae vaccinae." After some initial oppositions, this method rapidly spreaded to the rest of Europe. It arrived to Spain in 1801 and thence was transferred to Spanish America and Philippine Islands with the expedition leaded by Francisco Xavier Balmis. Along the XIX century the methods for obtaining and keeping the vaccine were notably improved. Both Jenner and Balmis are worthy of remembrance as great humanity benefactors.

Europe↗
PubMed1975

[Frequency of acrocentric chromosomal associations in children immunized with smallpox vaccine].

The frequency of associations of acrocentric chromosomes (AAC) diminished on the 7th day after vaccination in children primary vaccinated, primary revaccinated and secondary revaccinated against smallpox. This decrease reached its maximum by the 30th day and returned to its starting point after 6th months after vaccination. The degree of reduction of the frequency of AAC in every immunized children group correlated with the degree of increasing of antihemagglutinin titre. The relation of the number of group D chromosomes involved in AAC to the number of group G chromosomes varied in various individuals, these variations remaining after immunization. It was supposed that in PHA-stimulated lymphocyte cultures the degree of reduction of AAC frequency after vaccination against smallpox is a cytochemical marker of proliferation intensity of T-lymphocytes induced for immunopoiesis.

Antibodies, Viral↗
PubMed2003

Smallpox vaccine adverse events among civilians--United States, January 24-February 18, 2003.

During the civilian smallpox vaccination program, CDC and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported via passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 14, 2003, and received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of February 18.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

Smallpox vaccine adverse events among civilians--United States, February 18-24, 2003.

During the civilian smallpox vaccination program, CDC and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported through passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 21, 2003, and received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of February 24.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

Who will pay for the adverse events resulting from smallpox vaccination? Liability and compensation issues.

This paper summarizes liability and compensation concerns surrounding the smallpox vaccination program announced by President Bush on December 13, 2002. The paper examines the nature of adverse health events that are likely to occur in connection with the smallpox vaccine, assesses the liability protections that have been established for organizations and individuals participating in the vaccination program, and discusses the compensation mechanisms being considered to address the damages incurred by volunteers who may suffer from adverse vaccine reactions. Specifically, the implications of the Federal Tort Claims Act, workers' compensation programs, and the creation of a new no-fault compensation fund are explored.

Compensation and Redress↗
PubMed2003

Smallpox vaccine adverse events among civilians--United States, February 25-March 3, 2003.

During the civilian smallpox vaccination program, CDC, the Food and Drug Administration, and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported through passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 28, 2003, and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of March 3.

Adolescent↗