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PubMed2006

Smallpox Vaccine Injury Compensation Program: administrative implementation. Adoption of interim final rule as final rule with amendments.

This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term "child" survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.

Compensation and Redress↗
PubMed1975

[Pathomorphological and immunofluorescent studies of smallpox vaccine neurotropism].

Experiments were conducted on guinea pigs sensitized with the AK C-vaccine components. In intracardiac injection with smallpox vaccine there was shown a possibility of development of marked hemodynamic disturbances, of the inflammatory-dystrophic processes of irreversibel character, with a subsequent neuronophagia and demyelinization. Injection of smallpox vaccine into the circulation of intact guinea pigs was accompanied by development in the nervous system of insignificant circulatory disturbances and of the inflammatory dystrophic phenomena of reversible character. A method of immunofluorescence was used and the antigen of the vaccine virus was revealed in the neurons of the brain and the spinal cord of the sensitized and intact animals. Marked hemodynamic and insignificant inflammatory-dystrophic processes were revealed in the nervous system of a child which died of the post-vaccinal encephalitis; an antigen of the smallpox virus was found by the immunofluorescent method in the nerve cells and the vessels in various portions of the nervous system.

Animals↗
PubMed1965

Haemorrhagic smallpox. 2. Specific bleeding and coagulation studies.

A total of 60 patients in Madras with haemorrhagic and non-haemorrhagic clinical forms of smallpox were investigated by a variety of bleeding and coagulation studies in an attempt to reveal specific haematological defects that might account for the haemorrhagic diathesis in certain cases of smallpox.The non-haemorrhagic smallpox patients had no coagulation abnormalities, although some had thrombocytopenia.The early haemorrhagic patients showed a deficiency of platelets, prothrombin and accelerator globulin, and increased circulating antithrombin. Patients with the late form of haemorrhagic smallpox showed significant thrombocytopenia and less severe deficiencies of the same coagulation factors; a few also had increased antithrombin.The authors suggest that therapy with fresh, frozen or lyophilized plasma should be tried; fresh, platelet-rich plasma should offer the greatest benefit.

Blood Coagulation↗
PubMedDate not supplied

Fighting smallpox on the Texas border: an episode from PHS's proud past.

The motto of the Public Health Service (PHS) is "Service with Distinction." An example of how that motto was earned can be seen in the work of the professionals of the Marine Hospital Service (as PHS was then known) in a smallpox epidemic on the Texas border in 1895. Barely 2 years after Congress had given the U.S. Surgeon General the authority to intervene and prevent the spread of contagious diseases from one State to another, Surgeon General Walter Wyman, MD, stepped in. In response to a request from the Texas State Health Officer, Wyman sent a team of officers to assist the State and prevent the spread of smallpox. At that time the Surgeon General was head of the Marine Hospital Service, which became the Public Health Service in 1912. In a period of slightly more than 2 months, the epidemic was contained in the population of 411 refugees. Sixty people had died at the camp, 51 from smallpox. Although that fatality rate would be incredibly high by current standards, it was low under the circumstances. Milton Rosenau, MD, was a key to the containment of the disease and the humanitarian treatment of the survivors, a group of black Americans who had fled from Mexico after having been lured there with the promise of land that would be their own. Rosenau would later become the head of the Hygienic Laboratory, precursor of the National Institutes of Health.

Black or African American↗
PubMed1976

[Electron microscopic study of the kinetics of smallpox vaccine interaction with alveolar macrophages when administered intratracheally].

Electron microscopy was applied to the study of the dynamics of endocytosis of smallpox vaccine by alveolar macrophages in intratracheal immunization of guinea pigs; 5 to 15 minutes after administration of smallpox vaccine the viruses were absorbed on the macrophage surface, penetrated into the cells by invagination and vesiculation. A possibility of adaption of smallpox virus in the alveolar macrophages 12 hours after the vaccination was confirmed documentally.

Administration, Oral↗
PubMed1998

Commentary: smallpox eradication in west and central Africa revisited.

In May 1980, the Thirty-third World Health Assembly adopted a resolution accepting the report of the Global Commission for the Certification of Smallpox Eradication and affirming its belief that this once-universal disease had been eradicated worldwide, 21 years after the global eradication programme had begun in 1959. A key element in the eradication effort was the surveillance-containment strategy, which was first tested in Nigeria in 1966, and which led to its adoption throughout the world. West and Central Africa became the first region of the world to be smallpox free and one by one other regions followed. One of the major lessons to be learned from the smallpox eradication programme is that interdependence is required if global results are to be achieved. Unfortunately, however, humanity has failed to learn this lesson in the long-term, and although global health has improved dramatically the gaps between the rich and poor remain vast.

Africa, Central↗
PubMed1962

The use of hyperimmune antivaccinia gamma-globulin for the prevention and treatment of smallpox.

Smallpox prophylaxis studies having shown that the classical Jennerian type of vaccination may in some instances prove inadequate to prevent the development of the disease or may be contra-indicated for certain persons, attempts were made to evolve a method which could supplement or replace such vaccination. Investigations reported in this paper have demonstrated that the administration of gamma-globulin obtained from the sera of various animals hyperimmunized with vaccinia virus gives highly effective results in the prevention of different forms of experimental vaccinial infection. Encouraging results were also obtained with this gamma-globulin given prophylactically to 13 persons who had been in close contact with smallpox patients during an outbreak of this disease in Moscow in 1960. The author suggests that hyperimmune antivaccinia gamma-globulin of animal origin may also prove effective in the treatment of postvaccinal complications.

Humans↗
PubMed1974

Air sampling of smallpox virus.

Airborne smallpox virus has been recovered in an isolation hospital using an adhesive surface sampling technique in the presence of very low aerosol concentrations. Previous work in this field is reviewed. Successful recovery of airborne virus depends on sampling large volumes of air with a suitable sampler and thorough investigation of the whole sample taken for the presence of viable virus. More information on the characteristics and behaviour of airborne smallpox virus is needed in particular with regard to the future design and siting of smallpox isolation units.

Air Microbiology↗
PubMedDate not supplied

Potential virulence determinants in terminal regions of variola smallpox virus genome.

Smallpox eradication culminated the most successful antimicrobial campaign in medical history. To characterize further the linear double-stranded DNA genome of the aetiological agent of smallpox, we have determined the entire nucleotide sequence of the highly virulent variola major virus, strain Bangladesh-1975 (VAR-BSH; 186,102 base pairs, 33.7% G + C; Genbank accession number, L22579). Here we highlight features of the molecule and focus on a few of the 187 putative proteins that probably contribute to pathogenicity and virus host-range properties. One hundred and fifty proteins were markedly similar to those of vaccinia virus (smallpox vaccine), for which a complete sequence has been reported for strain Copenhagen (VAC-CPN; 191,636 base pairs, 33.3% G + C). The remaining 37 proteins reflected variola-specific sequences or open reading frame divergences for variant proteins, which are often truncated or elongated compared with their vaccinia counterparts.

Animals↗
PubMed2006

Chimpanzee/human mAbs to vaccinia virus B5 protein neutralize vaccinia and smallpox viruses and protect mice against vaccinia virus.

Chimpanzee Fabs against the B5 envelope glycoprotein of vaccinia virus were isolated and converted into complete mAbs with human gamma 1 heavy chain constant regions. The two mAbs (8AH8AL and 8AH7AL) displayed high binding affinities to B5 (Kd of 0.2 and 0.7 nM). The mAb 8AH8AL inhibited the spread of vaccinia virus as well as variola virus (the causative agent of smallpox) in vitro, protected mice from subsequent intranasal challenge with virulent vaccinia virus, protected mice when administered 2 days after challenge, and provided significantly greater protection than that afforded by a previously isolated rat anti-B5 mAb (19C2) or by vaccinia immune globulin. The mAb bound to a conformational epitope between amino acids 20 and 130 of B5. These chimpanzee/human anti-B5 mAbs may be useful in the prevention and treatment of vaccinia virus-induced complications of vaccination against smallpox and may also be effective in the immunoprophylaxis and immunotherapy of smallpox.

Amino Acid Sequence↗
PubMedDate not supplied

The new cell culture smallpox vaccine should be offered to the general population.

A series of major factors must be weighed in deciding whether or not, and to what extent, a particular country should consider pre-exposure vaccination for smallpox. These include the risk of a bioterrorist attack using smallpox, the risk of secondary spread from another country, the risks and benefits of vaccination, the effectivenes s of vaccination pre- and post-exposure, the prevalence of immunocompromised persons, the capacity of the medical care delivery system and the wealth of a nation. We review here the issues and variables relevant for policy making, propose a framework for country-specific decision making and suggest the World Health Organization has a key role to play, particularly with regard to lower-income countries. In doing so, we support the proposition.

Bioterrorism↗
PubMedDate not supplied

Smallpox: gone but not forgotten.

Smallpox represents both the acme of man's efforts to combat infectious diseases and one of his greatest fears. The disease emerged in prehistoric times to spread throughout the world causing blindness and death in millions of people. An acute infection caused by variola virus, one of the Orthopoxviruses, with skin eruption and marked toxemia had an average case fatality rate of 30%. Variola minor, a milder form of the disease, had a case fatality of one percent. Humans are the sole host, and survival confers lifelong immunity. Immunization was practiced since ancient times by inoculation with the variola virus until Jenner's demonstration of the efficacy and safety of vaccination with vaccinia virus. Following an intensive eradication effort by the World Health Organization, the world was declared to be free of smallpox in 1979. The decision to destroy all remaining stocks of variola virus in 1999 has met with some controversy.

Animals↗
PubMed2005

Prediction of smallpox outbreak and evaluation of control-measure policy in Japan, using a mathematical model.

Since the September 1 terrorist attacks and moreover, since the anthrax exposure events in 2001 in the United States, bioterrorism attacks seem to be a real threat. Of course, the public health authorities in Japan have started to prepare control measures for such events. We report here our attempts, using a mathematical model, to estimate outbreak size and to examine the most effective measures; comparing ring vaccination (contact tracing, isolation, and vaccination among contacts) and mass vaccination of the susceptible population in the area. The basic framework of the mathematical model follows a model used in previous research. The initial susceptible population is assumed to be 30 million persons. Concerning the important parameters, such as the number of initial-exposure cases, R0 (infectious power, or natural history) and, the starting day of intervention after the initial exposure, we checked the robustness of our conclusions by sensitivity analysis. We found that mass vaccination is preferable to ring vaccination when the values for the initial-exposure cases and R0 are high and when the start of intervention by public health authorities is delayed. In the base-case situation, the mass vaccination strategy needs almost 30 million vaccine doses. On the other hand, though ring vaccination needs fewer doses, it needs fewer than 50,000 doses in the worst-case scenario, that with larger first exposure, higher R0, or later start of public health authority intervention. This mathematical model can measure the prevalence of an infectious disease and can evaluate control measures for it before an outbreak. Especially, it is useful for the planning of the outbreaks of emerging diseases such as severe acute respiratory syndrome (SARS) or for bioterrorism attacks involving such diseases as smallpox. In further research, we will have to take into account the population people vaccinated of for smallpox, who account for about 70% of the total population in Japan.

Disease Outbreaks↗
PubMed2004

Frequency of vaccinia virus isolation on semipermeable versus nonocclusive dressings covering smallpox vaccination sites in hospital personnel.

BACKGROUND: The Centers for Disease Control and Prevention recommends a semipermeable occlusive dressing for hospital workers who receive smallpox vaccination. OBJECTIVE: The study was designed to determine the frequency of vaccinia virus isolation from the outer surface of semipermeable dressings and to compare the prevalence of vaccinia virus on the outer surface of semipermeable dressings with its prevalence on the outer surface of nonocclusive dressings. METHODS: A prospective, observational study was conducted on hospital employees who received smallpox vaccination at a military academic medical center. Subjects were instructed to wear a semipermeable dressing if they had direct patient contact. Employees without direct patient care had the option of wearing a semipermeable dressing or a nonocclusive dressing. Prior to a programmed dressing change, the outer surface of the bandage site was swabbed and cultured for virus. Samples were considered positive when cytopathic effects were observed, with results confirmed as vaccinia by polymerase chain reaction. RESULTS: A total of 212 cultures were obtained from 93 subjects. All cultures directly obtained from active lesions were positive (13/13). Positive cultures were obtained from 7% (10/135) of the semipermeable dressings and 23% (15/64) of the nonocclusive dressings (P <.05). Ten percent (8/79) of the semipermeable dressings with purulent exudate observed underneath the bandage were culture positive, compared with 4% (2/56) of semipermeable dressings with no purulent exudate observed underneath the bandage (P=.19). CONCLUSIONS: Compared with nonocclusive dressings, the semipermeable dressing reduced, but did not eliminate, the frequency with which vaccinia virus was cultured from the surface of the dressing. Virus was present, but only rarely, on the dressing surface in the absence of purulent exudate under the semipermeable dressings.

Bandages↗
PubMed2004

The effect of semipermeable dressings on smallpox vaccine site evolution.

BACKGROUND: Many hospital systems in the United States are contemplating the implementation of a smallpox vaccination program. The Centers for Disease Control and Prevention and other organizations recommend use of occlusive dressings over the vaccination site of health care workers in contact with patients. Minimal data are available on the impact of an occlusive dressing on the evolution of the vaccinia inoculation site. METHODS: We conducted a prospective observational study in which subjects were instructed to cover their vaccination site with either a semipermeable dressing over gauze or gauze alone. We recorded the duration of semipermeable dressing use and parameters pertaining to vaccination site evolution, to include time until scab separation. RESULTS: The increased use of a semipermeable dressing is associated with increased time until scab separation (n = 41, r =.48, P =.001 by regression analysis). This analysis predicts a 9-day difference in time until scab separation between patients that wore semipermeable dressings 100% of the time versus not at all. No significant correlation was observed between semipermeable dressing use and size of maximum erythema, time until maximum erythema, size of erythema on day 6 or 8, nor time until pustule formation. CONCLUSION: Semipermeable dressing use appears to prolong the time until scab separation and possibly the duration of infectivity and risk of secondary transmission. Health care organizations may wish to consider this information when instituting a smallpox vaccination program.

Adult↗
PubMed2004

Smallpox in the 21st century.

The viral disease, smallpox, was well known through the end of the 20th Century. Because it has been eradicated from natural populations, the present clinical experience with managing the disease is limited. Similarly, research in the pathophysiology, treatment, and prevention of the disease has recently become a priority. Concerns regarding smallpox as a weapon of bioterrorism have led to the implementation of a new prophylactic vaccine program, a renewal in variola vaccine research, and treatment regimens against variola infection.

Humans↗
PubMed2004

Society for assisted reproductive technology position statement on donor suitability of recipients of smallpox vaccine (vaccinia virus).

Although there is presently no definitive evidence linking vaccinia virus transmission through reproductive cells, SART/ASRM accordingly recommends that assisted reproductive technology (ART) practitioners consider deferring donors who have recently received smallpox vaccine or contracted symptomatic vaccinia virus infection through close contact with a vaccine recipient (until after the vaccine or infectious scab has spontaneously separated). Good donor practice further suggests that donors who are not in good health, including those with recent complications from smallpox vaccine, should be similarly deferred.

Female↗
PubMed2006

Society for Assisted Reproductive Technology position statement on donor suitability of recipients of smallpox vaccine (vaccinia virus).

Although there is presently no definitive evidence linking vaccinia virus transmission through reproductive cells, SART/ASRM accordingly recommends that ART practitioners consider deferring donors who have recently received smallpox vaccine or contracted symptomatic vaccinia virus infection through close contact with a vaccine recipient (until after the vaccine or infectious scab has spontaneously separated). Good donor practice further suggests that donors who are not in good health, including those with recent complications from smallpox vaccine, should be similarly deferred.

Humans↗