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Should smallpox vaccine be made available to the general public?

In June 2002, the Advisory Committee on Immunization Practices (ACIP) approved draft recommendations concerning preparation for potential biological terror attacks that utilize the smallpox virus. ACIP recommends against both mandatory and voluntary vaccination of the general public. The present paper examines the moral and political considerations both for and against each of the general public vaccination options considered by the ACIP in the context of the state's authority over vaccination for the purposes of protecting public health. Although it is clear that compulsory mass vaccination is not justified at this time, the issues surrounding voluntary vaccination are more complex. Should smallpox vaccination prior to an outbreak be made available to the general public? The paper concludes that the vaccine should not be made available at this time. This conclusion, however, is based upon contingent features of current circumstances, which would change once an outbreak occurred. In the even of a terror-related outbreak of smallpox, the general public's access to voluntary vaccination would become justified, even in areas beyond where the outbreak has occurred.

Advisory Committees↗

Smallpox and biological warfare: the case for abandoning vaccination of military personnel.

Smallpox was officially declared eradicated from the world in 1980. Earlier, in 1972, over 50 nations signed the Biological Weapons Convention renouncing this entire category of weapons. Despite this international agreement, both the United States and the Soviet Union continue to vaccinate their military troops against smallpox, thus implying that each fears the other might still use it in biological warfare. Vaccination is not a harmless procedure, and vaccinia infections continue to be reported in troops and their contacts. Negotiating an end to the vaccination of troops would be a final step in ending the fear of smallpox.

Biological Warfare↗

Modeling potential responses to smallpox as a bioterrorist weapon.

We constructed a mathematical model to describe the spread of smallpox after a deliberate release of the virus. Assuming 100 persons initially infected and 3 persons infected per infectious person, quarantine alone could stop disease transmission but would require a minimum daily removal rate of 50% of those with overt symptoms. Vaccination would stop the outbreak within 365 days after release only if disease transmission were reduced to <0.85 persons infected per infectious person. A combined vaccination and quarantine campaign could stop an outbreak if a daily quarantine rate of 25% were achieved and vaccination reduced smallpox transmission by > or = 33%. In such a scenario, approximately 4,200 cases would occur and 365 days would be needed to stop the outbreak. Historical data indicate that a median of 2,155 smallpox vaccine doses per case were given to stop outbreaks, implying that a stockpile of 40 million doses should be adequate.

Biological Warfare↗

Surveillance and control measures during smallpox outbreaks.

We reviewed historical data from 2 smallpox outbreaks in Liverpool and Edinburgh during the early and middle years of the 20th century to assess their contribution to developing modern strategies for response to a deliberate release of smallpox virus. Reports contemporaneous to these outbreaks provide detail on the effectiveness of public health interventions. In both outbreaks, extensive contact tracing, quarantine, and staged vaccination campaigns were initiated, and the outbreaks were controlled within 15 months and 3 months, respectively. In Edinburgh, the number of fatalities associated with vaccination exceeded the number of deaths from the disease. In Liverpool, ambulatory, vaccine-modified cases and misdiagnosis as chickenpox resulted in problems with outbreak control. The relatively slow spread of smallpox, as exemplified by the report from Liverpool, allowed for effective implementation of targeted intervention methods. Targeted surveillance and containment interventions have been successful in the past and should be explored as alternatives to mass vaccination.

Adolescent↗

Biological agents as weapons 1: smallpox and botulism.

1. Early recognition by clinicians of illnesses suggesting a biological attack is integral to the public health response. 2. The four biological agents of most concern are smallpox virus, botulinum toxin, and anthrax and plague bacteria. 3. Smallpox is distinguishable from chickenpox by the prominent prodromal period and lesions that develop at the same pace and, on any part of the body, appear identical to each other, evolve slowly and are peripherally distributed. 4. The degree of protection conferred by smallpox vaccination given 20 or more years ago is unknown. 5. Foodborne and inhalational botulism could result from deliberate release of toxin. 6. Botulism presents with cranial nerve palsies and descending paralysis in a patient with normal conscious state and no fever.

Bioterrorism↗

Anticipating smallpox as a bioterrorist weapon.

The treat of bioterrorism means it is important to be able to diagnose smallpox. The responsibility for the initial recognition of cases lies with clinicians, and early diagnosis is the key to the successful control of an outbreak. Unless rapidly contained, a bioterrorist release of smallpox would constitute not just a national but a global threat to health. This brief review sets smallpox in its modern context as an infection potentially spread by bioterrorists and recommends sources of information from the twentieth century that will assist clinicians in diagnosing the disease.

Bioterrorism↗

Standardization of smallpox vaccines and the eradication programme--a WHO perspective.

Smallpox vaccine was born in 1796 and the need for it ended in 1980 with the eradication of smallpox. What was remarkable was that in its 200 years history, when the global smallpox eradication programme really needed the vaccine in 1967, it was found that, on the whole, quality was unsatisfactory and supply was short. Unconventional counter measures were taken by WHO, including an international independent testing system, provision of reference preparations in large quantity etc. They effectively solved the problems meeting the target eradication schedule of 10 years. The lessons learned would be of some value to the future eradication or effective control programme of vaccine preventable diseases.

History, 20th Century↗

[The comparative study of the safety of a vaccinal process in both oral and epicutaneous immunization against smallpox].

Results of comparative studies of tableted and epicutaneous live smallpox vaccines are presented. In experiments on rabbits by using histological, immunofluorescent, immunological and virological methods, higher safety and efficiency of the tableted vaccine than that of traditional smallpox epicutaneous vaccine were determined. The natural and physiological character of oral immunization was shown. The oral immunization was concluded to be a safe method of inoculation now and perspective for the use of recombinant vaccines based on vaccine virus in the absence of population immunity against smallpox.

Administration, Cutaneous↗

[Resume smallpox vaccination?].

The confirmation of the eradication of smallpox (WHO, 1980) brought to the interruption of smallpox vaccination. Recently, with the possibility of a bioterrorism use of smallpox, the problem of mass vaccination has reemerged. The proposals to tackle this problem are briefly reviewed.

Adult↗

Smallpox vaccination--implications for the occupational health professional.

Because of the announcement of the ACIP recommendation on December 13, 2002 and the commencement of the smallpox vaccine program at various facilities nationally, adverse events data are being carefully analyzed by CDC researchers. As previously discussed, CDC recommend a cardiac risk profile be included in the pre-event vaccination screening criteria. A definitive link between the onset of myopericarditis and the smallpox vaccine is suspected, but under investigation. The CDC ascertains there is uncertain evidence of any association between ischemic heart disease and vaccinia (CDC, 2003c). As the pre-event vaccine program expands, occupational health professionals should be cognizant of changes to the smallpox vaccine recommendations and modify their policies and protocols appropriately.

Bioterrorism↗

Why, which, how, who, when? A personal view of smallpox vaccination for the 2000s.

The uncertainty about the extent of proliferation of smallpox virus holdings since the early 1990s, and particularly whether terrorist groups or so-called rogue states might now hold the virus, confronts potential target countries with a continuing dilemma. An increasingly large majority of their populations have never been vaccinated, and those who have been vaccinated may have become susceptible to smallpox again. Yet recent attempts by the United States and other governments to persuade large numbers of key personnel and others to accept vaccination have at least partially failed and a different long-term strategy is needed. This strategy should be based on surveillance of rash illnesses, improved public education, more refined contingency planning and a new approach to smallpox vaccination. The last should if possible be based on cell-grown, less reactogenic vaccines, even though it may be some years before these can become available. Meanwhile this article examines other expedients including the use of existing lymph vaccines.

Bioterrorism↗

Certification of smallpox eradication.

The world's last known case of smallpox resulting from human-to-human transmission in an endemic focus occurred in Somalia in October 1977, and there remains the task of documenting the global eradication of the disease and establishing the safety of vaccination. Those countries as yet uncertified have been grouped into four categories according to the procedures recommended for their certification. An important criterion for deciding the type of procedure is how recently smallpox was endemic in a particular country. This paper is concerned with those countries in which the disease has been nonendemic for some years but which have not yet received certification of eradication. One such country is Burma, which was certified free of smallpox in 1977, some 8 years after its last reported case but 2 years after the last case in Bangladesh, with which it shares a long frontier. The procedures used in Burma and the lessons that were learnt therefrom are described.

Adolescent↗

Ring vaccination versus mass vaccination in event of a smallpox attack.

Since vaccination is critical in responding to smallpox exposure, vaccination strategies must be evaluated during bioterrorism preparedness. Information on historical factors, smallpox characteristics, public health capabilities and hypothetical attack scenarios was used to evaluate major vaccination strategies. In event of a smallpox attack, the optimal strategy is situational, mass vaccination may be best for dense island populations such as Oahu.

Bioterrorism↗

[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 vaccination reactions, prophylaxis, and therapy of complications.

Smallpox vaccination in the United States is a routine public health measure which has been under intensive review during the last decade. The most frequently occurring adverse reactions to vaccination are benign and require little or no systemic therapy. These reactions include accidental infection, erythematous and urticarial rash, and generalized vaccinia. Chickenpox occurring concurrently with vaccination presents no problem unless vaccinia has widely superinfected the chickenpox lesions. There is no risk to the pregnant woman who is vaccinated, but there is a slight risk that the fetus will develop fetal vaccinia. The vaccinia does not cause congenital malformations. Vaccinia hyperimmune globulin (VIG) in prophylactic dosage may be given to a pregnant woman who is traveling to a smallpox infected or endemic area in order to prevent fetal vaccinia. Vaccinia necrosum and eczema vaccinatum require vigorous systemic therapy with VIG, and often thiosemicarbazone. Post-vaccinial encephalitis, while frequently serious, has not been shown to be ameliorated by VIG therapy, although there are data which suggest VIG has some value in prophylaxis for encephalitis. Prophylaxis, prompt recognition, and proper therapy may reduce the fatality rates of these complications. Revaccination of patients who have suffered a complication is a frequent clinical problem. Revaccination of an individual who has had post-vaccinial encephalitis or vaccinia necrosum is contraindicated unless the risk of contracting smallpox outweighs the risk of the above two diseases. Revaccination of children who have had eczema vaccinatum is not contraindicated. Revaccination of children with a history of accidental infection or erythematous or urticarial rash presents no known or theoretically increased risk.

Eczema↗

Smallpox vaccination by intradermal jet injection. 2. Cutaneous and serological responses to primary vaccination in children.

Primary vaccination by intradermal jet injection, using diluted smallpox vaccine, was compared with multiple-pressure vaccination in 625 Jamaican children. The cutaneous and antibody response patterns were evaluated. The primary take rates among those jet vaccinated were 97% or more in those receiving vaccines with a titre of 10(6.3) TCID(50)/ml and 10(7.0)TCID(50)/ml, and 96% in those vaccinated by multiple pressure, using undiluted vaccine. The primary take rates in subjects receiving jet-injected vaccine with titres of 10(6.0) TCID(50)/ml and 10(5.0) TCID(50)/ml were 90% and 62%, respectively. Among subjects tested who developed Jennerian vesicles, all but 3 demonstrated seroconversion. In those who failed to develop primary Jennerian vesicles, there was also a failure of neutralizing-antibody development. Vesicle and scar sizes were generally smaller in the jet-vaccinated subjects than in those vaccinated by the multiple-pressure technique. Infants tolerated jet vaccination without difficulty. Vaccinial complications did not occur in any subject. The intradermal jet injection of 0.1 ml of vaccine with a titre 10(6.3) TCID(50)/ml or higher is recommended as a highly effective method for achieving successful primary smallpox vaccination. The method appears best suited for use in mass smallpox-vaccination programmes.

Child↗

[Connection between the group factors of the blood systems ABO, MNSs, and rhesus and peculiarities of the vaccination process in children immunized against smallpox].

The ahthors present new data on the character of the vaccine process in children associated with the characteristics of the blood group ABO, MNSs and Rh systems. The greater frequency of occurrence and more manifest reactions were noted in children with blood groups A, B, AB, M and Rho (D) - in comparison with those having blood groups O, Rho (D) +, MN and N. There was a significant prevalence of chromosomal aberrations in the primarily immunized children with blood groups A in comparison with groups O, B and AB. The data obtained pointed to the negative effect of the mimi-rating antigens of the smallpox virus on the immunogenesis in smallpox. Search for methods of releasing the vaccine of these antigens is necessary for reduction of the reactogenic properties and increase of immunogenecity of the smallpox vaccines.

ABO Blood-Group System↗

[Validation of the subcutaneous-jet method of smallpox vaccination].

Reactogenic properties and survival of the smallpox vaccine virus in the organism of the vaccinated rabbits were studied for the purpose of experimental substantiation of the subcutaneous-jet method of smallpox vaccination; serological shifts were determined, and also the intensity of the immunity created to the intracerebral and intranasal infection with the pathogenic strain of the causative agent was assessed. The results of experiment were confirmed in revaccination of humans pointing to weak reactogenic properties and high immunological efficacy of the subcutaneous-jet method of smallpox vaccination.

Animals↗