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In April 1947, during a smallpox outbreak in New York City (NYC), more than 6 million people were vaccinated. To determine whether vaccination increased cardiac death, we reviewed NYC death certificates for comparable periods in 1946, 1947, and 1948 (N = 81,529) and calculated adjusted relative death rates for the postvaccination period. No increases in cardiac deaths were observed.
A national survey of 1,001 Australians found that most were concerned about a bioterrorist attack and were ill-informed about smallpox prevention and response. Since general practitioners were commonly identified as the initial point of care, they should become a focus of bioterrorism response planning in Australia.
Nine hundred and thirty-eight reports of adverse reactions of smallpox vaccination in Australia between 1960 and 1976 have been analysed according to the type of reaction, and the age and sex of vaccinee. In an estimated 5,000,000 vaccinations, the reaction rate was 188/million, and the death rate 1-5/million. Generalized vaccinia was the most common reaction. The more serious reactions--eczema vaccinatum, progressive vaccinia, and neurological and cardiac complications--accounted for 7-4% of the reports. A small number of rarely reported non-specific inflammatory reactions is also included. There was a marked difference in the number of reactions reported in females and males (the female-male ratio was 1-6:1), and this difference increased with age. Paradoxically, of eight reports of cardiac complications, seven concerned males. The administration of vaccinial immune globulin was usually followed by a rapid resolution of the adverse reactions.
In experiments on rabbits it was found that although administration of inactivated smallpox vaccine did not induce a demonstrable antibody response in the serum it enhanced the immune response to subsequent inoculation with live vaccine. The dose of inactivated vaccine corresponded to 8 x 10(7) PFU before inactivation (by (60)Co gamma-radiation); the dose of live vaccine was 1.2 x 10(5) PFU. When the interval between the two inoculations was 7-days, virus-neutralizing antibody appeared after 5 days and reached levels 2-4 times those obtained with live vaccine alone. With longer intervals (up to 60 days) the enhancement of the immune response was even greater. It seems likely that use of the two-step method may reduce the incidence of post-vaccination encephalitis and clinical studies to determine the optimum conditions for safety and efficacy are at present being undertaken.
A lyophilized smallpox vaccine made from infected monolayer cultures of primary rabbit kidney cells was used together with a calf lymph vaccine in a field trial in Lombok, Indonesia, in 1973. About 60 000 children below 15 years of age were vaccinated: some 50 000 with the tissue culture vaccine and about 10 000 with calf lymph vaccine. Similar results were obtained with both vaccines in primary vaccinees and in revaccinees as regards the take rate, pock reactions, and serious secondary reactions.
Children (aged from 3 to 9 years) vaccinated against smallpox by multiple puncture (3 punctures by bifurcation needle), by a single cut and with vaccine diluted with a double dose of the solvent were observed. Vaccination by the methods tested considerably diminished the vaccinal reactions and failed to influence appreciably the formation of a full-value humoral immunity; only dilution of the vaccination material reduced the dynamics of the immunogenesis at the early periods after the vaccination. In children aged 3--5 and 6--9 years general vaccinal reactions were of the same character, whereas local reactions and immunological response were more pronounced in older children. A method of multiple puncture is recommended for mass vaccinations and also for vaccination of children with relative contraindications to the vaccinations.
As a result of the 2001 anthrax attacks, the U.S. government is trying to forge a plan to handle something much worse: an outbreak of smallpox due to terrorist activity. Here's a look at where the debate stands today.
According to current plans, emergency department (ED) staff will be offered the smallpox vaccination, but important staffing, logistic, and liability issues still are unclear. The need for staff to take off work is a major worry for ED managers. It is unclear who will assume responsibility for disability and liability. There is a concern about immunocompromised individuals being exposed to vaccinated staff.
People with HIV and certain other medical conditions must avoid smallpox vaccination, and also vaccinia infections from others who have been vaccinated recently.
Your staffing and patient care will be affected dramatically by the smallpox vaccination program, so you'll need to educate the entire ED staff and plan for scheduling changes. Vaccinate staff in small groups to avoid major staffing problems. You'll always need to schedule a vaccinated nurse at triage. Most of your staff could become ill with side effects from the vaccine.
Any attempt to widely disperse smallpox vaccinations will necessitate educating people about the risks and benefits of vaccination. Most disease management programs have extensive experience in distributing educational materials and programs to health care workers and patients as well as in tracking response to interventions. Can this experience lend a hand in the event of widespread vaccination?
You'll need a policy to reduce risks of inadvertent transmission of the smallpox virus to address staff participation in the military's vaccination program. Vaccinated staff must wash hands, especially after touching the vaccination site or bandages. Implement Centers for Disease Control and Prevention guidelines to avoid transmission to staff, patients, and visitors. Have newly vaccinated staff avoid contact with immunocompromised patients if possible.
In California, one hospital decided the time was right to inoculate staff volunteers with the smallpox vaccine. Weighing the same pros and cons--civic responsibility, health risk, cost and reluctance of staff--other hospitals opted out of inoculations, at least for now. What led these organizations to such divergent decisions?
Participants in the smallpox vaccination program report minimal disruption to staffing and very few adverse outcomes. There have been no cases of transmission from health care workers to patients. Consider giving staff members an excused day off if they feel ill after receiving the vaccine. Vaccinated staff must perform daily bandage checks and appropriate hand hygiene.
The debate continues over whether hospitals will vaccinate their clinicians for smallpox. Some hospitals see the vaccination program as part of their mission, while others are taking a wait-and-see attitude.
Concerns about the possibility of bioterrorism or unconventional weaponry using the variola virus have emerged following the events of September 11, 2001. Immunization of emergency personnel in Israel against smallpox started in September 2002. This case report describes the skin reaction following immunization with vaccinia virus. Physicians should be aware of the variations at the site of the inoculation.
In a vaccination and laboratory study, two dried smallpox vaccines (designated P and Q) were tested at intervals of 4, 8, 16, and 32 weeks after storage at both 37 degrees C and 45 degrees C. Vaccine P was also tested after 64 weeks at these temperatures and gave 100% successful vaccination rates after all periods of storage at both temperatures. Vaccine Q deteriorated within four weeks, rapidly at 45 degrees C and less rapidly, but very substantially, at 37 degrees C. There was no clear evidence of the cause of this deterioration, but there was a suggestion of denaturation of some of the samples stored at the higher temperature. So far as could be ascertained, the laboratory results-rabbit skin scarification tests and chorio-allantoic membrane pock counts-ran parallel with the vaccination success rates. The pock count was found to be the more accurate method of laboratory titration. Vaccine P as used in the trial was not an exceptional batch.Vaccines which give a pock count of 10(8) infective units per ml will give the highest possible rate of successful primary vaccinations.A statistical note on the trials is given in an annex.
In a further vaccination and laboratory study with two dried smallpox vaccines (designated "P" and "Q") and one glycerinated vaccine, the potency of samples of each vaccine was deliberately lowered by exposure to heat. Groups of volunteers were vaccinated with the fully potent vaccines and with those of reduced potency. All subjects who developed a vesicular response were challenged one year later by revaccination with a potent vaccine, and the results obtained in the different groups were compared. No significant variation could be detected in the response of the different groups to the challenge vaccination. These findings indicate that if vesiculation is obtained with a vaccine, even though potency has been reduced to a point where it produces less than 50% successful primary vaccinations, satisfactory protection will result one year later. It also appears that successful vaccination with a dried vaccine confers as good immunity as that obtained from glycerinated lymph. Vaccines with a pock count of 10(6) infective units per millilitre will produce about 40% successes in primary vaccination.