House on Fire (16 page)

Pilot projects were initiated in each state, and in October 1962, the Government of India launched a nationwide program. Within five months, the entire country was involved in an attack phase, scheduled to extend for two to three years. As in other smallpox eradication plans throughout the world, the objective was mass vaccination, with three years to complete the attack phase and 80 percent coverage during that time—even though there was no scientific evidence showing the efficacy of these three goals. This stage was to be followed with a maintenance phase during which those missed in the attack phase would be vaccinated.

Shortcomings aside, this was the largest commitment the Government of India had ever made to attack smallpox. The logistical and organizational aspects of the campaign were impressive. A central organization was developed in the Directorate General of Health Services to coordinate the program. State organizations and district operating units were developed. Vehicles, vaccine, and other supplies were acquired,
and more than thirteen thousand workers were deployed in 152 mobile units. Each mobile unit included 72 vaccinators, 12 sanitary inspectors, 2 health educators, a paramedical assistant, and a medical officer. The Central Government included a budget line of Rs. 68.90 million (about US $8.61 million) to assist state governments, and the USSR provided hundreds of millions of doses of freeze-dried smallpox vaccine.
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It soon became obvious that 80 percent coverage was not going to be achieved in two years. Indeed, even if 80 percent coverage had been achieved, it would not have stopped smallpox, given the population density of India. For example, Delhi, while reporting vaccination coverage of 84 percent, was simultaneously in the grip of a smallpox epidemic. Some blamed the epidemic on the fact that so many people were moving into Delhi from all parts of India. But a Delhi-based assessment team demonstrated that for every imported case there were thirty-six local cases. The team also found an unacceptable time lag from the onset of a case until it was reported and outbreak control vaccinations could begin. The euphoria of starting a new program had already run into the brick wall of reality.

Looking for a corrective, the program only ran itself even deeper into the wall. The Delhi assessment committee recommended revising the eradication target from 80 to 100 percent. Given the difficulty of achieving 80 percent coverage in most of the country, this new target could only have lowered morale even further.

In 1964, the Central Council of Health reviewed the progress of the national smallpox eradication program and made the same recommendation: 100 percent vaccination coverage in all sectors of the population. Vaccination figures did increase afterward, but later surveys indicated that this was only because the same easily accessible populations, such as schoolchildren, were being given repeat vaccinations. The same lesson had to be learned repeatedly throughout the world: the number of vaccinations given is a meaningless figure.

A year later, India's National Institute of Communicable Diseases evaluated the smallpox eradication program, examining selected districts around the country.
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The institute found the following: The reported vaccination figures were much higher than observed figures based on
sample surveys of the population. Immunity levels were far lower than anticipated, and primary vaccinations were, in some places, reaching as little as 50 percent of the target population. Take rates varied from 40 to 95 percent, depending on the technique involved, and vaccinators rarely attempted to revaccinate a person who did not get a take. Smallpox continued in some communities, despite reports of high vaccination coverage. Finally, case reporting was both delayed and incomplete.

The vast gap between the goal of 100 percent vaccination and the low take rates, plus primary vaccination rates as low as 50 percent, was discouraging, but the value of independent assessment had been demonstrated. This study's pursuit of the truth set the tone for the frequent admonishment to smallpox workers in the 1973 campaign, borrowed from the American Management Association: “You get what you inspect, not what you expect.”

In 1967, a year after the WHA passed the resolution to establish a funded global smallpox eradication program, a joint Government of India and WHO assessment team was organized. Four states were selected for evaluation: Maharashtra, which had a high incidence of smallpox; Uttar Pradesh and Punjab, which had intermediate incidence; and Tamil Nadu, with a low reported incidence. Within each state, districts and villages were selected at random for investigation.

The results were depressingly similar to those from the earlier evaluations. The number of reported vaccinations was high—494 million in the five years from 1962 to 1966—but only 70 million of these were primary vaccinations. And over 83,000 cases of smallpox were reported in 1967—the highest number in a decade and the second highest number of reported cases since 1951. The report also noted that India accounted for 65 percent of all reported smallpox cases in the world. If this was not enough bad news, the surveys in these four states indicated that despite all of the attention given to smallpox in recent decades and improvements in reporting, only one case in ten was coming to the attention of the authorities. Thus approximately 830,000 cases of smallpox had actually occurred in India in 1967.
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While the usual recommendations were repeated—better coverage and more attention to vaccinating children—several recommendations
were of historic significance. One was that every outbreak must be investigated by a medical officer to establish the diagnosis, trace the source, institute containment actions, and notify other districts as required. Another was a call to replace the rotary lancet with a newer, more efficient, and less expensive vaccination tool, the bifurcated needle, which had just been successfully tested in field trials.

Figure 9.
The bifurcated needle: inexpensive, dependable, and easily used. CDC/James Gathany

Developed by Benjamin Rubin at Wyeth Pharmaceuticals, the bifurcated needle was incredibly simple and had several advantages over the jet injector.
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The bifurcated needle was a simple steel rod with two tongs that when dipped into vaccine held the right amount for one vaccination. The vaccinator simply held the needle at right angles to the skin and pushed. The length of the tongs prevented going too far into the skin. Studies showed that removing visible dirt from the vaccination site was sufficient; cleaning the skin with alcohol, soap, or acetone was unnecessary. The field trials showed that the technique was easy to teach, provided take rates of 98 percent or higher, and required only about 20 percent of the vaccine used with multiple pressure techniques.
The needles were also inexpensive, costing about a half-cent each, and they could be reused, after sterilization, dozens and even hundreds of times. Supplies were lightweight and could be taken easily from door to door, and vaccinators could, under good conditions, do up to five hundred vaccinations in a day. A single individual vaccinator could not do as many vaccinations as with a Ped-O-Jet, but the ease of training and the ability to deploy large numbers of vaccinators using the bifurcated needle more than made up for that deficit.
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The various evaluations, especially the one by the National Institute of Communicable Diseases, had an impact. The Government of India was determined to demonstrate its interest in eliminating smallpox and was especially stung by the report that it harbored two-thirds of the world's smallpox cases.

By this time, the successes with the surveillance/containment strategy in West and Central Africa were well known, and D. A. Henderson, at the WHO office in Geneva, kept pushing India to incorporate it into its smallpox programs. In an August 4, 1967, letter to the WHO regional director in New Delhi, Henderson wrote, “Additionally, emphasis must, of course, be placed on active surveillance and containment measures.”
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This directive was passed on in the Central Government's letter to the various states regarding the fourth five-year plan, which began in April 1969: “It is vitally important for the success of the eradication program that right from the beginning emphasis must be placed on surveillance. This consists of smallpox case detection, immediate reporting, epidemiological investigation and the prompt institution of containment measures. Cross-notification of smallpox cases should invariably be practiced in all suspected import or export of cases. A system should be developed whereby all categories of medical and health staff are required to participate in the prompt notification of smallpox cases.”
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Through the years of that plan, at a time when the exchange rate was about Rs. 7 to the dollar, the Central Government steadily increased its support to the states from Rs. 7.72 million in 1969–70 to Rs. 28.55 million in 1973–74. The number of vaccinators was increased in both urban and rural areas to about one vaccinator per twenty-five thousand persons, with a supervisor for every four vaccinators. In each district, one paramedical
assistant was provided for every seven blocks—a block including about one hundred thousand people; there were over five thousand blocks in all of India. Each of the 386 districts had a mobile squad of five vaccinators that could be sent to any area as required. The Government of India assisted states in reaching this staffing level, in addition to providing other primary health workers who would be available in districts and blocks. This was an incredible army of people, approaching thirtyfive thousand in number, assembled for smallpox alone. It would have taken astonishing foresight to have seen that within a couple of years, this would be only the core of a much larger army concentrating on smallpox.

The international community also stepped up assistance. WHO provided four long-term special epidemiologists and an average of three short-term consultants for two months each year, in addition to the staff working at the Southeast Asia Regional Office (SEARO) in New Delhi. The epidemiologists were assigned to the states with high incidences of smallpox.

Finally, in 1972, the reporting system was streamlined. The earlier system was based on the date of disease onset, which makes sense for the epidemiologist trying to determine rates of transmission, seasonal changes, and delays in reporting, but leads to endless and complicated record keeping. All reporting was changed to the week of report, no matter how long the delay in reporting. It was a breath of fresh air.

In addition, a weekly reporting network was organized. The Primary Health Center (PHC, usually the same as a block) was responsible for collecting reports from the entire block, subcenters, and local staff, as well as sending a weekly epidemiologic report to the district health officer. The district health officer then consolidated these reports into a single district report that was sent to the Directorate General of Health Services. The states reported by district to the central government and the WHO smallpox workers. If no smallpox cases had been detected, the PHCs, districts, and states were expected to send a “nil” report anyway, to differentiate “no report” from “zero cases reported.” Experience had shown that people who forget to report a disease often have no qualms of conscience; they see it as a simple mistake. However, they will not
falsify the record by reporting no cases if they actually saw cases. This requirement improved the accuracy of reports.

By 1973, the USSR had donated 1 billion doses of freeze-dried vaccine. WHO and the United Nations Children's Fund (UNICEF) provided equipment for India to manufacture its own freeze-dried vaccine in four facilities, located at Patwadangar in Uttar Pradesh, Hyderabad in Andhra Pradesh, Belgaum in Karnataka, and Guindy in Tamil Nadu. One of the great success stories of this campaign is the fact that by 1973, India was producing all of its own freeze-dried vaccine. The four producers settled on a protocol that used buffalo calves, stringent aseptic measures, and a standard seed virus. They also developed their own techniques for freeze-drying. Even dependence on imported ampules ended when the facility in Patwadangar developed an indigenous ampule that could be sealed by machines. Indigenously produced peptone was used as the stabilizer, and the final product met WHO standards for purity, potency, and stability. The national reference vaccine was shown to be stable even two months after storage at room temperature.

Everything was falling into place: government commitment, increased national and international resources, increased vaccination staff, sufficient vaccine of good quality, an easy system for vaccinating using bifurcated needles, a timely reporting system, and cross-notification of cases between districts to provide a national approach. However, smallpox was still not disappearing. Reported cases increased by over 25 percent between 1970 and 1971, and then increased by over 50 percent from 1971 to 1972. It was a confusing time as efforts escalated and yet smallpox did not diminish. Some people began to wonder if smallpox was indeed divinely inspired.