The need of the hour is winning this battle that has drained us economically, socially and psychologically. That said, the decision to roll out the vaccine is a good start. Let’s keep our fingers crossed.
A good policy must fulfil four criteria — it must have clarity in objectives, strategic design, financing and outcomes, all in sync. For example, the objective of the national roll out can be to stop infections, check current transmission and/or reduce if not eliminate mortality, depending upon the efficacy of the vaccine. The polio vaccine, for instance, achieves all three for life while the flu shot can protect against infection only for a year. Such characteristics then determine the strategies, funding and ways to measure outcomes. So, when eradication became an objective, the polio strategy was redesigned.
In the COVID vaccine roll out, there is no clear data for either of the two vaccines proposed for use in the programme. We do not know if they provide protection for life, for a year or six months, its efficacy among the elderly or the very sick or in stopping new infections. Getting such data requires at least three years and cannot be obtained in a few months. India also does not have any advance purchase agreements for vaccines that have some of this data due to the completion of Phase 3 trials. The two vaccines to be used in India, have not completed the Phase 3 that confirm safety and efficacy when tried out on a large sample.
Given these limitations, the government has drawn up strategic guidelines for implementing an ambitious vaccine programme covering 30 crore people by July. With meticulous attention to detail, the guidelines draw upon the knowledge of running national campaigns acquired over three decades of implementing the Universal Immunisation Programme that resulted in eradicating polio and protecting 75 per cent children against 14 vaccine preventable diseases. These guidelines detail the skills, roles and responsibilities of the required human resources, logistics for delivering vaccines at point of use, physical infrastructure, monitoring systems based on digital platforms and feedback systems for reporting adverse events. The approach involves 19 departments, donor organisations and NGOs at the national, state, district and block level. The guidelines also mention the priority criteria — caregivers, front line workers of the departments of health, defence, municipalities and transportation; persons above the age of 50 and those below 50 having diabetes, hypertension, cancers and lung diseases. In other words, the guidelines are a reference manual for what is to be done, by whom, when and how.
The guidelines are ideal but do not reflect the real world of the health system that is full of flaws, defects, inconsistencies and cracks. Of the 28,932 cold chain points, half are in the five southern states, Maharashtra and Gujarat. The eight states in the North and Odisha that account for over 40 per cent of the country’s population have only 28 per cent of the cold chain points. Combined with poor human resources — doctors, nurses, pharmacists — a weak private sector, poor safety and hygiene standards, frequent power outages, poor infrastructure in terms of physical space, the capacity to implement with the expected speed, quality and accuracy is daunting. The immunisation can disrupt routine health service delivery — antenatal care, national programmes like those pertaining to TB or other immunisation drives and exhaust workers, particularly if we have yet another wave of the infection or other outbreaks like the bird flu that is being witnessed in some states now.
While data for the above-50-year-olds is available in the electoral rolls (though there are complaints of exclusions making the Census a better option), line listing of the under 50s with comorbidities can be challenging. Disease burden of NCDs’ is much higher in southern states that also have a higher proportion of the elderly. Not only are urban-rural variations substantial, but urban areas have weak public health infrastructure and a multiple number of private providers, mostly unregistered, thanks to the poor implementation of the Clinical Establishment Act, 2010.
Patient tracking can be problematic as many may not have been diagnosed, go to multiple providers, or have multiple addresses as in the case of migrants. Fudging, false certification and siphoning off vaccines to private facilities in the event of vast price differentials cannot be ruled out.
The non-availability of efficacy data could also impact the procurement and supply of vaccines, result in huge wastage, and can introduce scope for errors and duplication. Instead of rolling out the programme throughout the country in one go and given the complexity of the line listing of priority groups, it may be useful to consider other options such as covering all at one time in an area, instead of sequencing them into different groups. The areas could be ranked on the basis of a vulnerability index built by triangulating data sets from disease burden, caseload of COVID infections, demographic profile, health-seeking behaviour and availability of infrastructure etc, block, district and state wise. Such an approach could enable having differential strategies to suit the health system capacities to organise, deliver and monitor.
But central to the success of the roll out will be the confidence of the people in the vaccines. Non transparency of data, needless haste and opacity with which the licenses were given, worsened by caveats and conditions, strident defence by the ruling party in its attempt to stifle healthy conversation that could result in allaying doubts and fears, clumsy attempts to politicise the discourse by media channels have only deepened suspicions. The worst outcome is the denting of our international reputation and respect built over years of adherence to scientific rigour. Coming out of this messy situation is necessary and one option — as adopted for the polio eradication programme — is to establish an independent team of experts under the aegis of the WHO to ensure adherence to recruitment standards, consent conditions, adverse event record management, compensation standards, conditionalities required in emergency authorisation and trial conditions. This will create confidence in the community and international authorities as well.
Finally, it is important to understand that vaccination is an incomplete solution to ending the epidemic, since the virus is mutating. Adopting safe behaviour is. Launching a nuanced communication strategy will be fundamental. The government can use its experience of controlling the HIV/AIDS epidemic. Science, evidence and data analytics need to be the bedrock of the roll out policy, not politics and scoring brownie points for electoral advantages. The need of the hour is winning this battle that has drained us economically, socially and psychologically. That said, the decision to roll out the vaccine is a good start. Let’s keep our fingers crossed.
This article first appeared in the print edition on January 14, 2021 under the title ‘care and caution’. The writer is a former Union health secretary.
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