January 18, 2021

Sambaad Patra

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The Hindu Explains | Why was a COVID-19 vaccine dry run necessary, and how was it organised? – The Hindu

4 min read

The story so far: With two vaccine candidates — Covishield from the Pune-based Serum Institute of India and Covaxin of Bharat Biotech — at final stages of emergency use authorisation (EUA) in India, several States and Union Territories conducted a dry run for a COVID-19 vaccination programme on Saturday. A Health Ministry release said this was organised in 125 districts spanning 285 locations. Four States — Andhra Pradesh, Assam, Gujarat and Punjab — had done a pilot dry run on December 28-29 and the Health Ministry said no major issues were observed in the operational aspects.

Why was it necessary?

Under India’s ‘Expanded Programme on Immunization’, which was initiated in 1978, the country has gathered experience in administering essential vaccines to children and pregnant women. In 1985, the programme was renamed ‘Universal Immunisation Programme’, under which about 12 different vaccines are provided through the government health system. Other than inoculation, there is a three-tier system at the district, State and national levels to monitor coverage and adverse events and to ensure that the vaccines adhere to quality norms.

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Roughly 9 million immunisation sessions are conducted annually in India, according to the UNICEF. Despite that, only about 60% of eligible children are fully immunised, with wide variations among States. Because a COVID-19 vaccine will involve two jabs spaced at least four weeks apart, and will need to be administered to potentially over a billion Indians, it requires more planning, personnel and logistical arrangements. India’s priority list of beneficiaries includes healthcare workers, municipal workers, police personnel, those over 50 years of age, and younger people with identified co-morbidities. This, the government has calculated, works out to 300 million people, and given the pace of vaccine production and administration, it will be August till all on the priority list are inoculated. With at least two vaccines on the EUA list, the whole exercise involves an unprecedented level of digitisation.

A Health Ministry document notes that the purpose of the dry run was to “assess operational feasibility of using [the] Co-WIN application in [a] field environment, to test the linkages between planning, implementation and to identify the challenges and guide [the] way forward prior to actual implementation. This is also expected to give confidence to programme managers at various levels”.

How was it organised?

The dry run was carried out in one or two districts of the States and sessions were organised at district hospitals or medical colleges, community or primary healthcare centres, private health facilities, and at outreach sites in urban and rural areas. The dry run tested all the key steps in the COVID-19 vaccination process in a field environment. The programme involved State administrators generating a ‘user ID’. These ‘IDs’ were sent as a phone message to 25 volunteers at each session site. There are five such sites in each district. Each site is manned by a medical officer, who is entrusted with ensuring that these groups of 25 people are inoculated. Though no actual shots were administered, details of every person who is to get the jab are being punched into the Co-WIN application, which is part of the database that will keep track of every inoculation. The dry run involved dummy boxes of vaccines being brought to the centre; cold storage points were also checked to ensure coordination with the actual points of vaccine delivery. Once the session was completed, all data and feedback were relayed back to district, State, and eventually Central centres for feedback and analysis.

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The exercise began earlier this week in Assam, Andhra Pradesh, Gujarat and Punjab. States have already prepared lists of priority groups — healthcare workers, municipal workers, and Army and police personnel — and beneficiaries who had registered themselves on the Co-WIN app were sent SMSs informing them about the time and place of their “COVID-19 vaccination” as a mock drill.

What has been the experience of the trial run?

The Punjab government successfully completed the exercise at 12 sites in two districts. Health officials in Assam said they focused on “software efficacy” and would be carrying out the physical part of the drill involving 300 people in two districts. The two-day exercise in Andhra Pradesh was conducted at five session sites, including public and private medical institutions, with 25 dummy beneficiaries (healthcare workers) at each site.

Following the dummy run, are actual vaccines ready to be rolled out?

So far, only two vaccine candidates — Covishield, developed by the Serum Institute-Pune and based on the AstraZeneca ‘Oxford’ vaccine, and Covaxin, developed by Bharat Biotech and the Indian Council for Medical Research (ICMR) — have been cleared by an expert panel of the Drug Controller General of India. A formal approval by the DCGI is imminent, which will then allow the companies to supply doses to the government for distribution. The SII has said it has already stockpiled 50 million doses and will have another 50 million ready by next week. It is reasonable to assume that the first vaccines will begin to go out within the coming weeks.

The dummy runs are useful as a warm-up exercise, but they will reveal little about the toughest parts of the vaccination process, namely the actual inoculation, reactions, severe adverse reactions and potential hospitalisation. So far, as part of vaccine trials in India, thousands of people have been administered test vaccines in hospital settings. Many future inoculations are expected to be conducted in rural settings, where necessary healthcare infrastructure is absent. The United States, which has approved the Pfizer and Moderna vaccines, had expected to vaccinate 20 million people within a month, but has barely progressed to 2.8 million.

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