Constant, long-term monitoring of adverse events after vaccination is essential
In the next couple of weeks, Phase-3 data of two COVID-19 vaccines tested by Indian manufacturers are expected to be submitted for emergency use approval. If even one of the vaccines gets the approval, a countrywide rollout to immunise the four high-risk groups starting with healthcare workers will begin soon thereafter. India has been vaccinating millions of young children with a variety of vaccines each year and hence has the entire system in place to roll out any new vaccine under the universal immunisation programme. But this is the first time a vaccine to be administered outside the programme and specifically for adults is to be rolled out. Since several aspects of the COVID-19 vaccination programme are new — vaccinating millions of adults belonging to specific groups, administering two doses of the vaccine a few weeks apart, and the process of enrolling the recipients and rolling out the immunisation programme — the government has rightly decided to undertake a dry run for vaccine administration. The dry run is expected to be initiated this week in four States — Andhra Pradesh, Assam, Gujarat, and Punjab. It will allow the administrators to test the vaccination process and check the usage of the Co-WIN IT platform for management of the entire vaccination process including data entry, allocation of date and time and a drill of session sites with test beneficiaries. The linkages between planning, implementation and reporting mechanisms will also be tested.
Since four high-risk groups have been prioritised to receive the vaccine, the first task is to register the recipients on the Co-WIN platform. Unlike vaccinating children under the universal immunisation programme, the COVID-19 vaccine will be administered to 100 adults at each designated site on a pre-defined date and time. Prior to vaccination, the bona fide of the registered adults are to be determined. The IT platform has to generate the date and time when people can receive the second dose. When more than one vaccine becomes available, it is essential to ensure that people receive the same vaccine twice. Checking and reporting of all adverse events immediately and days after the vaccination is essential, all the more as no COVID-19 vaccine has undergone long-term follow-up for safety during the trial. Both the vaccines that are at an advanced stage of testing in India do not require ultra-low temperature for delivery and storage. Hence, the existing facilities of the universal immunisation programme in most districts can be used for storing the vaccines. As the plan is to vaccinate 300 million people in the four high-risk groups, 600 million doses will be required. This exercise should therefore look at creating additional storage capacity at these facilities to store millions of COVID-19 vaccines, as facilities for vaccine storage cannot be dedicated to a single vaccine.