Vaccine focus

| Updated on December 09, 2020 Published on December 09, 2020

India must proceed cautiously on emergency use approval of Covid 19 vaccines

The Central Drugs Standard Control Organisation (CDSCO) cannot be faulted for hesitating on ‘emergency use approval’ for the Covid-19 vaccines developed by Astra Zeneca and Bharat Biotech — reportedly on grounds of inadequate data. While India needs to vaccinate large sections of its population at the earliest, any serious lapse in safety and efficacy in the initial stages can derail the entire vaccination effort by turning the public mood against the initiative. The CDSCO must fully satisfy itself, on the basis of Phase III clinical trials, that the vaccines can be rolled out in Indian conditions. While rushing to meet stringent timelines, it must be kept in mind that India’s daily disease count is down to mid-July levels of sub-40,000, considerably below the mid-September peak of close to 100,000 cases. An article on the Astra Zeneca vaccine, published by Lancet on Tuesday, observes that while its efficacy is about 70 per cent overall, there needs to be more clarity on whether the worldwide trials have established its effectiveness and safety in elderly populations. “The limitations include that less than 4 per cent of participants were older than 70 years of age, no participants older than 55 years of age received the mixed-dose regimen, and those with comorbidities were a minority, with results for that subgroup not yet available,” the article observes, while adding that its samples represent developing country populations, unlike those by competitors.

Even as the CDSCO sifts through the data, it is necessary to press for data disclosure at the global level on clinical trials in the event of a national emergency. The TRIPS framework in this respect needs to be dovetailed with the 1968 Helsinki Declaration of the World Medical Association on ‘medical research involving human subjects’. The declaration observes: “Researchers have a duty to make publicly available the results...and are accountable for the completeness and accuracy of their reports.” The WHO must spell out the norms and obligations here. While a vaccine for Covid 19 is in huge demand, regulators need to be circumspect. India’s New Drugs and Clinical Trials Rules, 2019, do provide for emergency use, but there should be no short-cuts.

The National Expert Group on Vaccine Administration has laid out a vaccination plan that will first cover 30 crore people, which includes frontline healthcare workers and those above 50 years of age. Of the nearly 2.5 lakh auxillary nurses and midwives who conduct vaccination programmes, 60 per cent will be used for Covid, according to reports. The experience of conducting elections and universal immunisation programmes will come in handy. While an app that records vaccine delivery can make the effort simpler, the challenge is to ensure that adults return for the second dose. Our logistics can be mobilised with the requisite coordination, given both public and private sector expertise. For now though, the priority is to get the choice of vaccine right.

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Published on December 09, 2020
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