India’s COVID Crisis: Why ICMR and Centre should Take their Regulatory Roles Seriously

Recently, the Indian Council of Medical Research (ICMR) released their analysis of breakthrough infections – a concept that looks into the number of people who were infected after receiving at least one dose of the COVID-19 vaccine.ICMR claims that COVID-19 infections were seen in only 2-4 of every 10,000 individuals vaccinated. To arrive at these numbers, the ICMR needed to collect the vaccination status of all individuals who submitted a sample for an RT-PCR test since vaccinations began.However, an analysis by Rukmini S, an independent data journalist, shows that the ICMR did not have the mechanism in place to do this analysis till as recently as 7 April. On the ground, this data is not being collected by major testing chains across the country, even today. The dataset used by ICMR to arrive at these numbers is faulty.US COVID Aid to India: What Our Vaccine Diplomacy ‘Didn’t Achieve’One can argue that ICMR has access to the vaccination database and can carry out its own surveys to arrive at these numbers. While that would be a good initiative, why did ICMR do a poor job of collecting and analysing information?The US Centre for Disease Control (CDC) runs V-Safe, a programme to monitor the health status of vaccinated individuals. Once registered on their app, it sends out surveys to check on health status on a weekly basis.This continues for six weeks and is extended to one year. We do not know of any similar tool having been deployed in India by MoHFW or ICMR.Where Did ICMR Go Wrong?ICMR declared its analysis on 20 April 2021. This was just two days after India administered 12 crore doses. ICMR’s analysis covered all recipients of the 12 crore doses.A week ago, on 12 April, India had administered 10.3 crore doses. That would mean that ICMR claimed that the vaccine offered protection to 1.7 crore people after monitoring them for less than a week. That’s 14 percent of the people in its supposed dataset.Instead of releasing absolute protection numbers, ICMR could have provided details of how many people had mild infections and how many needed to be hospitalised. Aarogya Setu, CoWin: Why Tech ‘Magic Wands’ Haven’t Cast a SpellWe all have anecdotes about vaccinated individuals being infected in this wave. We also have reports of frontline workers infected, hospitalised and even succumbing to the virus, after vaccinations.ICMR’s analysis could have shed light on these issues and made a stronger case for the vaccines.Since last year, ICMR has been engaging in activities that are not its job.It spent the bulk of 2020 approving kits and labs for COVID testing. It is now trying to justify the emergency-use approvals to vaccines given by the Centre. Demonstrating the effectiveness of the vaccine is the job of the manufacturers, especially when they have been given a free hand by the Central government.Both the Centre and ICMR are guilty of being very hands-on and wanting to centralise all activity related to the pandemic.When things go south, they end up spending valuable time and resources on defending their previous actions. It is high time that both move out of pandemic management and assume their regulatory roles.Turning Over a New LeafThere are many advantages of doing this.To begin with, it shows that the government is aware of the hasty approvals, but is not shrugging-off its responsibility. It is concerned about the effectiveness of the vaccines and will stop the administration of vaccines that aren’t working.This will be a crucial function the Centre has to perform as more vaccines come up for approvals. The ICMR must use its premier position to collate real-world data about vaccines and use its technical expertise to determine their utility. Data fudging is not its forte and it must refrain from it. Is India ‘Hesitating’ to Get Remdesivir From Bangladesh? Why?For Phase 3 of the vaccination drive, the Centre must clearly state that it will not procure any vaccines but only oversee the vaccination process. This will also iron out unnecessary issues that have arisen from differential pricing for the Centre and states or manufacturers aligning themselves to the Centre.It must work to clear hurdles for importing vaccines doses in the short term and raw materials and equipment needed for the increasing capacity of manufacturing in the long term.States are now to procure vaccines for deployment from 1 May. State-based regulatory agencies do not have the capacity to verify efficacy claims from multiple manufacturers. Requiring separate regulatory approvals in each state is unnecessary red tape that would also delay the rollout.In its new role, the Centre would be in a position to provide a national dashboard of statistics for vaccines deployed. This would ease the purchasing decisions for the state. With no role to play in procurement or distribution of the vaccines, the Centre does not have to defend its decisions and can be transparent in sharing the collected data.A few months ago, India was celebrating a victory over COVID-19 and the launch of the world’s largest vaccination program. The second wave has shown that we cannot take things for granted until the cases cease to zero.Even after that, there will be some surprises down the road. We must assume that a third wave is also imminent. We do not know how long immunity will last from vaccines and whether a wave is being caused by an immune escaping mutant.Indian High Courts Show the Way; Hold EC Responsible For 2nd WaveTracking vaccinated people for the next year and beyond will give us real data about which vaccines are working.Accordingly, we can switch to ones that work against variants, while dropping the ineffective ones. COVID-19 might become endemic and we might even need yearly shots like the flu.The data we collect now will help us understand the direction we are heading in. So, let’s collect and analyse it in a fair, thorough and impartial manner.(A molecular biologist by day and a blogger by night, Ameya Paleja writes about genetics, microbes and the future of technology at Coffee Table Science. Scientific research and policy making are also areas of his interest. You can tweet to him at @ameyapaleja. This is an opinion piece and the views expressed are the author’s own. The Quint neither endorses nor is responsible for them.)

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Topics: Indian Council for Medical Research ICMR report COVID-19 India