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Monitor Those Vaccine Side Effects

Our system of tracking long term side effects and breakthrough infections leaves a lot to be desired

The government has finally got around to admitting that some “potential thromboembolic events” – or formation of blood clots – have been detected following Covishield vaccination. These are fairly rare side effects – according to the health ministry, less than 1 per million doses. This was expected, given that such clots had already been detected as a rare side effect of the AstraZeneca/Oxford vaccine abroad and Covishield is essentially the same vaccine produced under license by the Serum Institute of India (SII). It is also the vaccine that over 80% of the people who have taken jabs in India have received.

Though India has constituted an Adverse Events After Immunisation (AEFI) committee, the monitoring of side effects and other events post vaccination is not very robust in the country. Long term side effects, breakthrough infections, post vaccination deaths – none of these are being monitored very closely in the country.

The CoWin platform, which has been built to schedule appointments for vaccination, does not have a facility to self report any adverse effect in the long term. It also does not actively prompt a person who has taken the vaccination to report about side effects. Nor does it allow families of people who have been vaccinated to report an adverse events that show up in a few weeks. There is also no institutionalised follow up for post vaccination monitoring, even for small samples. Much depends on self reporting and given the number of places the vaccination is taking places, even these reports may not get captured and followed up rigorously.

More importantly, no one is following up about breakthrough cases despite full vaccination. According to the Indian Medical Association (IMA), over 270 doctors have died in the past two months from Covid – and 50 of them died in a single day. Many of them were fully vaccinated, having taken both jabs. The IMA has data only on its members and there are other doctors whose deaths are not captured in its statistics. Nor is the data on how many nurses and other healthcare workers, apart from doctors, who have passed away despite full vaccination.

Deaths that have occurred post vaccination is also not being recorded satisfactorily in the vaccination follow ups. In fact, if a case is at all reported, it is often dismissed as being for other causes.

By and large, the side effects of at least one vaccine in India – Covishield — are well known because it has been administered in multiple countries, where the monitoring is far more rigorous and adverse effects are immediately studied. A number of countries have revised their recommendations for it. Both Australia and Philippines have restricted the vaccine to specific age groups, generally discouraging people under 60 from taking it. Other countries too have suspended or limited its use while its side effects are studied in greater detail. Most experts think that the benefits of the vaccine far outweigh the rare side effects but it is still being monitored carefully around the world.

But while Covishield or rather the Astra Zeneca vaccine is being administered and close post-vaccination monitoring is being done by authorities in different countries, the case of Covaxin, the other vaccine being given in India, is very different.

Covaxin was developed by the Indian Council of Medical Research (ICMR) and Bharat Biotech. It got the emergency approval from the Drugs Controller General of India (DCGI) even before it had completed Phase III clinical trials for efficacy. The government started administering it without waiting for the trials to be over and the proper data submitted. Since then, Bharat Biotech has made public interim efficacy data of its Phase III trials but the full data has not yet been peer reviewed or shared in a public forum. Despite this, the Indian drugs regulator decided recently to allow the company to start Clinical Trials on children.

Covaxin is probably an excellent vaccine – certainly the science behind it, by inactivating a live virus, is quite sound. But there is still too little known about its final Clinical Phase III trial data. Nor is there any effort by Indian authorities to actively track and monitor side effects that may crop up after some time.

A third vaccine – Sputnik  V – developed in Russia by the Gamaleya Research Institute of Epidemiology and Microbiology and licensed in India to Dr Reddy’s Lab – has also just started being administered in India. The current doses are all that have been imported but soon Dr Reddy’s will be producing it in India as well.

Sputnik V, though it is not being administered in any of the major western nations, is still well monitored because it is being used in several countries. But still, it makes sense to monitor it closely for rare side effects in India once a bigger rollout happens.

Vaccines that have been approved by major drug regulators are generally safe. Still, all Covid vaccines were developed in less than a year when typically any new vaccine takes half a decade or more to develop. This speed was necessary because of the danger Covid presents. Most regulators around the world allowed some leeway for these to be rushed to the market.

But in all major countries, post vaccination monitoring is taken very seriously precisely because these vaccines are new and they were developed very quickly. In India, unfortunately, this is not quite the case. Some of it is because of our population and the logistic complexities. Monitoring vaccine after effects in a smaller, developed country is easier than it is in country with India’s geographical spread and population size and with medical systems lagging behind the western world.

Still, the Indian authorities should keep better track of vaccines being administered, their long term side effects and even their real world efficacy. And while the dangers of the pandemic makes a good case for the Indian drug regulator to be flexible while giving an emergency approval to a drug or vaccine, it is also its duty to ensure that data is being collected and monitored and analysed rigorously as these are being administered. So far, there is little evidence that the DCGI is doing this.

Prosenjit Datta

Prosenjit Datta is former editor of Businessworld and Business Today magazines

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