As India Ramps Up COVID-19 Vaccinations, Data On Adverse Events Are Missing

"We have been trying to get authorities to investigate properly whether her health issues after the vaccination have anything to do with the COVID-19 vaccine, but no one is being responsive, nor sending us any reports, or telling us if there is an ongoing investigation into the case," Pallala told IndiaSpend on the phone speaking from Bengaluru this month.

Pallala's cousin is still in hospital, receiving treatment for the low platelet count. Doctors have told Pallala that they can administer another course of treatment, but her pending bills have to be cleared. Pallala is also facing difficulty in obtaining her health insurance claims for these bills.

Until March 1, 2021, COVID-19 vaccinations were only open to healthcare and other frontline workers, like the anganwadi worker. On that date, the government expanded the eligibility for receiving a COVID-19 vaccine to persons aged over 60 years and persons between 45 to 59 years who have specified comorbidities. The government also brought private hospitals, that are empanelled under various central and state government health schemes, into the vaccination programme. Those eligible would pay up to Rs 250 per dose to get vaccinated at these private hospitals, or get vaccinated at a government facility free of charge.

Along with this scaling up of COVID-19 vaccination infrastructure come concerns about how well adverse events following immunisation (AEFIs) are being tracked, reported, recorded and investigated by the government, experts told IndiaSpend. The Ministry of Health and Family Welfare's (MoHFW) daily updates on the vaccination effort, however, have provided no information on AEFIs since February 26.

Even before that, what little information was provided was incomplete. Where numbers of cases of AEFISs were mentioned, there was no detail or description of the adverse events. In one case, the cause of death was written intracranial bleeding; in other instances, the updates only said that post-mortem details were awaited or that the post mortem was not done.

The government's target is to give 500 million COVID-19 vaccine shots to 250 million people by July 2021. India is looking to vaccinate "one-sixth of humanity", said R.S. Sharma, CEO of India's National Health Authority, on March 2. This makes India's vaccination programme the "world's largest".

With a mass-immunisation programme operating at this scale, experts say that a robust surveillance system is necessary to detect and treat adverse events.

Gaps, discrepancies in health ministry data on AEFIs after COVID-19 vaccination

India has administered 17.7 million shots (either first or second dose) of one of two COVID-19 vaccines, by March 4, 2021. This is 3.5% of its target of 500 million shots by July 2021.

Among countries, India has administered the fourth-highest number of vaccines so far, after the US (80.5 million), China (52.5 million) and the UK (21 million). Of these, how many AEFIs have people faced, how many have been recorded, and how many investigated?

As of now, the data on this are hard to find because the MoHFW has reported AEFIs intermittently, and without much detail, in its daily press releases on India's COVID-19 vaccination effort, according to an IndiaSpend analysis of these releases since January 16, when vaccinations began. IndiaSpend has sent queries to the MoHFW on March 4, asking how it is recording AEFI cases and conducting investigations, and will update this article when they reply.

On February 26, the government said 46 people had died and 51 had been hospitalised following COVID-19 vaccinations. These were healthcare and other frontline workers. Thereafter, the government has not reported serious AEFIs (involving deaths or hospitalisations) of people after COVID-19 vaccinations.

Even for some cases of deaths reported in February, information on the stage of investigation into the cause of death is uneven and scant. Post mortem had been done in some cases but not in others. These and other press releases say that the government was still waiting for the investigation reports.

In fact, in none of the 46 cases of deaths or 51 hospitalisations so far, has the government publicly announced the conclusions from any investigations. On the other hand, the daily updates repeatedly said "No case of serious/severe AEFI/Death is attributable to vaccination, till date" till February 26. After that date, even this limited AEFI update has stopped.

"India needs solid monitoring of safety data given the scale of vaccinations coming up, and especially as people already with comorbidities and the elderly are being vaccinated first. Whether or not safety issues are linked to the vaccine, data should be collected well and analysed," Swapneil Parikh, internal medicine specialist and co-author of The Coronavirus: What you Need to Know about the Global Pandemic, told IndiaSpend.

A total 8,483 adverse events had been recorded in India's vaccination programme as of February 4, 2021, the MoHFW informed parliament. On February 5, however, the ministry reported 7,580 AEFIs to parliament. There is no explanation for the discrepancy, or a break-up of what kind of adverse events people experienced, or categorisation by level of health risk, or status of investigations.

On February 13, the government also said that 11% of the healthcare and other frontline workers vaccinated reported that they had not been informed about AEFIs, and that state and union territory governments should improve efforts to provide this information.

"Currently, we are observing gaps in how serious adverse events are being investigated at the district level. In many instances local authorities have been quick to make public statements that there is no link to the vaccine, even before investigations and post-mortem have taken place. In some cases there is a post mortem, in some cases there isn't. It's important that investigations at the district level are robust and the quality of evidence is sufficient because higher level AEFI committees at the State and national level depend on this evidence for making causality assessments," said Malini Aisola, a public health activist based in New Delhi. Aisola has been in touch with families of those who have had adverse events following COVID-19 vaccinations and is documenting how many of them are trying to get these AEFIs investigated and get medical treatment.

Improving surveillance and confidence in vaccines

While making decisions about vaccines, scientists, government regulators and people considering taking the vaccine, everywhere, look for the risk-to-benefit ratio: Do the benefits outweigh the risks? This means that there will be some risks, some adverse events, but that the benefits may outweigh these risks.

However, people also do not want to find themselves in medical trouble after taking the vaccine, uncertain about whether that trouble has stemmed from the vaccine and whether they can afford to then treat it. Such concerns about safety can lead to vaccine hesitancy. This is why surveillance for adverse events, thorough investigation and complete transparency are vital, say experts.

Currently, the CO-WIN app is open to administrators not beneficiaries, and AEFIs are to be reported on the app.

Shahid Jameel, virologist and director of the school of biosciences at Ashoka University, Haryana, as well as Parikh, both recommend that given the potential scale of COVID-19 vaccinations in India, the government should provide multiple ways to report an AEFI, such as a dedicated call centre. People should be able to call the centre to report adverse events, and the call centre itself should contact those who have been vaccinated and ask about any adverse events. The latter could be a more suitable solution for a developing country like India, where not everyone may have a smartphone or internet access, or even enough awareness to self-report AEFIs.

"Having a phone number to call or receive calls from will set a person's mind to rest about their adverse reactions. This can build confidence in the system and the vaccines," Jameel told IndiaSpend.

How do other countries report COVID-19 AEFIs?

"Looking at how some other governments have been recording and analysing big volumes of adverse event data and publishing the findings, it's a big contrast with how the Indian government is reporting AEFI," said Parikh, who has been vaccinated for COVID-19 in Mumbai. "While foreign governments are also saying the AEFIs are not linked to the COVID-19 vaccine, this is after they have published their analysis. They have provided reasoning."

In the US, where safety data have been collected by the Centers for Disease Control and Prevention (CDC) from the start of the vaccination programme on December 14, 2020, the CDC has been publishing regular, large-scale analyses of adverse events following COVID-19 immunisation. "Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history," said the CDC's February report.

Deaths of 113 persons who received vaccine shots starting in December were studied for the February report. After analysing the death certificates, autopsy reports, medical records, clinical descriptions and background mortality (rate of death irrespective of the cause), the CDC concluded that there was no evidence to suggest a causal relationship between the deaths and the COVID-19 vaccines.

In the next study, published in March by the CDC's COVID-19 vaccine safety committee, 966 deaths following vaccination were investigated. This report also concluded that the adverse events reported after 75 million vaccinations were consistent with what was already observed in clinical trials for the vaccines, that more serious AEFIs were rare, and that other safety monitoring, such as for pregnant women, would continue.

In the UK, the medicines and health regulator (MHRA) has said it will follow a "transparent process" and will regularly publish an up-to-date summary of safety experiences and AEFI reports on the COVID-19 vaccines. The UK government also publishes a weekly report on COVID-19 adverse reactions.

The MHRA's February 2021 report says that 58,427 AEFIs were reported between December 9, 2020, and February 14, 2021. Another 13,679 AEFIs were reported before this period. The regulator had also received 406 reports of deaths following vaccinations. After analysing 58,240 of these reports, it also concluded that the AEFIs were not unusual in comparison to other types of vaccines, that the safety experience is consistent with the clinical trials', and there are no indications that the vaccine played a role in the deaths.

"Till date, the Indian government has not reported the status of investigation in each serious adverse event and not even put out information of the final causality assessments of the few cases where this has been supposedly completed. But yet they have been saying there is no link to vaccination," said Aisola. "The government should realise that there are merits to transparency in sharing AEFI and findings of relatedness to vaccination, especially since vaccination has been scaled up through the next phase."

How does the Indian government report AEFIs apart from COVID-19?

Besides COVID-19 immunisation, the government runs the massive Universal Immunisation Programme (UIP) for immunising children and mothers. Like the COVID-19 vaccination programmes, the UIP is also massive in its reach and targets 56 million people with 390 million vaccine shots annually.

The MoHFW publishes consolidated reports on investigations into AEFIs among children following routine immunisation. In the 19 AEFI reports published between 2012 and 2019, and among the 5,025 AEFI cases assessed, the government has found that none were related to a "quality defect in the manufacture of the vaccines used". One undated report relating to 367 AEFI cases from 2012 to 2014 says that the AEFIs are all "within expected rates—given scale of vaccination" but that the government still needs to improve "overall surveillance".

The AEFI data published on the MoHFW website also show a substantial lag. For instance, in November 2020, the MoHFW published the results of investigations into AEFIs from 2016 to 2019. In August 2019, it published AEFI data from 2014 to 2018. Data earlier than 2012 are not publicly available on the MoHFW website.

Addressing adverse events following any and all vaccinations is important, experts say. "We focus a lot on mortality, but even less serious adverse events like fevers, if unaddressed, can cause fear in people's minds," said Parikh. "With thousands of people getting vaccinated now, their fears should be addressed so that they believe in the value of vaccines and carry on that behaviour with their families, getting their children and others vaccinated for other diseases too."

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