In the UK, all spontaneous reports received post Covid-19 vaccination are available in the public domain. But in India, there is a shroud of secrecy around data, adverse events post-vaccination, and deaths. Now a group of public health professionals, lawyers, and scientists has written two letters to the government asking for details of the adverse events, deaths, and investigations. But nothing is forthcoming. If the government continues to be evasive, trust in the system will be eroded and vaccine hesitancy will only increase, warns VEENA JOHARI.

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INDIA’S death rate from coronavirus is about 1.38%, while the average number of new infections presently is about 40,000 cases. Some states like Maharashtra, Kerala, Karnataka and Punjab have seen a rapid, second wave of coronavirus despite an increase in vaccination. Almost 25 lakh people on average are being vaccinated every day.

The government in the second phase of vaccination has prioritised the elderly and those above 45 years with co-morbidities. The irony is that people living in areas where there are reported active cases of Covid-19 are not getting the vaccine if they do not fall within this criteria, while 6.5% (23 lakh doses) of vaccines have been wasted.

Is the wastage a distribution problem, not being able to vaccinate within four hours of opening the vial (each vial contains 10 doses) or a lack of trust?

Any medical intervention, be it a drug, surgery, or vaccine, has side-effects. Recognising the adverse events following immunisation (AEFI), investigating the causes and implementing follow-up actions can reduce errors related to the vaccination or the vaccine. These can be preventable and timely medical management can be provided.

LACK OF REPORTING

Confirming, documenting, identifying and investigating AEFIs, examining the operational aspects of the vaccination drive, determining similar adverse events and other such actions ought to be part and parcel of any vaccine roll-out. There may be no doubt that for Covid-19 vaccines, the benefits of vaccination may outweigh the risks.

Any medical intervention, be it a drug, surgery, or vaccine, has side-effects. Recognising the adverse events following immunisation, investigating the causes, and implementing follow-up actions can reduce errors related to the vaccination or the vaccine. These can be preventable and timely medical management can be provided. 

However, even then, every serious adverse event needs to be reported, investigated, and analysed if it is linked to the vaccine or the vaccination.

To reduce serious AEFI, it is important to recognise that such risks or side effects occur, and the methods to reduce this need to be provided at each centre where the vaccinations are taking place.

Not conducting a systematic and thorough investigation, not providing immediate medical care or not providing compensation would be a violation of the right to life and health of those adversely affected post-vaccination.

Every serious adverse event needs to be reported, investigated, and analysed if it is linked to the vaccine or the vaccination. To reduce serious AEFI, it is important to recognise that such risks or side effects occur, and the methods to reduce this need to be provided at each centre where the vaccinations are taking place. 

The importance of reporting AEFI was exemplified in the recent past, with regard to the rotavirus vaccine, where serious adverse events of intussusceptions were reported after the vaccine was approved. The vaccination program can, therefore, now, follow up and look out for these adverse events, manage it in time, thus preventing fatal outcomes.

OPEN SOCIETIES

In the UK, all spontaneous reports received post Covid-19 vaccination are available in the public domain. A March 16, 2021, report of Covid-19 vaccine Astra Zeneca analysis reported a total of 2,28,337 reactions from the drug, with 289 fatal outcomes from January 4, 2021 to March 7, 2021. Similar reporting in the UK is available even for the Pfizer vaccine analysis.

Some European countries paused the vaccination to investigate the serious AEFIs, and after determining blood clots and low platelets as a rare event, some re-started the vaccination.

Placing findings in the public domain and being open and transparent while investigating the AEFIs not only builds trust in the system, but also helps people to take an informed decision knowing the risks involved.

As of today, the UK has vaccinated half its adult population with either of the vaccines.

In the UK, all spontaneous reports received post Covid-19 vaccination are available in the public domain. A March 16, 2021, report of Covid-19 vaccine Astra Zeneca analysis reported a total of 2,28,337 reactions from the drug, with 289 fatal outcomes from January 4, 2021 to March 7, 2021. Similar reporting in the UK is available even for the Pfizer vaccine analysis. 

The government has said that as of 16.3.2021 there have been 71 deaths post-vaccination, with more than 80% vaccinees taking Covishield. Most deaths were after vaccination with the Covishield vaccine, with a couple of deaths after vaccination with Covaxin (Bharat Biotech).

Covishield is manufactured by the Serum Institute of India, pursuant to an agreement with Astra Zeneca, and has been rolled out after receiving emergency approval following bridge trials in a small number of healthy people in India.

The government has been issuing statements in the media that none of the deaths are related to the vaccine, and there is nothing to fear. We do have a right to the information relating to the vaccines and vaccination, including those relating to AEFIs and serious AEFIs.

In India, on the other hand, the data of adverse events following immunisation is not available in the public domain. Daily updates by the Ministry of Health and Family Welfare merely give information on the uptake of the vaccines, but do not provide details of the adverse events post-vaccination. The government has said that as of March 16, 2021, there have been 71 deaths post-vaccination, mostly following the Covishield vaccine. 

Unfortunately, the government does not realise that by merely making statements without placing the data in the public domain and without providing details, trust in the system gets dismantled.

DEMANDING INFORMATION

A group of public health professionals, lawyers, scientists, etc., have written two letters to the government asking it to provide details of the adverse events following immunisation with the Covid-19 vaccines and to make the data public.

One letter was written within 15 days of starting the roll-out of the vaccines—January 31, 2021–when the first phase of the vaccination drive was for frontline and healthcare workers.

A group of public health professionals, lawyers, scientists, etc., have written two letters to the government asking it to provide details of the adverse events following immunisation and to make the data public. However, there has been no response to either of the letters by any of the recipients and no information has been placed in the public domain by the government. 

It was reported that within 15 days of the rollout, 11 deaths had taken place post-vaccination in the 42-56 years age group that were ascribed to cardiovascular problems or “brain stroke”. The second letter was sent two months after the roll-out, on March 16, 2021, by when about 65 deaths were reported post-vaccination. However, on March 17, 2021, the government issued a statement of there being 71 deaths post-vaccination as of March 16, 2021.

The letters not only highlighted the importance of placing AEFI reports in the public domain, but the fact that the deaths met WHO’s definition of a “cluster” of serious AEFIs that must be investigated urgently. A cluster AEFI is defined as “two or more cases of the same adverse event related in time, place or vaccine administration occur”. “Awareness of vaccine reaction rates and background rates of reported events is essential for assessing a cluster in terms of the strength of the signal it may provide,” it said.

NO ACCOUNTABILITY

However, there has been no response to either of the letters by any of the recipients and no information has been placed in the public domain by the government.

The silence by the government raises serious doubts about its system of reporting the adverse events, the investigations into it and the analysis of the data relating to them following immunisation. The government has insisted on registration for the vaccination through the Co-WIN app.

However, the glitches in the system, not being the user-friendly and slow entry of the data, raise questions as to whether the adverse events are being reported promptly or not.

For serious adverse events, where death or hospitalisation has occurred, it is not known what data is available, who has access to it, whether the local AEFI committees have seen the data, how have they investigated the serious adverse events and what data they basing their findings on. In fact, the composition of various AEFI committees is also a closely guarded secret.

GOVERNMENT’S EXCUSE

Past experience in India is an eye-opener in this regard. In 2012 when the HPV vaccine was being proposed for India, a Phase IV trial, which was also called a demonstration project, was conducted in the rural and tribal areas of two states in India. This vaccine led to the death of seven girls between 9-14 years. The post-mortem report of some of the girls was not available, and in cases where it was, the reports did not have details and were scanty. No conclusions as to linkage to the vaccine could be drawn from such post mortem reports. However, the government took the shield of statistics to show the cause of death of the girls and concluded that these were more likely to be the reasons for the deaths than the vaccine. The case is pending in the Supreme Court, with no orders on compensation either.

Once again, the government is planning to use the same bizarre tactic to show that deaths in a particular age group in the general population take place due to various reasons, and so, deaths post-vaccination are more likely to be due to those occurrences, rather than related to the vaccine.

The shortcomings are largely due to gathering the data related to the adverse events, obtaining proper medical records of hospitalisations and deaths, getting proper and thorough post-mortem reports, investigating and analysing the data objectively and without any kind of political or other pressure.

Such tactics are used only to hide their shortcomings and their total incapability of addressing the shortcomings. The shortcomings are largely relating to gathering the data relating to adverse events, obtaining the proper medical records of hospitalizations and deaths, getting proper and thorough post mortem reports, investigating into the deaths, and analyzing the data objectively and without any kind of political or other pressures weighing the process down.

It takes courage and needs a person with guts, who can speak the truth, to say what we should know, rather than what they (government) want to hear. Is such a person there in any of the AEFI Committees? We will never know.

But, if the government continues to be secretive and evasive about the data relating to the serious adverse events post-vaccination, the trust in the system will become obscure, the vaccine hesitancy will only increase, and more and more people may be willing to take the risk of acquiring the disease (that may manifest as mild, moderate or severe), rather than take a vaccine that would reduce the severity of the disease.

(Veena Johari is a lawyer in Mumbai, and has been working on issues relating to health and human rights, clinical trials, access to medicines, etc. The views expressed are personal.)