A review of India’s failure to provide assistance to those injured by the Covid-19 vaccine

The rest of the day after Omtri’s vaccination went well. But within five days, she developed a prickling sensation in her fingers; then, a high fever. The family consulted a physician from the city’s Apollo Hospital, who suspected that Omtri was just having an allergic reaction, and prescribed her an anti-allergic medication. When her fever did not subside for a few days, he advised a blood examination. It revealed that Omtri’s platelets had dropped to a dangerous 40,000 per cubic millimetre, against a normal range of between 1.5 lakh and 4 lakh.

Eleven days later, she began to vomit, and could not walk. That night, an MRI scan showed that her brain had several blood clots and a haemorrhage in the right frontal region. Doctors in Apollo Hospital immediately performed a craniotomy surgery on her, but her condition steadily worsened from that point on.

On June 14, two weeks after her vaccination, doctors declared Omtri brain dead. Her desperate parents first explored all medical options to save her. Eventually, on June 19, they decided to donate her heart, lungs, liver, and kidneys for transplants. “In the hope of seeing her live through others,” Gangu said.

What Gangu didn’t know at that point, she said, was that her daughter had suffered a vaccine-induced thrombotic thrombocytopenia, a rare adverse event in which blood clots restrict the flow of blood into vital organs, and also result in a low platelet count. The parents only heard later of the possible link between the vaccine and thrombotic thrombocytopenia from an uncle of Gangu’s, who was also a doctor.

It was also only later that the family learnt, they told Scroll.in, that the hospital had informed the district immunisation committee that Omtri’s death was likely a result of an AEFI, or an adverse event following immunisation. This, in medical terms, is any health complication that results from a vaccine or drug, or the process of delivering either.

In fact, much before Omtri’s death, there was wider evidence of the link between the AstraZeneca vaccine and cases of thrombotic thrombocytopenia across the world. Beginning March 2021, several European countries, starting with Denmark, suspended its use over these concerns. By April, early estimates suggested that one in every 1,00,000 people who were administered the vaccine suffered these complications.

In India, however, there was limited awareness of the problem. The government, as well as the Serum Institute of India, had published information about AEFIs at that point, but thrombotic thrombocytopenia had found no mention as a possible outcome.

Further, data suggests that in India, the system of reporting cases and collating data on AEFI, which is crucial to devising strategies to deal with them, is faring poorly.

India launched its Covid-19 vaccination programme on January 16, 2021. It has so far administered 2.1 billion doses to more than a billion people, making it the second-largest Covid-19 vaccination drive globally, after China’s. According to information on CoWIN, the government portal that records daily vaccinations, adverse reactions have so far been noted in 0.006% of all vaccine doses administered in India. Across the world, countries have reported far higher AEFI rates. Argentina has reported AEFIs in 0.06% of vaccinations, ten times more than India. Canada, Brazil and Colombia’s AEFI rate is 0.05%, eight times higher, while Chile and Paraguay reported AEFI in 0.03% of vaccinations, five times higher than India. Dr Jacob Puliyel, a former member of National Technical Advisory Group on Immunisation, or NTAGI, which advises the Indian government on vaccines, noted that this discrepancy was unusual, since it is unlikely that “the Indian population is immune to adverse effects of vaccines”. Puliyel concluded, “There is underreporting.”

In fact, according to data that the health ministry shared with Scroll.in, the country has so far recorded 89,231 instances of AEFI in response to the Covid-19 vaccination, of which 1,148 resulted in deaths. The total number accounts for only 0.004% of the 2.1 billion doses administered up to October 29 – an even lower rate than that stated on CoWIN.

There are also significant discrepancies within India. According to health ministry data that Scroll.in procured through a Right to Information application, across India, Kerala has reported the most AEFI cases – a total of 490, including 242 deaths. The most populous state Uttar Pradesh, which has administered six time more doses of vaccine than Kerala, has reported less than half this number, with 159 AEFIs, including 85 deaths.

Dr NK Arora, who heads the national expert group on vaccination administration, agreed that the apparent lower rate of AEFI in India could be a result of underreporting. “In India, data shows most adverse events are reported within the first seven days,” he said, adding that those that occur later than are often not reported. “In Western countries, adverse events that occur up to 28 days are usually reported,” he noted.

“There is no doubt that a vaccine’s benefit outweighs its risks,” said Malini Aisola, a public health activist. “But when vaccination began, districts avoided reporting adverse events with the excuse to ostensibly avoid vaccine hesitancy in people.”

Research suggests that there is not enough public awareness in India on the kinds of adverse events that may occur, and the ways that they can be reported. A Bengaluru study found that 76.5% of 217 Covid vaccine recipients who suffered an AEFI did not report it. “It is, therefore, important to take up more awareness campaigns about reporting of AEFIs through the CoWIN,” the study said.

Given this lack of awareness and poor dissemination of information, it is unsurprising that Omtri’s parents struggled to obtain information about their daughter’s death. Ahead of donating her organs, a government doctor conducted an autopsy on her, as is mandatory, in Apollo Hospital. Her parents told Scroll.in that the autopsy report was not shared with them. When they asked for information about the possibility of an AEFI, they recounted, the hospital told them to approach district authorities, who had been given the relevant information.

Omtri’s father, Pavan Omtri, decided to get to the bottom of the matter. In October, he filed two Right to Information applications with the state and Central government to access information on the autopsy and the inquiry into the possibility of an AEFI. His request was rejected by both. Unwilling to give up, he filed an appeal and a third RTI application with the state in November.

A few months after Omtri’s death, her family received a new shock.

“In November we came across a medical journal which spoke about a successful organ donation of an AEFI case in Hyderabad,” Gangu said. “The similarities were right there. We were shocked that as parents we were not informed about what caused our daughter’s death, while the hospital published a report publicly.”

Finally, in December 2021, following an appeal under the Right to Information Act, the Union health ministry provided the family with an answer. They confirmed that Omtri had suffered “thrombosis with thrombocytopenia syndrome” and succumbed to “vaccine product related reaction” – that is, that the vaccine had led to her death. However, Apollo Hospital told Scroll.in that the district AEFI committee in Hyderabad had informed them that it was not a case of an adverse event. They also maintained that the hospital had informed the family about their suspicions of an AEFI when Omtri died.

As the family struggled through RTI applications, in October 2021, Gangu also filed a writ petition in the Supreme Court demanding that the government establish a protocol for early detection and treatment of AEFIs, that it set up an expert medical board to investigate her daughter’s death, and provide the family with a significant monetary compensation. This August, the Supreme Court issued notice to the Centre to respond to Gangu’s writ petition.

Gangu noted that there were some who sought to downplay the importance of AEFI deaths, because, they argue, these deaths are rare. But, she said, even if the problem only affected one individual in several thousands, “that one life also has a right to live”.

Health activists point out that a more efficient reporting system for adverse events in response to the COVID-19 vaccine would also have allowed the country to lead the world in establishing an early treatment protocol for dealing with such cases. “India was busy suppressing its data,” Aisola said. “In the initial six months, the World Health Organisation did not have access to our data on adverse events because India was evaluating at a snail’s pace.”

Aisola said that although the government had laid down a clear and systematic protocol on paper, the adverse event mechanism remains “weakest at the district level” because “district officials were either brushing aside cases of adverse events or not collecting adequate evidence to substantiate it”.

A detailed email to the Ministry of Health and Family welfare about the lack of data, poor reporting and investigation into AEFIs, had yielded no response as of the time of publishing.

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A minor AEFI, according to health ministry guidelines, can include symptoms such as fever, vomiting, body pain and swelling. A severe AEFI can include high grade fever, and more swelling – but can typically be managed without hospitalisation. A serious AEFI usually involve conditions for which a person needs hospitalisation, and which may lead to disability or death. So far, major adverse events documented following Covid-19 vaccinations include an allergic reaction called anaphylaxis, thrombosis and paralysis.

The eminent virologist Dr Shahid Jameel, who was head of the Indian Sars-CoV-2 Genomics Consortium, a government panel to study mutations in the coronavirus, said that most Western countries had a well-established system to inquire into AEFI cases. “They capture the data, record it and also make this information public,” Jameel said. “In India this system does not work well.”

Jameel cited his own example. He was vaccinated in March 2021. For three days after, he had high fever. “I called a government helpline number,” he said. “The guy at the other end did not know anything. Then I called the hospital where I was vaccinated. He said he will call back, but he never did.”

Jameel suspects his case, although a minor adverse event, was never officially recorded in the government system. “Underreporting is a big problem in India,” he said.

Jameel added, however, “But the country is doing vaccination on such a large scale. Vaccination is not just in health centres but elsewhere too” – in community centres, schools, colleges. “It may not be possible to capture adverse events everywhere,” he noted.

An individual experiencing an adverse event can report it through one of a few different channels. They may, for instance, report it to the local district immunisation officer, or to the vaccination site where they received the jab. Alternatively, they can approach the Indian Pharmacopoeia Commission, or the vaccine manufacturer. Government workers and officials, meanwhile, can report cases on a portal known as Safe-Vac.

In May, the Central government also enabled reporting by the public on CoWIN, after the Supreme Court directed it to make the process easier for patients and doctors. The court also directed the Centre to publish data on AEFI cases publicly, while ensuring confidentiality – the government is yet to act on this.

Coimbatore-based Venugopalan Govindan, aged 51, who suffered hyperthyroidism and Graves’ ophthalmopathy after his vaccination last year, and registered his AEFI through CoWIN, described the portal as “a black hole”. He noted, “Nobody called me to ask for symptoms or medical reports. There is no acknowledgment if my report has been inquired. There is silence from the government.”

Aisola explained that whatever channel a person chose to report through, it was essential that the information quickly reached the district immunisation officer, who bears the responsibility of inquiring into AEFI cases. The officer has to fill a preliminary case investigation form and submit it to a state and a national committee within 10 days. These committees were created in 1988, when the AEFI surveillance system was set-up – their responsibilities include ensuring that safe immunisation procedures are followed, encouraging vaccine uptake and investigating adverse events.

The district AEFI committee has to visit the immunisation site, vaccine storage points, the patient’s residence and neighbourhood, and the treatment centre, to collect information about the patient’s health before vaccination, hospitalisation or postmortem reports, and the vaccine storage facility. The committee has to submit a final case investigation form, along with all relevant medical documents, to the state and national committee within 70 days.

The cases are classified into one of eight categories, ranging from A1, which is caused by a “vaccine product related reaction”, and A3, which is caused by an “immunization error related reaction”, to C, which refers to cases deemed “coincidental”, to D, or unclassifiable cases. Broadly, the district committee classifies minor cases and forwards severe and serious cases to the state and national committees for final classification.

But the state and national committees rely on documents and evidence collected by the district committee, and in many instances the reports submitted by the latter are incomplete, a senior World Health Organisation representative in Maharashtra said.

In fact, in Govindan’s case, the government’s lack of response to his attempt to report his AEFI was particularly distressing because he suffered a tragedy last year, and could not find closure because of a paucity of information. In July 2021, his daughter Karunya Venugopal, a data science student, died, a month after she was vaccinated. The 20-year-old suffered multisystem inflammatory syndrome and died after four weeks of hospitalization. In October, the national committee classified her death under the B1 category: cases where the AEFI has a “temporal relationship” with the vaccination, but where there is insufficient evidence to determine whether the vaccination was the cause.

In some cases, families continue to wait for the final report more than a year after losing a member to suspected AEFIs. Among them is Dr Satish Chandra, who was director at the National Institute for Mental Health and Neurosciences, or NIMHANS, in Bengaluru in 2015.

Chandra told Scroll.in that after vaccination, his brother-in-law, K Sarvottam, suffered thrombosis, and then a brain haemorrhage, and died in Bengaluru in March 2021. “I reached out to top decision makers in the health ministry when he was on a ventilator,” he said. “Till date there is no response.”

Chandra reported the case to the district AEFI committee. Sarvottam’s treating doctor, Gurucharan Adoor, even made a presentation to the committee, showing members evidence of vaccine-induced haemorrhage. “We showed them records and recommended this be categorised as AEFI,” Adoor told Scroll.in. But, Chandra said, after that they heard nothing from the government.

The health ministry’s website lists 1,527 reports of AEFIs from across India. Scroll.in analysed these and found that it typically took between three and eight months for the final reports to be published. Sarvottam’s case was not among them – suggesting that in the 18 months since his death, either his case had not been discussed in the national committee, or that it had been discussed, but that there was a delay by the AEFI secretariat in publishing its report.

Chandra said that he later learnt that vaccine-induced thrombosis can be treated with intravenous immunoglobulin. “Our intention to report this was to bring it in records,” he said. “But the local AEFI committee did not bother to visit the hospital or family to gather evidence.”

On the ground, district officers explain they are ill equipped to handle adverse event investigations when they are overseeing such massive vaccination numbers: while currently, between 3 lakh and 4 lakh people are vaccinated against Covid-19 in India each day, until last year the number was between 60 lakh and 80 lakh. “That is a huge number to follow up with,” said a health official in Nandurbar, a tribal-dominated district north of Maharashtra.

That strikingly low numbers of AEFI events are reported is apparent in the district: Nandurbar has not reported even a single serious adverse event related to Covid-19 vaccinations, despite having administered 20 lakh doses of vaccine. It reported 34 minor AEFIs up to mid-October – this accounts for a reporting rate of less than 0.002% of total vaccinations, lower even than the national average.

Puliyel said district officials fear reporting high AEFI numbers because they consider it “a big black mark on themselves”. He explained, “It could mean their vaccine storage, handling or immunisation process is at fault. No one likes to be held accountable when such a big campaign is at work.”

Until 2020, national vaccination programmes in India, such as for polio, measles and rubella, had only focused on children. The committees at the district level had paediatricians, forensic experts, and government authorities. When the Covid-19 vaccination programme was rolled out, these were expanded to include other experts, such as a gynaecologist, neurologist and cardiac specialist. But several district officials said the committee members were not given adequate training on the process.

According to Aisola, “Districts frequently discard adverse events without investigation, claiming that they were linked to comorbidities.”

The failure to adequately report these adverse events can have serious repercussions. It can, for instance, deprive patients of the right treatment at the right time and drive families deep into debt. Such was the case with 13-year-old Mahi Manek and her family in Solapur district’s Ropale village.

Manek’s family says the sixth-grade student was healthy and fit until July 1. That day, her primary school organised a Covid-19 immunisation camp in collaboration with Ropale’s primary health centre. Her parents were not informed about it. She received a second shot of Biological E’s Corbevax, which, in December 2021, was approved for emergency use in India.

Manek developed high fever the same day. Two days later, she collapsed while walking to school. Ever since, she has been unable to lift her right hand or move her right foot. Her family took her to several hospitals, in Pandharpur, Solapur, Belgaum and Mumbai. Her uncle, Chaitanya Rokade, told Scroll.in that she suffered a brain haemorrhage and was operated on twice, once in Solapur and then in Mumbai.The cost of her treatment had totaled to Rs 7.5 lakh.

Manek requires a third surgery now, but the family has run out of savings. In early September, when this reporter met her, a fragile Manek lay on a bed in Mumbai’s KEM hospital’s ward number 33. Her right hand and leg were stillparalysed. In October, she returned home, but her parents had to travel frequently to Mumbai to seek donations for her third surgery.

Manek’s case is not listed in government AEFI records. This is unsurprising, given that though Rokade informed the school principal, the latter did not report the case. “We did not know we were supposed to inform the health centre,” principal Bibhishan Patil said. “She collapsed two days after vaccine, not the same day.”

When Scroll.in contacted the health centre’s medical officer, Dr Vijay Sarade, he said that Manek had suffered a cerebral bleed. “It looks like AEFI,” he said, but added he had “not reported this as AEFI yet”. The Ropale PHC administered 77,000 doses up to early October, and had not reported any AEFIs up till then.

Manek’s mother Jyotsana believes the family will never know if the child had suffered an adverse event following immunisation. “We could either go after authorities or get her treated,” she said. “We chose the latter.”

Even when cases of AEFI are reported in India, they are often poorly investigated. “Chances of developing something severe is minimised if we have a vigilant system and provide care fast,” said virologist Dr Gagandeep Kang, from Vellore’s Christian Medical College.

Rushil Tamboli, from Awaken India Movement, which is providing people with legal assistance to seek compensation in cases of AEFI, said in many cases of suspected AEFI deaths, post-mortems are not conducted to gather strong evidence, as required byhealth ministry guidelines. “How will a committee with its members sitting in another city understand the case if autopsy is not carried?” he said. A government health official from Madhya Pradesh explained that in cases where the port-mortem is carried out, the detailed analysis of organs or tissues, known as histopathology, which is to be conducted by a government forensic laboratory, can be delayed by months, leading to a delay in evidence collection for the AEFI report.

The 1,527 reports uploaded on the health ministry’s website include minor, severe and serious cases. The last of these was uploaded five months ago – indicating either that the committee hasn’t generated any further reports, or that there is a delay in publishing them.

Arora, who heads the national expert group, said the committee meets two or three times a month. “Sometimes we discuss one case for an hour,” he said. “You may feel the progress is slow, but we do detailed evaluation.” He added that in the last one-and-a-half years, 24 “sentinel sites” have been set-up across India to improve reporting and investigations – these refer to health institutes or medical departments that have been specifically tasked with monitoring the reporting of AEFIs.

Scroll.in’s analysis of the 1,527 reports on the health ministry website revealed that in 51% cases, the adverse reaction was found to be “coincidental”, while 18% cases were found to have occurred due to an immunisation error, or vaccine product related reaction. Strikingly, the national AEFI committee found 17% of the cases to be “inconclusive” or “unclassifiable”.

Kang explained that another hurdle when it came to determining AEFIs was that India did not have baseline assessments of several specific health problems, particularly with regard to their occurrence at different ages. For instance, she said, if a 30-year-old suffers a seizure after vaccination, and the AEFI committee finds overall that the number of such seizures among that age group after vaccination is higher than in the general population of the group, it can determine that the vaccine caused the seizure. “But in absence of baseline data, we cannot say that the vaccine is 100% responsible,” she said. “Seizures could be caused by a number of factors. That is where the problem begins.”

The problems with India’s handling of Covid-19 AEFI cases are compounded by the fact that the country does not have a system to compensate those who are affected.

Scroll.in filed a Right to Information application seeking details of the government’s compensation policy for AEFIs resulting from Covid-19 vaccinations. The health ministry responded that “there is no policy for compensation for recipient of Covid-19 vaccines after its approval against any kind of side effects or medical complications that may arise due to inoculation.” An email to Serum Institute of India and Bharat Biotech, the manufacturer of Covaxin, the other of the two most common vaccines used in India, yielded no response.

In March 2021, the World Health Organisation introduced a “no-fault compensation programme” as part of its Covax initiative, which seeks to ensure equitable access to vaccines across the world. Under this programme, for vaccines procured through the initiative, Covax provides a lump-sum compensation to those suffering serious adverse events in 92 low and middle income countries. The programme protects manufacturers from liability – in recognition of the fact that they had to deliver a vaccine quickly, and could not spend years to assess clinical safety data.

Though India is listed among the 92 countries, a health ministry official told Scroll.in that it had only received a small quantity of vaccine under the initiative, and had not accessed any compensation under it.

In some countries, manufacturers sought indemnity from different governments before entering their market. Many countries, including the United States, United Kingdom, Canada, and most countries in the European Union, provided this indemnity to manufacturers, essentially taking on the responsibility of dealing with AEFI cases themselves.

India did not sign such an indemnity clause with manufacturers. But so far, a senior government official confirmed, the government has not directed any manufacturer to pay compensation to any patient who had suffered an AEFI following a Covid-19 vaccination.

Government officials told Scroll.in that the Central government had assured free treatment to those who suffered adverse events – but on the ground, patients have received little support from government hospitals.

Sudhir Waghmare, who is 40, and who lives in Pune, is a case in point. In October 2021, Waghmare received his first shot of Covishield at a Pune government school. Ten days later, he felt like there was “current passing through his hand”, then he felt weak, and found himself unable to swallow food or to balance properly while walking. Within three weeks of vaccination, he experienced paralysis in his limbs, and could no longer hold a kettle at his stall. He was hospitalised for 13 days, then required home-rest for six months to recuperate.

Waghmare owns a tea stall in a busy timber market in the city, and earlier managed to earn between Rs 2,000 and Rs 3,000 per day. But his visits to numerous doctors, and his various treatments, ate up Rs 6 lakh. He exhausted his savings, and borrowed money from friends and family.

He blames the vaccine for the sudden paralysis attack. “Nothing else explains it,” he said. “I had no other health complications before that.”

Waghmare suffered Guillain-Barré syndrome, an adverse event well documented in some recipients of the AstraZeneca vaccine. A United Kingdom study noted that among those who received a first dose of the vaccine were at greater risk of contracting this syndrome than those who received other vaccines.

Waghmare said that after he began experiencing these symptoms, he returned to the vaccination site and informed the nurse. The nurse asked him to visit a municipal hospital but did not report it on CoWIN. Even as he struggles to get make ends meet again, Waghmare believes that he should be provided “compensation for the medical bills I incurred and the months I could not work due to treatment”.

This reporting was supported by a grant from the Thakur Family Foundation. Thakur Family Foundation has not exercised any editorial control over the contents of this article.

Ref: https://scroll.in/article/1036361/how-india-failed-those-who-were-harmed-by-the-covid-19-vaccine