There was a huge lack of transparency about vaccine-related complications in the government’s awareness campaigns, activists said
Important advisories for identifying and treating Thrombotic Thrombocytopenia Syndrome, where blood clots form in small blood vessels throughout the body, in case of Covishield were never publicly disseminated, claimed activists Health activists have criticised the Centre for washing its hands off compensation for adverse effects following immunisation (AEFI) four months after celebrating India’s global milestone of administering more than two billion doses of COVID-19 vaccines.
Activists told Down To Earth (DTE) that COVID-19 vaccination — for all intents and purposes — was practically mandated since proof of immunisation was a prerequisite for travel and entry into offices among other essential work for a long time.
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They also picked out holes in the Centre’s affidavit filed before the Supreme Court November 23, 2022 that vaccination was not mandatory and that the informed consent mechanism was null and void in a voluntary uptake of doses.
Malini Aisola, a public health activist and co-convener of All India Drug Action Network, told DTE:
The vaccination drive was actively promoted by the government as a public health measure to curb the pandemic. It was being provided free of cost at public centres. People went to get vaccinated because of their faith in the government which repeatedly assured the vaccines were safe and efficacious.
“In spite of rolling out relatively untested vaccines and its role in aggressively promoting vaccination, the government refused to set up any institutional compensation mechanism,” she claimed.
The affidavit was submitted in response to a petition filed by the parents of two girls who died after being given the COVID-19 vaccine last year.
Rachana Gangu’s daughter received the first dose of Covishield May 29 and died of Thrombotic Thrombocytopenia Syndrome (TTS) — a rare AEFI — within a month June 19. Investigations by the national committee looking into the AEFI were able to confirm an association of her death with the vaccine.
Venugopalan Govindan’s daughter was given the first dose of Covisheld June 18 and died in less than a month July 10. However, the national committee could not find enough evidence to arrive at a definitive conclusion about any link with the vaccine.
“A vaccine beneficiary always has the option to access even more information about the vaccine and its possible adverse effects from health workers at the vaccination centre or their doctor before making an informed decision on their own,” the affidavit read.
Therefore, making the government pay for adverse events was not “not legally sustainable”, it added.
The affidavit also claimed that the government had made all relevant information about COVID-19 vaccines freely available in the public domain through the health ministry and the manufacturer.
The annexed section (page 239 and 240 of the affidavit) has material the government used to spread awareness about possible side effects. It describes pain, redness and swelling at the injection site, low-grade fever, headache, generalised weakness and discomfort for two-three days after inoculation as expected reactions.
“None of this is information about the possibility of brain bleeds. It says if there are severe effects, approach the doctor, but does not detail what these severe effects are. This is not informed consent. They have downplayed the importance of AEFIs — suggesting only mild side-effects,” Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, said.
Aisola added it was blatantly untrue that information regarding vaccines ‘potential serious side effects were provided to the public such that individuals could make a choice.
Important advisories for identifying and treating TTS in case of the Covishield vaccine were never publicly disseminated for the benefit of beneficiaries and medical institutions / personnel. They were never uploaded to the Union health ministry’s official website.
The press release that referred to TTS, while seeking to downplay the risk of clotting events, was shoddy, imprecise (did not even mention the word ‘platelets’) and totally incomprehensible to a layperson, Aisola said.
“During this period, AEFIs were being consciously suppressed by keeping their reporting and investigation system weak, as there was a feeling it could hamper the drive,” she noted.
Read COVID-19 vaccine deaths: Kerala HC wants compensation guidelines from Centre
India has so far administered more than 2.13 billion doses of the COVID-19 vaccine since the drive was first launched for healthcare and frontline workers in January 2021. There have been 92,114 cases of AEFIs as of 19 November, according to details listed in the affidavit.
Of the 92,114 cases, 89,332 (0.0041 per cent) were minor AEFIs and 2,782 (0.00013 per cent) resulted in serious or severe AEFI, including death. Of the serious AEFI, 26 reported TTS — what Gangu’s daughter died of — and 12 had died till September 30.
“No information has been made clear about who to contact in the event of an adverse reaction. While there are government helpline numbers and email addresses, it appears to function like a black hole,” Aisola said.
Other countries like Argentina (0.06 per cent of vaccinations), Canada, Brazil, Colombia (0.05 per cent of vaccination for each country) and Chile (0.03 per cent of vaccinations) have far higher AEFIs than India (0.006 per cent of vaccinations), as reported by the website Scroll.
Puliyel cited the May 2022 verdict in Puliyel v Union of India where the court directed the government:
… the Union of India is directed to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform. These reports shall be made publicly accessible, without compromising on protecting the confidentiality of the persons reporting, with all necessary steps to create awareness of the existence of such a platform and of the information required to navigate the platform to be undertaken by the Union of India at the earliest.
The government is possibly in contempt of court for not having taken any steps towards making this a publicly accessible platform of reported adverse effects, Puliyel remarked.
There is another caveat. Compensation can be sought only under two circumstances; if an adverse event is recorded during a clinical trial and once the vaccine has been approved for administration, “appropriate remedies in law are open to vaccine beneficiaries per their families including approaching the civil courts for a claim of damages/compensation” which is typically decided on a case-by-case basis.
Covishield, like other COVID-19 vaccines, was administered under the Emergency Use Authorisation (EUA), known as Restricted Emergency Use (REU) in India.
“It remains unclear as to under what circumstances a vaccine crosses over from REU to regular authorisation,” Aisola said. “The specific conditions that would need to be met for that REU, a terminology framed during the pandemic, to be converted to a full authorisation have remained something of a mystery,” she added.
The REU category means the manufacturer is not liable for harm from its incompletely tested vaccine and the government must take responsibility for allowing marketing of this product.
Puliyel believes a new category has been created so as to try and avoid taking responsibility for its decisions and this ruse makes the call for exemplary compensation persuasive so as to prevent ill-conceived reckless decision making in the future.
India also lacks a no-fault compensation programme under which beneficiaries are compensated for AEFI without having to prove the link between a serious injury and COVID-19 vaccine.
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