Government called revelations ‘ill-informed & erroneous’
Health activists have routinely raised their voices against the government’s stand about the COVID-19 vaccines being voluntary. Photo: iStock.
The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) stated a range of side-effects of COVID-19 vaccines in response to an RTI application. ICMR is the autonomous body under the Union Ministry of Health and Family Welfare and CDSCO is the apex drug regulatory body.
The disclosures were made by ICMR’S public information officer (PIO) Leyanna Susan George and CDSCO’s PIO Sushanta Sarkar in response to the application filed by Pune-based businessman Prafful Sarda.
Also read: Kerala HC directs NDMA to formulate compensation policy for those dying due to COVID-19 vaccine
However, the union ministry was quick to rubbish the admission as “ill-informed” and providing “erroneous information” in a press release from January 17, 2023.
“As is the case with all other vaccines, those who get vaccinated with different COVID-19 vaccines may experience mild symptoms like injection site tenderness, pain, headache, fatigue, myalgia, malaise, pyrexia, chills, arthralgia etc,” the government said in its press release.
Rarely, few individuals may experience severe adverse events depending on certain predisposing conditions, it added.
The RTI response listed the following as side-effects of Covishiled — the India-made version of the AstraZeneca vaccine produced in the United Kingdom: Shortness of breath, chest pains, pain in limbs or swelling on pressing of calf / arms, weakness / paralysis of limbs of any particular side or parts of the body, including cranial nerves, unprecedented seizures, pain in eyes, blurred vision or diplopia, change in mental status, encephalopathy or depressed level of consciousness.
Mild adverse reactions have been mentioned for Covaxin, the indigenous vaccine manufactured by the government-run Bharat Biotech. These include headaches, fatigue, fever, body ache, abdominal pain, nausea, vomiting, dizziness, giddiness, tremors, sweating, cold and cough.
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Covovax — the India-made version of the protein-based Novavax vaccine — may trigger injection site pain / tenderness / induration, fatigue, malaise, headaches, fever, soreness of muscles, joint pains, nausea or vomiting, chills, body-ache or extreme pain in limbs, asthenia (weakness or lack of energy), injection site pruritus (itching, rash, red skin, hives), enlarged lymph nodes, back pains and rarely dizziness or drowsiness.
While Covishiled and Covaxin have received the government’s approval for conditional market sales, Sputnik-V and Covovax remain under the restricted emergency use category.
“The replies by ICMR-CDSCO are blatantly shocking. Though the government has declared that ‘vaccination is totally voluntary’, why was the compulsion created indirectly by barring people from travelling in buses, trains, flights, inter-state movements, going out to hotels, restaurants, multiplexes, malls, etc,” Sarda was quoted as saying by IANS.
This trapped more and more panicked people into getting themselves jabbed without knowing the after-effects, he added.
The government should share information on whether and how the public was made adequately aware of these side-effects, Sarda demanded.
This fight has been at the core of India’s COVID-19 vaccine programme. In December 2022, the government washed its hands off any responsibility surrounding adverse effects following immunisation (AEFI), citing that taking the vaccine was voluntary and not mandated. In such scenarios, the informed consent mechanism becomes null and void.
These arguments were made in the Centre’s affidavit filed before the Supreme Court November 23, 2022, responding to petitions filed by parents whose daughters died of blood clots following immunisation.
India had recorded 92,114 cases of AEFIs as of November 19, according to this document. The affidavit stated that making the government pay for an AEFI is not legally sustainable.
“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,” it noted.
Also read: What COVID-19 vaccine side effects might I expect?
However, information about Thrombotic Thrombocytopenia Syndrome (TTS) — a rare AEFI of which one of the girls died — is not readily available.
“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,” Down To Earth had reported earlier.
Health activists have routinely raised their voices against the government’s stand on the COVID-19 vaccines being voluntary.
It was — for all intents and purposes — practically mandated since proof of immunisation was a prerequisite for travel and entry into offices, among other essential work for a long time, Malini Aisola, a public health activist and co-convener of All India Drug Action Network, had told DTE.
In the absence of a no-fault compensation programme — under which beneficiaries can be compensated for AEFIs without having to prove the link between cause and effect — the public has only the civil court as recourse, which has proven to be an arduous process, experts said.
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