Covid vaccine side-effects: Did Centre ignore its own red flags?

Though the vaccines were permitted for 'emergency use' only, a mass-immunisation program was taken up as people panicked. Representational image: IANS

Mumbai: The focus is now on preventive and curative measures, mainly the 'life-saver vaccines' as the global panic over the COVID-19 pandemic is finally waning. The vaccines provided a cover against the invisible coronavirus and its variants which have already snuffed out nearly 69 lakhs (6.9 million) lives worldwide.

In mid-January 2021, a saviour called the COVID-19 vaccine was finally developed in India by two companies - the government-owned Bharat Biotech Ltd (BBL)'s "Covaxin" and the private Serum Institute of India (SII)'s "Covishield" - and approved for "restricted emergency use" to arrest the killer-run of the coronavirus.

Barely four months later in mid-May 2021 the Ministry of Health & Family Welfare raised red-flags on both Covaxin and Covishield that were being jabbed into the unsuspecting millions of countrymen, initially free of cost.

In a communication to all states, the MoHFW had spoken about the Adverse Events Following Immunisation (AEFI) and an analysis of the AEFI cases by the National AEFI Committee for TTS (Thrombosis with Thrombocytopenia Syndrome - which implies blood clots in veins).

The MoHFW categorically stated that "there is a very miniscule but definitive risk" of Thromboembolic events following Covishield (SII) jabs, but Covaxin (BBL) posed no such potential risk."

In a relief of sorts, the MoHFW added that the 'risk' was just "0.61/million doses" compared with 4/million in the UK or 10/million in Germany.

The Centre also prepared two separate advisories - one detailing diagnosis and treatment of TTS post-vaccine doses for health-care institutions and workers, and another for beneficiaries to encourage them to report any such side-effects and seek treatment.

Activists like Pune businessman Prafful Sarda said that when all this was known, "why did the government make the entire country a guinea pig to boost the profits of the vaccine-manufacturers".

He said that hundreds of cases are being filed in different countries as more and more serious adverse effects of the vaccines are coming to the fore and many deaths of perfectly healthy people are now being attributed to the immunisation.

Nagpur-based Council for Protection of Rights (CPR) chairman, barrister Vinod Tiwari said though the vaccines were permitted for 'emergency use' only, a mass-immunisation program was taken up as people panicked.

"It was indirectly made compulsory by denying people the right to travel in autos, taxis, trains, flights, inter-state or international, barring entry to most public places or workplaces, thus compelling them to get the jabs even against their wishes. It's time now to question all the governments, including India, on their ill-conceived actions," said Tiwari.

Incidentally, in March 2023, the ICMR launched a study into the alarming 'sudden heart attacks deaths' of many including youngsters and its possible link with vaccines. Its report is expected shortly.

Tiwari and Sarda demanded that "the courts must suo moto intervene for this public cause, identify those responsible for imposing vaccination on the country and punish them plus compensate the victims as per the relevant laws."

Launched by Prime Minister Narendra Modi, tens of millions of jittery people thronged vaccination centres for a 'protective prick', little concerned about its potential short-term or long-term effect/side-effects.

In all fairness, the Centre's advisory came months after the BBL and SII had released their own comprehensive list of side-effects - before the actual vaccine launch - but of course, few bothered to even glance through them.

Nevertheless, the BBL made it amply clear that "the clinical efficacy of Covaxin is yet to be established and is under study and serious or unexpected side-effects may occur" while stressing the need to follow all other precautions, as the vaccine is still being tested.

The SII declared that the "duration of protection against COVID-19 disease is currently unknown", plus serious and unexpected side-effects could occur, as the vaccine was still under clinical trials.

In case of any AEFIs, both companies appeared to shrug off responsibility and advised the people to rush to the nearest hospital, call the healthcare provider/vaccinator, medical officer etc. for any problems post-jabs.

The side-effects of COVAX as listed by the BBL: Injection site pain/swelling/redness/itching, stiffness in the upper arm, weakness in the injection arm, headaches, body-aches, fever, malaise, weakness, rashes, nausea/vomiting, or severe allergic reactions with symptoms like difficulty in breathing, swelling on the face and throat, a fast heart rate, rashes all over the body, dizziness and weakness.

The side-effects of COVISHIELD as listed by the SII: Very Common ones like tenderness, pain, warmth, redness, itching, swelling or bruising where the injection is given, generally feeling unwell, fatigue, chills or feeling feverish, headache, feeling sick (nausea), joint pain or muscle ache; Common ones like a lump at the injection site, fever, vomiting, flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills; and uncommon side-effects of feeling dizzy, decreased appetite, abdominal pain, enlarged lymph nodes, excessive sweating, itchy skin or rash.

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