From Manufacturer's Guarantee To Government Denying Liability, Decoding Buzz Around Covid-19 Vaccine Side-Effects

Vaccinations, like every other medical invention, have had both takers as well as sceptics. They are designed to give immunity against the dangers of a disease by introducing a weakened or an inactivated form of the disease-causing virus or bacterium. Due to this, it is common to experience some mild-to-moderate side effects after being vaccinated, as the immune system attempts to kill these newly introduced agents.

Similarly, the COVID-19 vaccines are known to cause different kinds of side effects for different groups of people. In many countries, they continue to be monitored to detect adverse events as clinical trials have indicated possibilities of long-lasting side effects. India was at the forefront of achieving a completely vaccinated population, and they ensured efforts were made on the same front to encourage people to get vaccinated.

However, a recent plea filed in the court brought about a case of alleged covid-vaccination death and demanded the government to pay compensation for the death. The Union government responded to this plea and told the Supreme Court that it cannot be held liable to pay compensation for deaths caused by adverse reactions to COVID-19 vaccines. With the case making headlines, The Logical Indian looks into the facts in hand about possible side effects and claims of assured compensations made in the past by vaccination manufacturers in the country.

What Do Statistics And Legal Affidavit Suggest?

Parents of two women – aged 19 and 20 – who allegedly died due to the adverse effects of the COVID-19 vaccine filed a petition at the apex court requesting compensation and investigation by an independent expert medical board to inquire into the deaths of their daughters. Responding to this, the Ministry of Health and Family Welfare (MoHFW) submitted an affidavit at the apex court denying the responsibility for the deaths allegedly caused by vaccination.

As per the submission, the government conveyed that 219.86 crore doses of COVID-19 vaccines have been administered in the country as of November 19, 2022. Among these, the country has recorded approximately 92,114 cases of adverse events following immunisation (AEFIs), which constitute about 0.0042 per cent of the population. Within these numbers, 89,332 cases were "minor," and the remaining 2,782 cases were serious and severe in nature. According to media reports, about 1,148 people have reportedly died after suffering from AEFIs.

A report published by The Wire quoted the government saying that the vaccines manufactured by third parties had successfully undergone regulatory review, and holding the state directly liable to provide compensation may not be "legally sustainable." They further suggested that the government had adopted substantial efforts to ensure a safe and effective vaccination programme, and they can not be held liable to compensate for deaths following AEFIs.

The affidavit also claimed that there was no form of legal compulsion to obtain the vaccination, and it was a purely voluntary action. As every medicine comes along with side effects and AEFIs reported worldwide, there has been sufficient information made available to the public to help them make an informed decision. Building upon this same idea, the government also referred to the Supreme Court's ruling in Dr. Jacob Puliyel vs Union of India, which observed that no person could be forced to get vaccinated and asked the government to revise restrictions on unvaccinated people.

Dismissing Allegations

Right from the introduction of the vaccine, the Ministry of Health and Family Welfare has been quick to dismiss allegations and provide information based on the vaccine doses. Rumours on Covid-19 vaccines causing infertility and other diseases spread like wildfire on unverified social media portals. The ministry acknowledged this and clarified on its website that such rumours were floated in the past against other vaccines as well, but none of them has been proven scientifically. They confirmed that all vaccines and their constituents are tested first on animals and later in humans to assess such possible side effects and are authorised to the markets only once its found to be safe for use.

Substantiating this further on January 2021, vaccine manufacturer Bharat Biotech said that compensation would be paid in case of any kind of serious adverse effect is proven to be causally related to the vaccine. According to a report by The Print, they also assured provisions of a "medically recognised standard of care in the government designated and authorised centres/hospitals" in case of any such adverse event.

Around the same time, a few United States (US) based bodies accused the political parties in India of speeding up the vaccine process and bringing vaccinations to the market without the completion of necessary trials. According to Telangana Today, both the vaccine makers and the government dismissed these allegations of Covaxin being a rushed job. The pharma company clarified that the vaccines were released only after the clinical trials proved successful and it was not under any political pressure. They slammed the US reports as "completely misleading, fallacious and ill-informed" and labelled it as a targeted narrative against Covaxin formed by individuals with no expertise in vaccines or vaccinology. Talking about the skipping of trial stages, the company officially stated that they had proceeded to phase three trials based on data and results from phase one studies.

They stood their ground regarding the safety record and minimal adverse events of the vaccine by saying that Covaxin was one of the most studied Covid-19 vaccines worldwide. It was reportedly evaluated in about 20 preclinical studies, including three challenge trials and nine human studies.

Facts In Hand About Vaccine Side-Effects

According to the Centres for disease control and prevention, the side effects of the COVID-19 vaccine can vary from person to person. Some people could experience minor discomfort, meanwhile, for some others, it could affect their ability to do daily activities. However, these side effects would generally go away in a few days. Adverse events with serious health problems are found rarely but can cause long-term health problems.

As per the symptoms enlisted in the Ministry'sMinistry's website, Covishield could come along with mild symptoms like tenderness or soreness at the injection site, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia, and so on. In the very rarest events, demyelinating disorders have been reported following vaccination. For Covaxin, the effects could be seen in the form of fever, body aches, abdominal pain, nausea, vomiting, dizziness-giddiness, tremor, sweating, cough, and so on.

Severe reactions were noted mostly in the cases of elderly above 45 years of age. One such case was reported from the UK, where 46-year-old developed distressing symptoms leading to her being in a coma for four days after she received the AstraZeneca shot. She was diagnosed with Guillain-Barré syndrome (GBS), a rare disorder where the patient's body's immune system attacks their nerves. According to a report by the Times Of India, this could escalate in a few cases to paralysing the entire body. Following the incident, the woman filed a complaint under the UK government's Vaccine Damage Payment Scheme (VDPS). GBS was yet another AEFI that was suggested to occur in the rarest cases and was largely found in men aged 50 years and older. With the vaccine-related case, the UK agencies were nudged to continue recording and studying the side effects of Covid-19 Vaccines.

Also Read: India Fastest In World To Reach 3 Million Vaccinations: Health Ministry