AstraZeneca, Serum Institute to be sued by parents of woman who died after Covishield jab: What happened?

The bereaved parents of a young woman who died in July 2021 are planning to sue AstraZeneca and the Serum Institute of India (SII). They say their daughter passed away after taking the Covishield jab, manufactured by SII in India.

The development comes after reports surfaced about the British-Swedish pharmaceutical giant AstraZeneca’s admission in court documents in the United Kingdom that its COVID-19 vaccine, in rare cases, can cause Thrombosis with Thrombocytopenia Syndrome (TTS). AstraZeneca’s COVID jab was sold as Covishield in India.

TTS is a rare condition that leads to blood clotting and low platelet count.

Let’s take a closer look.

What happened?

In July 2021, Karunya Venugopal, a 20-year-old data science student, died a month after getting vaccinated, as per a Scroll report.

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After being hospitalised for weeks, she passed away due to multisystem inflammatory syndrome.

“She developed severe complications eight days after taking the vaccine and died after a month in spite of three weeks of tertiary care hospitalisation,” her father, Venugopalan Govindan, told Economic Times (ET) in late 2022.

“She had no pre-existing health conditions and was completely healthy prior to taking the vaccine,” he added.

In November 2021, the health ministry’s immunisation division, after its inquiry, classified Karunya’s death as ‘B1’, which meant that the AEFI (adverse event following immunisation) had a “temporal relationship” with the vaccination, but there was insufficient evidence to prove it was caused by the vaccine.

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Govindan approached the Supreme Court, seeking monetary compensation from the government and for creating a protocol for early detection and treatment of AEFIs.

In November 2022, the Centre told the apex court that the government could not be held liable to provide compensation for the deaths due to the administration of COVID-19 vaccines. The government had said it took “substantial efforts” to ensure a safe and effective COVID-19 vaccination drive, reported The Hindu.

ALSO READ: AstraZeneca vaccine’s side effects. Why Covishield takers shouldn’t worry

Karunya’s parents mull suing SII

Now, after AstraZeneca accepted for the first time that its COVID-19 vaccine can cause TTS in rare cases, Karunya’s parents are mulling taking SII to court, as per an ET report. Govindan said the pharmaceutical giant’s admission has come “too late” after “so many lives have been lost”.

“AstraZeneca and SII should have stopped the manufacture and supply of these vaccines when 15 European countries either suspended or age-limited these due to deaths from blood clots that happened in March 2021, within a couple of months of the rollout of the vaccine itself,” he told ET.

Govindan also questioned the government and Covishield maker for not halting the rollout of the vaccine after data about its adverse effects emerged from around the world.

“If sufficient remedies aren’t obtained, for the sake of justice and to prevent recurrence of this atrocity that was perpetrated in the name of public health, we will file fresh cases against any and all of those perpetrators because of whose actions the deaths of our children ensued,” he was quoted as saying by ET.

“Eight of the victims’ families have connected and I am echoing the common sentiments of all of us,” Govindan  said, as per NDTV. 

The first reports of a link between AstraZeneca’s COVID-19 shots and TTS surfaced in early 2021. Several European countries, including Denmark, even stopped the use of the vaccine over these concerns for a while.

Another death after taking Covishield

Rithaika Sri Omtri, 18, got the first dose of Covishield in May 2021 in Hyderabad. As per a Scroll report, within five days of being vaccinated, she experienced a prickling sensation in her fingers and, later, a high fever.

As her fever did not subside for a few days, a doctor suggested her a blood test which revealed her platelets had dropped to a dangerous low of 40,000 per cubic millimetre, compared to a normal range between 1.5 lakh and 4 lakh.

Over 10 days later, Rithaika started vomiting and could not walk. An MRI scan of her brain showed that she had multiple blood clots and a haemorrhage in the right frontal region, Scroll reported.

Despite efforts to save her, she was declared brain dead, two weeks after her vaccination.

As per Scroll, Rithaika had suffered a “vaccine-induced (immune) thrombotic thrombocytopenia” or VITT, a rare adverse effect that leads to blood clots and low platelet count.

VITT was reported in some people who got adenoviral vector COVID-19 vaccines such as AstraZeneca’s Vaxzevria (marketed as Covishield in India) and Johnson & Johnson’s Janssen shots.

A probe by the AEFI committee categorised Rithaika’s death under the A1 cetagory, meaning a “vaccine product related reaction”, reported ET.

Rithaika’s mother, Rachana Gangu, was the second petitioner, who along with Govindan, had moved the apex court in late 2021, alleging her child died due to severe complications after getting the first dose of the COVID-19 vaccine.

In her writ petition, she had demanded compensation and the establishment of an expert medical board to inquire and probe her daughter’s death.

The cases in UK

AstraZeneca is being sued in a class action in the UK High Court over claims that its COVID-19 vaccine, developed with the University of Oxford, caused death and serious harm in 51 cases.

Victims and grieving relatives are seeking damages estimated to be valued up to 100 million pounds.

The first case against the pharmaceutical giant was filed last year by Jamie Scott, who was left with a permanent brain injury after suffering from a blood clot and a bleed on the brain. This happened after he got the vaccine in April 2021 and Scott has been unable to work since then, The Daily Telegraph reported.

While AstraZeneca is contesting the claims, it has “accepted, in a legal document submitted to the High Court in February that its COVID vaccine ‘can, in very rare cases, cause TTS’”, the report added.

With inputs from agencies