In response to mounting concerns regarding thrombosis with thrombocytopenia syndrome (TTS), a severe adverse event associated with AstraZeneca's Covid vaccine, the Serum Institute of India (SII), the manufacturer of the vaccine in India, stated that it had already provided comprehensive information about the side effects in its packaging insert as early as 2021.
On Wednesday, a spokesperson from the Serum Institute of India emphasized that ensuring the safety of vaccines remains their top priority.
However, a collective of parents who tragically lost their children to purported adverse effects following the Covishield vaccination believes that the number of deaths or serious injuries could be significantly higher in India than the government-reported figures. According to reports, AstraZeneca has acknowledged in a legal document that its COVID vaccine "can, in very rare cases, cause TTS."
"The number of people who have died due to TTS and other causes from the vaccine could be much more than the official figures. A lot of people have reached out to us and will join the fight," said Venugopalan Govindan, whose 20-year-old daughter, Karunya, allegedly died from complications related to vaccination. Govindan highlighted the lack of accountability in studying and publishing causality within a specific timeframe, citing instances where adverse events suffered in 2015 were not decided upon until 2023.
He expressed concern that the data is not deliberately made available in an analyzable format. "Many new families have reached out and will join in the fight," added Govindan. This indicates a growing momentum and solidarity among affected families seeking justice.
A senior member of the COVID working group stated that the assessment related to adverse events concluded in 2022, emphasizing that the number of deaths due to TTS is "extremely low." Previously, some of these parents had approached the court, attributing the administration of the COVID vaccine to the deaths of their children.
The petition primarily targeted the government and the authorities responsible for clearing the vaccines for administration, allegedly without proper studies, with SII not being a party to those cases. However, following AstraZeneca's admission, the parents are now hopeful of justice. AstraZeneca has requested the withdrawal of the European authorization for its COVID-19 vaccine, as stated by the EU medicines regulator. In an update on the European Medicines Agency's website on Wednesday, the regulator announced the withdrawal of approval for AstraZeneca's Vaxzevria "at the request of the marketing authorization holder.
"An SII spokesperson stated that the company halted the manufacturing and distribution of the vaccine in 2021. They explained, "With India achieving high vaccination rates in 2021 and 2022, coupled with the emergence of new mutant variant strains, the demand for previous vaccines diminished significantly." As a result, the spokesperson affirmed, "Consequently, since December 2021, we have ceased the manufacturing and supply of additional doses of Covishield."
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