May 09,2024
New Delhi: Amid concerns over thrombosis with thrombocytopenia syndrome (TTS) – a serious adverse event that causes blood clots and a low blood platelet count, linked to AstraZeneca’s Covid vaccine – Serum Institute of India (SII), the maker of the product in India, said that it had disclosed all information about the side-effects in its packaging insert in 2021 itself.
Safety of vaccines remained “paramount”, a SII spokesperson said on Wednesday.
However, a group of parents who lost their children to alleged adverse effects after taking Covishield, believes the number of deaths or serious injury could be much more in India than the government figures even as more parents join in to fight it out in the court.
According to reports, AstraZeneca has admitted 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 vaccine could be much more than the official figures. A lot of people have got in touch with us and will join the fight,” said Venugopalan Govindan, whose 20-year-old daughter, Karunya, died allegedly from complications related to vaccination.
Govindan said the AEFI system is inaccessible to common man to even file an adverse report.
“The adverse event facility incorporated in COWIN portal after the judgement in Jacob Puliyel case is not functional most of the time, and when it works, it just takes the entry, and we don’t ever hear back about it,” he said.
Govindan said that there is no accountability to study and publish causality within a certain timeframe (adverse events suffered in 2015 are decided in 2023). “Data is consciously not made available in an analysable way.”
The parents are in touch with lawyers and discussing their case as they contemplate filing a case against its manufacturer, Serum Institute of India (SII).
AstraZeneca is facing class action suits in the UK over allegations that the vaccine caused death and serious injury, including thrombosis with thrombocytopenia syndrome (TTS).
“Many new families have got in touch and will join in the fight,” Govindan added.
A senior member of the Covid working group said that the group finished the assessment related to adverse events in 2022 and the number of people dying due to TTS are “extremely low.”
A few of these parents had earlier approached court blaming administration of the Covid vaccine for the death of their children. The petition was mainly against the government and the authorities that cleared the vaccines for administration allegedly without proper studies, and SII was not a party in those cases. After AstraZeneca’s admission surfaced, the parents are now hopeful of justice.
“As responsible manufacturers, AstraZeneca and SII should have stopped the manufacturing and supply of these vaccines when 15 European countries either suspended or age-limited these vaccines due to the deaths from blood clots that happened in 2021 March, within a couple of months of the rollout of the vaccine,” he told ET.
Source: Pharma