Vaccine-major Serum Institute of India (SII) said it had disclosed “all rare to very rare side effects” linked to its Covid-19 vaccine, Covishied, in the packaging insert in 2021.
“We fully understand the ongoing concerns and It’s crucial to emphasize our commitment to transparency and safety. From the outset, we have disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS), in the packaging insert in 2021,” SII said, addressing the risk of blood clots and low platelet counts linked to the vaccine.
SII’s statement comes even as news from the UK indicated that AstraZeneca (AZ) was reportedly withdrawing its Covid-19 vaccine from global markets. AZ’s Covid-19 vaccine was produced and sold in India by SII, and over 170 crore doses were deployed.
On Tuesday, the European Union’s decision to withdraw its marketing authorisation for AZ’s Covid 19 vaccine Vaxzevria - on the company’s request (on March 5, 2024), came into effect. AZ said, it had made such a request because of the surplus of updated vaccines, and a decline in demand for its own.
AZ presently faces a class-action suit in the UK, from a small group of families reportedly affected by the vaccine. In court documents (in February), the company had said, the vaccine could “in very rare cases, cause TTS”, reports said.
Stopped manufacturing
An SII spokesperson said, “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. Consequently, since December 2021, we have stopped the manufacturing and supply of additional doses of Covishield.”
Meanwhile, Indian families allegedly affected by the vaccine are also looking to take a legal recourse. Standing by the safety profile of the vaccine, SII said, “Regardless of whether it’s AstraZeneca’s Vaxzervria or our own Covishield, both vaccines have been instrumental in saving millions of lives worldwide.,”