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covishield side effects: Disclosed all information on Covishield’s side effects in 2021, says SII

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Pune-based Serum Institute of India (SII) said on Wednesday that safety of vaccines remained “paramount” and that it had disclosed all information about the side effects of its Covishield vaccine against Covid-19 in its packaging insert in 2021 itself.

The statement comes days after a group of parents, whose children died during the pandemic after allegedly taking the Covishield vaccine, said that they would file a case against the company.

SII manufactured and supplied the vaccine under licence from AstraZeneca. The UK company, which sold the vaccine as Vaxzervria, last week admitted in court that the vaccine could cause a rare side effect.

“We fully understand the ongoing concerns and it’s crucial to emphasise our commitment to transparency and safety. From the outset, we have disclosed all rare to very rare side effects, including thrombosis with thrombocytopenia syndrome, in the packaging insert in 2021,” an SII spokesperson said.

Despite the challenges faced during the global pandemic, the safety of the vaccine remained paramount, the spokesperson added. “Regardless of whether it’s AstraZeneca’s Vaxzervria or our own Covishield, both vaccines have been instrumental in saving millions of lives worldwide. We commend the collaborative efforts of governments and ministries in facilitating a unified global response to the pandemic.”

Meanwhile, AstraZeneca on Wednesday announced a global withdrawal of Vaxzevria, citing a surplus of newer vaccine options as the primary reason.The company has voluntarily withdrawn the “marketing authorisation” for the vaccine within the European Union, and similar applications are expected to be made in other countries where the vaccine was approved.The SII spokesperson said the company had stopped manufacturing and supplying the vaccine in 2021.

“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,” the spokesperson said. “Consequently, since December 2021, we have stopped the manufacturing and supply of additional doses of Covishield”.