All Covishield side-effects were disclosed: Serum Institute of India

Amid concerns over Thrombosis (blood clotting) and Thrombocytopenia Syndrome (low platelet count), or TTS, rare complications associated with Covishield, the vaccine administered to protect against Covid-19, Pune-based Serum Institute of India (SII), which manufactured the vaccine in association with British pharma giant AstraZeneca, stated on Wednesday that it had disclosed its side-effects, including TTS, in the packaging insert in 2021.

Laying emphasis on safety as a priority, the company also highlighted Covishield’s role in saving millions of lives globally.

SII’s statement coincides with AstraZeneca’s battle against numerous lawsuits in the United Kingdom, after a patient alleged a permanent brain injury due to a blood clot formed post-vaccination in April 2021.

The pharma giant has started withdrawing the vaccine, saying it was “due to a surplus of available updated vaccines” in the market that target new variants of the virus. The company stopped manufacturing and supply of additional doses of Covishield in December 2021, said SII’s spokesperson in a statement.

AstraZeneca has reportedly admitted in one of the court documents that in rare cases their vaccine can cause TTS. However, it has denied that the decision to withdraw their vaccine is not linked to the court case.

AstraZeneca’s application to withdraw the Vaxzervria vaccine was made on March 5 and came into effect on May 7. The company voluntarily withdrew its “marketing authorisation” in the European Union, adding that the vaccine was no longer being produced. Similar withdrawals will be made across other countries that have been using the vaccine.

“According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally. Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic. As multiple variants of the Covid-19 vaccines have since been developed, there is a surplus of available updated vaccines. We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the Covid-19 pandemic,” read a statement issued by AstraZeneca on recently.

“Despite the challenges faced during the global pandemic, the safety of the vaccine remains paramount. 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,” said SII in its statement.