SII Ceases Covishield Production in 2021; Comprehensive Side-Effects Disclosure in Packaging

As AstraZeneca seeks to withdraw marketing approval for its Covid-19 vaccine in Europe, Serum Institute of India (SII), the provider of Covishield vaccines in India through its partnership with the company, announced Wednesday that it ceased production in December 2021.

The European Medicines Agency, governing body for medicines in the EU, confirmed Tuesday the withdrawal of marketing authorization for Vaxzevria, known as Covishield in India, at AstraZeneca’s request.

A spokesperson for SII stated, “We have consistently disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS), in the packaging insert in 2021.”

Previously, AstraZeneca acknowledged in British courts the potential rare side effect TTS, opening avenues for compensation in a class action lawsuit. TTS involves blood clots with low platelet count post-vaccination with adenovirus platform vaccines like Vaxzevria and Johnson & Johnson’s Janssen.

Initial TTS cases surfaced in Europe shortly after vaccination drives commenced, leading some countries to temporarily suspend AstraZeneca vaccine use. While vaccinations resumed, it was cautioned against for young women, most susceptible to TTS.

Although SII warned against TTS in late 2021, advising against vaccination for those with clotting history or autoimmune disorders, families of TTS victims alleged the package insert wasn’t readily accessible during mass vaccination drives, leaving recipients uninformed of potential effects.

AstraZeneca cited surplus updated vaccines and decreased demand amid the pandemic’s progression as reasons for withdrawal. SII halted Covishield production in India in December 2021, with high vaccination rates and new variant strains reducing demand.

India administered over 79% of its 2.2 billion vaccine doses as Covishield during the drive, with government data reporting at least 36 TTS cases and 18 deaths, predominantly in 2021.