The Serum Institute of India (SII) has stated that all side effects were disclosed in the package, and production of Covishield was halted in 2021.
An SII representative stated that they had disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS), in the packaging insert in 2021. Meanwhile, the Serum Institute of India (SII), which collaborated with AstraZeneca to supply Covishield vaccines in India, announced on Wednesday that it ceased production in December 2021.
The European Medicines Agency, the regulatory body for medicines in the European Union, announced on Tuesday that the marketing authorization for the Vaxzevria vaccine, known as Covishield in India, had been withdrawn at the request of AstraZeneca.
Earlier, media reports revealed that AstraZeneca admitted in British courts that its vaccines could, in very rare cases, potentially cause the rare side effect TTS. This admission could open doors for payouts in a class action lawsuit. TTS leads to blood clots combined with low platelet count after immunization with vaccines using an adenovirus platform like Vaxzevria and Johnson & Johnson’s Janssen.
The first cases of TTS emerged within months of vaccination drives commencing in Europe, prompting some countries to temporarily halt the use of the AstraZeneca vaccine. Although vaccination resumed, it was not recommended for young women, who were found to be most susceptible to TTS.
While SII included a warning regarding TTS in the latter half of 2021, stating that individuals with a history of clotting (thrombosis) and autoimmune disorders should refrain from using the vaccine, family members of those who died from TTS and other rare side effects claim that the package insert was not readily accessible during the mass vaccination drive, and there were no informational sessions about potential effects.
AstraZeneca, however, stated that the withdrawal was initiated due to a surplus of updated vaccines available since the pandemic. An AstraZeneca spokesperson told The Indian Express: “As multiple, variant COVID-19 vaccines have since been developed, there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzervria, which is no longer being manufactured or supplied. AstraZeneca has therefore decided to initiate the withdrawal of the Marketing Authorizations for Vaxzevria within Europe.”
In India, SII ceased Covishield production in December 2021 after a significant portion of the population had been vaccinated, and a stockpile was created. The company explained: “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.”
During the vaccination drive in India, over 79% of the 2.2 billion doses administered were Covishield. Data shared by the government’s Adverse Events Following Immunization (AEFI) committee indicates at least 36 TTS cases in the country with 18 fatalities, primarily occurring in 2021, the initial year of vaccination in India.