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'Stopped Covishield Manufacturing In 2021, Listed All Side-Effects In Package': SII

In a statement, an SII spokesperson stated, 'We have disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS), in the packaging insert since 2021.'
07:44 AM May 09, 2024 IST | simran rajpal
 stopped covishield manufacturing in 2021  listed all side effects in package   sii

On Wednesday, Serum Institute of India (SII), which had partnered with British pharmaceutical giant AstraZeneca to provide Covishield vaccines in India, announced that it had ceased production in December 2021, following AstraZeneca's request to withdraw marketing approval of its Covid-19 vaccine, Covishield in Europe.

On Tuesday, the European Medicines Agency, the medicine regulator for the European Union, announced the withdrawal of marketing authorization for the vaccine Vaxzevria, which is known as Covishield in India, at the request of the company.

In a statement, an SII spokesperson stated, "We have disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS), in the packaging insert since 2021."

Earlier, media reports indicated that AstraZeneca had admitted in British courts for the first time that its vaccines could potentially cause the rare side effect TTS in very rare cases, which could lead to payouts in a class action lawsuit. TTS results in blood clots combined with low platelet count after immunization with vaccines using an adenovirus platform, such as Vaxzevria and Johnson & Johnson’s Janssen.

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Serum Institute Issues Clarification On Covishield 

Within months of the vaccination drives beginning in Europe, the first cases of TTS came to light, leading some countries to halt the use of the AstraZeneca vaccine temporarily. Although authorities later resumed immunization with the vaccine, they did not recommend it for young women, who were found to be most susceptible to TTS.

While SII included a warning about TTS in the second half of 2021, stating that individuals with a history of clotting (thrombosis) and autoimmune disorders should avoid using the vaccine, family members of those who died from TTS and other rare side effects claimed that the package insert was never accessible to individuals receiving the shot during the mass vaccination drive, and there was no one present to inform them about the potential effects.

What did AstraZeneca say on this?

However, AstraZeneca stated that the withdrawal was initiated due to a surplus of available updated vaccines since the pandemic. An AstraZeneca spokesperson told The Indian Express in a statement, “As multiple variant COVID-19 vaccines have since been developed, there is a surplus of available updated vaccines. This surplus has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore decided to initiate the withdrawal of the Marketing Authorisations for Vaxzevria within Europe.”

In December 2021, most people in India had received vaccinations and a stockpile had been created before SII stopped manufacturing Covishield.

During the vaccination drive in India, Covishield accounted for over 79% of the 2.20 billion doses administered. Data shared publicly by the government’s Adverse Events Following Immunisation (AEFI) committee reveals at least 36 cases of TTS in the country, resulting in 18 deaths. Nearly all these TTS cases occurred in 2021, the first year of vaccination in India.

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