Disclosed all side-effects in package, stopped making Covishield in 2021: SII

With British pharmaceutical giant AstraZeneca asking for the withdrawal of marketing approval of its Covid-19 vaccine in Europe, Serum Institute of India (SII), which partnered with the company to provide Covishield vaccines in India, said Wednesday it had stopped production in December 2021.

The European Medicines Agency, the medicine regulator for the European Union, had on Tuesday said that the marketing authorisation of the vaccine Vaxzevria, known as Covishield in India, has been withdrawn at the request of the company.

An SII spokesperson said in a statement: “From the outset, we have disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS), in the packaging insert in 2021.”

Earlier, according to media reports, for the first time, AstraZeneca had admitted in British courts that its vaccines could, in very rare cases, have the potential to cause the rare side effect TTS, opening doors for payouts in a class action lawsuit. TTS leads to blood clots combined with low platelet count after immunisation with vaccines that use an adenovirus platform such as Vaxzevria and Johnson & Johnson’s Janssen.

The first cases came to light within months of the vaccination drives beginning in Europe, with some countries halting the use of the AstraZeneca vaccine for a while. Although immunisation with the vaccine was resumed, it was not recommended for young women, who were found to be most susceptible to TTS.

While SII did include warning regarding TTS in the second half of 2021, stating that people with a history of clotting (thrombosis) and autoimmune disorders should refrain from using the vaccine, family members of those who died of TTS and other rare side effects said that the package insert was never accessible to the people getting the shot during the mass vaccination drive and no one was there to inform them about the possible effects.

AstraZeneca, however, maintained that the withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic. AstraZeneca spokesperson in a statement 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 taken the decision to initiate withdrawal of the Marketing Authorisations for Vaxzevria within Europe.”

In India, SII stopped manufacturing Covishield in December 2021, after most people had been vaccinated and a stockpile was created. The company said: “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.”

Over 79% of the 220 crore doses administered in India during the vaccination drive was Covishield.

Data publicly shared by the government’s Adverse Events Following Immunisation (AEFI) committee so far shows there have been at least 36 TTS cases in the country with 18 deaths. Almost all these TTS cases pertain to 2021– the first year of the vaccination in India. (With ENS inputs, Pune)

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