SII stopped manufacturing Covishield since December 2021, says 'disclosed side effects details in packaging insert'

NEW DELHI: Serum Institute of India (SII) on Wednesday said that it stopped manufacturing and supplying the additional doses of Covishield in December 2021, a few days after a parent decided to sue the company following the death of a woman caused by the Covishield vaccine shot.

The spokesperson of SII said, "We fully understand the ongoing concerns and It's crucial to emphasize our commitment to transparency and safety."

" From the outset, we have disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome, in the packaging insert in 2021. Despite the challenges faced during the global pandemic, the safety of the vaccine remains paramount," spokesperson added.

AstraZeneca withdraws COVID vaccine worldwide
This disclosure comes amid AstraZeneca's announcement that it has begun the global withdrawal of its COVID-19 vaccine citing surplus of availability of updated vaccines since the pandemic.

Astrazeneca said that they are withdrawing the marketing authorisations for Vaxzevria, which is known as Covishield in India, within Europe.

"AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe. 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," it said.

"We will partner with regulatory authorities globally to initiate marketing authorisation withdrawals for Vaxzevria, where no future commercial demand for the vaccine is expected," it was quoted by 'The Daily Telegraph' as saying.

On Tuesday, the European Medicines Agency, the medicines regulator for the European Union (EU), issued a notice to confirm that Vaxzevria is no longer authorised for use in the 27-member economic bloc after AstraZeneca (AZ) voluntarily withdrew its authorisation in March.

In India, over 220 crore dosages of COVID-19 vaccines have been administered and a majority of those were Covishield.

"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," it said.

"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."

AstraZeneca admits its Covishield can cause rare side effect
In a legal document submitted to the High Court in February, AstraZeneca acknowledged for the first time that its Covid vaccine "can, in very rare cases, cause TTS" (thrombosis with thrombocytopenia syndrome). The company stated in the document that TTS occurrences can occur even without vaccination, emphasizing that expert testimony will be necessary to establish causation in each individual case.

What is Thrombosis with Thrombocytopenia Syndrome?
Thrombosis with thrombocytopenia syndrome (TTS) is a rare but serious condition characterized by the formation of blood clots combined with low levels of platelets in the blood. It has been predominantly associated with certain COVID-19 vaccines, particularly adenovirus vector vaccines like AstraZeneca and Johnson & Johnson's Janssen vaccine.

(With inputs from PTI)

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