‘Disclosed all rare side effects’: SII clarifies amid vaccine safety row

In India, the Serum Institute of India (SII) said it stopped the manufacturing of additional doses of Covishield since December 2021.

In response to widespread apprehension regarding Thrombosis with Thrombocytopenia Syndrome (TTS), a rare complication associated with the Covishield COVID-19 vaccine, the Serum Institute, the manufacturer of the vaccine developed by AstraZeneca, has said that the packaging of its product had "fully disclosed all uncommon to exceedingly rare side effects," including TTS.

A vial of the Covishield vaccine. (HT File Photo)

"We fully understand the ongoing concerns and it is crucial to emphasise 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," a spokesperson of Serum Institute of India said.

SII said it stopped the manufacturing of additional doses of Covishield since December 2021 in India.

The SII spokesperson 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. Consequently, since December 2021, we have stopped the manufacturing and supply of additional doses of 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," AstraZeneca said.

The company said it will work with regulatory authorities worldwide to initiate marketing authorisation withdrawals for Vaxzevria (known as Covishield in India) as demand has been overtaken by the evolving nature of coronaviruses.

The European medicines agency, the medicines regulator for the European Union issued a notice on Tuesday to confirm that Vaxzevria is no longer authorised for use in the EU after AstraZeneca voluntarily withdrew its authorisation in March.

Meanwhile, lauding the role played by the vaccine in ‘ending the pandemic,’ the company said, “We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally.”

(With inputs from PTI)