‘Fully understand ongoing concerns’: SII on AstraZeneca withdrawing Covid vaccine

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A Serum Institute of India (SII) spokesperson on Wednesday said that they fully understand the ongoing concerns over AstraZeneca’s withdrawal of Covid vaccine Vaxzervria saying they have disclosed all rare to very rare side effects in the packaging insert in 2021.

On AstraZeneca’s withdrawal of its Covid-19 vaccine Vaxzervria, SII spokesperson 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.”

UK-based pharmaceutical major AstraZeneca has started global withdrawal of its Covid-19 vaccine, which was provided in India as ‘Covishield’ in partnership with Serum Institute of India, days after it admitted to rare side-effects of blood clotting and lowering of platelet counts.

The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement.

In India, the company’s partner Serum Institute of India (SII) said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side-effects, including Thrombosis with Thrombocytopenia Syndrome, in the packaging insert in 2021.

“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 further 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.”

Earlier, according to global media reports, AstraZeneca had admitted that its Covid-19 vaccine could in very rare cases has the potential to cause a rare side-effect called Thrombosis with Thrombocytopenia Syndrome (TTS).

Without referring to the side-effects, 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.”

It further said, “Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.”

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

It said it will similarly work with regulatory authorities worldwide to initiate marketing authorisation withdrawals for Vaxzevria as demand has been overtaken by the evolving nature of coronaviruses.

In a separate statement, 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.”

Despite the challenges faced during the global pandemic, the safety of the vaccine remains paramount.

“Regardless of whether it’s AstraZeneca’s Vaxzervria or our own Covishield, both vaccines have been instrumental in saving millions of lives worldwide,” the spokesperson asserted.

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

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