The British-Swedish multinational pharmaceutical is also being sued by more than 50 alleged victims and grieving relatives in a High Court case in the UK
New Delhi:
In a significant move, pharma giant AstraZeneca has recalled its Covid-19 vaccine, made in collaboration with Oxford University, worldwide, months after admitting in the UK court about its potential rare blood clot side effect.
The company voluntarily withdrew its “marketing authorisation” of its Covid vaccine, sold as Covishield in India and Vaxzevria in Europe. It can now no longer be used in the European Union, the Telegraph reported.
While the company made the application to withdraw the vaccine on March 5, it came into effect on Tuesday.
Credited for saving more than six million lives, AstraZeneca “accepted, in a legal document submitted to the High Court in February, that its Covid vaccine ‘can, in very rare cases, cause TTS’,” the report said.
Thrombotic Thrombocytopenic Syndrome (TTS) is a rare side effect that can cause people to have blood clots and a low blood platelet count, linked to at least 81 deaths in the UK as well as hundreds of serious injuries.
The British-Swedish multinational pharmaceutical is also being sued by more than 50 alleged victims and grieving relatives in a High Court case in the UK.
However, AstraZeneca noted that the vaccine is being withdrawn for “commercial reasons” and is “not linked to the court case”, and that “the timing was pure coincidence”.
Because of multiple Covid variants and related-vaccines, “there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore decided to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe,” the company said in a statement.
The company noted that it will collaborate with global regulatory authorities “to initiate marketing authorisation withdrawals for Vaxzevria, where no future commercial demand for the vaccine is expected”.
Meanwhile, the Serum Institute of India (SII) has stopped the manufacture and supply of additional doses of Covishield from December 2021 in view of the significantly decreasing demand for previous vaccines, a spokesperson from the vaccine manufacturing 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. Consequently, since December 2021, we have stopped the manufacturing and supply of additional doses of Covishield,” a spokesperson from the SII said on Wednesday.
On the alleged side-effects of the vaccine, the SII said that they have disclosed all the rare to very rare side effects in its packaging since 2021.
“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,” the SII spokesperson said.
On AstraZeneca’s withdrawal of its Covid-19 vaccine Vaxzervria, Serum Institute of India spokesperson said that the safety of its vaccine remains “paramount”.
“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. We commend the collaborative efforts of governments and ministries in facilitating a unified global response to the pandemic,” the SII spokesperson said.
Agencies