As AstraZeneca announces vaccine withdrawal, Serum Institute says stopped Covishield in 2021
NEW DELHI: Days after AstraZeneca admitted for the first time in court documents that their Covid-19 vaccine can cause a rare and dangerous side effect, the British pharma giant announced that they are withdrawing it globally.
The global pharma giant, in collaboration with The University of Oxford, developed the AZD1222 vaccine after the Coronavirus outbreak in 2020. It said that they are 'incredibly proud' of the vaccine, but it had made a commercial decision to withdraw it.
In India and other low-and-middle-income countries, it was manufactured and supplied under Covishield by the Serum Institute of India (SII) through a licence from the university and the Swedish-British drugmaker.
In its statement, AstraZeneca said, "As multiple, variant COVID-19 vaccines have since been developed, there is a surplus of available updated vaccines. This surplus has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied."
The vaccine was superseded by updated vaccines that tackle new variants, the pharma company said.
According to an SII spokesperson, 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," the official 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," he added.
The Indian pharma company said 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 spokesperson reiterated.
What experts are saying
Professor K Srinath Reddy, honorary distinguished professor at the Public Health Foundation of India (PHFI), said Covid vaccines have to be judged by their ability to stimulate a protective response against the currently circulating forms of the virus to prevent serious disease.
"The original AstraZeneca vaccine no longer meets those criteria," he told The New Indian Express.
"The complication of thrombotic disorders being triggered as a rare adverse effect of virus vector vaccines also makes other vaccines the preferred option," he added.
However, he said, there is no risk to those who took the vaccines in India. "The risk is not reported after a long gap in time. It is a relatively early phenomenon -- a few weeks after injection," he added.
Dr Rajeev Jayadevan, Co-Chairman of the National Indian Medical Association (IMA) COVID Task Force, also echoed Dr Reddy, saying, "The side effects from the vaccine was a known fact since rollout. The extremely rare outcome of TTS was acknowledged by the World Health Organisation (WHO) in 2021. One cannot generalize rare outcomes, these are exceptions and not the rule.”
"The truth is that the majority of the population who took Covishield had no significant side effects and survived COVID. Crores of people in India took the vaccine and they are perfectly safe. We must not decry the good outcomes of the vaccine," he emphasised.
Dr Jayadevan said people are wrongly linking sudden deaths to TTS. "There were multiple risk factors for people who died suddenly such as smoking, binge drinking, diabetes, hypertension, lifestyle problems, COVID and family history."
The government is yet to comment on the global withdrawal announced by AstraZeneca.
In India, 1,74,93,57,213 doses of Covishield have been administered.
AstraZeneca says applied voluntarily for withdrawal on March 5
On Wednesday, AstraZeneca denied that the decision to withdraw the vaccine is linked to the court case where it accepted that it can "in very rare cases cause TTS or Thrombosis with Thrombocytopenia Syndrome".
TTS causes blood clots and a low blood platelet count in humans and has been linked to at least 81 deaths in the UK.
The company said it had voluntarily applied on March 5 to withdraw its "marketing authorisation" in the European Union, adding that the vaccine was no longer being produced and could no longer be used. Similar withdrawals will be made across other countries that have been using the vaccine.
The pharmaceutical giant is facing a 100 million pound lawsuit in UK over claims that the Covid jab caused deaths and injuries to several people.
"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. 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 company said in its statement.
"As multiple, variant Covid-19 vaccines have since been developed, there is a surplus of available updated vaccines. 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," the company said in a statement.