The pharmaceutical giant AstraZeneca’s COVID-19 vaccine is being withdrawn worldwide after the company acknowledged, for the first time in court documents, that it can cause a rare and dangerous side effect, according to a report in the British newspaper.
AstraZeneca has announced that the vaccine is being removed from markets for commercial reasons. It further stated that the vaccine is no longer being manufactured or supplied, having been superseded by updated vaccines that combat new variants.
The application to withdraw the vaccine was made on March 5 and came into effect on May 7.
The vaccine can no longer be used in the European Union following the company’s decision to withdraw its “marketing authorisation”.
Similar applications will be submitted in the UK and other nations in the coming months that have given the go-ahead to the vaccine, known as Vaxzevria.
In recent months, Vaxzevria has come under scrutiny over a very rare side effect, which causes blood clots and low blood platelet counts. In court documents, AstraZeneca admitted in the High Court in February that the vaccine “can, in very rare cases, cause TTS”.
TTS, which stands for Thrombosis with Thrombocytopenia Syndrome, has been associated with at least 81 deaths in the UK and hundreds of serious injuries. More than 50 alleged victims and grieving relatives have filed a lawsuit against AstraZeneca in a High Court case.
AstraZeneca has insisted that the decision to withdraw the vaccine is not related to the case or admission that it can cause TTS and termed the timing a pure coincidence, according to The Telegraph report.
“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. 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 Telegraph quoted AstraZeneca as saying.
In a statement, the pharmaceutical giant said, “As multiple, variant Covid-19 vaccines have since been developed, there is a surplus of available updated vaccines,” adding that this has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied, The Telegraph reported.
It further announced its decision to initiate the withdrawal of the marketing authorisations for Vaxzevria within Europe. The company 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.”
Last week, AstraZeneca reiterated its commitment to patient safety while emphasising the vaccine’s overall safety profile.
An AstraZeneca spokesperson stated, “Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines.”
This comes in the wake of a recent admission by AstraZeneca, the pharmaceutical company, that its Covid vaccine Covishield and Vaxzevria “can, in very rare cases, cause Thrombosis Thrombocytopenia Syndrome (TTS).”
Despite these rare occurrences, the pharmaceutical company maintained that extensive clinical trial data and real-world evidence consistently support the vaccine’s safety and efficacy. Regulatory agencies worldwide continue to assert that the benefits of vaccination outweigh the risks of such extremely rare side effects.
(With ANI inputs)