AstraZeneca withdrawing its COVID-19 vaccine worldwide months after it acknowledged a rare and dangerous side effect, The Telegraph reports.The Oxford-AstraZeneca COVID-19 vaccine Vaxzevria can cause a rare and dangerous side effect, the manufacturers admitted in court documents months ago.The application to withdraw the vaccine's marketing authorization in the European Union was made on March 5 and came into effect on Tuesday.The jab was heralded by Boris Johnson as a “triumph for British science” but has more recently been linked with Thrombosis with Thrombocytopenia Syndrome (TTS), which causes blood clots and low blood platelet counts.AstraZeneca admitted in documents lodged with the High Court in February that the vaccine “can, in very rare cases, cause TTS”. TTS has been linked to at least 81 deaths in the UK and hundreds of serious injuries, The Telegraph reported.AstraZeneca is being sued by more than 50 alleged victims and grieving relatives in a High Court case, but stood by its vaccine as it announced why it was pulling the injection off the market.“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," the statement read.“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 Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe."Vaxzevria, which never had approval in the US, will soon be off the market in non-EU countries.The company said, “We will partner with regulatory authorities globally to initiate marketing authorisation withdrawals for Vaxzevria, where no future commercial demand for the vaccine is expected.”The UK largely stopped using the Oxford-AstraZeneca vaccine by the autumn of 2021, by which time it had supplied about 50 million doses in the UK. It was replaced there with Pfizer and Moderna jabs in time for the winter booster campaign at the end of 2021.Marco Cavaleri, head of vaccines at the European Medicines Agency, told Italian media other "monovalent" vaccines for the Wuhan Covid strain will also wind down.“No-longer-used and updated vaccines will be withdrawn, as per our indication," he said.AstraZeneca accepted the vaccine can cause TTS in a legal document in February this year, even though the causal mechanism has not been identified.Lawyers for claimants in the case argued that the drug caused vaccine-induced immune thrombocytopenia and thrombosis (VITT) — a subset of TTS — and that it was not as safe as individuals were entitled to expect.Astrazeneca had insisted that “patient safety is our highest priority” and added, “From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”But Kate Scott, whose husband Jamie was left with a permanent brain injury after having the vaccine and who was the first person in the UK to bring a legal action, told The Telegraph: “AstraZeneca’s Covid vaccine no longer being used in the UK or Europe, and soon the rest of the world, means no one else will suffer from this awful adverse reaction. “They say it is for commercial reasons, but maybe it’s because it can no longer be seen as being within the acceptable safety parameters, with 445 confirmed cases of VITT, 81 of these fatal in the UK alone.”Another Mr. Scott, 47, a father-of-two who has had to give up work, said, “This is good news, but I will always wish they had, like they did in other countries, paused it in the UK after just one case. More lives could have been saved and I would not be suffering the way I am.”Sarah Moore, a partner at law firm Leigh Day, which is bringing the legal claims, said the withdrawal was welcome and that most would view it as a consequence of the vaccine's connection with TTS.“We will continue to fight for the compensation our clients need and campaign for reform of the vaccine damage payment scheme," Moore said.The scheme, run by the government, has paid out to victims. But it has been branded inadequate, prompting them to bring separate civil claims against AstraZeneca, which the drugs firm is contesting.
AstraZeneca withdrawing its COVID-19 vaccine worldwide months after it acknowledged a rare and dangerous side effect, The Telegraph reports.The Oxford-AstraZeneca COVID-19 vaccine Vaxzevria can cause a rare and dangerous side effect, the manufacturers admitted in court documents months ago.The application to withdraw the vaccine's marketing authorization in the European Union was made on March 5 and came into effect on Tuesday.The jab was heralded by Boris Johnson as a “triumph for British science” but has more recently been linked with Thrombosis with Thrombocytopenia Syndrome (TTS), which causes blood clots and low blood platelet counts.AstraZeneca admitted in documents lodged with the High Court in February that the vaccine “can, in very rare cases, cause TTS”. TTS has been linked to at least 81 deaths in the UK and hundreds of serious injuries, The Telegraph reported.AstraZeneca is being sued by more than 50 alleged victims and grieving relatives in a High Court case, but stood by its vaccine as it announced why it was pulling the injection off the market.“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," the statement read.“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 Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe."Vaxzevria, which never had approval in the US, will soon be off the market in non-EU countries.The company said, “We will partner with regulatory authorities globally to initiate marketing authorisation withdrawals for Vaxzevria, where no future commercial demand for the vaccine is expected.”The UK largely stopped using the Oxford-AstraZeneca vaccine by the autumn of 2021, by which time it had supplied about 50 million doses in the UK. It was replaced there with Pfizer and Moderna jabs in time for the winter booster campaign at the end of 2021.Marco Cavaleri, head of vaccines at the European Medicines Agency, told Italian media other "monovalent" vaccines for the Wuhan Covid strain will also wind down.“No-longer-used and updated vaccines will be withdrawn, as per our indication," he said.AstraZeneca accepted the vaccine can cause TTS in a legal document in February this year, even though the causal mechanism has not been identified.Lawyers for claimants in the case argued that the drug caused vaccine-induced immune thrombocytopenia and thrombosis (VITT) — a subset of TTS — and that it was not as safe as individuals were entitled to expect.Astrazeneca had insisted that “patient safety is our highest priority” and added, “From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”But Kate Scott, whose husband Jamie was left with a permanent brain injury after having the vaccine and who was the first person in the UK to bring a legal action, told The Telegraph: “AstraZeneca’s Covid vaccine no longer being used in the UK or Europe, and soon the rest of the world, means no one else will suffer from this awful adverse reaction. “They say it is for commercial reasons, but maybe it’s because it can no longer be seen as being within the acceptable safety parameters, with 445 confirmed cases of VITT, 81 of these fatal in the UK alone.”Another Mr. Scott, 47, a father-of-two who has had to give up work, said, “This is good news, but I will always wish they had, like they did in other countries, paused it in the UK after just one case. More lives could have been saved and I would not be suffering the way I am.”Sarah Moore, a partner at law firm Leigh Day, which is bringing the legal claims, said the withdrawal was welcome and that most would view it as a consequence of the vaccine's connection with TTS.“We will continue to fight for the compensation our clients need and campaign for reform of the vaccine damage payment scheme," Moore said.The scheme, run by the government, has paid out to victims. But it has been branded inadequate, prompting them to bring separate civil claims against AstraZeneca, which the drugs firm is contesting.
