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Astrazeneca must release data on its Covid vaccine Vaxzevria – Health

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Astrazeneca must release data on its Covid vaccine Vaxzevria – Health

Soon after the approval of the corona vaccine from the British-Swedish company Astrazeneca, there were frightening reports. The vaccine called “Vaxzevria” had a terrible side effect in very rare cases. Individual vaccinated people suffered thrombosis in the brain or abdominal organs, and some died as a result. Because it was initially thought that young women in particular were affected, the vaccine in Germany was initially only recommended for people over 60 and later not at all.

But what did the manufacturer know about all this? Could the cases have been prevented? A woman from Upper Franconia also wanted to know this, who suffered a thrombosis in the intestine and fell into a coma after being vaccinated with the Astrazeneca vaccine in March 2021; she eventually had to have part of her intestines removed. The 33-year-old not only demanded compensation and compensation from the pharmaceutical company, but also the release of documents from the clinical trials.

Now she has achieved partial success before the Bamberg Higher Regional Court. On Monday, a civil chamber sentenced the company to provide comprehensive information on all known effects and side effects of its corona vaccine as far as they affect the plaintiff’s clinical picture, as a court spokesman announced. This also included all further findings that were gained in this context between the approval of the vaccine in December 2020 and February 2024.

The exact name of the plaintiff’s clinical picture is “thrombosis with thrombocytopenia syndrome”, or TTS for short. The serious thrombosis, which occurs in extremely rare cases not only after vaccinations with the Covid vaccine from Astrazeneca, but also with the very similar vaccine from Johnson & Johnson, is accompanied by a lowering of blood platelets (thrombocytes). The background is apparently antibodies that can form as a result of the vaccination and attack the blood platelets. The corona vaccines from Astrazeneca and Johnson & Johnson are both based on modified cold viruses.

It is not exactly known how common TTS is after vaccination with these vector vaccines. The only thing that is certain is that it is extremely rare. According to the European Medicines Agency, as of early April 2021, a total of 169 cases of cerebral vein TTS and 53 cases of abdominal TTS had been detected among 34 million vaccinated people. Scientists initially assumed that these complications were more common in younger people and women, but they are now thought to be evenly distributed across the entire population.

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The plaintiff’s lawyer, Volker Loeschner, told the German Press Agency that he and his client were very happy about the court’s decision. He assumes that this success will be followed by further claims for information in similar proceedings. It was the first trial of its kind in Germany.

A court spokesman pointed out that the information only related to the woman’s illness and only had to be made available to the plaintiff; The woman had also wanted to obtain information about other side effects, but the chamber refused. The court did not allow an appeal.

Meanwhile, the lawsuit for damages and compensation for pain and suffering continues. Astrazeneca’s lawyers have so far ruled out a settlement with the plaintiff and referred to the decision of the Hof Regional Court. The court dismissed the woman’s lawsuit in the first instance because it could not identify a product defect or an information error in connection with the vaccine.

A spokeswoman for the company emphasized that Astrazeneca had always met the high standards of the regulatory authorities and that the benefits of the vaccination were still positive. “Medicines regulators around the world have confirmed that the benefits of vaccination with our Covid-19 vaccine Vaxzevria outweigh the risks of the extremely rare potential side effects,” she said.

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