The European Medicines Agency is weighing up whether to take further action as one person died and another was severely ill in Austria after being given AstraZeneca’s Covid-19 vaccine.
Both people had received shots from the same batch of vaccines, ABV 5300, which has also been delivered to other countries across Europe, the EMA told the Financial Times.
The EMA and the Austrian regulator said there was no evidence that the vaccine had caused the incidents, but the Austrian authorities have halted use of the batch as a precaution.
One woman, 49, died as a result of “severe coagulation disorders”, while another, 35, developed a pulmonary embolism but was recovering, the Austrian Federal Office for Safety in Health Care said on Sunday. Both had received the vaccine before to the events, it said.
The EMA said its pharmacovigilance risk assessment committee was reviewing the reports in order to consider whether any action should be taken across the EU. The batch consists of about 1m doses, according to a person familiar with the matter, with about 48,000 doses delivered to Austria.
AstraZeneca said it was in touch with Austrian regulators, adding that there have been “no confirmed serious adverse events” associated with its vaccine to date. Trials and real world evidence “have concluded that the . . . vaccine is safe and effective”, it said.
The AstraZeneca vaccine has been administered to millions of people worldwide and has shown a consistent safety profile. No deaths have been attributed directly to any Covid-19 vaccination anywhere in the world.
The Austrian regulator said thrombotic events like those described on Sunday are “not among the known or typical side effects of the vaccine in question”. It noted clinical trial data did not show “any worrying data or signals” in this respect when compared with placebo patients. Work was under way “at full speed” to exclude a possible connection, it added.
奥地利联邦医疗安全办公室周日表示，一名49岁的妇女因 "严重的凝血障碍 "而死亡，另一名35岁的妇女出现肺栓塞，但正在康复中。两人都收到了疫苗前到事件，它说。
奥地利监管机构表示，像周日描述的血栓事件“不属于有关疫苗的已知或典型副作用”。它指出，与安慰剂患者相比，临床试验数据没有显示这方面的“任何令人担忧的数据或信号”。它补充说，正在 "全速 "开展工作，以排除可能的联系。