AstraZeneca coronavirus vaccine under investigation, safety review


Vials labelled "Astra Zeneca COVID-19 Coronavirus Vaccine" and a syringe are seen in front of a displayed AstraZeneca logo, in this illustration photo taken March 14, 2021. [Photo/Agencies]

TALLINN - At least 20 European countries have fully or partially suspended the use of the AstraZeneca coronavirus vaccine following reports of suspected deaths from blood clots after vaccination, which prompted the European Medicines Agency (EMA)'s investigation and the World Health Organization (WHO)'s safety review.

On Tuesday, Sweden joined countries like Bulgaria, Denmark, Lithuania, Luxembourg, Latvia, the Netherlands, Ireland, France, Germany, Italy, Spain, Slovenia, Cyprus and Portugal to suspend the use of the AstraZeneca vaccine.

The Public Health Agency's move came out of concerns of potential serious side effects, including blood clots in combination with low levels of platelets that have been observed in a few younger individuals following vaccination, said Swedish epidemiologist Anders Tegnell.

"The decision is a precautionary measure," Tegnell said. "There is good knowledge about the vaccine, but it is still important that we now pause the vaccinations until the European Medicines Agency has investigated whether these events may be related to vaccination."

Having suspended the use of one particular batch of AstraZeneca COVID-19 vaccines due to safety concerns, Latvia and Lithuania on Tuesday also announced the temporary halt of the use of the vaccine.

Lithuanian Health Minister Arunas Dulkys described the decision as "a precaution" pending the EMA's final conclusions on the safety of the vaccine, adding that both the EMA and the WHO say that there is no evidence that the vaccine could cause blood clots.

Latvian Health Minister Daniels Pavluts said that experts' decision to suspend the use of the vaccine had been unexpected and it meant a pause in the immunization process.

Although there have been a small number of cases in Latvia where people have died a few days after receiving the AstraZeneca vaccine, none of these cases involved thromboembolism and no evidence has been found to suggest that the deaths were caused by the vaccine, said the State Agency of Medicines of the Republic of Latvia.

Moreover, both Italian Prime Minister Mario Draghi and Portuguese Prime Minister Antonio Costa on Tuesday stressed "precaution" for the decision to at least temporarily ban the use of AstraZeneca's coronavirus vaccine in their respective countries.

Estonian Minister of Health and Labor Tanel Kiik on Tuesday said on social media that the Estonian national expert committee on immunoprophylaxis supports continuing the use of AstraZeneca's coronavirus vaccine.

"We decided that we will not stop vaccinations. For now, it is not clearly proven that the vaccine is related to thrombosis," immunoprophylaxis expert committee member Professor Irja Lutsar told Estonian TV.

Late on Monday, Romanian health authorities decided "to continue the vaccination campaign in Romania with all the vaccines against COVID-19 currently authorized at the European level".

Romania decided last Thursday to temporarily quarantine the 4,317 doses of AstraZeneca vaccine that had not been used among the 81,600 doses of the problematic batch received, but to continue the vaccination with the AstraZeneca serum from other batches.

In Austria, as of Monday evening, the head of the vaccination department in the Ministry of Health saw no reason to cancel the upcoming vaccinations.

There is currently no evidence of a causal connection between the AstraZeneca vaccine and the currently discussed health events "which can also occur in unvaccinated people," according to Austrian Health Minister Rudolf Anschober, who called for "a common pan-European approach".

In addition, the Greek authorities decided to continue to use the AstraZeneca vaccine in the country as originally scheduled, the official news agency AMNA reported on Tuesday.

For his part, British Prime Minister Boris Johnson on Monday defended the safety of the AstraZeneca coronavirus vaccine, saying regulators of his country's Medicines and Healthcare products Regulatory Agency (MHRA) "see no reason at all to discontinue the vaccination program".

"We are closely reviewing reports but the evidence available does not suggest the vaccine is the cause," and "people should still go and get their COVID-19 vaccine when asked to do so," said Dr. Phil Bryan, head of vaccine safety at the MHRA, in a statement on Monday.

France has entered "a form of third wave (of the coronavirus pandemic) characterized by numerous virus variants", Prime Minister Jean Castex said on Tuesday, stressing that his government still considers vaccination a top priority in its strategy to stem the spread of the virus.

The suspension of the vaccine by several European states highlights the gap between an approach of the precautionary principle and the urgency of deploying strategies to fight the virus, said an editorial in Le Monde newspaper on Tuesday.

The success of a vaccination campaign is as much about the effectiveness of the vaccine as it is about the confidence it inspires, it noted.

As the world is struggling to contain the pandemic, vaccination is underway in an increasing number of countries with the already-authorized coronavirus vaccines.

Globally, 264 candidate vaccines are being developed worldwide - 82 of them in clinical trials, according to information released by the WHO on Tuesday.


在这张2021年3月14日拍摄的插图照片中,在展示的阿斯利康标志前可以看到标有“阿斯利康新冠肺炎冠状病毒疫苗”的小瓶和注射器。[图片/机构]塔林-至少有20个欧洲国家已经完全或部分暂停使用阿斯利康冠状病毒疫苗,此前有报道称,接种疫苗后疑似死于血栓,这促使欧洲药品管理局(EMA)进行调查,世界卫生组织(WHO)进行安全审查。周二,瑞典与保加利亚、丹麦、立陶宛、卢森堡、拉脱维亚、荷兰、爱尔兰、法国、德国、意大利、西班牙、斯洛文尼亚、塞浦路斯和葡萄牙等国一道,暂停使用阿斯利康疫苗。瑞典流行病学家安德斯·泰内尔(Anders Tegnell)说,公共卫生机构的这一举措是出于对潜在严重副作用的担忧,包括血凝块以及在接种疫苗后在一些年轻人中观察到的低水平血小板。“这个决定是一个预防措施,”特内尔说。“对疫苗有很好的了解,但我们现在暂停疫苗接种仍然很重要,直到欧洲药品管理局调查这些事件是否与疫苗接种有关。”出于安全考虑,拉脱维亚和立陶宛暂停了一批阿斯利康新冠肺炎疫苗的使用,并于周二宣布暂时停止使用该疫苗。立陶宛卫生部长阿鲁纳斯·杜尔克斯(Arunas Dulkys)将这一决定描述为在欧洲药品管理局对疫苗安全性做出最终结论之前的“预防措施”,并补充说,欧洲药品管理局和世卫组织都表示,没有证据表明疫苗可能导致血凝块。拉脱维亚卫生部长丹尼尔斯·帕夫卢茨(Daniels Pavluts)表示,专家们暂停使用疫苗的决定是出乎意料的,这意味着免疫过程的暂停。拉脱维亚共和国国家药品管理局表示,虽然拉脱维亚有少量病例在接种阿斯利康疫苗后几天死亡,但这些病例中没有一例涉及血栓栓塞,也没有证据表明死亡是由疫苗引起的。此外,意大利总理马里奥·德拉吉(Mario Draghi)和葡萄牙总理安东尼奥·科斯塔(Antonio Costa)周二都强调,对于至少暂时禁止在各自国家使用阿斯利康冠状病毒疫苗的决定,要采取“预防措施”。

爱沙尼亚卫生和劳动部长塔内尔·基尔克(Tanel Kiik)周二在社交媒体上表示,爱沙尼亚国家免疫预防专家委员会支持继续使用阿斯利康的冠状病毒疫苗。“我们决定不停止疫苗接种。目前,还没有明确证明这种疫苗与血栓形成有关,”免疫预防专家委员会成员Irja Lutsar教授告诉爱沙尼亚电视台。周一晚间,罗马尼亚卫生当局决定“继续在罗马尼亚开展疫苗接种活动,接种目前在欧洲层面获得授权的所有针对新冠肺炎的疫苗”。罗马尼亚上周四决定暂时隔离收到的81600剂有问题的阿斯利康疫苗中尚未使用的4317剂阿斯利康疫苗,但继续用其他批次的阿斯利康血清进行疫苗接种。在奥地利,截至周一晚上,卫生部疫苗接种部门的负责人认为没有理由取消即将到来的疫苗接种。奥地利卫生部长鲁道夫·安斯乔伯(Rudolf Anschober)表示,目前没有证据表明阿斯利康疫苗与目前讨论的健康事件之间存在因果关系,“健康事件也可能发生在未接种疫苗的人身上”,他呼吁采取“一种共同的泛欧洲方法”。此外,官方通讯社AMNA周二报道,希腊当局决定继续按原计划在该国使用阿斯利康疫苗。就英国首相鲍里斯·约翰逊(Boris Johnson)而言,他周一为阿斯利康冠状病毒疫苗的安全性进行了辩护,称英国药品和保健品监管机构(MHRA)的监管人员“认为没有任何理由停止疫苗接种计划”。“我们正在密切审查报告,但现有的证据并不表明疫苗是原因,”MHRA疫苗安全负责人菲尔·布莱恩博士在周一的一份声明中说,“当有人要求时,人们仍然应该去接种新冠肺炎疫苗”。法国总理让·卡斯特克斯(Jean Castex)周二表示,法国已进入“以众多病毒变异为特征的第三波(冠状病毒大流行)形式”,他强调,法国政府仍将疫苗接种视为遏制病毒传播战略的重中之重。《世界报》周二的一篇社论说,几个欧洲国家暂停疫苗接种凸显了预防原则和部署战略抗击病毒的紧迫性之间的差距。它指出,疫苗接种运动的成功既关乎疫苗的有效性,也关乎它激发的信心。随着世界努力遏制这一流行病,越来越多的国家正在接种已经授权的冠状病毒疫苗。根据世卫组织周二发布的信息,全球范围内正在开发264种候选疫苗,其中82种正在临床试验中。

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