Johnson & Johnson Delays Vaccine Rollout in Europe After US Health Agencies Call for Pause

强生推迟在欧洲推出新冠疫苗

 

Johnson & Johnson said it would delay the planned rollout of its Covid-19 vaccine in Europe after US health agencies called for a pause of the jab’s use on Americans while they investigate several incidents of rare blood clots.

强生公司（Johnson & Johnson）表示，将推迟在欧洲推出其新型冠状病毒肺炎（COVID-19，即2019冠状病毒病）疫苗的计划。此前，美国卫生机构已建议暂停给美国人接种这款疫苗，同时正在对多起罕见的血栓事件进行调查。

In a joint statement on Tuesday, the US Centers for Disease Control and Prevention and the Food and Drug Administration said they were reviewing six reported US cases of “rare and severe” blood clots in individuals who had received the J&J vaccine. The individuals were all women aged between 18 and 48, who developed symptoms six to 13 days after vaccination.

在周二发布的一份联合声明中，美国疾病控制与预防中心（CDC）和美国食品药品监督管理局（FDA）表示，它们正在调查美国报告的6例接种强生疫苗后出现“罕见且严重”血栓的病例。这些病例中的患者全部为年龄在18至48岁之间的女性，她们在接种强生疫苗6至13天后出现了上述症状。

Peter Marks, the head of the division at the FDA that oversees vaccines, said scientists believed the J&J vaccine was causing similar severe reactions to those experienced by a small number of people who have received the AstraZeneca shot.

FDA疫苗监管部门负责人彼得·马克斯（Peter Marks）表示，科学家们认为，强生疫苗引发的严重反应，与少数阿斯利康（AstraZeneca）疫苗接种者身上出现的反应类似。

“The probable cause that we believe may be involved here is a similar mechanism that may be going on with the other adenoviral vector vaccine,” he said. “That is an immune response that occurs very, very rarely after some people receive the vaccine. That immune response leads to activation of these platelets and these extremely rare blood clots.”

“我们认为可能导致了这种情况的原因，与其他腺病毒载体疫苗可能涉及的机制类似。”他说，“这是一种免疫反应，是一部分人接种疫苗后出现的非常、非常罕见的反应。这种免疫反应会导致血小板被激活、引发极其罕见的血栓。”

The intervention from the US agencies is only a recommendation, although CVS and Walgreens, two of the country’s biggest pharmacy chains, immediately paused their use of the vaccine.

虽然美国卫生机构只是建议暂停接种，但美国两大连锁药店CVS和沃尔格林（Walgreens）都立即暂停了使用该疫苗。

US officials said they expect the pause to last “a matter of days”, with the CDC’s vaccine advisory committee due to meet on Wednesday to debate whether to continue recommending the vaccine for everyone.

美国官员表示，他们预计此次暂停将持续“数天”，CDC的疫苗咨询委员会将于周三开会，讨论是否继续向所有人推荐接种这款疫苗。

The European Medicines Agency said it was a continuing a probe announced last week with a view to deciding whether “regulatory action may be necessary”. It was “currently not clear” if there was a causal link between the vaccine and the blood clot symptoms, it said. However, J&J took pre-emptive action, announcing that it would halt its planned rollout of the jab in Europe, which was due to start on Wednesday.

欧洲药品管理局（EMA）表示，它正在继续进行上周宣布的一项调查，目的是决定“是否有必要采取监管行动”。该局表示，“目前尚不清楚”强生疫苗与血栓症状之间是否存在因果联系。然而，强生已经抢先行动，宣布将暂停原定于周三在欧洲推出其疫苗的计划。

“We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines,” J&J said in a statement. “At present, no clear causal relationship has been established between these rare events and the Janssen [J&J] Covid-19 vaccine,” it said, adding that it was working closely with experts and regulators to assess the data.

“我们获悉，在接种新冠疫苗后，已经出现血栓事件、包括血小板减少症患者的报告。”强生在一份声明中表示。“目前不确定这些罕见事件与强生新冠疫苗之间是否存在明确的因果关系。”该公司表示，并称正在与专家和监管机构密切合作，对数据进行评估。

The delay to the planned rollout in Europe is another setback for the EU, which had hoped J&J’s vaccine would enable member states to accelerate sluggish vaccination campaigns following months of squeezed supply and logistical problems.

强生推迟在欧洲推出疫苗是欧盟遭遇的另一大挫折。欧盟曾寄希望于强生疫苗能够让各成员国迟缓的疫苗接种工作加快脚步，持续数月的疫苗供应紧张和物流问题一直困扰着欧盟。

J&J was due to supply 55m of the 360m doses that the EU is expecting to receive in the second quarter. Since J&J is a single-shot vaccine – the other approved Covid-19 vaccines require two doses – 55m shots are enough to immunise just over a quarter of the 207m people the bloc hopes to vaccinate between April and June.

欧盟预计在第二季度接收3.6亿剂疫苗，其中5500万剂原定由强生提供。由于强生疫苗是一款单剂疫苗（其他获批的新冠疫苗均需接种两剂），5500万剂疫苗足以承包欧盟4月至6月接种目标——2.07亿人——的逾四分之一。

 

“This is quite a significant blow if the rollout of the J&J vaccine is delayed for several weeks,” said David Oxley, senior Europe economist at Capital Economics.

凯投宏观（Capital Economics）高级欧洲经济学家戴维·奥克斯利（David Oxley）表示：“如果强生疫苗推出的时间推迟数周，这将是一个相当巨大的打击。”

The call to suspend the rollout of the J&J vaccine because of blood clot fears follows similar issues with the AstraZeneca jab, which were investigated by the EMA. Last week, the EMA concluded that very rare cases of unusual blood clots should be listed as a side effect of the AstraZeneca vaccine.

在强生疫苗因可能引发血栓而被叫停接种之前，阿斯利康疫苗已遭遇了类似问题，EMA已对后者展开了调查。上周，EMA得出结论称，非常罕见的血栓病例应被列为阿斯利康疫苗的副作用之一。

Both jabs are adenovirus-based vaccines. The BioNTech/Pfizer and Moderna shots use messenger RNA technology. Moderna and BioNTech shares jumped 10.5 per cent and 6.1 per cent, respectively, on Tuesday as the vaccine makers benefited from news of the J&J pause.

这两款疫苗都是腺病毒载体疫苗。BioNTech/辉瑞（Pfizer）和莫德纳（Moderna）疫苗使用的都是信使核糖核酸（mRNA）技术。受益于强生疫苗暂停接种的消息，莫德纳和BioNTech的股价周二分别上涨10.5%和6.1%。

Norway’s health authorities estimated that their vaccination plans could be delayed by eight to 12 weeks if they could not use either the J&J or the Oxford/AstraZeneca vaccine.

挪威卫生部门估计，如果强生和牛津/阿斯利康疫苗都无法使用，该国的疫苗接种计划可能延误8至12周。

In the US, almost 7m doses of the J&J vaccine have already been administered. Federal vaccine distribution sites will stop using the jab, and individual states are likely to follow suit. New York health commissioner Howard Zucker said in a statement on Tuesday morning that the state would follow the federal recommendation and suspend using the jabs “immediately” while the vaccine was evaluated.

美国已经接种近700万剂强生疫苗。联邦疫苗分发点将停止使用该疫苗，各州很可能也将停用。纽约州卫生专员霍华德·朱克（Howard Zucker）在周二上午发表的一份声明中表示，在该疫苗接受调查期间，该州将听从联邦的建议，“立即”暂停使用该疫苗。

Anyone with an existing appointment for the J&J vaccine at the state’s mass vaccination states would be given the Pfizer shot instead, Zucker said.

朱克表示，所有已在该州的大规模接种计划中预约强生疫苗的人都将改为接种辉瑞疫苗。

Eric Kremer, an expert in adenoviruses at the Montpellier Molecular Genetics Institute, said that while the side effect was “extremely rare”, the J&J cases did not look “encouraging”.

蒙彼利埃分子遗传学研究所（IGMM）腺病毒专家埃里克·克雷默（Eric Kremer）表示，虽然这一副作用“极其罕见”，但强生相关病例看起来并不“乐观”。

Cody Meissner, chief of paediatric infectious diseases at Tufts Children’s Hospital and a member of the FDA’s immunisation advisory panel, said: “It’s not completely surprising that there appears to be some association with blood clots because the AstraZeneca vaccine also used an adenovirus.”

塔夫茨儿童医院（Tufts Children’s Hospital）小儿传染病负责人、FDA免疫顾问小组成员科迪·迈斯纳（Cody Meissner）表示：“该疫苗似乎与血栓有某种联系，这并不完全出人意料，因为阿斯利康的疫苗也使用了腺病毒（载体）。”

South Africa also suspended use of the J&J vaccine on Tuesday in response to the US pause. South Africa has used J&J doses to vaccinate nearly 300,000 health workers to date with no reports of clotting disorders linked to jabs in the country.

美国建议暂停接种强生疫苗后，南非周二也暂停了使用该疫苗。南非已经为近30万名医务工作者接种了强生疫苗，到目前为止未出现与该疫苗相关的血栓事件报告。

Zweli Mkhize, South Africa’s health minister, said that the suspension was “a precautionary halting” in order to understand the US decision, not a complete rejection of the J&J shot, which has become a major plank of the country’s rollout plan with over 30m doses on order.

南非卫生部长兹韦利·姆希泽（Zweli Mkhize）表示，此次暂停只是“预防性的”，是为了弄清楚美国的决定，而非完全拒绝强生疫苗。强生疫苗是南非疫苗接种计划的主力，该国已订购超过3000万剂强生疫苗。

“We hope the deliberations will only take a matter of days,” Mkhize added. “We expect it should not have a significant impact on the rollout.”

姆希泽补充说：“我们希望调查只需要几天时间。我们预计此举不会对该疫苗的推广接种产生重大影响。”

The CDC and FDA said the symptoms of cerebral venous sinus thrombosis and low blood platelet levels discovered in the six women – the same symptoms identified in recipients of the AstraZeneca vaccine – may require different treatment to typical blood clots and that anticoagulant drugs “may be dangerous”.

美国CDC和FDA表示，6名女性出现的颅内静脉窦血栓形成（CVST）和血小板减少症——与阿斯利康疫苗接种者中出现的症状相同——可能需要不同于针对常见血栓的治疗方式，使用抗凝药物“可能有风险”。

The White House insisted the pause would not prevent it hitting its target of overseeing 200m vaccinations in the Biden administration’s first 100 days.

白宫坚称，此次暂停并不会影响拜登（Biden）政府在执政头100天完成2亿剂疫苗接种的目标。

“This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 per cent of the recorded shots in arms in the United States to date,” Jeff Zients, the co-ordinator of the president’s Covid-19 task force, said in a statement.

总统新冠肺炎特别工作组协调员杰夫·齐恩茨（Jeff Zients）在一份声明中表示：“宣布暂停（使用强生疫苗）不会对我们的疫苗接种计划产生重大影响：强生疫苗在美国迄今录得的疫苗已接种剂数中只占不到5%。”

“Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300m Americans.”

“得益于总统今年早些时候采取的行动，美国已搞定足够为3亿美国人接种的辉瑞和莫德纳疫苗。”

Pfizer plans to ramp up production of its vaccine, chief executive Albert Bourla tweeted Tuesday. The company now expects to be able to supply the US 10 per cent more doses, for a total of 220m, by the end of next month, and the 300m agreed with Washington by mid-July, a fortnight earlier than planned.

辉瑞首席执行官艾伯乐（Albert Bourla）周二在Twitter上表示，该公司计划加大疫苗产量。该公司目前预计，到下月底将能够把供给美国的疫苗数量增加10%，达到2.2亿剂；到7月中旬完成与华盛顿约定的3亿剂疫苗供应，比原计划提前两周。

Additional reporting by Donato Paolo Mancini in Rome, Richard Milne in Oslo, Michael Peel in Brussels, Martin Arnold in Frankfurt and Joseph Cotterill in Johannesburg.

多纳托·保罗·曼奇尼（Donato Paolo Mancini）罗马、理查德·米尔恩（Richard Milne）奥斯陆、迈克尔·皮尔（Michael Peel）布鲁塞尔、马丁·阿诺德（Martin Arnold）法兰克福、约瑟夫·科特里尔（Joseph Cotterill）约翰内斯堡补充报道。

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