Johnson & Johnson Delays Vaccine Rollout in Europe After US Health Agencies Call for Pause
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.
強生公司（Johnson & Johnson）表示，將推遲在歐洲推出其新型冠狀病毒肺炎（COVID-19，即2019冠狀病毒?。┮呙绲挠媱?。此前，美國衛生機構已建議暫停給美國人接種這款疫苗，同時正在對多起罕見的血栓事件進行調查。
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.
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.
“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.”
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.
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.
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.
“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.
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.
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.
“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.
凱投宏觀（Capital Economics）高級歐洲經濟學家戴維·奧克斯利（David Oxley）表示：“如果強生疫苗推出的時間推遲數周，這將是一個相當巨大的打擊?！?
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.
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.
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.
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.
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.
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”.
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.”
塔夫茨兒童醫院（Tufts Children’s Hospital）小兒傳染病負責人、FDA免疫顧問小組成員科迪·邁斯納（Cody Meissner）表示：“該疫苗似乎與血栓有某種聯系，這并不完全出人意料，因為阿斯利康的疫苗也使用了腺病毒（載體）。”
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.
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.
“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.”
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”.
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.
“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.
“Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300m Americans.”
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.
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.
多納托·保羅·曼奇尼（Donato Paolo Mancini）羅馬、理查德·米爾恩（Richard Milne）奧斯陸、邁克爾·皮爾（Michael Peel）布魯塞爾、馬丁·阿諾德（Martin Arnold）法蘭克福、約瑟夫·科特里爾（Joseph Cotterill）約翰內斯堡補充報道。