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UPDATE 3-J&J COVID-19 vaccine under EU review over blood clots

UPDATE 3-J&J COVID-19 vaccine under EU review over blood clots

更新3-强生新冠肺炎疫苗正在接受欧盟对血栓的审查
路透社 ·  2021/04/10 01:25

* EMA says no causal link yet of blood clots to either vaccine
   * Four cases of blood clots in recipients of J&J shots
   * J&J says working with regulators to assess data on its vaccine
   * Probe of AstraZeneca vaccine and blood clots already ongoing

(Recasts, adds details, expert comment)
By Pushkala Aripaka and Julie Steenhuysen
April 9 (Reuters) - Europe's drug regulator said on Friday
that it is reviewing rare blood clots in four people in the
United States who received Johnson & Johnson's COVID-19
vaccine.
The European Medicines Agency's safety committee has also
been looking at how AstraZeneca's COVID-19 vaccine is
associated with very rare cases of unusual blood clots and said
it was now reviewing reports of capillary leak syndrome in
people given AstraZeneca's vaccine.
Johnson & Johnson (J&J) said it was aware of the rare
reports of blood clots in individuals given its COVID-19
vaccine, and was working with regulators to assess the data and
provide relevant information.
"At present, no clear causal relationship has been
established between these rare events and the Janssen COVID-19
vaccine," the company said in an emailed statement.
Of the four serious cases of clotting and low platelets,
three occurred in the United States during the rollout of J&J's
vaccine from its Janssen unit, the European Medicines Agency
(EMA) said. That was in addition to one person who died from a
clotting disorder reported in J&J's clinical trial.
Nearly 5 million people in the United States had received
J&J's vaccine as of Thursday morning, according to the U.S.
Centers for Disease Control and Prevention.
The report from the European Medicines Agency is the first
to mention a probe of blood clots associated with the J&J
vaccine.
The U.S. Food and Drug Administration said it would respond
shortly to a request for comment.
It follows a probe of blood clots in the brain reported in
people given the AstraZeneca vaccine that have caused some
European countries to change their vaccine recommendations.
In its report on Friday, EMA's safety committee said unusual
blood clots linked with low blood platelets should be listed as
very rare side effects of the AstraZeneca vaccine.
It has also started to investigate reports of capillary leak
syndrome - which causes blood vessel swelling and a drop in
blood pressure - in five people who received the AstraZeneca
vaccine. The safety panel said it was not clear whether these
were linked with the vaccine. AstraZeneca did not immediately
respond to a request for comment.
Ian Douglas, a professor of pharmacoepidemiology at London
School of Hygiene & Tropical Medicine, said the reports were
part of a normal process in which the EMA's safety committee
reviews important safety signals as they arise.
"It’s too early to comment on the signal of capillary leak
with the AZ vaccine, or clots with the Janssen vaccine, but from
what we’ve seen in the last few weeks, the EMA’s PRAC
(Pharmacovigilance Risk Assessment Committee) will doubtless
assess all the evidence they have as thoroughly and quickly as
possible," he said.
Some countries in Europe and Asia have restricted the use of
AstraZeneca's vaccine, Vaxzevria, in younger people following an
update by EU and UK regulators this week that found a link
between the events and the shot. Regulators have said the
benefits of the vaccine outweigh the risks.
Dr. Jesse Goodman, an infectious disease expert at
Georgetown University in Washington D.C. and a former chief
scientist for the U.S. Food and Drug Administration, said in a
briefing on Thursday that he was "fairly convinced" the brain
blood clots were linked with the AstraZeneca vaccine, but said
the events are rare and the risk during an active outbreak from
COVID "is much higher."
J&J's single-dose vaccine has been approved for EU use, but
a rollout is yet to begin. It is mainly being used in the United
States currently.
The J&J and AstraZeneca shots are two of the four approved
COVID-19 vaccinations in Europe.


/><^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
COVID-19 Global Cases Tracker
COVID-19 Global Vaccinations Tracker
FACTBOX-Some countries limit AstraZeneca vaccine use after
possible link to blood clots
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(Reporting by Pushkala Aripaka, Manas Mishra in Bengaluru, Kate
Kelland in London, Julie Steenhuysen in Chicago, Deena Beasley
in Los Angeles; Editing by Shinjini Ganguli, Hugh Lawson and
Susan Fenton)
((Pushkala.A@thomsonreuters.com; Twitter: @pullthekart; Mobile:
+91 852 751 3793 ;)

*EMA表示,目前还没有血液凝块与这两种疫苗的因果联系*接受强生针剂注射的人有四例血液凝块*强生表示与监管机构合作评估其疫苗的数据*对阿斯利康疫苗和血栓的调查已经在进行中(重铸,添加细节,专家评论)作者:Pushkala Aripaka和Julie Steenhuysen路透4月9日电-欧洲药品监管机构周五表示他们正在检查四个人罕见的血液凝块。收到强生新冠肺炎的美国人疫苗。欧洲药品管理局(European Medicines Agency)的安全委员会也我一直在关注阿斯利康的新冠肺炎疫苗与罕见的不寻常血液凝块有关,他说它现在正在审查关于#年毛细血管渗漏综合征的报告。人们接种了阿斯利康的疫苗。强生(J&J)表示,它意识到了这种罕见的关于服用新冠肺炎的个体出现血栓的报道疫苗,并正在与监管机构合作评估数据和提供相关信息。“目前还没有明确的因果关系。建立在这些罕见事件和扬森新冠肺炎之间疫苗。“该公司在一份电子邮件声明中说。在四例严重的凝血和血小板减少的病例中,其中三起发生在强生推出期间的美国来自其Janssen部门-欧洲药品管理局(European Medicines Agency)的疫苗(EMA)称。此外,还有一人死于强生的临床试验报告了凝血障碍。美国有近500万人收到了根据美国食品和药物管理局的数据,强生的疫苗截至周四上午。疾病控制和预防中心。来自欧洲药品管理局的这份报告是第一份提到一项与强生有关的血液凝块的调查疫苗。美国食品和药物管理局(FDA)表示,将对此做出回应很快回复了记者的置评请求。在此之前,据报道,一项关于大脑中血液凝块的探针注射阿斯利康疫苗的人已经引起了一些欧洲国家改变他们的疫苗建议。在周五的报告中,EMA的安全委员会表示,不同寻常的是与低血血小板有关的血液凝块应列为阿斯利康疫苗非常罕见的副作用。它还开始调查有关毛细管泄漏的报道。综合征-会导致血管肿胀和血流量下降血压-在5名接受阿斯利康治疗的人中疫苗。安全小组表示,目前还不清楚这些与疫苗有关。阿斯利康没有立即做出回应。回复置评请求。伊恩·道格拉斯(Ian Douglas),伦敦大学药物流行病学教授卫生与热带医学院表示,这些报告是作为EMA安全委员会正常程序的一部分在重要的安全信号出现时对其进行检查。“现在评论毛细管泄漏的信号还为时过早。使用AZ疫苗,或使用Janssen疫苗凝块,但来自我们在过去几周所看到的,EMA的PRAC(药物警戒风险评估委员会)无疑会对他们掌握的所有证据进行全面、快速的评估有可能。“他说。欧洲和亚洲的一些国家已经限制使用阿斯利康(AstraZeneca)的Vaxzevria疫苗在年轻人中应用欧盟和英国监管机构本周发布的最新数据发现了两者之间的联系在事件和枪击之间。监管机构表示,疫苗的益处大于风险。杰西·古德曼(Jesse Goodman)博士是一名传染病专家华盛顿特区的乔治敦大学和一位前校长美国食品和药物管理局的科学家在一份报告中说周四的简报说他“相当确信”大脑血液凝块与阿斯利康疫苗有关,但表示这些事件很少见,在活跃的疫情爆发期间的风险来自“COVID”要高得多。强生的单剂疫苗已获准在欧盟使用,但新产品的推出还没有开始。它主要在美国使用。目前在美国。强生和阿斯利康是获得批准的四种疫苗中的两种欧洲的新冠肺炎疫苗接种。/>新冠肺炎全球案例追踪新冠肺炎全球疫苗接种跟踪者FACTBOX-一些国家在以下情况下限制阿斯利康疫苗的使用可能与血栓有关 ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>(Pushkala Aripaka,Manas Mishra在孟加拉国报道,Kate凯兰(Kelland)伦敦,朱莉·斯蒂芬森(Julie Steenhuysen)芝加哥,蒂娜·比斯利在洛杉矶;编辑:Shinsini Ganguli,Hugh Lawson和苏珊·芬顿(Susan Fenton)(Pushkala.A@thomsonreurs.com;Twitter:@Pullthekart;手机:+91 852 751 3793 ;)

译文内容由第三方软件翻译。


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