By Neha Arora, Krishna N. Das and Euan Rocha

作者:尼哈·阿罗拉，克里希纳·n·达斯，尤安·罗查

NEW DELHI, Feb 15 (Reuters) - Britain's drug regulator is auditing manufacturing processes at Serum Institute of India (SII) which could pave the way for AstraZeneca's AZN.L COVID-19 vaccine to be shipped from there to the UK and other countries, according to two sources close to the matter.

路透新德里2月15日电- - -英国药品监管机构正在审核印度血清研究所(SII)的生产过程，这可能为阿斯利康(AstraZeneca)的AZN铺平道路。据两名知情人士透露，COVID-19疫苗将从中国运往英国和其他国家。

SII, the world's largest vaccine manufacturer, is currently mass producing the AstraZeneca vaccine, developed in conjunction with Oxford University, for dozens of poor and middle-income countries but not the UK, which has been getting its supply of the shot primarily from domestic facilities.

SII是世界上最大的疫苗制造商，目前正在大规模生产阿斯利康疫苗，该疫苗是与牛津大学(Oxford University)合作开发的，面向数十个贫穷和中等收入国家，但不包括英国。英国一直主要从国内设施获得疫苗供应。

If the UK's Medicines and Healthcare products Regulatory Agency (MHRA) gives SII's manufacturing process for the Oxford/AstraZeneca shot a greenlight it would allow the drug to be exported to the UK and to other countries which recognise MHRA's clearances, one of the sources said.

一位消息人士说，如果英国药品和保健产品监管局(MHRA)给SII的牛津/阿斯利康制药生产工艺开了绿灯，那么该药物将被出口到英国和其他认可MHRA许可的国家。

Reuters could not determine what was the rationale for the audit. SII did not respond to a request for comment on it. The MHRA confirmed that an inspection was happening but declined further comment.

路透社无法确定此次审计的理由是什么。SII没有回应记者的置评请求。MHRA证实正在进行检查，但拒绝进一步置评。

"Due to commercial confidentiality we do not comment on inspections that are still ongoing," the regulator's chief executive Dr June Raine said in a statement to Reuters.

“出于商业机密考虑，我们对仍在进行的检查不予置评，”该监管机构首席执行官琼•雷恩博士(Dr June Raine)在发给路透社的一份声明中表示。

The two sources, who asked not to be named as the matter is private, said the audit should be relatively routine for SII, as its site already supplies other vaccines to the UK.

这两位不愿透露姓名的消息人士表示，对于SII来说，审核应该是相对常规的，因为该公司的网站已经向英国供应了其他疫苗。

The inspection comes as countries around the world scramble to secure vaccine supplies amid supply disruptions and delivery cuts from leading drugmakers such as Pfizer Inc PFE.N, Moderna MRNA.O and AstraZeneca.

由于辉瑞等主要制药公司的供应中断和供货中断，世界各国都在争相确保疫苗供应。N,现代化MRNA。O和阿斯利康。

It was not immediately clear whether an MHRA approval would allow the UK or AstraZeneca to route SII volumes of COVISHIELD - the brand name under which SII markets the AstraZeneca shot - to the EU, which has been pressuring the UK for supply from AstraZeneca's facilities in the UK, amid shortages in Europe.

尚不清楚是否MHRA批准允许英国或阿斯利康路线他们卷COVISHIELD——他们的品牌市场的阿斯利康挨枪子儿——欧盟,已经迫使英国供应从阿斯利康的设施在英国,在欧洲的短缺。

The EU's drug regulator, the European Medicines Agency (EMA), audits sites from which it plans to source medicines but during the global pandemic, with multiple COVID-19 vaccines being developed, it is also partly leaning on inspections carried out by some other international regulators.

欧盟药品监管机构欧洲药品管理局(EMA)对计划采购药品的地点进行审计，但在全球大流行期间，随着多种COVID-19疫苗的开发，EMA也在一定程度上依赖于其他一些国际监管机构的检查。

"Inspection outcomes for Covid-19 vaccines conducted by the MHRA will be considered by EMA," said the regulator. Any such approved sites would also need an EMA sign off before they can export to the EU, the regulator told Reuters.

该监管机构表示:“EMA将考虑MHRA对Covid-19疫苗的检查结果。”监管机构告诉路透社，任何获得批准的场所在出口到欧盟之前都需要EMA的批准。

MHRA declined to comment on specifics, but Raine said it was collaborating "with international partners in response to the global pandemic and on matters of mutual interest."

MHRA拒绝就细节置评，但Raine表示，该机构正"与国际合作伙伴合作，应对全球疫情，并就共同关心的问题作出反应"。

AstraZeneca, which has previously tapped SII to help fulfill some of its vaccine orders from Brazil, South Africa and Saudi Arabia, did not respond to a request for comment on whether it needs SII to help meet commitments in the UK, or in any other nations that would recognise an MHRA certification.

阿斯利康,曾利用他们来帮助完成一些疫苗的订单来自巴西、南非、沙特阿拉伯、没有回应置评请求是否需要他们帮助满足承诺在英国,或任何其他国家会承认一个MHRA认证。

The second source, along with a government official in New Delhi, said the UK has expressed an interest in purchasing vaccines from SII. The two sources said the volumes or timelines for any such purchases were unclear.

另一位消息人士和新德里的一位政府官员说，英国已经表示有兴趣从SII购买疫苗。这两位消息人士表示，此类购买的数量或时间表尚不清楚。

A UK government spokeswoman said: "Any discussions that have taken place between the UK Government and India on vaccines are not related to securing extra vaccine supply to the UK."

一位英国政府发言人说:“英国政府和印度之间就疫苗进行的任何讨论都与确保英国获得额外的疫苗供应无关。”

The UK has so far ordered 100 million doses of AstraZeneca's vaccine.

到目前为止，英国已经订购了1亿剂阿斯利康的疫苗。

"Most countries have approached us and India's government," SII told Reuters, but it did not comment on any UK outreach. "We are trying our best to meet demand, and supply the vaccine to as many countries as possible, keeping India as the priority."

“大多数国家已经接触了美国和印度政府，”SII告诉路透社，但它没有对英国的接触置评。“我们正尽最大努力满足需求，并向尽可能多的国家供应疫苗，印度仍是重中之重。”

SII's chief executive, Adar Poonawalla, told Reuters in late January, his family-owned firm was keen to support AstraZeneca's supply needs but its primary focus was on India and other poorer nations in Asia and Africa. He said at the time SII had no plans to divert supplies to Europe.

SII首席执行官Adar Poonawalla在1月底对路透表示，他的家族企业渴望支持阿斯利康的供应需求，但其主要关注的是印度和其他较贫穷的亚洲和非洲国家。他当时表示，SII没有将供应转移到欧洲的计划。

(Neha Arora and Krishna N.Das reported from New Delhi and Euan Rocha reported from Mumbai; Additional reporting by Paul Sandle, Kate Kelland and Alistair Smout in London, Francesco Guarascio in Brussels and Ludwig Burger in Frankfurt; Editing by Carmel Crimmins)

(Neha Arora和Krishna N.Das在新德里报道，Euan Rocha在孟买报道;保罗•桑德勒(Paul Sandle)、凯特•凯兰(Kate Kelland)和阿利斯泰尔•斯莫特(Alistair Smout)伦敦、弗朗西斯科•瓜拉西奥(Francesco Guarascio)布鲁塞尔、路德维希•伯格(Ludwig Burger)法兰克福补充报道;编辑:Carmel Crimmins)

((euan.rocha@tr.com; +91 22 6180 7257; Reuters Messaging: euan.rocha.reuters.com@reuters.net))

((euan.rocha@tr.com);+91 22 6180 7257;路透社消息:euan.rocha.reuters.com@reuters.net))