歐盟批准強生(J&J)在意大利的 COVID-19 疫苗生產線, 以增加供應

Recently Yahoo News on-line reported the following:

EU approves production line for J&J's COVID-19 vaccine in Italy to boost supply

Fri., June 25, 2021, 7:02 a.m.

June 25 (Reuters) - Europe's medicines regulator said on Friday it had approved the production of Johnson & Johnson's single-dose COVID-19 vaccine at an additional site in Italy, as it looks to speed up the supply of the shot in the European Union.

The approval came after the EU said J&J was expected to miss its EU supply target for the second quarter after millions of doses were banned for use in Europe over safety concerns following a contamination incident at a U.S. site.

The Italian site, located in Anagni and operated by U.S.-based Catalent, will help with vial filling and packaging of the vaccine developed by J&J, the European Medicines Agency (EMA) said.

EU governments have been asking Johnson & Johnson at least since January to use the Italian plant for bottling J&J vaccines produced in Europe, EU internal documents show.

But under the EU's supply contract J&J had agreed to carry out so-called fill & finish at its sites in the United States at least for the first months of its rollout, even if that meant a double transatlantic transfer for shots produced in Europe.

Johnson & Johnson has a vaccine factory in Leiden, in the Netherlands, operated by its unit Janssen.

A spokesman for the European Commission said the EU executive welcomed the approval of the Italian factory as it could help speed up production and vaccinations.

J&J has committed to delivering 200 million doses to the bloc this year, of which 55 million were expected by the end of June, but has so far shipped less than 15 million vaccines to the bloc.

The U.S. company is also forecast to deliver only 7 million doses in July to the EU, an EU Commission's document shared on Thursday with EU leaders showed.

It is not clear how many doses the J&J factory in Leiden is producing. The company has repeatedly declined to answer questions about whether there may be production problems there.

The EMA said on Friday its recommendation to allow production at the Italian site did not need formal approval from the European Commission and the facility can become operational immediately.

Catalent said it was "prepared to deliver large scale commercial volumes from the site as soon as is practicable".

 (Reporting by Pushkala Aripaka in Bengaluru, Francesco Guarascio in Brussels and Michael Erman in New Jersey; Editing by Anil D'Silva and Elaine Hardcastle)

Translation

路透 6 月 25 日 - 歐洲藥品監管機構週五表示，已批准在意大利的另一個地點去生產強生(J&J)公司的單劑量 COVID-19 疫苗，以期加快該疫苗在歐盟的供應 。

該批准是在歐盟表示強生預計將無法實現其第二季度歐盟供應目標之後獲得的批准。此前在美國一家工廠發生污染事件後，出於安全考慮禁止數百萬劑藥物在歐洲使用。

歐洲藥品管理局 (EMA) 表示，意大利工廠位於Anagni，由美國Catalent 運營，將幫助強生  開發的疫苗進行小瓶灌裝和包裝。

歐盟內部文件顯示，至少自 1 月以來，歐盟各國政府一直要求強生公司使用這家意大利工廠來裝瓶在歐洲生產的強生疫苗。

但根據歐盟的供應合同，強生已同意至少在其推出的頭幾個月, 會在其美國工廠進行所謂的入樽和完成工序，即使這意味著歐洲生產的需要雙重跨大西洋的運送。

強生在荷蘭Leiden擁有一家疫苗工廠，由其子公司Janssen運營。

歐盟委員會發言人表示，歐盟執行官對意大利工廠的批准表示歡迎，因為這有助於加快生產和疫苗接種。

強生已承諾今年向歐盟提供 2 億劑疫苗，其中預計到 6 月底將達到 5500 萬劑。但迄今為止向歐盟運出的疫苗不到 1500 萬劑。

歐盟委員會周四與歐盟領導人共享的一份文件顯示，預計這家美國公司 7 月僅向歐盟提供 700 萬劑疫苗。

目前尚不清楚Leiden的強生工廠生產多少劑。該公司一再拒絕回答有關那裡是否可能存在生產困難的問題。

EMA 週五表示，其允許在意大利工廠生產的建議是不需要歐盟委員會的正式批准，該設施可以立即投入運營。

Catalent表示，它 “準備在可行的情況下盡快從該站點交付大規模的商業数量” 。

              So, J&J will start the production of Covid-19 vaccines in Italy soon.