This December 2, 2020 photo courtesy of Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States. Johnson & Johnson’s single-dose vaccine protects against COVID-19, according to an analysis by U.S. regulators on Wednesday, February 24, 2021, paving the way for a final decision on a new and easier-to-use shot to tame the pandemic. The Food and Drug Administration scientists confirmed that it was about 66% overall effective, and also said that J&J’s vaccination, which could speed up vaccinations by requiring only one dose instead of two, is safe to use. (Johnson & Johnson via AP)
The European Medicines Agency announced on Friday that it has approved production of Johnson & Johnson’s single-dose COVID-19 vaccine at an additional location in Italy to expedite delivery of the shot in the European Union.
The approval came after the EU announced that J&J was expected to miss its EU delivery target for the second quarter after millions of cans were banned for use in Europe due to safety concerns following a contamination incident at a US facility.
The Italian site, which is located in Anagni and operated by US-based Catalent, will help fill and pack the vaccine developed by J&J, the European Medicines Agency (EMA) announced.
EU governments have asked Johnson &J Johnson to use the Italian facility for bottling J&J vaccines manufactured in Europe since January at the latest, as internal EU documents show.
The application for approval of the Italian plant was only made last week, on June 18, the EMA told Reuters.
As part of the EU delivery contract, J&J had undertaken to carry out a so-called Fill & finish at least for the first months of the rollout at its locations in the USA, even if this meant a double transatlantic transfer for recordings produced in Europe.
Johnson & Johnson has a vaccine factory in Leiden, The Netherlands, operated by his Janssen unit.
A European Commission spokesman said the EU executive welcomed the approval of the Italian factory as it could help speed up production and vaccinations. At the time of the application, however, she did not want to comment.
J&J is committed to delivering 200 million doses to the block this year, 55 million of which were expected by the end of June, but has so far delivered fewer than 15 million vaccines to the block.
The US company is also expected to deliver only 7 million cans to the EU in July, as a document by the EU Commission with the EU heads of state and government showed on Thursday.
It is not clear how many cans the J&J factory in Leiden produces. The company has repeatedly refused to ask whether there could be production problems there.
The EMA said on Friday that its recommendation to allow production at the Italian site does not require formal approval from the European Commission and the facility can be put into operation immediately.
Catalent said it was « ready to ship large commercial volumes from the site as soon as possible ».
Catalent and J&J in March https://www.catalent.com/catalent-news/catalent-expands-partnership-with-johnson-johnson-to-significantly-increase-capacity-for-sterile-manufacturing-and-packaging-of -covid-19-vaccine-in-italy has expanded its partnership to start production in Anagni by the end of this year and support production of the vaccine until the end of 2022 by reserving an additional vial filling line on site.
(Reporting by Pushkala Aripaka in Bengaluru, Francesco Guarascio in Brussels and Michael Erman in New Jersey; editing by Anil D’Silva, Elaine Hardcastle and Louise Heavens)
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