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 US site.
The Italian site, located in Anagni and operated by US-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 US 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 US 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”.
Catalent and J&J in March expanded their partnership to start production in Anagni by the end of this year, and help support production of the vaccine through late 2022 by reserving an additional vial-filling line at the site.