J&J obliged to send vaccine to US for fill and finish to EU’s ire
The process is part of the original contract but the EU sees it hampering its already slow Covid-19 vaccine rollout
London/New York — Johnson & Johnson (J&J) will ship some Covid-19 vaccines ordered by the EU to the US for the last stage of production, raising concern among some member states that the bloc’s inoculation programme could be hampered by further delays, according to a diplomatic note.
EU ambassadors were told at a briefing last Wednesday that J&J will send a portion of its vaccine produced in Europe to the US for what’s known as fill and finish. In that stage, the shot is put into vials, packaged and shipped for distribution.
After diplomats asked whether the process could be carried out in Europe, a senior EU official told the ambassadors that doing some fill and finish in the US was a condition of the contract with the drugmaker, suggesting it could not be renegotiated, according to the note. The official explained that J&J had been transparent about the matter and that the company is intent on delivering on schedule, the note said.
The discussion comes at a tense moment for the EU after the bloc, in the face of a shortfall of shots, moved to require drugmakers to obtain prior authorisation for vaccine exports. J&J’s exports would, in principle, be subject to that process, the European Commission, the EU’s executive arm, said in an e-mailed reply to questions. The commission also said that it couldn’t indicate what proportion of the J&J batches would be finished in the US due to confidentiality.
J&J said its manufacturing timeline will enable the company to meet its full-year 2021 supply commitments. The drugmaker is establishing a supply network involving multiple manufacturing sites in different facilities, sometimes in different countries, to be prepared to distribute the vaccine globally if it proves safe and effective.
The move to control exports drew criticism from drugmakers as many Covid-19 vaccines rely on a global supply chain. J&J, for example, is making the vaccine in the Netherlands, and has clinched deals with contract manufacturers at seven sites, spanning the US, SA, India, and two other EU locations in Italy and Spain.
These facilities each serve different roles, so the drug substance must often be transported to a different country for fill and finish, according to the company. The process, including quality testing and release, can take three months.
The EU has secured 200-million doses of J&J’s single-shot vaccine, with an option for a further 200-million.
Results from late-stage trials published last week found that it prevented 66% of moderate to severe cases of Covid-19. The trials showed the shot was particularly effective at stopping serious disease, with 100% of hospitalisation and deaths prevented.
J&J is planning to file for emergency authorisation in the US this week and is expected to seek clearance from the European regulator this month.
During Wednesday’s meeting, Denmark’s ambassador asked the senior EU official whether the J&J shot could be distributed early, ahead of a regulatory green light, according to the note. The EU has so far resisted similar requests with the other vaccines it has secured.
The European Medicines Agency (EMA) has cleared three vaccines — produced by Pfizer and German partner BioNTech, Moderna, and AstraZeneca with its partner, the University of Oxford. All three have faced delays, with Astra’s expected delivery shortfalls having the biggest impact for the EU’s sluggish vaccine rollout.
The spat with AstraZeneca was a key driver in the EU’s decision to hastily introduce the export authorisation mechanism last week.
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