Johnson & Johnson will send some Covid-19 vaccines ordered by the European Union for the final stage of production in the US, which raises concerns among some member states that vaccination of the block could be hampered by further delays, according to a diplomatic note Bloomberg.
EU ambassadors were told during an information session last Wednesday that the pharmaceutical company would send a portion of the vaccine produced in Europe to the US for the so-called filling and finishing. At that point, the shot is placed in vials, packaged and sent for distribution.
After diplomats asked if the process could be carried out in Europe, a senior EU official told the ambassadors that it was a condition of the contract with the drug manufacturer in the US, indicating that it could not be renegotiated . . The official explained that J&J was transparent about the matter and that the company intended to deliver on schedule, the note reads.
Vaccine production workshops in Europe
The discussion comes at a tense moment for the EU after the bloc, in light of a shortage of shots, moved to require drugmakers to obtain prior authorization for the export of vaccines. It is unclear how this could affect J & J’s production process and whether the company will need authorization to ship its medicine to the US for filling and finishing before the vaccines return to Europe for distribution.
J&J said the manufacturing timeline will enable the company to fulfill its full annual commitments in 2021. The drugmaker is establishing a supply network involving several manufacturing sites in different facilities, sometimes in different countries, before the vaccine – if it proves safe and effective – can be distributed worldwide, according to an email.
The European Commission, the EU’s executive, did not immediately respond to requests for comment.
The move to control exports has drawn 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 concluded contract manufacturers at seven locations, spanning the US, South Africa, India and two other EU branches in Italy and Spain.
The facilities each fulfill different roles, so according to the company, the medicines often have to be transported to another country for filling and finishing. The process, including quality testing and release, can take up to three months.
200 million doses
The EU has ensured 200 million doses of J & J’s single-vaccine vaccine, with an option for another 200 million.
Results of late stage trials published last week found that it occurs in 66% of moderate to severe cases of Covid-19. The trials showed that the shot was particularly effective in stopping serious illnesses, with 100% of hospitalizations and deaths. The drugmaker plans to file an emergency permit in the US this week and is expected to do so seeks approval from the European regulator this month.
At Wednesday’s meeting, Denmark’s ambassador asked senior EU officials whether the J&J shot could be distributed earlier, before the 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 has cleared three vaccines – manufactured by Pfizer Inc. and German partner BionNTech SE, Moderna Inc., a AstraZeneca Plc with its partner, Oxford University. All three experienced delays, with Astra’s expected delivery shortages have the biggest impact on the slow explosion of the vaccine in the EU.
The splash with Astra was a major driver in the EU’s decision to introduced the export authorization mechanism in a hurry last week.
– With the help of Jonathan Stearns and Riley Griffin
(Updates with the company’s comment in fifth paragraph.)