Johnson & Johnson will send some Covid-19 vaccines ordered by the European Union to the United States for the final stage of production, and worried some member states that the block’s inoculation program may be hampered by further delays, according to a diplomatic note seen by Bloomberg.
EU ambassadors were informed last Wednesday in a briefing that the pharmaceutical company will send a portion of the vaccine produced in Europe to the US for what is known as filling and finishing. At this stage, the shot is put into vials, packaged and sent for distribution.
After diplomats asked if the process could be carried out in Europe, a senior EU official told ambassadors that doing some filling and ending up in the United States was a condition of the contract with the pharmacist, suggesting that no it could be renegotiated, according to the note. . The official explained that J&J had been transparent on the matter and that the company intended to deliver on time, the note said.
Vaccine production sites in Europe
The discussion comes at a tense time for the EU after the bloc, faced with the firing deficit, moved to force drug manufacturers to obtain prior authorization for the export of vaccines. It is unclear how this may affect J&J’s production process and whether the company will need authorization to ship its pharmacological substance to the U.S. to fill and finish it before the vaccines return to Europe for distribution.
J&J said its manufacturing timeline will allow the company to meet its supply commitments throughout the year 2021. The drugmaker establishes a supply network that includes multiple manufacturing centers at different facilities, sometimes in different countries, before the vaccine, if it is safe and effective, can be distributed worldwide, according to a statement sent by email.
The European Commission, the EU’s executive arm, did not immediately respond to requests for comment.
The move to control exports attracted criticism from drug manufacturers, as many Covid-19 vaccines depend on a global supply chain. J&J, for example, manufactures the vaccine in the Netherlands and has established agreements with contract manufacturers in seven locations, covering the United States, South Africa, India and two other EU locations in Italy and Spain.
These facilities have different functions, so the drug substance often has to be transported to a different country to fill and finish, according to the company. The process, including quality testing and publication, can take three months.
200 million doses
The EU has assured it 200 million single vaccine doses from J&J, with an option for an additional 200 million.
Final phase test results published last week found that it prevented 66% of moderate to severe cases of Covid-19. Trials showed that the shot was particularly effective at stopping serious illness, with 100% of hospitalizations and deaths prevented. The drug maker plans to file an emergency permit application in the U.S. this week and is expected to do so. apply for permission from the European regulator this month.
During Wednesday’s meeting, the Danish ambassador asked the senior EU official if the J&J shot could be distributed soon, before a regulatory green light, according to the note. The EU has so far resisted similar requests with the other vaccines it has obtained.
The European Medicines Agency has eliminated three vaccines produced by Pfizer Inc. and German partner BionNTech SE, Moderna Inc., i AstraZeneca Plc with its partner, Oxford University. All three have faced delays, with those from Astra delivery deficits are expected to have the greatest impact on the slow deployment of EU vaccines.
The dispute with Astra was a key factor in the EU’s decision to do so quickly introduce the export authorization mechanism last week.
– With the help of Jonathan Stearns and Riley Griffin
(Updates with company comments in the fifth paragraph.)