After diplomats asked if the trial could be carried out in Europe, a senior EU official told ambassadors that filling and finishing the vaccine in the US was a condition of the contract with the drug manufacturer and could not be renegotiated. The official explained that J&J had been transparent about the matter and that the company intended to deliver on time, the note said.
The discussion comes at a pivotal moment for the EU after the bloc, due to vaccine shortages, required drug manufacturers to obtain prior approval to export vaccines. The pharmaceutical company promises to meet its full-year 2021 delivery commitments.
The vaccine developed by Janssen is probably the fourth to be authorized in the EU. The European regulator, the European Medicines Agency, has been watching the studies into that drug for some time now. That is the last step before the company applies for a permit. Janssen released the results of those trials last Friday: the vaccine protects for 66 percent, has no serious side effects and prevents hospitalizations and deaths.
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