The European Union’s drug regulator announced Friday it will stop administering doses of the Johnson & Johnson coronavirus vaccine that were made at a Baltimore plant at around the time when manufacturing issues were uncovered there.
The European Medicines Agency (EMA) said that the vaccines it has received from the plant were not affected by the contamination, which saw the Johnson & Johnson vaccines accidentally made with an ingredient for the AstraZeneca vaccine, which was also being manufactured there. Still, the shots it received from the site will not be used out of an abundance of caution.
“Based on available information, batches of the vaccine released in the EU are not affected by the cross contamination. However, as a precaution and to safeguard the quality of vaccines, the supervisory authorities have recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred,” the EMA said in a statement.
“Authorities in the EU are doing everything possible to safeguard supplies and mitigate the effects of any delay in the delivery of this vaccine.”
It was not immediately clear how many doses would be impacted by the move.
Emergent BioSolutions, which runs the Baltimore plant, did not immediately respond to a request for comment from The Hill.
The EMA announcement marks the latest blow to Emergent, which has suffered a wave of negative publicity once the contamination concerns were revealed earlier this year, leading to the plant’s shutdown in April.
The U.S. Food and Drug Administration (FDA) is ordering Johnson & Johnson to throw out 60 million doses of its single-shot COVID-19 vaccine produced, while allowing another 10 million to be distributed with a warning that the FDA cannot guarantee they were produced using good manufacturing practices.
Federal officials “determined several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed,” the agency said.
Post source: Thehill
No related posts.