A U.S. pharmaceutical factory producing raw materials for Janssen vaccine has been closed. According to the US FDA regulatory agency, the hygiene level of the Baltimore plant is far below the standard level, which means that the vaccine may have been contaminated.
For example, the floors and walls of the Emergent BioSciences factory are dirty, paint is peeling off, and employees do not observe strict hygiene regulations. According to the FDA, the images show workers taking drug waste without proper packaging, which may cause the new vaccine to come into contact with the drug waste.
Employees also walked from where the Janssen vaccine is being used to another department that produces the AstraZeneca vaccine. According to FDA regulations, it is not clear whether the staff will take a bath and change clothes in the meantime in accordance with the guidelines.
At the end of March, the plant was also affected by negative news because the ingredients of AstraZeneca and Janssen were accidentally mixed together.according to New York Times This makes 15 million doses unusable. This error prompted an investigation by the FDA.
According to the FDA, the plant’s Janssen vaccine has not yet been used. The nearly 8 million injections that Janssen sent to the United States came from European factories. The Baltimore vaccine is currently in storage.
Due to rare side effects, the United States has temporarily stopped vaccinating Janssen.In the Netherlands Today’s first injection After taking this vaccine, the US Drug Administration EMA ruled that side effects are so rare that the benefits outweigh the risks.
It is not clear how long the US factory will be closed, but experts worry that this may take several months. Both the Janssen factory and the parent company expressed their desire to resolve the problem as soon as possible.
Consequences for the Netherlands
It is not clear whether the closed factory will affect Dutch deliveries.The spokesperson for the outgoing minister De Jonge said Against AD The Netherlands insists that “Jansen has indicated something to be delivered”.
The Janssen vaccine is also produced in Leiden and India. Due to the large number of infected people in India, the government has restricted the export of vaccines.