FDA authorizes more J&J vaccines made at Emergent plant

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The FDA has authorized another batch of Johnson & Johnson COVID-19 vaccines made at Emergent BioSolutions' Baltimore plant to be distributed for use, the agency said June 15. 

A total of three batches from the facility have been approved, totaling about 25 million doses of vaccine, a U.S. official told The Wall Street Journal

The FDA June 11 ordered Johnson & Johnson to toss 60 million doses made at the plant due to possible contamination. 

The agency said that after conducting a thorough review, it found the three batches are suitable for use. It said it's still not ready to approve Emergent as an authorized manufacturing facility, but that it's continuing to work through issues at the plant with both Emergent and Johnson & Johnson. 

There are still more than 100 million vaccine doses made by both Johnson & Johnson and AstraZeneca sitting at the plant waiting for FDA action, the Journal reported. The FDA is expected to make a decision on AstraZeneca's vaccine made at the plant later this week or next, the U.S. official told the Journal.

Emergent said in a statement to the Journal: "We welcome the approval of an additional batch of J&J vaccine made at Emergent. We remain committed to addressing the FDA's observations in order to resume production as soon as possible and look forward to continuing our work to end this pandemic." 

 

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