FDA authorizes J&J partner to help with vaccine production

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That decision could come “very soon,” possibly even today, one of the people said.

Emergent is already sending millions of doses to Catalent, the people said. But those shots cannot be used until Emergent receives its own FDA authorization. Catalent has not yet responded to questions about which company made the active ingredient for the doses it has begun shipping out. But a person familiar with the matter said J&J is currently using drug substance flown in from the Netherlands, not substance produced by Emergent, to manufacture its vaccine.

The delayed Emergent authorization comes as U.S. health officials are increasingly worried that J&J will not be able to meet its March delivery goal. Despite logistical challenges and regulatory delays that have hindered getting Emergent and Catalent-supplied doses to the public, J&J has insisted that it will hit its 20-million-dose goal this month.

Adding to the confusion, FDA refused to confirm that it had authorized Catalent to produce J&J vaccine, saying that information about which contract manufacturers a pharmaceutical company enlists is considered “confidential commercial information” that it is legally prohibited from disclosing.

“The manufacture of authorized COVID-19 vaccines is limited to those facilities identified and requested for authorization by the sponsor,” FDA said in a statement.

The agency is regularly barred from publicly discussing drugmakers’ manufacturing plants. It has caused confusion before, such as when Hurricane Maria hit Puerto Rico in 2017 and FDA could confirm that pharmaceutical companies would experience production delays, but could not disclose which ones they were.

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