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FDA clears 10 millions of Johnson & Johnson doses with a warning ‘no guarantee manufacture followed good practices’

The US Food and Drug Administration (FDA) is going to allow about 10 million doses of the Johnson & Johnson’s coronavirus vaccine to be distributed in the United States or sent to other countries along with a warning that there is no guarantee the manufacturer Emergent BioSolutions followed good practices when producing them, the New York Times reported on Friday.

The FDA has also ordered Johnson & Johnson to discard 60 million of its single-dose COVID-19 vaccines produced at the currently closed plant in Baltimore. The US drug regulator ordered the move due to the risks of the doses being contaminated as a result of an accident in late March at the Baltimore plant operated by Emergent BioSolutions, the report said citing sources familiar with the situation.

Later on Friday, FDA confirmed that it plans to authorize the distribution of two batches of Johnson & Johnson vaccines in the United States and overseas and noted that it is not yet ready to include the Emergent BioSolutions plant into a list of the authorized vaccines manufacturing facilities.

FDA also confirmed that any export of the vaccines produced by Emergent BioSolutions for Johnson & Johnson will be conducted under condition that appropriate relevant information about manufacture process will be shared with the health regulators in the countries where the vaccines will be used.

On April 5, Johnson & Johnson admitted to having produced a faulty batch of coronavirus vaccines at the East Baltimore facility owned by Emergent BioSolutions reportedly due to a mix-up of two ingredients that led to the ruining of about 15 million doses.

Savio Rodrigues

Savio Rodrigues Founder & Editor-in-Chief
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