August 5, 2021

FDA orders disposal of about 60 million Johnson & Johnson vaccines from a plant where millions of doses were mistakenly damaged

Published:

12 jun 2021 01:49 GMT

On the other hand, the regulatory body will allow around 10 million doses to be distributed in the US or shipped to other countries.

The U.S. Food and Drug Administration (FDA) ordered Johnson & Johnson on Friday to discard about 60 million doses of its coronavirus vaccine, produced in a troubled Baltimore factory, due to a possible contamination, reports The New York Times, citing people familiar with the matter.

On the other hand, according to the media, the agency will allow around 10 million doses to be distributed in the US or sent to other countries, but with a caveat Regulators cannot guarantee that Emerging BioSolutions, the company that operates the plant, has followed good manufacturing practices.

The agency confirmed in a statement that it is authorizing the emergency use of two batches of this vaccine, while it has determined that “several others are not suitable for use,” without specifying the number of doses they cover.

The mistake in the plant

Regarding the plant, the FDA explains that at the moment it cannot include it among the authorized manufacturing facilities, but it continues to work with the pharmaceutical company and with the Emergent BioSolutions administration to achieve this.

In April, the FDA halted production of Johnson & Johnson’s vaccine at that plant after an error was detected that led to millions of doses of the drug going to waste in March.

As reported in late March by The New York Times, operators at the Emergent BioSolutions plant accidentally mixed the components for the manufacture of Johnson & Johnson’s vaccine with those they had to use to produce the AstraZeneca drug. The error allegedly ended up with about 15 million doses of the vaccine from the American pharmaceutical company, which had to stop distribution in the country. In response, the Biden Administration in turn stopped manufacturing of the AstraZeneca drug at the plant and put Johnson & Johnson in direct control of vaccine production at its facility.

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